40 results on '"Giorgia Annechini"'
Search Results
2. Role of Rituximab Addition to First-line Chemotherapy Regimens in Nodular Lymphocyte-predominant Hodgkin Lymphoma: A Study by Fondazione Italiana Linfomi
- Author
-
Manuel Gotti, Roberta Sciarra, Alessandro Pulsoni, Francesco Merli, Stefano Luminari, Caterina Zerbi, Livio Trentin, Alessandro Re, Chiara Rusconi, Simonetta Viviani, Andrea Rossi, Federica Cocito, Barbara Botto, Erika Meli, Antonello Pinto, Irene Dogliotti, Guido Gini, Benedetta Puccini, Francesca Ricci, Luca Nassi, Alberto Fabbri, Anna Marina Liberati, Michele Merli, Andrea Riccardo Filippi, Maurizio Bonfichi, Valentina Zoboli, Germana Tartaglia, Giorgia Annechini, Gianna Maria D’Elia, Ilaria Del Giudice, Isabel Alvarez, Andrea Visentin, Stefano Pravato, Daniela Dalceggio, Chiara Pagani, Silvia Ferrari, Caterina Cristinelli, Tanja Lazic, Virginia Valeria Ferretti, Umberto Ricardi, and Luca Arcaini
- Subjects
Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is a rare entity whose neoplastic cells retain a B-cell phenotype with expression of CD20. Radiotherapy is recommended for favorable stage IA disease while for other stages guidelines suggest therapeutic strategies similar to those used for classic HL. The role of rituximab, although quite widespread, is not completely elucidated. We retrospectively analyzed baseline characteristics of 308 consecutive patients with NLPHL diagnosed in 19 Italian centers from 2000 to 2018. With a median follow-up of 8.4 years (interquartile range: 4.5–12.4) for treated patients, median overall survival (OS) was not reached and estimated 5-year OS was 97.8% and 5-year progression-free survival (PFS) was 84.5%. Five-year cumulative incidence of histological transformation was 1.4%, 95% confidence interval (CI), 0.5%-3.8%. After adjusting for lymphocyte count, splenic involvement, bulky disease and B symptoms (fever, drenching night sweats, unintentional loss >10% of body weight within the preceding 6 months), patients with stage II or more showed superior PFS with immunochemotherapy in comparison to chemotherapy alone (hazard ratio = 0.4, 95% CI, 0.2-0.8; P = 0.015). Our data suggest an advantage of the use of rituximab combined with chemotherapy ± radiotherapy in the treatment of stage II–III–IV NLPHL.
- Published
- 2023
- Full Text
- View/download PDF
3. Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma
- Author
-
Armando Santoro, Rita Mazza, Alessandro Pulsoni, Alessandro Re, Maurizio Bonfichi, Vittorio Ruggero Zilioli, Manuela Zanni, Francesco Merli, Antonella Anastasia, Stefano Luminari, Giorgia Annechini, Manuel Gotti, Annalisa Peli, Anna Marina Liberati, Nicola Di Renzo, Luca Castagna, Laura Giordano, Francesca Ricci, and Carmelo Carlo-Stella
- Subjects
Specialties of internal medicine ,RC581-951 - Abstract
Abstract: The complete remission (CR) rate achieved with induction chemotherapy prior to autologous stem cell transplantation (ASCT) represents the strongest prognostic factor in relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL). By inducing a CR rate of 75%, the bendamustine, gemcitabine, vinorelbine (BEGEV) regimen represents an optimal chemotherapy regimen prior to ASCT. Presented here are the 5-year results of BEGEV followed by ASCT in R/R cHL. With a median follow-up of 5 years, progression-free survival (PFS) and overall survival (OS) for the whole series (n = 59) were 59% and 78%, respectively. ASCT was performed in 43 of 49 responding patients (73% by intention to treat [ITT]; 88% by response to BEGEV) and resulted in 33 with continuous CR (56% by ITT; 77% of transplanted patients), 7 with disease relapse, and 3 with nonrelapse mortality. For patients who received transplants, the 5-year PFS and OS were 77% and 91%, respectively, with no significant difference between relapsed and refractory patients. No patient experienced secondary leukemia or myelodysplasia. In summary, the long-term efficacy data, the benefits for both relapsed and refractory patients, and the excellent safety profile provide a strong rationale for further development of the BEGEV regimen. This trial was registered at EudraCT as #2010-022169-91 and at www.clinicaltrials.gov as #NCT01884441.
- Published
- 2020
- Full Text
- View/download PDF
4. Life-threatening autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura: successful seletive splenic artery embolization
- Author
-
matteo molica, Fulvio Massaro, Giorgia Annechini, Erminia Baldacci, Gianna maria D'elia, Riccardo Rosati, Silvia maria trisolini, Paola Volpicelli, Robin Foà, and Saveria Capria
- Subjects
Selective splenic artery embolization, warm auto-immune hemolytic anemia,idiopathic thrombocytopenic purpura ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Selective splenic artery embolization (SSAE) is a nonsurgical intervention characterized by the transcatheter occlusion of the splenic artery and/or its branch vessels using metallic coils or other embolic devices. It has been applied for the management of splenic trauma, hypersplenism with portal hypertension, hereditary spherocytosis, thalassemia and splenic hemangioma. We hereby describe a case of a patient affected by idiopathic thrombocytopenic purpura (ITP) and warm auto-immune hemolytic anemia (AIHA) both resistant to immunosuppressive and biological therapies, not eligible for a surgical intervention because of her critical conditions. She underwent SSAE and achieved a hematologic complete response within a few days without complications. SSAE is a minimally invasive procedure to date not considered a standard option in the management of AIHA and ITP. However, following the progressive improvement of the techniques, its indications have been extended, with a reduction in morbidity and mortality compared to splenectomy in patients with critical clinical conditions. SSAE was a lifesaving therapeutic approach for our patient and it may represent a real alternative for the treatment of resistant AIHA and ITP patients not eligible for splenectomy.
- Published
- 2016
- Full Text
- View/download PDF
5. Impact of Sars-CoV-2 prophylaxis with tixagevimab-cilgavimab in high-risk patients with B-cell malignancies: a single-center retrospective study.
- Author
-
Assanto ,, Giovanni Manfredi, primary, Totaro, Matteo, additional, Rebecca, Poggiali, additional, Adele, Delli Paoli, additional, Giorgia, Annechini, additional, Gianna Maria, D’Elia, additional, Francesco, Aji, additional, Luigi, Petrucci, additional, Francesca, Fazio, additional, Ilaria, Del Giudice, additional, Maurizio, Martelli, additional, Alessandra, Micozzi, additional, and Gentile, Giuseppe, additional
- Published
- 2023
- Full Text
- View/download PDF
6. Early Palliative Home Care versus Hospital Care for Patients with Hematologic Malignancies: A Cost-Effectiveness Study
- Author
-
Giovanna Palumbo, Massimo Breccia, Daniele Armiento, Johannes M. Giesinger, Nicoletta Martone, Maria Giulia Marini, Erminia Baldacci, Andrea Tendas, Giorgia Annechini, Gregorio Antonio Brunetti, Claudio Cartoni, Maurizio Martelli, Fabio Efficace, Luigi Reale, Clara Minotti, Pasquale Niscola, and Ida Carmosino
- Subjects
medicine.medical_specialty ,Palliative care ,Cost effectiveness ,Cost-Benefit Analysis ,03 medical and health sciences ,0302 clinical medicine ,cost analysis ,030502 gerontology ,Humans ,Medicine ,Intensive care medicine ,cost-effectiveness ,General Nursing ,palliative care ,business.industry ,leukemia ,hematologic patients ,General Medicine ,Home Care Services ,Hospitals ,Hospital care ,Anesthesiology and Pain Medicine ,home care ,Hematologic Neoplasms ,030220 oncology & carcinogenesis ,Cost analysis ,0305 other medical science ,business ,Value (mathematics) - Abstract
Background: There is paucity of data on the potential value of early palliative home care for patients with hematologic malignancies. Objective: To compare costs, use of resources, and clinical out...
- Published
- 2021
- Full Text
- View/download PDF
7. Venous Thromboembolism (VTE) in Patients with Hodgkin Lymphoma: Retrospective Evaluation of Throly and Khorana Risk Scores
- Author
-
Giovanni Manfredi Assanto, Martina Salvatori, Sara Pontecorvo, Natalia Cenfra, Gianna Maria D'elia, Giorgia Annechini, Maurizio Martelli, Alessandro Pulsoni, Ilaria Del Giudice, and Antonio Chistolini
- Subjects
Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
- Full Text
- View/download PDF
8. Minimal residual disease monitoring in early stage follicular lymphoma can predict prognosis and drive treatment with rituximab after radiotherapy
- Author
-
Alessandro Pulsoni, Irene Della Starza, Ilaria Del Giudice, Gianna Maria D'Elia, Maria Elena Tosti, Lavinia Grapulin, Giorgia Annechini, Lucia Anna De Novi, Anna Guarini, Robin Foà, Marzia Cavalli, and Luca Vincenzo Cappelli
- Subjects
Male ,early stage follicular lymphoma ,MRD ,radiotherapy ,rituximab ,medicine.medical_specialty ,Neoplasm, Residual ,medicine.medical_treatment ,Follicular lymphoma ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,hemic and lymphatic diseases ,Internal medicine ,Humans ,Medicine ,In patient ,Stage (cooking) ,Lymphoma, Follicular ,Digital droplet pcr ,Neoplasm Staging ,business.industry ,Hematology ,medicine.disease ,Minimal residual disease ,body regions ,Radiation therapy ,Real-time polymerase chain reaction ,030220 oncology & carcinogenesis ,Female ,Rituximab ,business ,030215 immunology ,medicine.drug - Abstract
Since 2000, we have investigated 67 consecutive patients with stage I/II follicular lymphoma (FL) for the presence of BCL2/IGH rearrangements by polymerase chain reaction (PCR), real time quantitative PCR (RQ-PCR) and digital droplet PCR (ddPCR). All patients were treated with involved-field radiotherapy (IF-RT) (24-30 Gy). From 2005, patients with minimal residual disease (MRD) after IF-RT received rituximab (R) (375 mg/m2 , 4 weekly administrations). The median follow-up is 82 months (17-196). At diagnosis, 72% of patients were BCL2/IGH+. Progression-free survival (PFS) was significantly better in patients with undetectable/low levels (
- Published
- 2019
- Full Text
- View/download PDF
9. UPDATED RESULTS OF THE FIL 'MIRO' STUDY, A MULTICENTER PHASE II TRIAL COMBINING LOCAL RADIOTHERAPY AND MRD‐DRIVEN IMMUNOTHERAPY IN EARLY‐STAGE FOLLICULAR LYMPHOMA
- Author
-
Anna Ferreri, Giovanni Manfredi Assanto, Giovanni Partesotti, L. Grapulin, Umberto Ricardi, Simone Ferrero, Tommasina Perrone, Patrizia Bernuzzi, Marzia Cavalli, Attilio Guarini, Manuela Zanni, Sara Galimberti, Anna Marina Liberati, Clara Mannarella, I. Del Giudice, A. L. Molinari, Emanuele Cencini, Alessandro Pulsoni, Antonella Anastasia, Luca Nassi, Silvia Bolis, Carola Boccomini, Robert Foa, Francesca Re, Vittorio Ruggero Zilioli, Caterina Stelitano, L.A. De Novi, Maria Elena Tosti, Elena Ciabatti, Stefano Luminari, I. Della Starza, Natalia Cenfra, Monica Tani, Donato Mannina, M. Ladetto, Luca Arcaini, Barbara Mantoan, Alessandra Dondi, Gerardo Musuraca, Daniela Renzi, Paolo Corradini, V. Gattei, Giorgia Annechini, and Sara Rattotti
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Follicular lymphoma ,Hematology ,General Medicine ,Immunotherapy ,medicine.disease ,Ofatumumab ,Peripheral blood ,chemistry.chemical_compound ,medicine.anatomical_structure ,Local radiotherapy ,chemistry ,Internal medicine ,medicine ,Bone marrow ,Stage (cooking) ,Prospective cohort study ,business - Abstract
Background: Early-stage follicular lymphoma (FL) is usually managed with involved field radiotherapy (IFRT), allowing a complete and long lasting eradication of the disease only in 40-50% of patients (pts). The aim of this multicenter phase II prospective study was to evaluate the role of MRD in identifying pts unlikely to be cured by IFRT, for whom an immunotherapy consolidation could improve outcome. Methods: 110 pts with stage I/II FL were enrolled and treated with 24 Gy IFRT. Peripheral blood (PB) and bone marrow (BM) samples were centralized to the FIL (Fondazione Italiani Linfomi) MRD Network of EuroMRD-certified laboratories. In BCL2/IGH+ pts at baseline by both nested PCR (NEST) and RQ-PCR (RQ) in BM a/o PB, MRD was analyzed after IFRT and every 6 months over a 3-year period. Pts with MRD+ by both NEST and RQ in BM a/o PB after IFRT or who became MRD+ during the follow-up were treated with 8 weekly doses of the anti-CD20 MoAb ofatumumab (OFA). The primary objective of the study was to define the efficacy of immunotherapy in obtaining a negative MRD. Results: Of the 106 evaluable pts, 50 were males. Median age was 55 y (29-83). The FLIPI score was 0 in 59% of pts, 1 in 35%, 2 in 6%. 68% of pts had inguinal site involvement. At baseline, 30% of pts had a BCL2/IGH rearrangement (30 MBR, 1 MBR and mcr, 1 mcr) in BM a/ o PB;the concordance between compartments was 90%. All but one pt achieved a clinical response after IFRT;one additional pt died soon after IFRT of unrelated causes. MRD evaluation after IFRT revealed the persistence of BCL2/IGH+ cells in PB a/o BM in 60% of pts. MRD + pts, either after IFRT (n = 18) or in case of conversion to MRD+ during the follow-up (n = 6), received OFA, obtaining a conversion to MRD-in 22/24 pts (91.7%-CI 73.0-99.0), significantly superior to the expected 50% (Fig). After a median F-U of 38 m, 17 pts who achieved a MRD-with OFA are still negative;5 converted to MRD+ (2 received OFA retreatment, achieving a second MRD-;2 pts were not re-treated due to Sars-Cov2 pandemic;1 relapsed). A clinical relapse or progression was observed in 23 pts: 18 (24.6%) among the 73 “no marker” pts and 5 (15.6%) among the 32 BCL2/IGH+ at baseline (p = 0.3), with no significant difference in PFS (p = 0.25). Two early relapses were observed among the 12 pts who became MRD-after IFRT and 3 among the 24 treated at least once with OFA (1 MRD+, 1 MRD-, 1 converted from MRD-to MRD+). Only 1 Pt relapsed while MRD-after OFA. Conclusions: MRD data indicate that RT alone is often insufficient to eradicate the disease, inducing a MRD-only in 40% of pts, notably long-lasting only in half of them. The primary objective of this study-MRD conversion after immunotherapy-was largely achieved. The strategy of an immunotherapy consolidation after IFRT in MRD+ pts allowed increasing molecular responses. However, this strategy is applicable only to 30% of enrolled pts. A clinical advantage of the MRD driven treatment strategy is suggested although not significan.
- Published
- 2021
- Full Text
- View/download PDF
10. FAVOURABLE PROGNOSTIC ROLE OF HIGH BASAL MAXIMAL STANDARDIZED UPTAKE VALUE IN FOLLICULAR LYMPHOMA
- Author
-
I. Del Giudice, Gianna Maria D'Elia, Alessandro Pulsoni, Gianfranco Lapietra, M. De Luca, Mattia Brescini, Giorgia Annechini, Giulia Ciotti, Giovanni Manfredi Assanto, Agostino Chiaravalloti, and Roberta Agrippino
- Subjects
Cancer Research ,medicine.medical_specialty ,business.industry ,Follicular lymphoma ,Standardized uptake value ,Hematology ,General Medicine ,medicine.disease ,Basal (phylogenetics) ,Endocrinology ,Oncology ,Internal medicine ,medicine ,business - Published
- 2021
- Full Text
- View/download PDF
11. THE ROLE OF END OF TREATMENT PET CT EVALUATED BY DEAUVILLE FIVE‐POINT SCALE AS PROGNOSTIC ROLE IN HODGKIN LYMPHOMA
- Author
-
Giorgia Annechini, Gianna Maria D'Elia, M. De Luca, Giulia Ciotti, Alessandro Pulsoni, Giovanni Manfredi Assanto, Roberta Agrippino, Marialuisa Martelli, Agostino Chiaravalloti, and Gianfranco Lapietra
- Subjects
Cancer Research ,medicine.medical_specialty ,PET-CT ,Oncology ,business.industry ,medicine ,Hodgkin lymphoma ,Deauville five point scale ,Hematology ,General Medicine ,Radiology ,business - Published
- 2021
- Full Text
- View/download PDF
12. High Basal Maximal Standardized Uptake Value (SUV
- Author
-
Agostino Chiaravalloti, Mattia Brescini, Giulia Ciotti, Maurizio Martelli, Giorgia Annechini, Maria Lucia De Luca, Gianna Maria D'Elia, Ilaria Del Giudice, Alessandro Pulsoni, Giovanni Manfredi Assanto, and Roberta Agrippino
- Subjects
Cancer Research ,medicine.medical_specialty ,PET-SCAN ,Follicular lymphoma ,Standardized uptake value ,lymphoma ,Gastroenterology ,Group B ,Article ,03 medical and health sciences ,Basal (phylogenetics) ,0302 clinical medicine ,follicular lymphoma ,Internal medicine ,medicine ,RC254-282 ,lymphoproliferative disease ,business.industry ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,SUV ,Metabolic tumor volume ,medicine.disease ,Lymphoma ,Oncology ,030220 oncology & carcinogenesis ,Cohort ,business ,030215 immunology ,Cohort study - Abstract
Background: Despite that the unfavorable prognostic role of a high Total Metabolic Tumor Volume (TMTV) in Follicular Lymphoma has been demonstrated, the role of SUVmax alone at baseline PET/CT could have a different prognostic role. Patients and Methods: We performed a retrospective observational monocentric cohort study. All patients affected by FL who underwent a basal PET/CT were included. Two subgroups were identified and compared in terms of PFS and OS: (A) Basal SUVmax ≤ 6, and (B) Basal SUVmax >, 6. Results: Ninety-four patients were included, 34 in group A (36.2%) and 60 in group B (63.8%). The PFS at two years was comparable in the two groups (97%). The five-year PFS was 73.5% for group A and 95% for group B (p 0.005). The five-year PFS in the whole cohort was 87.5%. A clear advantage was confirmed in group A in the absence of other risk factors. Patients with SUVmax ≤ 6 and no risk factors showed a 5-year PFS of 73% against 83% for patients with SUVmax >, 6 and at least two risk factors. Conclusion: A high FDG uptake favorably correlated with PFS. A low basal SUVmax reflected a higher rate of late relapse requiring a prolonged follow-up. The basal SUVmax is an approachable parameter with prognostic implications.
- Published
- 2021
13. The current role of interferon in hairy cell leukaemia: clinical and molecular aspects
- Author
-
Robin Foà, Francesco Malaspina, Salvatore Perrone, Giorgia Annechini, Alessandro Pulsoni, Enrico Tiacci, Maurizio Martelli, Gianna Maria D'Elia, Giovanni Manfredi Assanto, Alessandra Pucciarini, Maria Lucia De Luca, and Costantino Riemma
- Subjects
Male ,Hairy Cell ,Drug Resistance ,Comorbidity ,Kaplan-Meier Estimate ,Gastroenterology ,0302 clinical medicine ,Interferon ,Retrospective analysis ,80 and over ,Complete response ,Aged, 80 and over ,Leukemia, Hairy Cell ,Tumor ,Leukemia ,Kinase ,Drug Substitution ,Hematology ,Minimal Residual Disease Negativity ,interferon ,Middle Aged ,Progression-Free Survival ,MRD ,030220 oncology & carcinogenesis ,Cohort ,Female ,medicine.drug ,Adult ,Proto-Oncogene Proteins B-raf ,medicine.medical_specialty ,Mutation, Missense ,Short Report ,Purine analogue ,Antineoplastic Agents ,Disease-Free Survival ,BRAF ,03 medical and health sciences ,Internal medicine ,medicine ,Biomarkers, Tumor ,Humans ,Point Mutation ,lymphoproliferative disease ,Aged ,Retrospective Studies ,Salvage Therapy ,Hairy cell leukaemia ,business.industry ,Interferon-alpha ,Alopecia ,Haematological malignancy ‐ Clinical ,Drug Resistance, Neoplasm ,Mutation ,Neoplasm ,Missense ,business ,Biomarkers ,030215 immunology ,Follow-Up Studies - Abstract
Summary We investigated the current role of interferon‐alpha (IFNα) in hairy cell leukaemia (HCL) in a retrospective analysis of patients with HCL. A cohort of 74 patients with HCL was divided in to three groups: (A) patients aged >65 years with first‐line treatment; (B) patients with comorbidities with first‐line treatment; (C) patients who were purine analogues resistant. In total, 94% achieved a response, with a complete response rate of 24%. After a median (range) follow‐up of 60 (7–236) months, 55 patients (78%) are still responding. The 5‐year progression‐free survival was 95%, 68%, and 96% in groups A, B and C respectively. A proportion of patients were monitored through their B‐Raf proto‐oncogene, serine/threonine kinase (BRAF)‐V600E status. IFNα remains a possible option in select patients with HCL, where minimal residual disease negativity is achievable.
- Published
- 2020
14. Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma
- Author
-
Carmelo Carlo-Stella, Maurizio Bonfichi, Laura Giordano, Anna Marina Liberati, Nicola Di Renzo, Annalisa Peli, Francesco Merli, Stefano Luminari, Alessandro Re, Manuel Gotti, Luca Castagna, Rita Mazza, Manuela Zanni, Alessandro Pulsoni, Antonella Anastasia, Francesca Ricci, Giorgia Annechini, Armando Santoro, and Vittorio Ruggero Zilioli
- Subjects
Bendamustine ,Oncology ,medicine.medical_specialty ,Clinical Trials and Observations ,Salvage therapy ,Deoxycytidine ,Transplantation, Autologous ,Disease-Free Survival ,Autologous stem-cell transplantation ,Recurrence ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Bendamustine Hydrochloride ,Humans ,Medicine ,Progression-free survival ,business.industry ,Hematopoietic Stem Cell Transplantation ,Induction chemotherapy ,Hematology ,Hodgkin Disease ,Gemcitabine ,Chemotherapy regimen ,Transplantation ,Regimen ,business ,medicine.drug - Abstract
The complete remission (CR) rate achieved with induction chemotherapy prior to autologous stem cell transplantation (ASCT) represents the strongest prognostic factor in relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL). By inducing a CR rate of 75%, the bendamustine, gemcitabine, vinorelbine (BEGEV) regimen represents an optimal chemotherapy regimen prior to ASCT. Presented here are the 5-year results of BEGEV followed by ASCT in R/R cHL. With a median follow-up of 5 years, progression-free survival (PFS) and overall survival (OS) for the whole series (n = 59) were 59% and 78%, respectively. ASCT was performed in 43 of 49 responding patients (73% by intention to treat [ITT]; 88% by response to BEGEV) and resulted in 33 with continuous CR (56% by ITT; 77% of transplanted patients), 7 with disease relapse, and 3 with nonrelapse mortality. For patients who received transplants, the 5-year PFS and OS were 77% and 91%, respectively, with no significant difference between relapsed and refractory patients. No patient experienced secondary leukemia or myelodysplasia. In summary, the long-term efficacy data, the benefits for both relapsed and refractory patients, and the excellent safety profile provide a strong rationale for further development of the BEGEV regimen. This trial was registered at EudraCT as #2010-022169-91 and at www.clinicaltrials.gov as #NCT01884441.
- Published
- 2020
15. Reappraising the timing of transplant for indolent non-Hodgkin lymphomas
- Author
-
Adriano Salaroli, Gianna Maria D'Elia, Salvatore Perrone, Alessandro Pulsoni, Antonietta Ferretti, Giorgia Annechini, Saveria Capria, Robin Foà, and Walter Barberi
- Subjects
Oncology ,medicine.medical_specialty ,Neoplasm, Residual ,Transplantation Conditioning ,medicine.medical_treatment ,Follicular lymphoma ,Hematopoietic stem cell transplantation ,Transplantation, Autologous ,Time-to-Treatment ,03 medical and health sciences ,0302 clinical medicine ,Refractory ,Recurrence ,immune system diseases ,Positron Emission Tomography Computed Tomography ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Humans ,Transplantation, Homologous ,In patient ,Clinical Trials as Topic ,business.industry ,Lymphoma, Non-Hodgkin ,Remission Induction ,Hematopoietic Stem Cell Transplantation ,Hematology ,RELAPSED DISEASE ,Prognosis ,medicine.disease ,Combined Modality Therapy ,Tissue Donors ,Surgery ,Treatment Outcome ,surgical procedures, operative ,Drug Resistance, Neoplasm ,030220 oncology & carcinogenesis ,Reduced Intensity Conditioning ,Rituximab ,Stem cell ,business ,030215 immunology ,medicine.drug - Abstract
Indolent non-Hodgkin lymphomas (iNHL) remain incurable with standard approaches. The timing of autologous stem cell transplant (ASCT) is changing following the introduction of new drugs that can potentially defer the transplant, improved reduced intensity conditioning (RIC) and haploidentical allogeneic SCT (allo-SCT).The most relevant aspects concerning the role of hematopoietic stem cell transplantation in the management of iNHL are discussed. Literature search methodology included examination of PubMed index and meeting presentations. Expert commentary: ASCT is not currently employed as consolidation in first-line, being reserved to patients with refractory/relapsed disease. The curative potential of graft-versus-lymphoma (GVL) after RIC allo-SCT could be particularly beneficial in patients with iNHL relapsing after ASCT. This scenario could be modified in the near future by better definition of high-risk patients at diagnosis, by the improvement of minimal residual disease (MRD) evaluation and by the introduction of new drugs in the therapeutic algorithm.
- Published
- 2016
- Full Text
- View/download PDF
16. Long-Term Treatment of Hairy Cell Leukemia Patients with Interferon: Clinical and Molecular Aspects
- Author
-
Gianna Maria D'Elia, Enrico Tiacci, Francesco Malaspina, Alessandro Pulsoni, Salvatore Perrone, Maria Lucia De Luca, Costantino Riemma, Giovanni Manfredi Assanto, Giorgia Annechini, Maurizio Martelli, and Robin Foà
- Subjects
medicine.medical_specialty ,Long term treatment ,business.industry ,Maintenance dose ,Immunology ,Alpha interferon ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Discontinuation ,Interferon ,Internal medicine ,Medicine ,Rituximab ,Hairy cell leukemia ,business ,Pcr analysis ,medicine.drug - Abstract
Introduction. Hairy cell leukemia (HCL) is a rare clonal B-cell chronic lymphoproliferative disorder. Current treatments for HCL include purine analogs (PA), which are used successfully as front-line therapy in young and fit patients. The therapeutic armamentarium has been recently extended by the introduction of rituximab, BRAF oral inhibitors and other novel agents. Interferon alpha (IFNα) has been the first agent capable of inducing a response in HCL patients and of changing the natural course of the disease. It has been extensively used up to the introduction of PA. Nowadays, IFNα front-line is limited to pregnant women (or desiring a pregnancy), to patients with severe neutropenia or frail, or to relapsed/refractory patients. We hereby report the experience of 74 patients treated continuously with IFNα at our Center in Rome. Methods. A retrospective analysis was performed on patients with HCL or with variant HCL treated between 1990 and 2020 with IFNα until progression or toxicity. The initial dosage was 3 MUI subcutaneously three times weekly (3d/week). In responding patients, after 12 months the dose was progressively tapered to reach a very low maintenance dose, ranging from 0.1 MUI 3d/week to 0.9 3d/week. After 12 months of treatment, the degree of response was based on peripheral blood count evaluation, bone marrow biopsy and IFNα front-line; C) patients resistant to PAs who received IFNα as second or further line of treatment. Results. After 12 months of treatment, 70 patients (95%) achieved either a PR or a CR in 52 (70%) and 18 (24%) cases, respectively. Four (5.4%) patients were considered as non-responders. After a median follow-up of 92 months (range 7-236), 55 patients (75%) still maintained their response while receiving maintenance IFNα. The estimated 5-year and 10-year PFS were 89% and 77%, respectively (Fig. 1). The median PFS for these patients has not been reached at 10 years. Patients in CR at 12 months of treatment showed a significantly superior PFS rate (p 0.001). The 10-year PFS was 94% for patients in CR compared to 73% for patients who obtained a PR during abdominal ultrasound. The mutational status of BRAF V600E by PCR analysis was assessed in a subset of patients during treatment. Three groups of patients were identified: A) patients >65 years who received IFNα front-line; B) patients 3500/mmc at the start of treatment: the estimated median PFS was 236 vs 108 months (p 0.004). Twenty-two patients in response during IFNα maintenance were tested for MRD basing on BRAF status: 32% were negative during treatment (7 out of 22). All patients with negative MRD were in CR. G1-2 extra-hematologic toxicity, occurred as flu-like syndrome and fatigue, was observed in 25 patients (76% in group A), 13/25 patients discontinued IFNα for toxicity; 1 case of alopecia was reported. No patient required discontinuation due to G3-4 hematologic toxicity. Four deaths occurred, 2 due to secondary neoplasms and 2 in very elderly patients. Conclusions. IFNα still retains a role in selected HCL patients. In young patients with comorbidities front-line IFNα remains a possible option, although not as effective as PAs. In elderly patients, the continuous administration allows remarkable results with acceptable toxicity. Also in patients resistant to PAs, INFα is capable of inducing durable responses in a considerable part of patients. The data on MRD demonstrate the possibility of achieving a molecular response. Although the role of IFNα is further limited by the advent of new agents, when administered in a continuous schedule it still represents a valid therapeutic option in specific subsets of HCL patients. Figure Disclosures Martelli: sandoz: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; celgene: Membership on an entity's Board of Directors or advisory committees; roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees. Foà:Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Speakers Bureau; Novartis: Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees. Tiacci:Roche: Research Funding; Abbvie: Other: Travel and meeting expenses. Pulsoni:Pfizer: Consultancy; Merk: Consultancy; Takeda: Consultancy; Gilead: Speakers Bureau; Sandoz: Consultancy; roche: Consultancy, Speakers Bureau; Bristol Myers Squibb: Speakers Bureau.
- Published
- 2020
- Full Text
- View/download PDF
17. Pegylated Naloxone in the Treatment of Persistent Opioid-Induced Constipation in Patients with Hematological Malignancies
- Author
-
Michelina Santopietro, Giovanna Palumbo, Pasquale Niscola, Claudio Cartoni, Gregorio Antonio Brunetti, Andrea Tendas, and Giorgia Annechini
- Subjects
Male ,medicine.medical_specialty ,Narcotic Antagonists ,(+)-Naloxone ,030204 cardiovascular system & hematology ,Gastroenterology ,Polyethylene Glycols ,03 medical and health sciences ,0302 clinical medicine ,Text mining ,Internal medicine ,Medicine ,Humans ,Pain Management ,In patient ,030212 general & internal medicine ,Aged ,Pharmacology ,Aged, 80 and over ,business.industry ,Naloxone ,Hematology ,Pain management ,Analgesics, Opioid ,Opioid induced constipation ,Hematologic Neoplasms ,Female ,business ,Cardiology and Cardiovascular Medicine ,Constipation - Published
- 2018
18. Current and future therapeutic approaches for the treatment of follicular lymphoma
- Author
-
Giorgia Annechini, Alessandra Serrao, Alessandro Pulsoni, Luca Vincenzo Cappelli, Martina Canichella, Laura Ballotta, Gianna Maria D'Elia, Robin Foà, Pulsoni, A, Cappelli, Lv, Ballotta, Laura, Canichella, M, Serrao, A, Annechini, G, D'Elia, Gm, and Foà, R
- Subjects
0301 basic medicine ,novel agent ,medicine.medical_specialty ,PET prognosis ,follicular lymphoma ,molecular biology ,MRD ,novel agents ,stem-cell transplant ,Follicular lymphoma ,Antineoplastic Agents ,Disease ,PET prognosi ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Maintenance therapy ,Drug Development ,Medicine ,Humans ,Pharmacology (medical) ,Molecular Targeted Therapy ,Stage (cooking) ,Precision Medicine ,Intensive care medicine ,Watchful Waiting ,Lymphoma, Follicular ,Neoplasm Staging ,Modalities ,business.industry ,medicine.disease ,Prognosis ,Minimal residual disease ,030104 developmental biology ,Oncology ,Novel agents ,030220 oncology & carcinogenesis ,Quality of Life ,Immunotherapy ,business - Abstract
Introduction: Recent advances in prognostication as well as management of Follicular Lymphoma (FL) are moving to personalized approach. Areas covered: Prognostic scores as well as consolidated and innovative therapeutic approaches are evaluated according to the various presentation modalities. For asymptomatic, low-tumor burden FL, a ‘watch and wait’ policy is currently the first-choice approach, although possible alternatives are discussed. Early stage FL may be treated with local radiotherapy although the role of minimal residual disease in possible additional agents should be determined. The first line treatment for symptomatic FL is chemo-immunotherapy followed by two years maintenance therapy with anti-CD20 monoclonal antibodies. A deeper knowledge of FL biology has opened new perspectives regarding the timing of therapy and has offered new targets for the development of novel agents that aim to change the therapeutic scenario of FL management. Expert commentary: The introduction of novel agents could question the incurability of FL and change the therapeutic goal from prolonging the complete remission state to eradicating the disease in young/fit patients, as well as improving quality of life in elderly/unfit patients. In the near future, combining new biologic agents and adoptive cell therapies could help in achieving these aims.
- Published
- 2018
19. Long-term response to daratumumab in a patient with advanced immunoglobulin light-chain (AL) amyloidosis with organ damage
- Author
-
Alessandro Pulsoni, Martina Canichella, Gianna Maria D'Elia, Maria Lucia De Luca, Alessandra Serrao, and Giorgia Annechini
- Subjects
medicine.medical_specialty ,Time Factors ,Immunoglobulin light chain ,Antibodies ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Monoclonal ,medicine ,AL amyloidosis ,Humans ,Immunoglobulin Light-chain Amyloidosis ,Aged ,Antibodies, Monoclonal ,Female ,Hematology ,business.industry ,Daratumumab ,General Medicine ,medicine.disease ,Organ damage ,Long term response ,030220 oncology & carcinogenesis ,Immunology ,business ,030215 immunology - Published
- 2018
- Full Text
- View/download PDF
20. Nivolumab as a safe and effective treatment in an HIV patient with refractory Hodgkin lymphoma
- Author
-
Gianna Maria D'Elia, Giorgia Annechini, Maria Lucia De Luca, Martina Canichella, Alessandra Serrao, Alessandro Pulsoni, and Germana Tartaglia
- Subjects
Male ,0301 basic medicine ,Oncology ,medicine.medical_specialty ,Immunoconjugates ,Transplantation Conditioning ,Lymphoma ,Anti-HIV Agents ,Drug Resistance ,Antineoplastic Agents ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Refractory Hodgkin Lymphoma ,Humans ,Karnofsky Performance Status ,Brentuximab vedotin ,AIDS-Related ,Brentuximab Vedotin ,Peripheral Blood Stem Cell Transplantation ,Transplantation ,Hematology ,business.industry ,Antineoplastic Agents, Immunological ,CD4 Lymphocyte Count ,Drug Resistance, Neoplasm ,Hodgkin Disease ,Lymphoma, AIDS-Related ,Middle Aged ,Nivolumab ,Transplantation, Autologous ,Viral Load ,General Medicine ,medicine.disease ,Immunological ,030104 developmental biology ,030220 oncology & carcinogenesis ,Neoplasm ,business ,Autologous ,Viral load ,medicine.drug - Published
- 2018
- Full Text
- View/download PDF
21. EARLY STAGE Follicular Lymphoma: First Results of the FIL 'Miro' Study, a Multicenter Phase II Trial Combining Local Radiotherapy and MRD-Driven Immunotherapy
- Author
-
Alessandro Pulsoni, Valter Gattei, Sara Galimberti, Antonella Anastasia, Monica Tani, Tommasina Perrone, Patrizia Bernuzzi, Giovanni Partesotti, Marzia Cavalli, Carola Boccomini, Lucia Anna De Novi, Clara Mannarella, Luca Nassi, Caterina Stelitano, Marco Ladetto, Natalia Cenfra, Giorgia Annechini, Sara Rattotti, Emanuele Cencini, Maria Elena Tosti, Anna Lia Molinari, Barbara Mantoan, Luca Arcaini, Paolo Corradini, Daniela Renzi, Elena Ciabatti, Anna Guarini, Robin Foà, Silvia Bolis, Irene Della Starza, Ilaria Del Giudice, Vittorio Ruggero Zilioli, Stefano Luminari, Andrés J.M. Ferreri, Gerardo Musuraca, Giovanni Manfredi Assanto, Francesca Re, Simone Ferrero, Anna Marina Liberati, Umberto Ricardi, Donato Mannina, Lavinia Grapulin, and Emanuela Zanni
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Chronic lymphocytic leukemia ,Immunology ,Follicular lymphoma ,Phases of clinical research ,Cell Biology ,Hematology ,Immunotherapy ,medicine.disease ,Ofatumumab ,Biochemistry ,Radiation therapy ,chemistry.chemical_compound ,chemistry ,Internal medicine ,medicine ,Combined Modality Therapy ,Stage (cooking) ,business - Abstract
Introduction Limited stage follicular lymphoma (FL) is usually managed with involved field radiotherapy (IFRT), although different approaches are currently carried out, ranging from watch and wait to combined treatment. RT on involved lymph nodes allows eradication of the disease only in 40-50% of patients. Anti-CD20 monoclonal antibodies (MoAb), widely used in advanced stage FL, are likely to be effective in reducing the relapse risk, although no scientific evidence of their role has been provided. The aim of this multicenter phase II prospective study was to evaluate the role of MRD in identifying patients unlikely to be cured by RT, for whom an immunotherapy-based consolidation could improve outcome. Methods 110 patients with stage I/II FL were enrolled. IFRT was administered to all patients at a dose of 24 Gy. Peripheral blood (PB) and bone marrow (BM) samples were centralized to the Italian FIL (Federazione Italiani Linfomi) MRD Network of EuroMRD-certified laboratories: the presence of a BCL2/IGH rearrangement was investigated at baseline in all patients by nested PCR (NEST) and RQ-PCR (RQ), the latter according to the EuroMRD guidelines. In patients BCL2/IGH+ at baseline by both NEST and RQ in BM and/or PB, MRD was analyzed in both tissues after IFRT and every 6 months over a three-year follow-up period. Patients with positive MRD by both NEST and RQ in BM and/or PB after IFRT or who became positive during the follow-up were treated with 8 weekly doses of the anti-CD20 MoAb ofatumumab. The primary objective of the study was to define the efficacy of immunotherapy in obtaining the disappearance of BCL2/IGH rearranged cells. Results Preliminary data are available for 107 patients, 57 males, 50 females. Median age was 55 years (29-83). 17% had G1 FL, 32% G2, 40% G3A, 11% NOS. The FLIPI score was 0 in 59% of patients, 1 in 35%, 2 in 6%. 69% of patients had inguinal site involvement. Despite a negative BM biopsy, at baseline 30% of patients (n=32) had a BCL2/IGH rearrangement (30 MBR, 1 MBR and mcr, 1 mcr) in the BM and/or PB; the concordance between compartments was 90%, with 10% of negative PB showing a positive BM. No significant differences were observed in relapse probability between patients with or without a molecular marker. All patients were submitted to IFRT and all obtained a clinical response, which was complete in 79 of the 101 evaluated patients (78%) and partial in 22 (22%). MRD evaluation after treatment revealed the persistence of BCL2/IGH rearranged cells in the PB and/or BM in 60% of patients. According to the design of the protocol, MRD-positive patients, either after IFRT (n=18) or in case of conversion to a positive signal during the follow-up (n=7), received 8 weekly administration of ofatumumab. A conversion to MRD negativity, evaluated in 23 treated patients, was obtained in 20 (87% - CI 65.1-97.1). This result was significantly superior to the expected 50%. One death occurred after IFRT, due to ischemic stroke. Adverse events likely correlated to ofatumumab occurred in 7/25 treated patients, consisting of infusion reactions in 5, leading to a permanent interruption of immunotherapy in 3. After a median follow-up of 18 months, all patients who achieved a MRD negativity with ofatumumab underwent a regular molecular follow-up and are still MRD-negative. Overall, clinical relapse or progression were observed in 17 patients: 13 (18%) among the 73 "no marker" patients; 2 relapses (16%) were observed among the 12 MRD-negative patients after IFRT and 2 relapses were observed among the 23 patients treated with the anti-CD20 MoAb (8.7%), 1 having achieved a MRD negativity and 1 not. No significant differences in event-free survival have so far been observed between the three groups. Conclusions The MRD data of this phase II trial for early stage FL indicate that RT alone is often insufficient to eradicate the disease, being capable of inducing a negative MRD only in 40% of evaluable cases, with a long-lasting effect only in half of them. The primary objective of this study - MRD negativity after immunotherapy - was achieved, obtaining the disappearance of BCL2/IGH rearranged cells in the majority of patients treated with ofatumumab. The strategy of an immunotherapy consolidation after IFRT in MRD-positive patients allowed to increase molecular responses. A longer follow-up and further studies on larger patient populations will allow to conclusively define the impact of this MRD-driven strategy also on clinical outcome. Disclosures Pulsoni: Roche: Consultancy, Speakers Bureau; Takeda: Consultancy; Pfizer: Consultancy; Sandoz: Consultancy; Gilead: Speakers Bureau; Merk: Consultancy; Bristol Meyer Squibb: Speakers Bureau. Ferrero:Servier: Speakers Bureau; EUSA Pharma: Membership on an entity's Board of Directors or advisory committees; Gilead: Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Luminari:ROCHE: Other: Role as Advisor ; CELGENE: Other: Role as Advisor & Travel Grant; TAKEDA: Other: Travel Grant; GILEAD: Other: Lecturer . Liberati:Amgen: Membership on an entity's Board of Directors or advisory committees, Other: Clinical trial support; Celgene: Honoraria, Other: Clinical trial support; Bristol-Myers Squibb: Honoraria; Takeda: Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy; Janssen: Honoraria; Servier: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Clinical trial support; Roche: Other: Clinical trial support; Novartis: Other: Clinical trial support. Ferreri:Roche: Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy; Kite: Consultancy. Nassi:Takeda: Consultancy; Janssen: Consultancy; Merck: Consultancy. Corradini:Roche: Honoraria; Novartis: Honoraria; kite: Honoraria; KiowaKirin: Honoraria; Janssen: Honoraria; Gilead: Honoraria; Daiichi Sankyo: Honoraria; Celgene: Honoraria; Amgen: Honoraria; Abbvie: Honoraria; Servier: Honoraria; Sanofi: Honoraria; Takeda: Honoraria. Mannina:Janssen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees. Arcaini:Celgene: Speakers Bureau; Gilead Sciences: Research Funding; Bayer, Celgene, Gilead Sciences, Roche, Sandoz, Janssen-Cilag, VERASTEM: Consultancy; Celgene, Roche, Janssen-Cilag, Gilead: Other: Travel expenses. Galimberti:Roche: Speakers Bureau; Celgene: Speakers Bureau; Novartis: Speakers Bureau. Ladetto:AbbVie: Honoraria; Roche: Honoraria; ADC Therapeutics: Honoraria; Acerta: Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; J&J: Honoraria; Celgene: Honoraria. Foà:Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Shire: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Speakers Bureau; Celltrion: Membership on an entity's Board of Directors or advisory committees; Amgen Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Shire: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. OffLabel Disclosure: The anti-CD20 MoAb Ofatumomab is employed to eradicate Minimal Residual Disease in early stage Follicular Lymphoma(FL). The drug is registered for Chronic Lymphocytic Leukemia, not for FL.
- Published
- 2019
- Full Text
- View/download PDF
22. Impact of Different Treatment Approaches on Pregnancy Outcomes in 99 Women Treated for Hodgkin Lymphoma
- Author
-
Alessandro Pulsoni, Vitaliana De Sanctis, Giorgia Annechini, Maurizio Valeriani, Marco Alfò, Francesco Romeo Filippone, Mattia Falchetto Osti, Riccardo Maurizi Enrici, Roberta Muni, Giuseppe Minniti, and Elena Cavalieri
- Subjects
Adult ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Vinblastine ,Pregnancy outcome ,Congenital Abnormalities ,Bleomycin ,Young Adult ,Pregnancy ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Chemotherapy ,Radiology, Nuclear Medicine and imaging ,Mechlorethamine ,Young adult ,Retrospective Studies ,Gynecology ,Radiation ,Radiotherapy ,business.industry ,Obstetrics ,Chemoradiotherapy ,Hodgkin lymphoma ,Retrospective cohort study ,medicine.disease ,Hodgkin Disease ,Abortion, Spontaneous ,Dacarbazine ,Radiation therapy ,Low birth weight ,Oncology ,Doxorubicin ,Vincristine ,Premature birth ,Procarbazine ,Prednisone ,Premature Birth ,Female ,medicine.symptom ,Underweight ,business ,Pregnancy Complications, Neoplastic ,Pregnancy Outcome ,Radiology, Nuclear Medicine and Imaging - Abstract
Purpose The aim of this study was to evaluate the pregnancy outcomes in women with Hodgkin lymphoma (HL) diagnosis, treated between 1972 and 1999 at Department of Radiotherapy and Hematology of University “Sapienza” of Roma. Methods and Materials We retrospectively studied 99 female patients that conceived after treatment for HL. Fifty-nine (59%) were treated with chemotherapy and radiotherapy, 32 (32%) with radiotherapy alone as supradiaphragmatic or as infradiaphragmatic and 8 (8%) patients with chemotherapy alone. Results Ninety-nine patients reported 145 pregnancies. We observed 132 deliveries (2 of them twin births) after a median of 55 months (range, 14–278 months) from the end of therapy. Twelve women (12%) experienced 13 miscarriages after a median of 50 months (range, 13–120) from the end of therapy. We recorded 9/132 (7%) premature births and 3/134 babies (2%) were underweight at the time of birth. We recorded 2 cases of congenital malformations. No statistical differences were recorded when adverse pregnancy outcomes were analyzed with respect to chemotherapy alone, radiotherapy alone, or combined therapy. Conclusions No significant associations between pregnancy outcomes and therapeutic approaches were found. In particular, the infradiaphragmatic radiotherapy showed no statistical association with miscarriages, premature birth, and low birth weight at term when compared with other therapeutic approaches.
- Published
- 2012
- Full Text
- View/download PDF
23. MINIMAL RESIDUAL DISEASE (MRD) IN EARLY STAGE FOLLICULAR LYMPHOMA CAN PREDICT PROGNOSIS AND DRIVE RITUXIMAB TREATMENT AFTER RADIOTHERAPY
- Author
-
Maria Elena Tosti, Attilio Guarini, L. Grapulin, L.A. De Novi, Luca Vincenzo Cappelli, I. Della Starza, Marzia Cavalli, Gianna Maria D'Elia, Alessandro Pulsoni, Giorgia Annechini, Robert Foa, and I. Del Giudice
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Follicular lymphoma ,Hematology ,General Medicine ,medicine.disease ,Minimal residual disease ,Radiation therapy ,Internal medicine ,Medicine ,Rituximab ,Stage (cooking) ,business ,medicine.drug - Published
- 2017
- Full Text
- View/download PDF
24. Bendamustine in Combination with Gemcitabine and Vinorelbine (BEGEV) Is an Effective Regimen for Heavily Pretreated, Relapsed/Refractory Hodgkin Lymphoma Patients: A Multicenter, Retrospective Real-World Study
- Author
-
Paolo Corradini, Alessandra Serrao, Armando Santoro, Arturo Chiti, Michele Merli, Massimo Magagnoli, Francesca Ricci, Simonetta Viviani, Giorgia Annechini, Carmelo Carlo-Stella, Marcello Rodari, Alessandro Pulsoni, Luca Castagna, Anna Guidetti, Francesco Landi, Francesco Passamonti, Andrea Nervini, Lucia Morello, Antonio Russo, Laura Giordano, and Rita Mazza
- Subjects
Bendamustine ,Oncology ,medicine.medical_specialty ,business.industry ,Immunology ,Phases of clinical research ,Salvage therapy ,Cell Biology ,Hematology ,medicine.disease ,Vinorelbine ,Biochemistry ,03 medical and health sciences ,Regimen ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Nivolumab ,Brentuximab vedotin ,business ,Progressive disease ,030215 immunology ,medicine.drug - Abstract
INTRODUCTION: The availability of novel monoclonal antibodies (moAbs) including the anti-CD30 Brentuximab Vedotin (BV) and the anti-programmed cell death-1 (anti-PD-1) Nivolumab and Pembrolizumab has introduced innovative options in the process of therapeutic decision making for relapsed/refractory classical Hodgkin lymphoma (R/R cHL). However, multiagent chemotherapy followed by autologous stem cell transplantation (auto-SCT) in chemosensitive patients still remains the standard-of-care treatment of R/R cHL. In a multicenter phase 2 study, the BEGEV (Bendamustine, Gemcitabine, Vinorelbine) regimen was previously reported as a highly effective treatment in the second-line salvage setting (Santoro et al., J Clin Oncol, 2016). Here, we report a retrospective analysis of efficacy and toxicity of the BEGEV regimen administered as second- or subsequent-line therapy to R/R cHL in a real-world setting. PATIENTS AND METHODS: From January 2013 to March 2018, 73 cHL patients (median age, 31 years; range, 16 - 69) were candidate to receive 4 courses of BEGEV as second-line (n= 50) or beyond second-line (n= 23) salvage therapy. Refractory patients were 56% in the second-line group and 78% in the group treated beyond second-line. This latter group received a median of 3 (range, 2-8) lines of therapy prior to BEGEV, including Brentuximab Vedotin (BV) (83%) and auto-SCT (43%). RESULTS: In keeping with the phase 2 study, hematological and non-hematological side effects were acceptable. In fact, 64 (88%) patients completed the planned treatment whereas only 9 (12%) patients experienced early therapy discontinuation due to progressive disease (n= 8) and sepsis (n= 1). Of 72 patients evaluable for response, 50 (69.4%) achieved complete remission (CR) and 7 partial remission (PR) with an overall response rate (ORR) of 79%; 1 patient experienced stable disease (SD) and 14 (19%) progressive disease (PD). All but one patient experiencing PD/SD were chemorefractory (14/15). The probability of achieving response (CR+PR) to BEGEV was significantly higher in chemosensitive vs chemorefractory patients (96% vs 70%, P=0.007) whereas no difference could be detected for patients receiving BEGEV as second-line vs those treated beyond second-line (84% vs 70%, P=0.217). All BEGEV responders (n=57) were offered SCT: 44 received auto-SCT, 9 allo-SCT and 1 tandem auto/allo-SCT; 1 patient is waiting for SCT, and 2 refused. With a median follow-up of 14 months, the 1-yr overall survival (OS) and progression-free survival (PFS) are 93% and 69%, respectively. Disease status (sensitive vsrefractory) at BEGEV had no impact on survival (1-yr OD: 94% vs 92%, P=0.57) likely due post-BEGEV consolidation therapy, whereas timing of BEGEV administraton (second-line vs subsequent-lines) significantly affected survival (1-yr OS: 97% vs 78%, P=0.018). CONCLUSION: Data from this real-world analysis further confirm that BEGEV is an effective and safe salvage treament in R/R cHL even when administered to heavily pre-treated patients, thus representing an optimal therapeutic platform prior to consolidation with SCT or immunotherapy. Disclosures Carlo-Stella: Sanofi: Consultancy; Genenta Science: Speakers Bureau; AstraZeneca: Speakers Bureau; Rhizen Pharmaceuticals: Research Funding; Amgen: Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau; MSD Italia: Speakers Bureau; Boehringher Ingelheim Italia: Consultancy; Janssen: Speakers Bureau; ADC Therapeutics: Research Funding, Speakers Bureau.
- Published
- 2018
- Full Text
- View/download PDF
25. Efficacy of the BEACOPP regimen in refractory and relapsed Hodgkinlymphoma
- Author
-
Angela Matturro, Robin Foà, Lavinia Grapulin, Federico De Angelis, Elena Cavalieri, Alessandro Pulsoni, Marco Vignetti, Fabiana Gentilini, Mikael Sacco, Fabio Torelli, Giorgia Annechini, Franco Mandelli, and Natalia Frattarelli
- Subjects
Adult ,Male ,BEACOPP ,Cancer Research ,medicine.medical_specialty ,Vincristine ,medicine.medical_treatment ,Procarbazine ,Gastroenterology ,BEACOPP Regimen ,Bleomycin ,Young Adult ,Recurrence ,Prednisone ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Refractory Hodgkin Lymphoma ,Aspergillosis ,Humans ,Pericarditis ,Cumulative incidence ,Cyclophosphamide ,Etoposide ,Retrospective Studies ,Peripheral Blood Stem Cell Transplantation ,business.industry ,Pneumonia ,Hematology ,Middle Aged ,Hodgkin Disease ,Shock, Septic ,Survival Analysis ,Regimen ,Treatment Outcome ,Oncology ,Doxorubicin ,Drug Resistance, Neoplasm ,Immunology ,Female ,business ,medicine.drug - Abstract
The BEACOPP regimen is a consolidated first-line treatment regimen for advanced stage Hodgkin lymphoma (HL), while few data are available on the efficacy of this regimen in advanced disease. About 50% of patients with HL relapsed after or refractory to first-line therapy achieve a durable response after peripheral blood stem cell transplantation (PBSCT). Patients relapsing after a PBSCT (performed as second line therapy) have a very poor prognosis. We evaluated the efficacy of BEACOPP in two settings: patients refractory or in relapse after first-line therapy (Group A) and patients relapsing after a PBSCT (Group B). Twenty-three patients with HL, admitted between February 2003 and April 2007, were retrospectively studied: 10 patients in Group A and 13 in Group B. Group A: Nine complete remissions (CR) and one partial remission (PR) were achieved following BEACOPP treatment. After a median follow-up of 32 months, one patient has died due to secondary leukemia, while the other eight are alive, five (50%) in second CR, three in third CR after PBSCT and one with disease. Group B: Eight of the 13 patients (62%) obtained a CR, one patient a PR, two were refractory and two have died of toxicity. To date, eight patients (62%) are alive, four (31%) still in CR. All patients experienced hematologic toxicity (WHO 3-4) with two deaths due to septic shock. These results show that BEACOPP is an effective regimen for both refractory/relapsed patients with HL after first-line treatment (Group A) and for patients relapsing after a PBSCT (Group B) with a 3-year probability of overall survival, progression-free survival, and cumulative incidence of relapse of 90, 50, and 33.3% in Group A, and 61, 31, and 37.5% in Group B, respectively.
- Published
- 2009
- Full Text
- View/download PDF
26. B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL)
- Author
-
Angelo Michele Carella, Giorgia Annechini, Emanuele Angelucci, Antonella Anastasia, Marcello Rodari, Eleonora Russo, Laura Giordano, Manuel Gotti, Armando Santoro, Roberta Murru, Monica Balzarotti, Alessandro Re, Ercole Brusamolino, Caterina Stelitano, Massimo Magagnoli, Angelagiovanna Congiu, Vittorio Ruggero Zilioli, Maurizio Bonfichi, Rita Mazza, Michele Spina, Flavia Salvi, Umberto Vitolo, Stefania Massidda, Barbara Botto, and Francesco Merli
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Adolescent ,medicine.medical_treatment ,Hematopoietic stem cell transplantation ,Vinblastine ,Gastroenterology ,Deoxycytidine ,Transplantation, Autologous ,Bortezomib ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Autologous stem-cell transplantation ,Refractory ,Recurrence ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Refractory Hodgkin Lymphoma ,Medicine ,Humans ,Ifosfamide ,Neoplasm Staging ,business.industry ,Remission Induction ,Hematopoietic Stem Cell Transplantation ,Induction chemotherapy ,Vinorelbine ,Hematology ,Middle Aged ,Combined Modality Therapy ,Hodgkin Disease ,Survival Analysis ,Gemcitabine ,Hematopoietic Stem Cell Mobilization ,Surgery ,Treatment Outcome ,Oncology ,Drug Resistance, Neoplasm ,030220 oncology & carcinogenesis ,Female ,business ,030215 immunology ,medicine.drug - Abstract
This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m(2)) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p
- Published
- 2016
27. Tapentadol PR for Pain Syndromes in Real Life Patients with Hematological Malignancy
- Author
-
Giada Mastrogiacomo, Romina Talone, Adriana Monteiro da Costa, Laura Scaramucci, Giorgia Annechini, Erminia Baldacci, Maria Teresa Petrucci, Sara Kiflom, Claudio Cartoni, Marta Chisini, Gregorio Antonio Brunetti, Pasquale Niscola, Ida Carmosino, Marco Giovannini, Giovanna Palumbo, Andrea Tendas, Giacomo Salvatore Morano, and Sara Grammatico
- Subjects
Male ,Dose ,Analgesic ,Pain ,03 medical and health sciences ,0302 clinical medicine ,Phenols ,Medicine ,Humans ,Pain Management ,030212 general & internal medicine ,Adverse effect ,Aged ,Retrospective Studies ,Pharmacology ,Aged, 80 and over ,business.industry ,Retrospective cohort study ,Hematology ,Middle Aged ,Tapentadol ,Analgesics, Opioid ,Nociception ,Opioid ,Anesthesia ,Hematologic Neoplasms ,Female ,Cardiology and Cardiovascular Medicine ,Cancer pain ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Background: More than 50% of oncohematological patients suffer from pain syndrome, mostly originating from the bone, which often include nociceptive and neuropathic complaints. Tapentadol, a recently available treatment option for cancer pain, exerts a dual analgesic mechanisms (opioid and noradrenergic), allowing for a high clinical efficacy as well as for a reduction in adverse events compared to traditional opioids. Aim: To explore the safety and efficacy of tapentadol as a suitable agent for the pain management in the setting of oncohematology. Methods: Our observational study included 36 patients with basal pain intensity (NRS) ranging from 5 to 10. Tapentadol prolonged release (PR) was given at the initial dose of 50 mg BID and careful titrated according to the achieved pain control. Results. Tapentadol PR was given at the dosages ranging from 200 and 260 mg/day after a careful titration, allowed for a clinically (-7 points NRS) remarkable reduction of pain intensity without any significant side effects. Conclusion: In oncohematological patients on pain, tapentadol PR was effective and well tolerated, so representing a suitable treatment option in this difficult setting.
- Published
- 2016
28. Splenic marginal zone lymphoma: Prognostic factors, role of watch and wait policy, and other therapeutic approaches in the rituximab era
- Author
-
Antonietta Ferretti, Maria Elena Tosti, Gianna Maria D'Elia, Alessandro Pulsoni, Robin Foà, Salvatore Perrone, and Giorgia Annechini
- Subjects
Oncology ,Male ,Cancer Research ,Lymphoma ,medicine.medical_treatment ,Follicular lymphoma ,Marginal Zone ,0302 clinical medicine ,immune system diseases ,hemic and lymphatic diseases ,80 and over ,Medicine ,Splenic marginal zone lymphoma ,Aged, 80 and over ,education.field_of_study ,Hepatitis C virus ,Hematology ,Middle Aged ,Prognosis ,Combined Modality Therapy ,Survival Rate ,Watch and wait ,030220 oncology & carcinogenesis ,Splenectomy ,Rituximab ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,Population ,Splenic Neoplasm ,Antineoplastic Agents ,NHL ,03 medical and health sciences ,Internal medicine ,Aged ,Follow-Up Studies ,Humans ,Lymphoma, B-Cell, Marginal Zone ,Neoplasm Staging ,Retrospective Studies ,Splenic Neoplasms ,education ,Survival rate ,Chemotherapy ,business.industry ,B-Cell ,medicine.disease ,Surgery ,business ,030215 immunology - Abstract
Splenic marginal zone lymphoma (SMZL) is an indolent lymphoma in which watch and wait (WW) approach as well as splenectomy and chemo-immunotherapy are usually recommended. The role of the different approaches in relation to risk factors was evaluated. One hundred patients with SMZL were retrospectively studied. Median age was 65 years. HCV positivity was 3.1%. The 10-year overall-survival was 95.1% (CI: 90-100%). Sixty-two asymptomatic, low tumour burden patients were submitted to WW. A low-risk group not requiring treatment was identified. Patients requiring treatment received splenectomy (36), chemotherapy-alone (27) and rituximab ± chemotherapy (16). In multivariate analysis, negative predictors for starting treatment were female-sex, splenomegaly, ECOG ≥ 1. Patients with low IIL-Score had a better 5-year TFT (24%). The median TFT of the WW cohort was 58.5 months; at 10 years, 17% of patients were still on WW. Splenectomy and rituximab ± chemotherapy showed similar results, while chemotherapy alone proved inferior. This real-life single-centre study of SMZL confirmed its very good prognosis with a survival likelihood overlapping that of general population. The prognostic role of IIL-Score was confirmed. The WW approach allowed a median PFS longer than in follicular lymphoma. Finally, our data confirm the inferiority of chemotherapy compared to splenectomy and rituximab±chemotherapy.
- Published
- 2016
29. Bendamustine in combination with gemcitabine and vinorelbine is an effective regimen as induction chemotherapy before autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma: Final results of a multicenter phase II study
- Author
-
Vittorio Ruggero Zilioli, Rita Mazza, Luca Castagna, Laura Giordano, Armando Santoro, Francesco Merli, Anna Marina Liberati, Giorgia Annechini, Alessandro Re, Nicola Di Renzo, Annalisa Peli, Flavia Salvi, Alessandro Pulsoni, Antonella Anastasia, Maurizio Bonfichi, Stefano Luminari, Carmelo Carlo-Stella, and Manuel Gotti
- Subjects
Oncology ,Male ,Cancer Research ,Antigens, CD34 ,Kaplan-Meier Estimate ,autologous ,Deoxycytidine ,0302 clinical medicine ,Autologous stem-cell transplantation ,antigens ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Bendamustine Hydrochloride ,Prospective Studies ,Hematopoietic Stem Cell Transplantation ,Vinorelbine ,Middle Aged ,Hodgkin Disease ,Hematopoietic Stem Cell Mobilization ,030220 oncology & carcinogenesis ,Female ,medicine.drug ,Bendamustine ,Adult ,medicine.medical_specialty ,Adolescent ,Vinblastine ,Transplantation, Autologous ,Disease-Free Survival ,03 medical and health sciences ,Young Adult ,Internal medicine ,Refractory Hodgkin Lymphoma ,Humans ,adolescent ,adult ,aged ,antigens, CD34 ,antineoplastic combined chemotherapy protocols ,bendamustine hydrochloride ,deoxycytidine ,disease-free survival ,female ,hematopoietic stem cell mobilization ,hematopoietic stem cell transplantation ,Hodgkin disease ,humans ,Kaplan-Meier estimate ,male ,middle aged ,prospective studies ,transplantation, autologous ,vinblastine ,young adult ,oncology ,cancer research ,Aged ,business.industry ,Induction chemotherapy ,medicine.disease ,Gemcitabine ,Transplantation ,Regimen ,CD34 ,business ,Febrile neutropenia ,transplantation ,030215 immunology - Abstract
Purpose This multicenter, open-label, phase II study evaluated the combination of bendamustine, gemcitabine, and vinorelbine (BeGEV) as induction therapy before autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory Hodgkin lymphoma (HL). Patients and Methods Patients with HL who were refractory to or had relapsed after one previous chemotherapy line were eligible. The primary end point was complete response (CR) rate after four cycles of therapy. Secondary end points were: overall response rate, stem-cell mobilization activity, and toxicity. Progression-free and overall survival were also evaluated. Results In total, 59 patients were enrolled. After four cycles of therapy, 43 patients (73%) achieved CR, and six (10%) achieved partial response, for an overall response rate of 83%. The most common grade 3 to 4 nonhematologic toxicities included febrile neutropenia (n = 7) and infection (n = 4). Regarding hematologic toxicities, grade 3 to 4 thrombocytopenia and neutropenia were each experienced by eight patients (13.5%). CD34+ cells were successfully harvested in 55 of 57 evaluable patients, and 43 of 49 responding patients underwent ASCT. With a median follow-up of 29 months, the 2-year progression-free and overall survival rates for the total population were 62.2% and 77.6%, respectively. The same figures for patients undergoing autograft were 80.8% and 89.3%, respectively. Conclusion This phase II study demonstrates that BeGEV is an effective salvage regimen able to induce CR in a high proportion of patients with relapsed or refractory HL before ASCT. These data provide a strong rationale for further development of the BeGEV regimen.
- Published
- 2016
30. Risk of secondary hypogammaglobulinaemia after Rituximab and Fludarabine in indolent non-Hodgkin lymphomas: A retrospective cohort study
- Author
-
Federico De Angelis, Maria Elena Tosti, Caterina Stefanizzi, Gianna Maria D'Elia, Saveria Capria, Alessandro Pulsoni, Robin Foà, Eleonora Russo, and Giorgia Annechini
- Subjects
Male ,Cancer Research ,Kaplan-Meier Estimate ,CHOP ,Gastroenterology ,Hypogammaglobulinemia ,Autologous stem-cell transplantation ,Bone Marrow ,Antineoplastic Combined Chemotherapy Protocols ,IgG Deficiency ,Aged, 80 and over ,non-Hodgkin lymphoma ,Incidence ,Lymphoma, Non-Hodgkin ,Hazard ratio ,Hematopoietic Stem Cell Transplantation ,Hematology ,Middle Aged ,Fludarabine ,Oncology ,Vincristine ,fludarabine ,hypogammaglobulinemia ,rituximab ,Rituximab ,Female ,Disease Susceptibility ,Immunotherapy ,Vidarabine ,medicine.drug ,Adult ,medicine.medical_specialty ,Transplantation, Autologous ,Immunocompromised Host ,Young Adult ,Internal medicine ,medicine ,Humans ,Risk factor ,Cyclophosphamide ,Aged ,Proportional Hazards Models ,Retrospective Studies ,business.industry ,Retrospective cohort study ,Pneumonia ,medicine.disease ,Doxorubicin ,Immunology ,Prednisone ,business - Abstract
The occurrence of secondary hypogammaglobulinemia (SH) after chemo-immunotherapy represents a potential side effect in patients with indolent non-Hodgkin lymphomas (iNHL). Few data are available on SH occurring after chemotherapy and/or Rituximab (R). We retrospectively investigated the incidence and the risk factors for SH and infectious complications in patients with iNHL after chemo-immunotherapy. Two hundred and sixty six patients treated between 1993 and 2011 were studied. Patients with a basal hypogammaglobulinemia or a monoclonal component were excluded. The incidence of SH was 2.2×1000 person-years (95% CI 1.6-2.9). Exposure to Fludarabine-based schedules (Fbs)±R was associated with a hazard ratio (HR) of 18.1 (95% CI: 4.3-77.0). Conversely, exposure to CHOP±R or CVP±R was not a risk factor (HR 0.3, 95% CI: 0.1-0.8; HR 0.3, 95% CI: 0.08-1.4, respectively). The role of R was studied comparing cohorts differing only for R; no differences were found comparing R-CHOP/R-CVP versus CHOP/CVP (HR 1.07, 95% CI: 0.38-3.05) and R-Fbs versus Fbs (HR 2.07, 95% CI: 0.62-6.99). Autologous stem cell transplantation (ASCT) is also a risk factor (HR: 5.2, 95% CI 2.1-13.0). SH patients presented a high risk for pneumonia development (HR 7.07 95% CI: 2.68-18.44). We recommend monitoring of serum immunoglobulins in an attempt to reduce the probability of infection after Fbs or ASCT.
- Published
- 2015
31. Catheter-associated bloodstream infections and thrombotic risk in hematologic patients with peripherally inserted central catheters (PICC)
- Author
-
Matteo Molica, Alice Di Rocco, Alfonso Guerriero, Roberto Latagliata, Antonio Chistolini, Paola Berneschi, Arianna Sammarco, Salvatore Giacomo Morano, Angelo Fama, Claudio Cartoni, Giorgia Annechini, Massimo Giampaoletti, Alessandra Micozzi, Massimo Breccia, Giovanni Rosa, Saveria Capria, Walter Barberi, Fulvio Massaro, Gregorio Antonio Brunetti, Giuliana Alimena, Clara Minotti, Corrado Girmenia, and Robin Foà
- Subjects
Adult ,Male ,Catheterization, Central Venous ,medicine.medical_specialty ,Bacteremia ,Infections ,Hematologic malignancies ,PICC ,Thrombosis ,Risk Factors ,Interquartile range ,Catheterization, Peripheral ,medicine ,Humans ,Aged ,Acute leukemia ,Proportional hazards model ,business.industry ,Incidence ,Incidence (epidemiology) ,Cancer ,Middle Aged ,medicine.disease ,Surgery ,Catheter ,Oncology ,Hematologic disease ,Catheter-Related Infections ,Hematologic Neoplasms ,Acute Disease ,Female ,Complication ,business - Abstract
The use of peripherally inserted central catheters (PICC) as an alternative to other central venous access devices (CVAD) is becoming very frequent in cancer patients. To evaluate the impact of complications associated to these devices in patients with hematologic malignancies, we revised the catheter-related bloodstream infections (CRBSI) and the catheter-related thrombotic complications (CRTC) observed at our institute between January 2009 and December 2012. A total of 612 PICCs were inserted into 483 patients at diagnosis or in subsequent phases of their hematologic disease. PICCs were successfully inserted in all cases. The median duration of in situ PICC placement was 101 days (interquartile range, 48–184 days). A CRBSI occurred in 47 cases (7.7 %), with a rate of 0.59 per 1000 PICC days. A CRTC was recorded in 16 cases (2.6 %), with a rate of 0.20 per 1000 PICC days. No serious complication was associated to these events. Cox regression analyses of variables associated to CRBSIs and to CRTCs showed that only the type of disease (acute leukemia compared to other diseases) was significantly associated to a higher incidence of CRBSIs, while no feature was predictive for a higher risk of CRTCs. PICCs represent a useful and safe alternative to conventional CVAD for the management of patients with hematologic malignancies.
- Published
- 2015
32. Early Stage Follicular Lymphoma. Predictive Role of Minimal Residual Disease (MRD) and Impact of MRD-Driven Treatment with Radiotherapy and Rituximab on Clinical Outcome
- Author
-
Giorgia Annechini, Anna Guarini, Marzia Cavalli, Maria Elena Tosti, Lucia Anna De Novi, Alessandro Pulsoni, Irene Della Starza, Ilaria Del Giudice, Lavinia Grapulin, Gianna Maria D'Elia, Robin Foà, and Luca Vincenzo Cappelli
- Subjects
medicine.medical_specialty ,Subsequent Relapse ,medicine.medical_treatment ,Immunology ,Follicular lymphoma ,Biochemistry ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,hemic and lymphatic diseases ,Internal medicine ,Biopsy ,medicine ,Stage (cooking) ,medicine.diagnostic_test ,business.industry ,Cell Biology ,Hematology ,medicine.disease ,Minimal residual disease ,Surgery ,body regions ,Radiation therapy ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Rituximab ,Bone marrow ,business ,030215 immunology ,medicine.drug - Abstract
Background. In localized follicular lymphoma (FL, stage I-II), BCL2/IGH+ cells can be detected in the peripheral blood (PB) and/or bone marrow (BM) in 66.7% of cases (Pulsoni et al, BJH 2007). We hereby analyzed the prognostic impact of MRD in localized FL and explored the possibility of a MRD-guided therapeutic approach on a series of patients with a long follow-up. Methods. Between April 2000 and February 2015, 67 consecutive patients with a confirmed histologic diagnosis of stage I/II FL followed at our Center were enrolled in the study. PB and BM samples were collected at enrollment in all patients and investigated by qualitative PCR to identify the presence of a BCL2/IGH rearrangement. Paraffin-embedded lymph nodes (LN) were studied when available. Patients who proved positive at baseline were studied for MRD every 6 months. Real-Time Quantitative PCR (RQ-PCR) was retrospectively performed according to material availability. All patients were treated with involved field radiotherapy (RT) (24-30 Gy); from 2005, patients who were MRD+ after RT received rituximab (R) (375 mg/m2, 4 weekly administration). The median follow-up is 67 months (17-183); 21 patients (31%) have relapsed after a median of 37 months (17-165) from diagnosis. Results. At baseline, a clonal marker was found by qualitative PCR in 48/67 cases (72%): 36 were MBR+ (54%), 6 mcr+ (9%), 6 showed a minor BCL2 rearrangement (9%), while 19 (28%) were negative. Fifteen of the latter 19 were analyzed by RQ-PCR and 4 proved MBR+. Of the 13 available LNs, 11 showed the same molecular marker identified in the PB/BM; 2 cases, negative in the PB/BM, showed a rearrangement in the LN only. After RT, 40/42 MBR+/mcr+ patients were analyzed: 20 resulted MRD-, while 20 persisted MRD+. Regardless of the post-RT MRD status, an equal number of relapses was recorded in both groups (7 each). R treatment was administered to the 20 MRD+ patients after RT. Sixteen (80%) achieved a MRD- status after R: over time, 7/16 patients converted to MRD+ and 4 relapsed, whilst 9/16 patients (56.2%) remain persistently MRD- and none has relapsed so far. To evaluate the impact of R, we considered a series of 27 patients MRD+ after RT or who were MRD- and became MRD+ during the follow-up. Of the 19 patients who received R (1 could not be studied), 15 (79%) did not relapse, while of the 8 untreated patients (pre-2005), 6 (75%) relapsed (p=0.025). Progression-free survival (PFS) was significantly longer for R-treated patients (p=0.0412) (Fig. 1). To define the predictive role of MRD in the entire cohort regardless of post-RT treatment, we considered the 39 patients with molecular follow-up. Thirteen have relapsed: 10/13 (77%) were MRD+ in the follow-up, including the pre-relapse time point, while 3 resulted persistently MRD-. Contrariwise, of the 26/39 patients in continuous remission, 18 (69%) were persistently MRD- while 8 were MRD+ (p=0.015). PFS was significantly better for MRD- patients (p=0.0163) (Fig. 2). RQ-PCR was performed in 30 MBR+ patients: 17 (57%) showed a tumor burden ≥10-5 and 13 Conclusions. Early stage FL at diagnosis can have a heterogenous disease extension: 2 of our cases were truly localized, showing a molecular marker only in the LN. However, in most cases the use of combined qualitative approaches, including canonical MBR/mcr and minor rearrangements, together with RQ-PCR has allowed to identify circulating BCL2/IGH+ cells (52/67 cases: 77.6%), despite a negative BM biopsy. RT induced a MRD negativity in 50% of BCL2/IGH+ patients, but this did not impact on clinical outcome. The administration of R in MRD+ patients decreased significantly the risk of a subsequent relapse and improved PFS. Regardless of treatment, MRD positivity during the follow-up is a predictor of relapse and PFS. Tumor burden at diagnosis is associated with MRD clearance after RT. We support the use of a MRD-driven treatment with anti-CD20 monoclonal antibodies in patients with localized FL after RT. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
- Published
- 2016
- Full Text
- View/download PDF
33. Regression of a case of Multiple Myeloma with antiviral treatment in a patient with chronic HCV infection
- Author
-
Sara Panfilio, Gianna Maria D'Elia, Federico De Angelis, Caterina Stefanizzi, Pasqualina D'Urso, Alessandro Pulsoni, and Giorgia Annechini
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Myeloma ,Case Report ,Gastroenterology ,Asymptomatic ,Hepatitis ,chemistry.chemical_compound ,Internal medicine ,medicine ,Multiple myeloma ,Chemotherapy ,HCV ,Treatment ,business.industry ,Ribavirin ,Hematology ,medicine.disease ,Bence Jones protein ,Lymphoma ,Chronic infection ,Oncology ,chemistry ,Immunology ,medicine.symptom ,business - Abstract
We report a case of a 54 year old patient with Multiple Myeloma (MM) and chronic HCV infection. In 2005 MM was diagnosed and a chemotherapy was prescribed. Before starting treatment a chronic HCV infection was found. When she came to our Institution for a second opinion, chemotherapy treatment was not considered immediately necessary so the patient was treated for the HCV chronic infection (Pegilated alpha-Interferon 180μg/week and Ribavirin 1000mg p.o./day). After one month of treatment she presented a reduction of Bence Jones protein (BJ) that further decreased in the following three months. The antiviral treatment was suspended after six months and a re-evaluation showed a complete viral response and a regression of MM. Sixty-eight months after the end of antiviral treatment the patient is asymptomatic and presents a condition compatible with an M-GUS. While the association between HCV infection and non-Hodgkin's lymphoma is consolidated and it is clearly demonstrated that antiviral treatment in these patients can induce a high proportion of partial and complete remission, a similar effect was never described in MM. The response obtained in our patient may suggest a possible a role of HCV in the pathogenesis of MM.
- Published
- 2012
34. Primary uterine localization of malt lymphoma: a case report and literature review
- Author
-
Gianna Maria D'Elia, Federico De Angelis, Alessandro Pulsoni, Giorgia Annechini, Claudio Agostinelli, Sara Panfilio, F. De Angeli, G. Annechini, C. Agostinelli, GM. D'Elia, S. Panfilio, and A. Pulsoni.
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,Primary (chemistry) ,business.industry ,MEDLINE ,MALT lymphoma ,Hematology ,Lymphoma, B-Cell, Marginal Zone ,Middle Aged ,medicine.disease ,Prognosis ,Lymphoma ,Text mining ,medicine.anatomical_structure ,malt lymphoma ,Internal medicine ,Uterine Neoplasms ,medicine ,Humans ,Female ,business ,Primary uterine ,B cell - Abstract
No abstract available
- Published
- 2011
35. Efficacy of bendamustine as salvage treatment in an heavily pre-treated Hodgkin lymphoma
- Author
-
Roberta Danieli, Giorgia Annechini, Massimo Breccia, Sara Panfilio, Federico De Angelis, Elena Cavalieri, Alessandro Pulsoni, and Gianna Maria D'Elia
- Subjects
Oncology ,Bendamustine ,Cancer Research ,medicine.medical_specialty ,business.industry ,Treatment outcome ,Salvage treatment ,Hematology ,Bendamustine hydrochloride ,Internal medicine ,medicine ,Hodgkin lymphoma ,business ,medicine.drug - Published
- 2010
- Full Text
- View/download PDF
36. Splenectomy Is Still a Valid Option For Splenic Marginal Zone Lymphoma
- Author
-
Angelo Fama, Federico De Angelis, Sara Tricarico, Robin Foà, Pasqualina D'Urso, Alessandro Pulsoni, Gianna Maria D'Elia, Caterina Stefanizzi, and Giorgia Annechini
- Subjects
medicine.medical_specialty ,Lymphocytosis ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Immunology ,Splenectomy ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Asymptomatic ,Surgery ,Regimen ,B symptoms ,Biopsy ,medicine ,Rituximab ,Splenic marginal zone lymphoma ,medicine.symptom ,business ,medicine.drug - Abstract
Introduction Splenic marginal zone lymphoma (SMZL) is an indolent B-cell lymphoma characterized by splenomegaly, frequent moderate lymphocytosis with or without villous morphology and possible involvement of various organs, especially the bone marrow (BM). Diagnosis is classically based on the spleen histology, but it can be made on the BM biopsy, based on the typical intrasinusoidal cell infiltration pattern and immunohistochemistry. Different therapeutic options are available, but to date there are no conclusive comparative data. Patients and methods We retrospectively analyzed 83 consecutive patients with a diagnosis of SMZL observed at our Institution between 1999 and 2013. The diagnosis was based on the BM biopsy in 79 patients; the BM was negative in 4 patients. Diagnosis was histologically confirmed on the spleen in 27 patients who underwent splenectomy. Patients presented a median age of 72.5 years (range 38-84); 43 were males. The median spleen size at diagnosis was 145 mm, ranging from 100 to 300 mm. The majority of patients were stage IV at diagnosis for BM infiltration (95%); B symptoms were present in 4 of them (4.8%). Forty-two patients (50.6%) had a lymphocytosis at diagnosis and 13 (15.6%) presented an IPI score higher than 3. Thirty-five of them (42%) had a MZL BM infiltration superior to 30% of the total bone cellularity. Forty-two patients (50.6%) underwent a watch and wait policy (WW), while 41 (49.4%) were treated within 6 months from diagnosis, mainly because of symptomatic splenomegaly; in these patients, treatment consisted of splenectomy, chemotherapy or chemotherapy plus immunotherapy with Rituximab. The features of patients submitted to WW with respect to patients treated at diagnosis were comparable for the various parameters mentioned above, except for spleen size (higher in patients treated at presentation) and lymphocyte count (higher in patients who were observed). After a median follow-up of 64 months, the overall median survival was 96%. Among the 42 WW patients, 18 (42.8%) are still untreated after a median follow-up of 57.5 months, while 24 (57.2%) have required therapy; the median treatment-free interval in these patients was 25.5 months. Concerning the 41 patients who underwent treatment at diagnosis, after a median follow-up of 50 months, 13 (31.7%) have required a subsequent second-line treatment. The interval between first-line approach and re-treatment in patients treated at diagnosis was 30 months. Overall, 27 patients were treated with splenectomy only (either at diagnosis or after a WW period): only 6 of them (22%) had a subsequent progression after a median latency of 42 months; 26 were treated with chemotherapy alone (alkylating agents in the majority of them, combination therapy in a minority): 15 of them (60%) had a subsequent relapse or progression after a median of 9 months; 12 patients received a Rituximab-containing regimen: of these, only 2 (16%) have so far required a second-line therapy after 10 and 26 months respectively. Conclusions The WW policy is a valid option for asymptomatic patients: in these patients, after 4.5 years from diagnosis more than 40% is still untreated. In patients requiring treatment, splenectomy alone is followed in the majority of patients by a long period of good disease control: only 22% required a second-line therapy after 3.5 years. The addiction of Rituximab to chemotherapy seems to reduce the probability of relapse and to prolong the response duration. However, these preliminary data need to be confirmed by larger studies. Disclosures: No relevant conflicts of interest to declare.
- Published
- 2013
- Full Text
- View/download PDF
37. Treatment Of Early Stage Follicular Lymphoma With Involved Field Radiotherapy and Rituximab. Role Of Bcl-2 Molecular Monitoring
- Author
-
Marzia Cavalli, Giorgia Annechini, Irene Della Starza, Lavinia Grapulin, Robin Foà, Gianna Maria D'Elia, Caterina Stefanizzi, Sara Tricarico, Alessandro Pulsoni, Federico De Angelis, and Pasqualina D'Urso
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Immunology ,Follicular lymphoma ,Cell Biology ,Hematology ,medicine.disease ,Single Center ,Biochemistry ,Gastroenterology ,Minimal residual disease ,Breast cancer ,medicine.anatomical_structure ,Internal medicine ,Biopsy ,medicine ,Rituximab ,Bone marrow ,business ,Lymph node ,medicine.drug - Abstract
Background Stage I or II follicular lymphoma (FL) is an uncommon disease, representing only 20% of FL. Conventional treatment is represented by local radiotherapy (RT), which allows eradication of the disease in about 50% of patients. Despite the negative bone marrow biopsy in all cases, most patients present Bcl-2 rearranged cells in the bone marrow (BM) and/or peripheral blood (PB). The aim of this study was to analyze the prognostic role of Bcl-2 molecular monitoring in a series of stage I-II FL cases followed at a single center. Methods Fifty-seven consecutive patients with a confirmed diagnosis of stage I/II FL were investigated at presentation by PCR in order to identify the presence of Bcl-2 rearranged cells in the BM and/or PB. All patients were treated with involved field RT (30-36 Gy). Subsequently, minimal residual disease (MRD) was evaluated every 6 months after RT in patients positive at baseline; patients negative at baseline were not retested. In part of the patients (after 2005) Rituximab was administered in case of persistently positive Bcl-2 cells in the BM or PB after radiotherapy. The PCR analysis of the Bcl-2/IgH rearrangement was performed according to published methods. It consists in a nested PCR that uses in the first round a couple of primers for the major breakpoint region (MBR) or for the minor cluster region (mcr). After this first step, the amplification products were re-amplified using oligonucleotide primers internal to the original ones. An aliquot of the PCR products was analysed on 2% agarose gel containing ethidium bromide in Tris-borate electrophoresis buffer and visualized under UV light. For MBR and mcr, a reproducible sensitivity level of 10-5 and 10-4 respectively, was obtained. Results 1. Prognostic value of basal PCR in BM/PB: PCR analysis revealed Bcl-2 rearranged cells in the PB and/or BM in 38/57 patients (66.7%) at presentation. After a median follow-up of 55 months, 11 patients (19.3%) had a clinical relapse; of them, 10 belonged to the group with positive PCR at baseline, while only 1 patient with negative basal Bcl-2 (1.7%) experienced a clinical relapse (Pearson’s chi2= 0.058, Fisher exact test = 0.079). Among the 11 patients who showed a clinical relapse, 5 presented a positive Bcl-2 at relapse, 3 were negative (1 already at baseline),while in 3 this information is not evaluable. 2. Effect of local RT: After irradiation of the sole site of the disease, Bcl-2 rearranged cells disappeared in 19 of 38 patients positive at baseline (50%). In 17/38 (44.7%), MRD remained positive, while 2 patients refused to perform the analysis. A negative MRD after RT does not seem to correlate with a lower relapse probability. Only 1 patient died of breast cancer. 3. Effect of rituximab treatment in Bcl-2+ patients: Fourteen patients with persistently positive Bcl-2 after RT were treated with Rituximab 375 mg/m2 for 4 weekly administrations: 9 of them (64%) patients became negative. This result was only temporary in 4/9 cases (1 clinical relapse). Among persistently Bcl-2 positive patients after Rituximab, 1 clinical relapse was also observed. Conclusions In limited stage FL, despite a negative BM biopsy, Bcl-2/IgH rearranged cells can be found in the BM and/or PB, and they can disappear after local RT of the involved lymph node(s) in 50% of cases (19/38). The basal presence of Bcl-2+ cells in the BM/PB has a prognostic role: no clinical relapses were observed in Bcl-2 negative cases at baseline, except for 1 patient. Conversely, a negative MRD after radiotherapy does not seem to correlate with a better prognosis. -Rituximab therapy can induce a negativization of Bcl-2 in MRD-positive patients. Nevertheless, Rituximab treatment was only partially effective: negativization was observed in the majority of MRD-positive patients, but it was only temporary in a proportion of them. In Rituximab-treated patients, clinical relapses occurred only in the presence of MRD. -Not all clinical relapses were preceded by MRD positivity; further data are necessary to establish the usefullness of MRD monitoring over time. Prognosis of patients with early-stage FL treated with local RT + Rituximab in case of MRD persistence, is excellent: cause-specific survival=100%, EFS=70% projected at 10 years. Disclosures: No relevant conflicts of interest to declare.
- Published
- 2013
- Full Text
- View/download PDF
38. Mobilization of Hematopoietic Stem Cells by a Bendamustine-Containing Regimen in Hodgkin's Lymphoma
- Author
-
Carmelo Carlo-Stella, Alessandro Re, Luca Castagna, Alessandro Pulsoni, Antonella Anastasia, Anna Marina Liberati, Francesco Merli, Giorgia Annechini, Cristina Gabutti, Ercole Brusamolino, and Armando Santoro
- Subjects
Oncology ,Bendamustine ,medicine.medical_specialty ,business.industry ,Immunology ,Cell Biology ,Hematology ,Leukapheresis ,Vinorelbine ,Hodgkin's lymphoma ,medicine.disease ,Biochemistry ,Gemcitabine ,Surgery ,Regimen ,medicine.anatomical_structure ,Internal medicine ,medicine ,Bone marrow ,business ,Prospective cohort study ,medicine.drug - Abstract
Abstract 1914 Introduction: Bendamustine has demonstrated efficacy as single agent in several lymphoproliferative disorders, including Hodgkin's lymphoma (HL). Despite the wide use of this compound, alone or in combination, there are no published data regarding its mobilizing activity. In 2011, we started a phase II open-label prospective study with Bendamustine, Gemcitabine and Vinorelbine (BeGEV) to evaluate the efficacy of this induction regimen before high dose chemotherapy plus autologus stem cell transplant (ASCT). One of the study objectives was to detect the role of Bendamustine as part of a mobilizing regimen for peripheral blood stem cell (PBSC) collection. Methods: Between August 2011 and July 2012, 16 consecutive patients with relapsed/refractory HL were enrolled in a Phase II open-label prospective study with BeGEV followed by ASCT. The treatment schedule was: Bendamustine (90mg/sqm, days 2–3), Gemcitabine (800mg/sqm, day 1 and 4) and Vinorelbine (25mg/sqm, day 1) plus G-CSF 10mcg/Kg beginning on day 7 continued daily until the target yield would be reached. PBSC collection was planned starting from cycle 1 or from cycle 3 in case of bone marrow involvement. Three million CD34+/Kg were considered as the minimum cell dose established for a safety rescue. Other than successful rate of harvest, we evaluated the absolute number of collected CD34+ cells/Kg, the number of procedures performed per cycle, preleukapheresis circulating CD34+ cells/mcL, white blood cells (WBC) count and the day of first collection. Adverse events were also recorded. All patients provided written informed consent at the time of study inclusion. Results: Of the 16 patients enrolled, 14 already underwent leukapheresis. All patients were able to mobilize readily and all achieved the primary end point with at least 3.6 × 10>6 CD34+/Kg collected in a single cycle. The median yield of CD 34+/Kg collected was 7.8 × 10>6 CD34+/Kg (range, 3.6–15) after a median of 1 procedure (range, 1–2). The median preleukapheresis circulating CD34+/mcL and WBC count/mcL were 76/mcL (range, 25–201) and 21750/mcL (range, 11200–87080), respectively. The median day of first collection was 12 (range, 9–15). Six pts underwent leukapheresis at cycle 1, 7 pts at cycle 2 (6 pts due to logistic reasons,1 to Cytomegalovirus reactivation). One pt underwent leukapheresis at cycle 3 for personal reasons obtaining the highest yield (15×10>6 CD34+/Kg). Hematologic and non-hematologic side effects were acceptable and no toxic deaths occurred. One patient developed blood-pressure decrement during the apheresis but she was able to complete the procedure without sequelae. To date, 6 patients (43%) underwent ASCT with prompt engraftment. Data about neutrophils and platelets engraftment will be presented in the final analysis. Comparison with historical IGEV published data (Magagnoli et al, BMT 2007) is reported in Table 1. Conclusions: This is the first prospective study evaluating Bendamustine as mobilizing agent in resistant HL pts before ASCT. Despite the small sample, our results show that BeGEV regimen, combined with G-CSF support, can be successfully and safely used to mobilize PBSC. Disclosures: No relevant conflicts of interest to declare.
- Published
- 2012
- Full Text
- View/download PDF
39. Prognostic Role of PET-FDG Before Autologous Stem Cell Transplantation in Advanced Hodgkin's Lymphoma
- Author
-
Fabio Torelli, Robin Foà, Saveria Capria, Elena Cavalieri, Angela Matturro, Giorgia Annechini, Federico De Angelis, Giovanna Meloni, Alessandro Pulsoni, and Livia Santini
- Subjects
Oncology ,medicine.medical_specialty ,Subsequent Relapse ,business.industry ,Immunology ,Cell Biology ,Hematology ,Hodgkin's lymphoma ,medicine.disease ,Biochemistry ,Chemotherapy regimen ,Surgery ,Transplantation ,Autologous stem-cell transplantation ,ABVD ,B symptoms ,Internal medicine ,medicine ,Progression-free survival ,medicine.symptom ,business ,medicine.drug - Abstract
Abstract 1548 Poster Board I-571 PET-FDG (PET) has assumed in recent years a relevant role in the management of patients with Hodgkin Lymphoma (HL). In advanced stage HL, PET performed after two courses of ABVD chemotherapy has demonstrated a very high negative predictive value (NPV) and positive predictive value (PPV), and is presently considered the most relevant available prognostic factor in correlation with outcome. The aim of our study was to investigate the prognostic role of PET performed before autologous stem cell transplantation (ASCT) in resistant or relapsed HL. From June 2002 to December 2008, 32 patients with resistant or relapsed HL underwent a salvage chemotherapy program consisting of 3 or 4 courses of IEV or IGEV chemotherapy with peripheral blood stem cell collection followed by BEAM conditioned ASCT. Eight patients were consolidated with the BEACOPP regimen (2 to 4 courses) before transplantation. Median age was 30.4 years (range 21.6 – 61.4); 19 were males. At the time of enrolment, B symptoms were present in 4 patients and bulky and/or extranodal disease was recorded in 7 patients; the International Prognostic Score (IPS) was ≥2 in 15 patients. Sixteen patients were resistant to first-line chemotherapy, 13 were in first relapse (in 6 cases occurred earlier than 12 months), 3 were in second or subsequent relapse. Pre-transplant PET evaluation was negative in 21 cases: of these, 16 are currently in continuous complete remission (CCR) after a median follow-up of 30 months (range 7.0 – 59.0), while 5 have relapsed after a median of 10 months from transplant (range 3.0 – 11.0). Among the 11 patients autografted after a positive PET, 9 have relapsed after a median of 8.3 months (range 3.3 – 18.6). In the figure is shown the progression free survival of the patients stratified by pre-transplant PET. On the entire population the negative predictive value (NPV) of pre-transplant PET was 76.2%, while the positive predictive value (PPV) was 81.8%. Analyzing separately patients enrolled with a primary resistant disease, the NPV was 62.5% and the PPV was 75.0%. In the group of patients enrolled in relapse NPV was 84.6% and PPV was 100%. The prognostic value of the following parameters at the time of enrolment was evaluated: presence of bulky and/or extranodal disease, number of previous chemotherapy lines, chemoresistance/chemosensitivity to pre-transplant therapy evaluated by CT scan: no statistically significant correlation with the outcome was recorded. In conclusion, our preliminary results show a relevant prognostic role of pre-transplant PET in patients with advanced phase HL: 76% of patients with a negative pre-transplant PET obtained a CCR compared to only 18% of those with a positive pre-transplant PET (p = 0.003). The predictive role of pre-transplant PET is superior in patients undergoing the transplant program for a relapsed disease with respect to those with a primary resistant disease. Other prognostic factors need to be considered, although none of those so far examined showed a statistically significant role. These data need to be conclusively confirmed on a larger number of patients and a longer follow-up. Disclosures No relevant conflicts of interest to declare.
- Published
- 2009
- Full Text
- View/download PDF
40. Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study.
- Author
-
Santoro A, Mazza R, Pulsoni A, Re A, Bonfichi M, Zilioli VR, Salvi F, Merli F, Anastasia A, Luminari S, Annechini G, Gotti M, Peli A, Liberati AM, Di Renzo N, Castagna L, Giordano L, and Carlo-Stella C
- Subjects
- Adolescent, Adult, Aged, Antigens, CD34 metabolism, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bendamustine Hydrochloride administration & dosage, Bendamustine Hydrochloride adverse effects, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Disease-Free Survival, Female, Hematopoietic Stem Cell Mobilization, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Prospective Studies, Transplantation, Autologous, Vinblastine administration & dosage, Vinblastine adverse effects, Vinblastine analogs & derivatives, Vinorelbine, Young Adult, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Hematopoietic Stem Cell Transplantation methods, Hodgkin Disease drug therapy, Hodgkin Disease surgery
- Abstract
Purpose: This multicenter, open-label, phase II study evaluated the combination of bendamustine, gemcitabine, and vinorelbine (BeGEV) as induction therapy before autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory Hodgkin lymphoma (HL)., Patients and Methods: Patients with HL who were refractory to or had relapsed after one previous chemotherapy line were eligible. The primary end point was complete response (CR) rate after four cycles of therapy. Secondary end points were: overall response rate, stem-cell mobilization activity, and toxicity. Progression-free and overall survival were also evaluated., Results: In total, 59 patients were enrolled. After four cycles of therapy, 43 patients (73%) achieved CR, and six (10%) achieved partial response, for an overall response rate of 83%. The most common grade 3 to 4 nonhematologic toxicities included febrile neutropenia (n = 7) and infection (n = 4). Regarding hematologic toxicities, grade 3 to 4 thrombocytopenia and neutropenia were each experienced by eight patients (13.5%). CD34+ cells were successfully harvested in 55 of 57 evaluable patients, and 43 of 49 responding patients underwent ASCT. With a median follow-up of 29 months, the 2-year progression-free and overall survival rates for the total population were 62.2% and 77.6%, respectively. The same figures for patients undergoing autograft were 80.8% and 89.3%, respectively., Conclusion: This phase II study demonstrates that BeGEV is an effective salvage regimen able to induce CR in a high proportion of patients with relapsed or refractory HL before ASCT. These data provide a strong rationale for further development of the BeGEV regimen., (© 2016 by American Society of Clinical Oncology.)
- Published
- 2016
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.