17 results on '"Delforge, Michel"'
Search Results
2. Treatment emergent peripheral neuropathy in the CASSIOPEIA trial
- Author
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Fokkema, Cathelijne, primary, Moreau, Phillipe, additional, Van der Holt, Bronno, additional, Lambert, Jérôme, additional, Van Duin, Mark, additional, Wester, Ruth, additional, Jongen, Joost L.M., additional, Van Doorn, Pieter A., additional, Godet, Sophie, additional, Jie, Kon Siong, additional, Fitoussi, Olivier, additional, Delforge, Michel, additional, Keita-Manta, Awa, additional, Luycx, Odile, additional, Cupedo, Tom, additional, Van de Donk, Niels W.C.J., additional, Zweegman, Sonja, additional, Vermeulen, Jessica T., additional, Sonneveld, Pieter, additional, and Broijl, Annemiek, additional
- Published
- 2022
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- View/download PDF
3. Chimeric antigen receptor T-cell therapy for multiple myeloma: a consensus statement from The European Myeloma Network
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Moreau, Philippe, primary, Sonneveld, Pieter, additional, Boccadoro, Mario, additional, Cook, Gordon, additional, Mateos, Ma Victoria, additional, Nahi, Hareth, additional, Goldschmidt, Hartmut, additional, Dimopoulos, Meletios A., additional, Lucio, Paulo, additional, Bladé, Joan, additional, Delforge, Michel, additional, Hajek, Roman, additional, Ludwig, Heinz, additional, Facon, Thierry, additional, Miguel, Jesus F. San, additional, and Einsele, Hermann, additional
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- 2019
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4. European Myeloma Network recommendations on tools for the diagnosis and monitoring of multiple myeloma: what to use and when
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Caers, Jo, primary, Garderet, Laurent, additional, Kortüm, K. Martin, additional, O’Dwyer, Michael E., additional, van de Donk, Niels W.C.J., additional, Binder, Mascha, additional, Dold, Sandra Maria, additional, Gay, Francesca, additional, Corre, Jill, additional, Beguin, Yves, additional, Ludwig, Heinz, additional, Larocca, Alessandra, additional, Driessen, Christoph, additional, Dimopoulos, Meletios A., additional, Boccadoro, Mario, additional, Gramatzki, Martin, additional, Zweegman, Sonja, additional, Einsele, Hermann, additional, Cavo, Michele, additional, Goldschmidt, Hartmut, additional, Sonneveld, Pieter, additional, Delforge, Michel, additional, Auner, Holger W., additional, Terpos, Evangelos, additional, and Engelhardt, Monika, additional
- Published
- 2018
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- View/download PDF
5. Impact of extramedullary disease in patients with newly diagnosed multiple myeloma undergoing autologous stem cell transplantation: a study from the Chronic Malignancies Working Party of the EBMT
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Gagelmann, Nico, primary, Eikema, Diderik-Jan, additional, Iacobelli, Simona, additional, Koster, Linda, additional, Nahi, Hareth, additional, Stoppa, Anne-Marie, additional, Masszi, Tamás, additional, Caillot, Denis, additional, Lenhoff, Stig, additional, Udvardy, Miklos, additional, Crawley, Charles, additional, Arcese, William, additional, Mariette, Clara, additional, Hunter, Ann, additional, Leleu, Xavier, additional, Schipperus, Martin, additional, Delforge, Michel, additional, Pioltelli, Pietro, additional, Snowden, John A., additional, Itälä-Remes, Maija, additional, Musso, Maurizio, additional, van Biezen, Anja, additional, Garderet, Laurent, additional, and Kröger, Nicolaus, additional
- Published
- 2018
- Full Text
- View/download PDF
6. Low frequency mutations in ribosomal proteins RPL10 and RPL5 in multiple myeloma
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Hofman, Isabel J.F., primary, Patchett, Stephanie, additional, van Duin, Mark, additional, Geerdens, Ellen, additional, Verbeeck, Jelle, additional, Michaux, Lucienne, additional, Delforge, Michel, additional, Sonneveld, Pieter, additional, Johnson, Arlen W., additional, and De Keersmaecker, Kim, additional
- Published
- 2017
- Full Text
- View/download PDF
7. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma.
- Author
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Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, and San Miguel J
- Subjects
- Adult, Aged, Aged, 80 and over, Dexamethasone administration & dosage, Female, Follow-Up Studies, Humans, Kidney Function Tests, Male, Middle Aged, Multiple Myeloma diagnosis, Multiple Myeloma mortality, Retreatment, Survival Analysis, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma complications, Multiple Myeloma drug therapy, Renal Insufficiency diagnosis, Renal Insufficiency etiology
- Abstract
Pomalidomide + low-dose dexamethasone is effective and well tolerated for refractory or relapsed and refractory multiple myeloma after bortezomib and lenalidomide failure. The phase III trial MM-003 compared pomalidomide + low-dose dexamethasone with high-dose dexamethasone. This subanalysis grouped patients by baseline creatinine clearance ≥ 30 - < 60 mL/min (n=93, pomalidomide + low-dose dexamethasone; n=56, high-dose dexamethasone) or ≥ 60 mL/min (n=205, pomalidomide + low-dose dexamethasone; n=93, high-dose dexamethasone). Median progression-free survival was similar for both subgroups and favored pomalidomide + low-dose dexamethasone versus high-dose dexamethasone: 4.0 versus 1.9 months in the group with baseline creatinine clearance ≥ 30 - < 60 mL/min (P<0.001) and 4.0 versus 2.0 months in the group with baseline creatinine clearance ≥ 60 mL/min (P<0.001). Median overall survival for pomalidomide + low-dose dexamethasone versus high-dose dexamethasone was 10.4 versus 4.9 months (P=0.030) and 15.5 versus 9.2 months (P=0.133), respectively. Improved renal function, defined as an increase in creatinine clearance from < 60 to ≥ 60 mL/min, was similar in pomalidomide + low-dose dexamethasone and high-dose dexamethasone patients (42% and 47%, respectively). Improvement in progression-free and overall survival in these patients was comparable with that in patients without renal impairment. There was no increase in discontinuations of therapy, dose modifications, and adverse events in patients with moderate renal impairment. Pomalidomide at a starting dose of 4 mg + low-dose dexamethasone is well tolerated in patients with refractory or relapsed and refractory multiple myeloma, and of comparable efficacy if moderate renal impairment is present. This trial was registered with clinicaltrials.gov identifier 01311687 and EudraCT identifier 2010-019820-30., (Copyright© Ferrata Storti Foundation.)
- Published
- 2016
- Full Text
- View/download PDF
8. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone.
- Author
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Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, and San Miguel JF
- Subjects
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone administration & dosage, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Multiple Myeloma mortality, Multiple Myeloma pathology, Neoplasm Staging, Prognosis, Recurrence, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Chromosome Aberrations, Multiple Myeloma drug therapy, Multiple Myeloma genetics
- Abstract
Patients with refractory or relapsed and refractory multiple myeloma who no longer receive benefit from novel agents have limited treatment options and short expected survival. del(17p) and t(4;14) are correlated with shortened survival. The phase 3 MM-003 trial demonstrated significant progression-free and overall survival benefits from treatment with pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone among patients in whom bortezomib and lenalidomide treatment had failed. At an updated median follow-up of 15.4 months, the progression-free survival was 4.0 versus 1.9 months (HR, 0.50; P<0.001), and median overall survival was 13.1 versus 8.1 months (HR, 0.72; P=0.009). Pomalidomide plus low-dose dexamethasone, compared with high-dose dexamethasone, improved progression-free survival in patients with del(17p) (4.6 versus 1.1 months; HR, 0.34; P <0.001), t(4;14) (2.8 versus 1.9 months; HR, 0.49; P=0.028), and in standard-risk patients (4.2 versus 2.3 months; HR, 0.55; P<0.001). Although the majority of patients treated with high-dose dexamethasone took pomalidomide after discontinuation, the overall survival of patients treated with pomalidomide plus low-dose dexamethasone or high-dose dexamethasone was 12.6 versus 7.7 months (HR, 0.45; P=0.008) in patients with del(17p), 7.5 versus 4.9 months (HR, 1.12; P=0.761) in those with t(4;14), and 14.0 versus 9.0 months (HR, 0.85; P=0.380) in standard-risk subjects. The overall response rate was higher in patients treated with pomalidomide plus low-dose dexamethasone than in those treated with high-dose dexamethasone both among standard-risk patients (35.2% versus 9.7%) and those with del(17p) (31.8% versus 4.3%), whereas it was similar in patients with t(4;14) (15.9% versus 13.3%). The safety of pomalidomide plus low-dose dexamethasone was consistent with initial reports. In conclusion, pomalidomide plus low-dose dexamethasone is efficacious in patients with relapsed/refractory multiple myeloma and del(17p) and/or t(4;14). This study is registered at ClinicalTrials.gov as NCT01311687 and with EudraCT as 2010-019820-30., (Copyright© Ferrata Storti Foundation.)
- Published
- 2015
- Full Text
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9. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma.
- Author
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San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, and Dimopoulos MA
- Subjects
- Aged, Aged, 80 and over, Dexamethasone administration & dosage, Female, Follow-Up Studies, Humans, Male, Multiple Myeloma pathology, Recurrence, Retreatment, Survival Analysis, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Multiple Myeloma mortality
- Abstract
Pomalidomide is a distinct oral IMiD(®) immunomodulatory agent with direct antimyeloma, stromal-support inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status. Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response). These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatment. ClinicalTrials.gov: NCT01311687; EudraCT: 2010-019820-30., (Copyright© Ferrata Storti Foundation.)
- Published
- 2015
- Full Text
- View/download PDF
10. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide.
- Author
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Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, and Facon T
- Subjects
- Aged, Aged, 80 and over, Cross-Sectional Studies, Dexamethasone administration & dosage, Female, Humans, Lenalidomide, Male, Melphalan administration & dosage, Multiple Myeloma psychology, Prednisone administration & dosage, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Health Status, Multiple Myeloma diagnosis, Multiple Myeloma drug therapy, Quality of Life psychology
- Abstract
We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide., (Copyright© Ferrata Storti Foundation.)
- Published
- 2015
- Full Text
- View/download PDF
11. Extended follow up of high-dose melphalan and autologous stem cell transplantation after vincristine, doxorubicin, dexamethasone induction in amyloid light chain amyloidosis of the prospective phase II HOVON-41 study by the Dutch-Belgian Co-operative Trial Group for Hematology Oncology.
- Author
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Hazenberg BP, Croockewit A, van der Holt B, Zweegman S, Bos GM, Delforge M, Raymakers RA, Sonneveld P, Vellenga E, Wijermans PW, von dem Borne PA, van Oers MH, de Weerdt O, Spoelstra FM, and Lokhorst HM
- Subjects
- Adult, Aged, Amyloidosis diagnosis, Amyloidosis etiology, Amyloidosis mortality, Antineoplastic Combined Chemotherapy Protocols adverse effects, Combined Modality Therapy, Dexamethasone administration & dosage, Doxorubicin administration & dosage, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Remission Induction, Transplantation, Autologous, Treatment Outcome, Vincristine administration & dosage, Amyloidosis therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Hematopoietic Stem Cell Transplantation adverse effects, Melphalan administration & dosage
- Abstract
In a prospective multicenter phase II study, we evaluated the effect of three courses of vincristine, doxorubicin and dexamethasone followed by high-dose melphalan and autologous stem cell transplantation on an intention-to-treat basis. Sixty-nine newly diagnosed patients with amyloid light chain amyloidosis were included between November 2000 and January 2006: 37 men and 32 women with a median age of 56 years, including 46% of patients with cardiac and 22% of patients with involvement of 3 or 4 organs. Initial results presented in 2008 showed a 4-year overall survival rate of 62% among all the patients, while the 4-year survival rate after transplantation was 78%. Here we report the long-term follow-up data after a median follow up of 115 months of the patients still alive. Median survival of all patients was 96 months from registration and for the transplanted patients ten years from the date of transplantation. Twelve (12%) patients died during induction therapy with vincristine, doxorubicin and dexamethasone, including 8 patients (12%) due to treatment-related mortality. Two patients died within one month following high-dose melphalan. We conclude that vincristine, doxorubicin and dexamethasone should not be applied as induction therapy for intensification in amyloid light chain amyloidosis. However, a 2-step approach consisting of a non-intensive less toxic induction therapy followed by high-dose melphalan and autologous stem cell transplantation may result in extended survival in newly diagnosed patients with amyloid light chain amyloidosis (clinicaltrials.gov identifier: 01207094)., (Copyright© Ferrata Storti Foundation.)
- Published
- 2015
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- View/download PDF
12. Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial.
- Author
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Dimopoulos MA, Delforge M, Hájek R, Kropff M, Petrucci MT, Lewis P, Nixon A, Zhang J, Mei J, and Palumbo A
- Subjects
- Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Humans, Induction Chemotherapy, Lenalidomide, Maintenance Chemotherapy, Melphalan administration & dosage, Prednisone administration & dosage, Surveys and Questionnaires, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Quality of Life
- Abstract
The MM-015 trial assessed the effect of lenalidomide-based therapy on health-related quality of life. Patients (n=459) with newly diagnosed multiple myeloma aged 65 years or over were randomized 1:1:1 to nine 4-week cycles of lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance; or lenalidomide, melphalan, and prednisone, or melphalan and prednisone, with no maintenance therapy. Patients completed health-related quality of life questionnaires at baseline, after every third treatment cycle, and at treatment end. Health-related quality of life improved in all treatment groups during induction therapy. Patients receiving lenalidomide maintenance had the most pronounced improvements, Global Health Status/Quality of Life (P<0.05), Physical Functioning (P<0.01), and Side Effects of Treatment (P<0.05) out of 6 pre-selected health-related quality of life domains. More patients receiving lenalidomide maintenance achieved minimal important differences (P<0.05 for Physical Functioning). Therefore, lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in patients with newly diagnosed multiple myeloma. (Clinicaltrials.gov identifier NCT00405756).
- Published
- 2013
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13. Value of infliximab (Remicade®) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group.
- Author
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Baron F, Suciu S, Amadori S, Muus P, Zwierzina H, Denzlinger C, Delforge M, Thyss A, Selleslag D, Indrak K, Ossenkoppele G, and de Witte T
- Subjects
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal adverse effects, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Female, Humans, Infliximab, Male, Medication Adherence, Middle Aged, Myelodysplastic Syndromes mortality, Survival Analysis, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Antibodies, Monoclonal therapeutic use, Antineoplastic Agents therapeutic use, Myelodysplastic Syndromes drug therapy
- Abstract
Tumor-necrosis factor alpha activity has been correlated to ineffective erythropoiesis in lower risk myelodysplastic syndromes. Infliximab (Remicade(®)) is an anti-tumor necrosis factor alpha chimeric antibody that is used in the treatment of patients with rheumatoid arthritis or Crohn's disease. Forty-six patients with myelodysplastic syndromes and a relatively low risk of developing acute leukemia were included in a randomized phase II study assessing the therapeutic activity of two dosages of infliximab administration (3 mg/kg vs. 5 mg/kg). The primary end point was the response rate. Responses were observed in 3 of 22 patients (13.1%) randomized to the 3 mg/kg arm, versus 0 of 21 patients randomized in the 5 mg/kg arm. According to the statistical design of the current study, neither of the two infliximab dose schedules tested showed sufficient activity as a single agent in this cohort of unselected patients with early myelodysplastic syndrome.
- Published
- 2012
- Full Text
- View/download PDF
14. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial.
- Author
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de Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellström-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, and Willemze R
- Subjects
- Adult, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Humans, Leukemia, Myeloid, Acute mortality, Middle Aged, Myelodysplastic Syndromes mortality, Neoplasms, Second Primary mortality, Neoplasms, Second Primary therapy, Survival Analysis, Transplantation, Autologous, Transplantation, Homologous, Hematopoietic Stem Cell Transplantation methods, Leukemia, Myeloid, Acute therapy, Myelodysplastic Syndromes therapy
- Abstract
Background: Allogeneic stem cell transplantation is usually considered the only curative treatment option for patients with advanced or transformed myelodysplastic syndromes in complete remission, but post-remission chemotherapy and autologous stem cell transplantation are potential alternatives, especially in patients over 45 years old., Design and Methods: We evaluated, after intensive anti-leukemic remission-induction chemotherapy, the impact of the availability of an HLA-identical sibling donor on an intention-to treat basis. Additionally, all patients without a sibling donor in complete remission after the first consolidation course were randomized to either autologous peripheral blood stem cell transplantation or a second consolidation course consisting of high-dose cytarabine., Results: The 4-year survival of the 341 evaluable patients was 28%. After achieving complete remission, the 4-year survival rates of patients under 55 years old with or without a donor were 54% and 41%, respectively, with an adjusted hazard ratio of 0.81 (95% confidence interval [95% CI], 0.49-1.35) for survival and of 0.67 (95% CI, 0.42-1.06) for disease-free survival. In patients with intermediate/high risk cytogenetic abnormalities the hazard ratio in multivariate analysis was 0.58 (99% CI, 0.22-1.50) (P=0.14) for survival and 0.46 (99% CI, 0.22-1.50) for disease-free survival (P=0.03). In contrast, in patients with low risk cytogenetic characteristics the hazard ratio for survival was 1.17 (99% CI, 0.40-3.42) and that for disease-free survival was 1.02 (99% CI, 0.40-2.56). The 4-year survival of the 65 patients randomized to autologous peripheral blood stem cell transplantation or a second consolidation course of high-dose cytarabine was 37% and 27%, respectively. The hazard ratio in multivariate analysis was 1.22 (95% CI, 0.65-2.27) for survival and 1.02 (95% CI, 0.56-1.85) for disease-free survival., Conclusions: Patients with a donor and candidates for allogeneic stem cell transplantation in first complete remission may have a better disease-free survival than those without a donor in case of myelodysplastic syndromes with intermediate/high-risk cytogenetics. Autologous peripheral blood stem cell transplantation does not provide longer survival than intensive chemotherapy.
- Published
- 2010
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15. Thalidomide in induction treatment increases the very good partial response rate before and after high-dose therapy in previously untreated multiple myeloma.
- Author
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Lokhorst HM, Schmidt-Wolf I, Sonneveld P, van der Holt B, Martin H, Barge R, Bertsch U, Schlenzka J, Bos GM, Croockewit S, Zweegman S, Breitkreutz I, Joosten P, Scheid C, van Marwijk-Kooy M, Salwender HJ, van Oers MH, Schaafsma R, Naumann R, Sinnige H, Blau I, Delforge M, de Weerdt O, Wijermans P, Wittebol S, Duersen U, Vellenga E, and Goldschmidt H
- Subjects
- Adult, Aged, Angiogenesis Inhibitors therapeutic use, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Cytarabine therapeutic use, Daunorubicin therapeutic use, Dexamethasone therapeutic use, Female, Humans, Male, Middle Aged, Remission Induction, Thioguanine therapeutic use, Treatment Outcome, Vincristine therapeutic use, Medical Oncology methods, Multiple Myeloma drug therapy, Thalidomide therapeutic use
- Abstract
In the prospective phase 3 HOVON-50/GMMG-HD3 trial, patients randomized to TAD (thalidomide, doxorubicin, dexamethasone) had a significantly higher response rate (at least PR) after induction compared with patients randomized to VAD (vincristine, adriamycin, dexamethasone, 72% vs. 54%, p<0.001). Complete remission (CR) and very good partial remission (VGPR) were also higher after TAD. After High Dose melphalan 200mg/m(2) response was comparable in both arms, 76% and 79% respectively. However, CR plus VGPR were significantly higher in the patients randomized to TAD (49% vs. 32%, p<0.001). CTC grade 3-4 adverse events were similar in both arms.
- Published
- 2008
- Full Text
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16. The role of stem cell source in autologous hematopoietic stem cell transplantation for patients with myelodysplastic syndromes.
- Author
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de Witte T, Brand R, van Biezen A, Delforge M, Biersack H, Or R, Meloni G, Bandini B, Sierra J, Kroger N, Gratwohl A, and Niederwieser D
- Subjects
- Analysis of Variance, Disease-Free Survival, Hematopoietic Stem Cell Transplantation mortality, Hematopoietic Stem Cells physiology, Humans, Leukemia, Myeloid, Acute blood, Leukemia, Myeloid, Acute therapy, Multivariate Analysis, Myelodysplastic Syndromes blood, Myelodysplastic Syndromes mortality, Recurrence, Registries, Retrospective Studies, Survival Analysis, Transplantation, Autologous, Hematopoietic Stem Cell Transplantation methods, Hematopoietic Stem Cells pathology, Myelodysplastic Syndromes therapy
- Abstract
Background and Objectives: Intensive chemotherapy followed by autologous hematopoietic stem cell transplantation (HSCT) is a curative treatment option for patients with myelodysplastic syndromes (MDS). Peripheral blood (PB) HSCT was introduced in 1992 and PB has become the source of choice of autologous stem cells worldwide. Autologous PB stem cells result in faster hematopoietic recovery, but may be associated with a higher risk of relapse., Design and Methods: We analyzed the data of 336 patients transplanted after 1992 with either bone marrow (BM) (n=104) or PB (n=232)., Results: Various factors had an impact on event-free survival in univariate analysis: age hazard ratio [HR]=1.1 per 10 years; p=0.12), source of stem cells (HR=1.2, p=0.22), interval between diagnosis and transplantation (HR=1.0 per month; p=0.87), and therapy-related vs primary disease (HR=0.5; p=0.002). In the multivariate Cox model, the event-free survival was not different after PB or BM HSCT with a HR of 0.93 (95% confidence interval of 0.67 - 1.30; p=0.67). The relapse risk after transplantation with stem cells from either source was similar with a HR of 1.1. A significant interaction (p=0.02) between age and the source of stem cells indicated a more favorable potential of autologous PB HSCT in young age groups., Interpretation and Conclusions: Autologous PB and BM HSCT result in equivalent outcomes. Therefore, given the more rapid hematopoietic recovery PB is the preferred source of stem cells.
- Published
- 2006
17. Mobilization of hematopoietic progenitors in low-grade myelodysplastic syndromes.
- Author
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Mijovic A, Delforge M, Sekhavat M, Czepulkowski B, and Mufti GJ
- Subjects
- Adult, Feasibility Studies, Female, Hematopoietic Stem Cells, Humans, Male, Middle Aged, Treatment Outcome, Hematopoietic Stem Cell Mobilization methods, Myelodysplastic Syndromes therapy
- Abstract
Mobilization of hematopoietic progenitors in 15 untreated patients with low-grade myelodysplastic syndrome (IPSS score < or =1) resulted in poor yields in seven patients; moreover, mobilized cells had abnormal cytogenetics and defective in vitro growth. Only three out of 15 patients had adequate progenitor cell collections for potential use in autologous transplantation.
- Published
- 2006
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