14 results on '"Soledad Zabaljauregui"'
Search Results
2. Survival analysis of transplant-eligible newly-diagnosed multiple myeloma patients harboring t(4;14), t(14;16), and/or del(17p) in the real-world setting
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David Garrido, Irma Slavutsky, Eloisa Riva, Camila Peña, Natalia Schutz, Luz Tarín-Arzaga, Humberto Martínez-Cordero, Virginia Bove, Rocío Osorio, Mauricio Chandía, Cecilia Beltrán, Javier Schulz, Daniela Cardemil, Carolina Contreras, Carmen Gloria Vergara, Javiera Donoso, Marcela Espinoza, Gabriel La Rocca, Hernán López-Vidal, Pilar León, Christine Rojas Hopkins, Pablo Soto, Sandra Aranda, Vivianne Torres, Macarena Roa, Paola Ochoa, Patricio Jose Duarte, Guillermina Remaggi, Sebastián Yantorno, Ariel Corzo, Soledad Zabaljauregui, Claudia Shanley, Sergio Lopresti, Sergio Orlando, Verónica Verri, Luis Quiroga, Carlos García, Vanesa Fernández, Jhoanna Ramirez, Azucena Verduga, Alicia Molina, María Pacheco, William Mantilla, Alex Mite, Inés Reyes, Brenner Sabando, Francisca Ramírez, Claudia Sossa, Virginia Abello, Henry Idrobo, Kenny Mauricio Galvez Cardenas, Domingo Saavedra, Guillermo Quintero, Raimundo Gazitúa, Lina Gaviria, Rigoberto Gomez, Mónica Osuna, Alicia Henao-Uribe, Omar Cantú-Martínez, David Gómez-Almaguer, Yarely Itzayana García-Navarrete, Antonio Cruz-Mora, Yahveth Cantero-Fortiz, Guillermo J Ruiz-Argüelles, and Dorotea Fantl
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Cancer Research ,Oncology - Abstract
Cytogenetic abnormalities (CA) such as t(4;14), t(14;16), and del(17p), are associated with a poor prognosis in Multiple Myeloma (MM) patients. However, there is scarce information regarding the Latin-American population. This study aims to analyze the impact of t(4;14), t(14;16), and del(17p) on the progression-free survival (PFS) and overall survival (OS) of transplant-eligible newly-diagnosed MM (NDMM) patients in Latin America. Retrospective survival analysis based on the Grupo de Estudio Latinoamericano de MM (GELAMM) registry, including all adult patients with NDMM harboring CA t(4;14), t(14;16), and/or del(17p). Fifty-nine patients were included; the median age was 57 years, 55.9% males, 22% ISS-I, 25.4% ISS-II, and 47.5% ISS-III. The majority (89.8%) had 1 alteration, whereas 10.2% had del(17p) and t(4;14). The frequencies of CA were del(17p) in 61.0%, t(4;14) in 25.4%, and t(14;16) in 3,4%. Autologous stem cell transplantation (ASCT) was performed in 61.0% of cases. Five-year OS for the entire cohort was 60.8% and 5-year PFS was 28.1%. Bortezomib-based induction regimen (BBR) (P = 0.029), consolidation with ASCT (P0.001), and maintenance therapy (P = 0.004) were associated with an improved 5-year OS. In the multivariate analysis, ASCT was the only variable with a positive impact on OS (HR 0.11, 95% CI 0.033 to 0.34, P0.001). The median PFS presented a non-statistically significant benefit in BBR, ASCT, and maintenance therapy groups. BBR induction, ASCT, and maintenance therapy were associated with improved OS in high-risk NDMM patients.
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- 2022
3. Real-world outcomes for the treatment of relapsed/refractory multiple myeloma patients with lenalidomide-dexamethasone combinations in a Latin American country. A retrospective cohort study from grupo argentino de mieloma múltiple
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Sergio Orlando, Paola Ochoa, Cecilia Foncuberta, Patricio Duarte, Soledad Zabaljauregui, Florencia Aizpurua, Sergio Lopresti, Dorotea Fantl, Gonzalo Garate, Jorge Milone, Dardo Riveros, Natalia Schutz, Claudia Shanley, Sebastian Yantorno, and Elvira Giannini
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Oncology ,medicine.medical_specialty ,Latin Americans ,business.industry ,Real world outcomes ,Retrospective cohort study ,Refractory Multiple Myeloma ,Hematology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Relapsed refractory ,Medicine ,business ,Dexamethasone ,Multiple myeloma ,030215 immunology ,medicine.drug ,Lenalidomide - Abstract
We compared the efficacy of lenalidomide-dexamethasone (Rd) based treatments for relapsed/refractory multiple myeloma patients (pts), in a real-world setting. In addition, we evaluated adverse even...
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- 2021
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4. Different outcomes for transplant-eligible newly diagnosed multiple myeloma patients in Latin America according to the public versus private management: a GELAMM study
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Ines Reyes, Sandra Aranda, Alicia Molina, Pilar León, Claudia Shanley, Christine Rojas Hopkins, Carmen Gloria Vergara, Macarena Roa, Humberto Martinez-Cordero, Carolina Contreras, Alicia Henao-Uribe, Veronica Verri, Guillermo J. Ruiz-Argüelles, Marcela Espinoza, Guillermina Remaggi, Eloisa Riva, Raimundo Gazitua, Jhoanna Ramirez, Vanesa Fernandez, Guillermo Quintero, Gabriel La Rocca, Yahveth Cantero-Fortiz, Soledad Zabaljauregui, Virginia Bove, Sergio Orlando, Claudia Sossa, Carlos Cristóbal Medina García, Omar Cantú-Martínez, Mónica Osuna, Kenny Mauricio Gálvez Cárdenas, Cecilia Beltran, Sergio Lopresti, Henry Idrobo, Pablo Soto, María Pacheco, Virginia Abello, Vivianne Torres, Luis Quiroga, Alex Mite, Patricio Duarte, Domingo Saavedra, Javiera Donoso, Paola Ochoa, Francisca Ramírez, Rigoberto Gomez, Yarely Itzayana García-Navarrete, Dorotea Fantl, Natalia Schutz, Ariel Corzo, Sebastian Yantorno, David Gómez-Almaguer, Rocío Osorio, Luz Tarín-Arzaga, Antonio Cruz-Mora, Daniela Cardemil, Javier Schulz, Camila Peña, Lina Gaviria, Brenner Sabando, Hernán López-Vidal, and Mauricio Chandia
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Cancer Research ,medicine.medical_specialty ,Latin Americans ,Newly diagnosed ,Transplantation, Autologous ,03 medical and health sciences ,0302 clinical medicine ,Autologous stem-cell transplantation ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Overall survival ,medicine ,Humans ,Multiple myeloma ,business.industry ,Hematopoietic Stem Cell Transplantation ,Hematology ,medicine.disease ,Latin America ,Treatment Outcome ,Oncology ,Late diagnosis ,030220 oncology & carcinogenesis ,Proteasome inhibitor ,Private healthcare ,Multiple Myeloma ,business ,030215 immunology ,medicine.drug - Abstract
The aim of this study was to describe clinical and survival characteristics of transplant-eligible multiple myeloma (MM) patients in Latin America (LA), with a special focus on differences between public and private healthcare facilities. We included 1293 patients diagnosed between 2010 and 2018. A great disparity in outcomes and survival between both groups was observed. Late diagnosis and low access to adequate frontline therapy and ASCT in public institutions probably explain these differences. Patients treated with novel drug induction protocols, followed by autologous stem cell transplantation (ASCT) and maintenance, have similar overall survival compared to that published internationally.
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- 2020
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5. Real world outcomes with <scp>Bortezomib Thalidomide dexamethasone</scp> and <scp>Cyclophosphamide Bortezomib dexamethasone</scp> induction treatment for transplant eligible multiple myeloma patients in a Latin American country. A Retrospective Cohort Study from Grupo Argentino de Mieloma Múltiple
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Guillermina Remaggi, Sergio Lopresti, Sergio Orlando, Patricio Duarte, Soledad Zabaljauregui, Dorotea Fantl, Claudia Shanley, Natalia Schutz, Verónica Verri, Sebastian Yantorno, Paola Ochoa, Carlos A. García, Luis Quiroga, Vanesa Fernandez, and Ariel Corzo
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Cancer Research ,medicine.medical_specialty ,Cyclophosphamide ,business.industry ,Bortezomib ,Retrospective cohort study ,Hematology ,General Medicine ,medicine.disease ,Thalidomide ,03 medical and health sciences ,Regimen ,0302 clinical medicine ,Autologous stem-cell transplantation ,Oncology ,Median follow-up ,030220 oncology & carcinogenesis ,Internal medicine ,Medicine ,business ,Multiple myeloma ,030215 immunology ,medicine.drug - Abstract
Data about treatment outcomes and toxicity in Latin America are scarce. There are differences with central countries based on access to healthcare system and socioeconomic status. Argentinean Society of Hematology recommends bortezomib-based triplets for induction treatment of transplant eligible newly diagnosed multiple myeloma patients. Most common options are CyBorD (cyclophosphamide, bortezomib and dexamethasone) and VTD (bortezomib, thalidomide and dexamethasone). Main goal of our retrospective, multicentric study was to compare very good partial response rate (VGPR) or better after induction treatment in a real-world setting in Argentina. Secondary objectives included comparison of complete response (CR) post-induction and after bone marrow transplantation, grade 3-4 adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Three hundred twenty-two patients were included (median age at diagnosis: 57 years; 52% male; 28% had ISS3; 14% with high-risk cytogenetics; median follow up: 34 months). CyBorD was indicated in 74% and 26% received VTD. In VTD arm, 72.62% of patients achieved at least VGPR vs 53.36% receiving CyBorD (odds ratio, OR: 1.96 [95% confidence interval, CI: 1.08-3.57; P = .026] after adjusting by age, ISS [International Staging System], lactate dehydrogenase levels (LDH) and cytogenetic risk. Difference in VGPR was 19.26% (95% CI: 15-24). CR rate were 35.92% (VTD) vs 22.55% (CyBorD) (adjusted OR: 2.13 [95% CI: 1.12-4.05]). Difference in CR was 13.37% (95% CI: 9.6-17.53). Adverse events (AEs) were more common with VTD (69.05% vs 55.46% for CyBorD; P = .030), especially grade 3-4 neuropathy (P = .005) and thrombosis (P = .001). Thromboprophylaxis was inadequate in 20.24% of patients. Hematological AEs were more common with CyBorD, especially thrombocytopenia (P = .017). PFS and OS at 24 months were not different between treatments. In this real-world setting, VTD was associated with better CR and VGPR than CyBorD. Nevertheless, CyBorD continues to be the preferred induction regimen in Argentina, based on safety profile. Frontline autologous stem cell transplantation improves quality of responses, especially in countries with limited access to new drugs.
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- 2020
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6. Clinical characteristics and evolution of hematological patients and COVID-19 in Argentina: a report from the Argentine Society of Hematology
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Ana L, Basquiera, Mercedes J, García, Juliana, Martinez Rolón, Julieta, Olmedo, Julia, Laviano, Rubén, Burgos, Gastón, Caeiro, Guillermina, Remaggi, Pablo, Raña, Mariano, Paoletti, Carlos M, González, Isolda, Fernández, Astrid, Pavlovsky, Maria A, Perusini, Andrea, Rodriguez, Luciana, Guanchiale, Analia, Carvani, Laura, Mandrile, Flavia, Figueroa, Angeles, Vicente Reparaz, Patricia N, Fragapane Mathus, Gonzalo, Garate, María E, Fauque, Gustavo, Kantor, Soledad, Cruset, Jacqueline S, Gonzalez Lorch, Milagros, Szelagowski, María P, Giarini, Natalia, Oliveira, María C, García, María V, Ventriglia, Patricio H, Pereyra, Daniel R, Gutierrez, Gustavo, Kusminsky, Josefina, Troccoli, María J, Freitas, Santiago, Cranco, Natalia, Del V Sanchez, Irene, Rey, María E, Funes, Sol, Jarchum, Julian, Freue, Augusto, Miroli, Osvaldo, Guerrero, Lisa, López Ares, Reinaldo, Campestri, Victor, Bove, Graciela N, Salinas, María, Cabrejo, Jorge H, Milone, Soledad, Zabaljauregui, Daniel, Gotta, Juan Carlos, Dupont, and German, Stemmelin
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COVID-19 Testing ,SARS-CoV-2 ,Argentina ,COVID-19 ,Humans ,Hematology ,Middle Aged - Abstract
Individuals with malignancies and COVID-19 have a lower survival compared with the general population. However, the information about the impact of COVID-19 on the whole hematological population is scarce. We aimed to describe the 30th day overall survival (OS) after COVID-19 infection in patients with a hematological disease in Argentina. A completely anonymous survey from the Argentine Society of Hematology was delivered to all the hematologists in Argentina; it started in April 2020. A cut-off to analyze the data was performed in December 2020 and, finally, 419 patients were reported and suitable for the analysis (average age: 58 years, 90% with malignant diseases). After the COVID-19 diagnosis, the 30-day OS for the whole population was 80.2%. From the entire group (419), 101 (24.1%) individuals required intensive care unit admission, where the 30-day OS was 46.6%. Among allogeneic stem cell transplant recipients, the 30-day OS was 70.3%. Factors associated with a low OS were two or more comorbidities, an active hematological disease and history of chemotherapy. In individuals with the three factors, the 30-day OS was 49.6% while the 30-day OS in those without those factors was 100%. Patients with hematological diseases have a higher mortality than the general population. This group represents a challenge and requires careful decision-making of the treatment in order not to compromise the chances of cure.El presente estudio tuvo por objetivo primario conocer la mortalidad de pacientes con enfermedad hematológica que presentaron infección por COVID-19 en Argentina. Para ello se difundió una encuesta desde la Sociedad Argentina de Hematología (SAH) entre los hematológos para informar sobre los pacientes con enfermedades hematológicas y diagnóstico de infección por SARS- CoV-2, entre el 19/4/2020, y el 7/12/2020. Se incluyeron individuos de todas las edades con diagnóstico de enfermedad hematológica benigna o maligna e infección por SARS-CoV-2 confirmada por técnica de RTPCR. Se analizaron 419 pacientes (mediana 58 años; 90% enfermedades malignas). La supervivencia al día 30 fue de 80.2%. La supervivencia fue menor en aquellos que requirieron internación (74.2%), cuidados intensivos (46.6%) y asistencia respiratoria mecánica (36.8%). Entre los trasplantados alogénicos la supervivencia fue 70.3%. Los factores vinculados a la supervivencia global fueron las comorbilidades, el estado de la enfermedad al momento de la infección y el antecedente de quimioterapia. Se pudo establecer un score en el que aquellos que tuvieron un puntaje de 4 alcanzaron una supervivencia del 49.6% al día 30, mientras que la de los pacientes con score 0 fue del 100% a 30 días. En comparación con la población general, los pacientes con enfermedades hematológicas presentan una mayor mortalidad vinculada al COVID-19, motivo por el cual es primordial definir pautas destinadas a disminuir la exposición de los mismos sin comprometer las posibilidades de beneficiarse del tratamiento de la enfermedad de base.
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- 2021
7. <scp>PET</scp> ‐adapted therapy after three cycles of <scp>ABVD</scp> for all stages of Hodgkin lymphoma: results of the <scp>GATLA LH</scp> ‐05 trial
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María Cabrejo, Horacio Fernandez Grecco, Ana Ines Varela, Astrid Pavlovsky, Eriberto Roveri, Romina Mariano, Francisco Sakamoto, Rossana L. Taus, Isolda Fernandez, Virginia Prates, Federico Sackmann, Silvia Rudoy, G. Remaggi, Ider Cerutti, Soledad Zabaljauregui, María Florencia Casale, Nicolas Matias Kurgansky, Ana Lisa Basquiera, Gustavo Milone, Pedro Negri, Vanesa Castano, Maximiliano Luis Riddick, Vanina Cabane, Lucia Zoppegno, Claudia Venturini, Silvia Saba, and Santiago Pavlovsky
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Adult ,Male ,Oncology ,medicine.medical_specialty ,Adolescent ,Estadística y Probabilidad ,Matemáticas ,Vinblastine ,Bleomycin ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,PET ADAPTED THERAPY ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,PROGNOSTIC FACTORS ,medicine ,Humans ,Prospective Studies ,HODGKIN LYMPHOMA ,Aged ,Aged, 80 and over ,business.industry ,ABVD ,Hematology ,Middle Aged ,Hodgkin Disease ,Survival Analysis ,Dacarbazine ,Doxorubicin ,Positron-Emission Tomography ,030220 oncology & carcinogenesis ,Hodgkin lymphoma ,Female ,STAGE AT DIAGNOSIS ,business ,Stage at diagnosis ,CIENCIAS NATURALES Y EXACTAS ,030215 immunology ,medicine.drug - Abstract
The role of Ann Arbor staging in determining treatment intensity after achieving a negative positron emission tomography (PET) has not been established in classical Hodgkin lymphoma (cHL). Patients with stage I–IV cHL, received three cycles of ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) and an interim PET scan (PET3). PET3-negative patients received no further therapy. PET3-positive patients received three additional cycles of ABVD plus involved-field radiation therapy or salvage chemotherapy, if refractory to ABVD, and were re-evaluated by PET scan (PET6). Study endpoints were 3-year progression-free survival (PFS) and overall survival (OS) rates. Two hundred and thirty-nine patients with early-stage and 138 with advanced-stage were evaluable. Overall, 260 patients (70%) were PET3-negative and had higher 3-year PFS (90% vs. 65%; P < 0 0001) and OS (98% vs. 92%; P = 0 007) rates than PET3-positive patients. All PET3-negative patients, regardless of disease stage at diagnosis, achieved similarly good PFS (90–91%; P = 0 76) and OS (97–99%). The only independent prognostic factor for PFS was PET3-negativity (Hazard ratio 3 8; 95% confidence interval 2 4–6 3; P < 0 0001). This study suggests that cHL patients who achieve a negative PET3 following ABVD have an excellent outcome, regardless of stage at diagnosis. An appropriately powered, phase III trial will be necessary to confirm these findings. Fil: Pavlovsky, Astrid. Fundación Para Combatir la Leucemia; Argentina. Centro de Hematología Pavlovsky; Argentina Fil: Fernández, Isolda. Fundación Para Combatir la Leucemia; Argentina. Centro de Hematología Pavlovsky; Argentina Fil: Kurgansky, Nicolas. Doctus; Argentina Fil: Prates, Virginia. Hospital Italiano de La Plata; Argentina Fil: Zoppegno, Lucia. Hospital General San Martín; Argentina Fil: Negri, Pedro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto Privado de Hematología y Hemoterapia; Argentina Fil: Milone, Gustavo. Fundación Para Combatir la Leucemia; Argentina Fil: Cerutti, Ider. Idhea Clinica Hematologica Dr Cerutti Ider; Argentina Fil: Zabaljauregui, Soledad. Academia Nacional de Medicina de Buenos Aires; Argentina Fil: Mariano, Romina. Provincia de Entre Rios. Hospital San Martin; Argentina Fil: Grecco, Horacio F.. Sanatorio Dr. Julio Méndez; Argentina Fil: Basquiera, Ana Lisa. Hospital Privado Universitario de Cordoba.; Argentina Fil: Saba, Silvia. Hospital Rodolfo Rossi; Argentina Fil: Rudoy, Silvia. Clínica Modelo de Morón; Argentina Fil: Sackmann, Federico. Fundación Para Combatir la Leucemia; Argentina Fil: Castano, Vanesa. Idhea Clinica Hematologica Dr Cerutti Ider; Argentina Fil: Remaggi, Guillermina. Fundación Para Combatir la Leucemia; Argentina Fil: Cabrejo, María del Rosario. Sanatorio Dr. Julio Méndez; Argentina Fil: Roveri, Eriberto. Idhea Clinica Hematologica Dr Cerutti Ider; Argentina Fil: Casale, María Florencia. Instituto Privado de Hematología y Hemoterapia; Argentina. Hospital General Centeno; Argentina Fil: Cabane, Vanina. Clínica Dr. Roberto Raña; Argentina Fil: Taus, Rossana. Hospital Rodolfo Rossi; Argentina Fil: Venturini, Claudia. Instituto Privado de Hematología y Hemoterapia; Argentina Fil: Sakamoto, Francisco. Instituto Privado de Hematología y Hemoterapia; Argentina Fil: Varela, Ana I.. Sanatorio Las Lomas Sociedad Anonima.; Argentina Fil: Riddick, Maximiliano Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Matemáticas; Argentina Fil: Pavlovsky, Santiago. Fundación Para Combatir la Leucemia; Argentina
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- 2019
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8. PET‐ADAPTED THERAPY AFTER THREE CYCLES OF ABVD FOR ALL STAGES OF HODGKIN LYMPHOMA: LONG TERM FOLLOW UP OF THE GATLA LH‐05 TRIAL
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L. Fiad, F. Negri, L. Guanchiale, Pedro Negri, F. Sackman, L. Ferrari, Eriberto Roveri, A. Cerutti, María Cabrejo, A. Enrico, Santiago Pavlovsky, F. Giuliani, A. Quartara, J. Maradei, Lucia Zoppegno, Maximiliano Luis Riddick, Astrid Pavlovsky, Nicolas Matias Kurgansky, C. Gumpel, C. M. Gonzalez, Virginia Prates, Silvia Rudoy, G. Remaggi, Romina Mariano, Ana Ines Varela, Isolda Fernandez, and Soledad Zabaljauregui
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Cancer Research ,medicine.medical_specialty ,Oncology ,ABVD ,business.industry ,Long term follow up ,Medicine ,Hodgkin lymphoma ,Hematology ,General Medicine ,Radiology ,business ,medicine.drug - Published
- 2021
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9. Real-world outcomes for the treatment of relapsed/refractory multiple myeloma patients with lenalidomide-dexamethasone combinations in a Latin American country. A retrospective cohort study from
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Patricio Jose, Duarte, Natalia Paola, Schutz, Paola, Ochoa, Sebastian, Yantorno, Sergio, Orlando, Sergio, Lopresti, Soledad, Zabaljauregui, Florencia, Aizpurua, Claudia, Shanley, Elvira, Giannini, Gonzalo, Garate, Cecilia, Foncuberta, Jorge, Milone, Dardo, Riveros, and Dorotea, Fantl
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Latin America ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Neoplasm Recurrence, Local ,Multiple Myeloma ,Lenalidomide ,Dexamethasone ,Progression-Free Survival ,Retrospective Studies - Abstract
We compared the efficacy of lenalidomide-dexamethasone (Rd) based treatments for relapsed/refractory multiple myeloma patients (pts), in a real-world setting. In addition, we evaluated adverse events (AE), progression-free survival (PFS) and overall survival (OS).In our retrospective, multicentric study, 156 pts with RRMM were included. 74/156 pts (47%) were refractory to bortezomib (V) and 43/156 (27%) pts to lenalidomide (R), with 24/156 (15%) of pts double refractory. Eighty-six pts (55%) received Rd with carfilzomib (KRd), 30 pts (19%) bortezomib (VRd), 30 pts (19%) daratumumab (DRd), and 10 pts (6%) ixazomib (IRd).The overall response (ORR) (≥ partial response) for the entire cohort was 71%, with a very good partial response rate or better (≥VGPR) of 35%. We found no significant differences in CR or ≥VGRP rates between treatments (p:0.229). Regardless of the combination received, those patients who achieved CR had significantly improved PFS (p: 0.007). The most frequent cause of treatment discontinuation was disease progression in 55/156 pts (35%). 8 pts (5%) discontinued treatment due to treatment-related adverse events (AE).This is the first report of Rd combinations for the treatment of RRMM in Latin America. All combinations proved to be effective with an acceptable toxicity.
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- 2021
10. Real world outcomes with Bortezomib Thalidomide dexamethasone and Cyclophosphamide Bortezomib dexamethasone induction treatment for transplant eligible multiple myeloma patients in a Latin American country. A Retrospective Cohort Study from Grupo Argentino de Mieloma Múltiple
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Natalia P, Schütz, Paola, Ochoa, Patricio, Duarte, Guillermina, Remaggi, Sebastián, Yantorno, Ariel, Corzo, Soledad, Zabaljauregui, Claudia, Shanley, Sergio, Lopresti, Sergio, Orlando, Verónica, Verri, Luis, Quiroga, Carlos A, García, Vanesa, Fernández, and Dorotea, Fantl
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Male ,Remission Induction ,Induction Chemotherapy ,Middle Aged ,Prognosis ,Dexamethasone ,Thalidomide ,Bortezomib ,Survival Rate ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Female ,Multiple Myeloma ,Cyclophosphamide ,Aged ,Follow-Up Studies ,Retrospective Studies - Abstract
Data about treatment outcomes and toxicity in Latin America are scarce. There are differences with central countries based on access to healthcare system and socioeconomic status. Argentinean Society of Hematology recommends bortezomib-based triplets for induction treatment of transplant eligible newly diagnosed multiple myeloma patients. Most common options are CyBorD (cyclophosphamide, bortezomib and dexamethasone) and VTD (bortezomib, thalidomide and dexamethasone). Main goal of our retrospective, multicentric study was to compare very good partial response rate (VGPR) or better after induction treatment in a real-world setting in Argentina. Secondary objectives included comparison of complete response (CR) post-induction and after bone marrow transplantation, grade 3-4 adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Three hundred twenty-two patients were included (median age at diagnosis: 57 years; 52% male; 28% had ISS3; 14% with high-risk cytogenetics; median follow up: 34 months). CyBorD was indicated in 74% and 26% received VTD. In VTD arm, 72.62% of patients achieved at least VGPR vs 53.36% receiving CyBorD (odds ratio, OR: 1.96 [95% confidence interval, CI: 1.08-3.57; P = .026] after adjusting by age, ISS [International Staging System], lactate dehydrogenase levels (LDH) and cytogenetic risk. Difference in VGPR was 19.26% (95% CI: 15-24). CR rate were 35.92% (VTD) vs 22.55% (CyBorD) (adjusted OR: 2.13 [95% CI: 1.12-4.05]). Difference in CR was 13.37% (95% CI: 9.6-17.53). Adverse events (AEs) were more common with VTD (69.05% vs 55.46% for CyBorD; P = .030), especially grade 3-4 neuropathy (P = .005) and thrombosis (P = .001). Thromboprophylaxis was inadequate in 20.24% of patients. Hematological AEs were more common with CyBorD, especially thrombocytopenia (P = .017). PFS and OS at 24 months were not different between treatments. In this real-world setting, VTD was associated with better CR and VGPR than CyBorD. Nevertheless, CyBorD continues to be the preferred induction regimen in Argentina, based on safety profile. Frontline autologous stem cell transplantation improves quality of responses, especially in countries with limited access to new drugs.
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- 2019
11. Early mortality in Transplant-eligible Multiple Myeloma patients in Latin America. An International Study of GELAMM
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Guillermo José Ruiz Argüelles, Paola Ochoa, Johana Ramirez, Sebastian Yantorno, Hernán López Vidal, Sergio Orlando, Christine Rojas, Mauricio Chandía, Soledad Zabaljauregui, Jorge Jerez, Carolina Contreras, Dorotea Fantl, Carmen Vergara, Natalia Schutz, Camila Peña, Fiorella Villano, Daniela Cardemil, Felipe Ramirez, Rocío Osorio, Pablo Soto, Patricio Duarte, Virginia Bove, Ariel Corzo, Cecilia Beltrán, Claudia Shanley, Verónica Verri, Luz Tarín-Arzaga, Luis Quiroga, Guillermina Remaggi, and Eloisa Riva
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Cancer Research ,Pediatrics ,medicine.medical_specialty ,Latin Americans ,Oncology ,business.industry ,medicine ,Hematology ,medicine.disease ,business ,Multiple myeloma - Published
- 2019
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12. Real World Outcomes in Latin-American Patients with Multiple Myeloma Under 40 Years Old
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Paola Ochoa, Ariel Corzo, Sebastian Yantorno, Yarely Itzayana García-Navarrete, Hernán López-Vidal, Alicia Molina, Ines Reyes, Henry Idrobo, Cecilia Beltran, Pilar Papilco, Pilar León, Vanesa Fernandez, Marcela Espinoza, Luz del Carmen Tarín Arzaga, Claudia Shanley, Camila Peña, Lina Gaviria, Pablo Soto, Antonio Cruz-Mora, Gabriel La Rocca, Veronica Verri, Alicia Henao-Uribe, Rocío Osorio, Patricio Duarte, Daniela Cardemil, Humberto Martinez-Cordero, Sergio Lopresti, Guillermina Remaggi, Virginia Abello, Guillermo Quintero, Mauricio Chandia, Yahveth Cantero-Fortiz, Vivianne Torres, Omar Cantú-Martínez, Virginia Bove, Javier Schulz, Rigoberto Gomez, David Gómez-Almaguer, Sergio Orlando, Juan José García García, Macarena Alejandra Roa Salinas, Dorotea Fantl, Guillermo J. Ruiz-Argüelles, Brenner Sabando, Jhoanna Ramirez, Soledad Zabaljauregui, Natalia Schutz, Fiorella Villano, Sandra Aranda, Carolina Contreras, Domingo Saavedra, Javiera Donoso, Monica Osuna Pérez, Claudia Sossa, Carmen Gloria Vergara, Christine Rojas, Francisca M. Ramirez Aspiazu, Eloisa Riva, Luis Quiroga, and Alex Mite
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Oncology ,medicine.medical_specialty ,biology ,business.industry ,Anemia ,education ,Immunology ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Chemotherapy regimen ,Immunoglobulin G ,Transplantation ,Internal medicine ,biology.protein ,medicine ,Vocal cord dysfunction ,Plasmacytoma ,business ,health care economics and organizations ,Survival analysis ,Multiple myeloma - Abstract
Background Multiple myeloma (MM) is a heterogeneous disease that is most frequently diagnosed in the elderly. Therefore, data on clinical characteristics and outcomes in the young population are scarce and it is recognized that it remains incurable even in this group of patients. We present here the outcomes of patients under 40 years old cohort in Latin-American countries. On behalf of GELAMM (Grupo de Estudio Latino-Americano de Mieloma Múltiple). Methods Retrospective international multicenter cohort study. We analyzed MM patients under 40 years old who received treatment in 6 Latin-American countries, between 2010 and 2018. Demographics and disease features were analyzed using descriptive statics. We examined treatment characteristics and response rates. The overall survival (OS) of the entire cohort was analyzed using Kaplan-Meier curves. Results Eighty-six patients of 6 countries were analyzed (Table1). The mean age was 35.4 years old, and 60% were male. The most frequent monoclonal component type was IgG followed by light chain MM. Risk determined by ISS was distributed in almost equal percentages. The most frequent cytogenetic alteration was the t (4;14) that was found in four patients out of 25 evaluated. The missing data were greater than 70%. Skeleton-related events were the most frequent clinical feature, followed by anemia and renal failure. Plasmacytomas and fractures were present in more than 20 percent of cases. With regard to treatment, VCD / CyBorD was the most used regimen, followed by VTD. The overall response rate (ORR) was 63%. Fifty-three patients received high dose therapy and autologous stem cell transplantation (62%). Only 8% received post-transplant consolidation, and 45% received maintenance therapy. The median OS of the entire cohort was 45 months, and a plateau in the survival curve was not observed, suggesting that patients continue relapsing over the time. Conclusion In this Latin American multicenter study, we found that the young population with MM has similar presentation characteristics to those of elderly patients. A significant amount of information is lost regarding the risk characterization, especially in regard with cytogenetics. With respect to treatment, less than half of the patients achieve very good partial response or better. It is striking that more than a third of this young patients did not access to high doses of chemotherapy and bone marrow transplantation. Maintenance therapy is offered to less than half patients. The median OS is lower than in other series of patients younger than 40 years, even than in the elderly cohorts. Prospective multicentric studies are required to elucidate the behavior of the disease in this group of patients. Disclosures Peña: Pfizer: Membership on an entity's Board of Directors or advisory committees; Janssen: Other: Congress inscription and flights; Biotoscana: Other: Congress inscription and flights; Novartis: Other: Congress inscription and flights; Tecnofarma: Other: Congress inscription and flights; Roche: Other: Congress inscription and flights. Rojas:Novartis: Membership on an entity's Board of Directors or advisory committees; Pfeizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees. Abello:Takeda: Other: Participation in advisory board meeting. Gomez-Almaguer:Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau.
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- 2019
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13. Unequal Outcomes in Transplant Eligible Patients with Multiple Myeloma in Latin America: Differences between Public and Private Centers
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Guillermo J. Ruiz-Argüelles, Christine Rojas, Henry Idrobo, Vivianne Torres, Jhoanna Ramirez, Soledad Zabaljauregui, Carlos Cristóbal Medina García, Brener Sabando, Raimundo Gazitua, Francisca M. Ramirez Aspiazu, Vanesa Fernandez, Carolina Contreras, Patricio Duarte, Virginia Bove, Sergio Orlando, Rigoberto Gomez, Sergio Lopresti, Guillermo Quintero, Omar Cantú-Martínez, Pilar Papilco, Antonio Cruz-Mora, Camila Peña, Lina Gaviria, Paola Ochoa, Claudia Sossa, Virginia Abello, Alicia Molina, Ines Reyes, Claudia Shanley, Kenny Galvez, Luis Quiroga, Alex Mite, Pilar León, Daniela Cardemil, Javier Schulz, Marcela Espinoza, Luz del Carmen Tarín Arzaga, Sandra Aranda, Pablo Soto, Alicia Henao-Uribe, Gabriel La Rocca, Mauricio Chandia, Dorotea Fantl, Yarely Itzayana García-Navarrete, Ariel Corzo, Sebastian Yantorno, Natalia Schutz, Fiorella Villano, Domingo Saavedra, Javiera Donoso, Monica Osuna Pérez, Guillermina Remaggi, Yahveth Cantero-Fortiz, Eloisa Riva, Hernán López-Vidal, Cecilia Beltran, Carmen Gloria Vergara, Macarena Roa, Veronica Verri, Rocío Osorio, and David Gómez-Almaguer
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Pediatrics ,medicine.medical_specialty ,business.industry ,Proportional hazards model ,Immunology ,Gold standard ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Transplantation ,Median follow-up ,medicine ,Progression-free survival ,business ,Survival analysis ,Multiple myeloma ,Cohort study - Abstract
Background Multiple myeloma (MM) is a frequent hematologic malignancy. The current gold standard frontline strategy includes a proteasome inhibitor (PI)-based induction, followed by autologous stem cell transplant (ASCT). Access to novel drugs in Latin America (LA) is limited. ASCT is available in most countries, but real access to it is highly heterogeneous. Data regarding patients´ outcomes in candidates to ASCT in the region is scarce. The aim of this study was to describe clinical characteristics and outcomes of MM transplant eligible patients in LA countries. Material and Methods Retrospective international multicenter cohort study. Consecutive MM transplant- eligible patients diagnosed between 2010 and 2018 from participating centers in Chile, Argentina, Ecuador, Mexico, Colombia, and Uruguay were included. Data were collected from clinical records in a standardized report form. We analyzed clinical characteristics at diagnosis and frontline therapy outcomes, including ASCT. Transplant-eligible patients were defined as fit patients younger than 66 years old. Active MM and response to treatment were defined according to current IMWG criteria. Inclusion criteria: 1.- Patients with newly diagnosed active MM between 2010 and 2018. 2.- Older than 18 years, and younger than 66 years. 3- Candidates for ASCT according to the evaluation of the attending physician Exclusion criteria: 1- Lack of minimum data in the clinical history 2- Plasma cell leukemia, AL amyloidosis or solitary plasmacytoma. 3- HIV infection 4-No consent and/or Ethics Committee approvals. Statistical analysis A descriptive statistic has been done. Comparisons of characteristics between groups was made usingT-student, Chi2 or ANOVA, as appropriate. Survival analysis was performed using Kaplan-Meier curves. Comparisons of survival between groups were made by the logarithmic recording method and the calculations of the risk relationships by Cox regression. Statistical analysis was performed by using STATA 13. Results We included 1293 patients in the study, 363 from Chile, 395 from Argentina, 209 from Colombia, 45 from Ecuador, 151 from Mexico, and 130 from Uruguay. The main characteristics at diagnosis and therapeutic strategies are shown in Table 1. Optimal response (sCR, CR and VGPR) was achieved in 38% of the patients in the cyclophosphamide, bortezomib, and dexamethasone (CyBorD) group, in 46% in the bortezomib, thalidomide, and dexamethasone (VTD) group, and in 36% in the cyclophosphamide, thalidomide, and dexamethasone (CTD) group, the 3 main induction regimens used. Only 53% of patients finally received ASCT. Significant differences were found between both groups, private and public institutions, regarding burden of symptoms, ISS staging, access to PI based induction, ASCT completion and adequate maintenance, with patients from the latter being more symptomatic, and receiving suboptimal therapy. FISH analysis was performed in less than 50% of patients, both in the public and private setting. With a median follow up of 34 months (range 1-113), median overall survival (OS) was 86 months. The 5-year progression free survival (PFS) was 38% and 5- year overall survival (OS) was 64%. When comparing public vs private settings, 5 year OS was 45% vs 80%, with a median OS of 56 months vs not reached, respectively (P In the multivariable analysis renal failure (p=0.03), achieving less than VGPR response (p Conclusion This is the largest report on transplant eligible patients with MM in LA. Great inequities are shown between public and private health systems. Survival in transplant-eligible patients is lower than that described in other regions. Only one third of patients had FISH performed. This means that very few patients are treated with a risk-based induction in LA. Patients in the public setting are diagnosed with a more symptomatic disease, probably due to a late diagnosis. OS is significantly worse in the public setting. This might be explained by the significant differences in access to PI-based induction, ASCT and maintenance between private and public institutions, with patients from the latter receiving suboptimal frontline therapy and maintenance. Reasons for 47% of potential candidates not being transplanted merit further analysis. Table 1 Disclosures Peña: Novartis: Other: Congress inscription and flights; Tecnofarma: Other: Congress inscription and flights; Roche: Other: Congress inscription and flights; Biotoscana: Other: Congress inscription and flights; Janssen: Other: Congress inscription and flights; Pfizer: Membership on an entity's Board of Directors or advisory committees. Rojas:Roche: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Pfeizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees. Abello:Takeda: Other: Participation in advisory board meeting. Gomez-Almaguer:Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau.
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- 2019
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14. Real World Outcomes with VTD and Cybord Induction Treatment for Transplant Eligible Multiple Myeloma Patients in a Latin American Country. Retrospective Cohort Study from Gamm (Grupo Argentino de Mieloma Multiple)
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Paola Ochoa, Ariel Corzo, Guillermina Remaggi, Sergio Orlando, Verónica Verri, Carlos Cristóbal Medina García, Patricio Duarte, Vanesa Fernandez, Claudia Shanley, Sebastian Yantorno, Dorotea Fantl, Natalia Schutz, Sergio Lopresti, Soledad Zabaljauregui, and Luis Quiroga
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Pediatrics ,medicine.medical_specialty ,Latin Americans ,business.industry ,Bortezomib ,medicine.medical_treatment ,Immunology ,Real world outcomes ,Retrospective cohort study ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Thalidomide ,Transplantation ,medicine ,business ,Multiple myeloma ,Neoadjuvant therapy ,medicine.drug - Abstract
Introduction: There are scarce data regarding treatment outcomes and toxicity in Latin American countries. Argentina is the second largest country in the region and the fourth most populated one. National Guidelines from the Argentinean Society of Hematology (SAH) recommends the use of bortezomib based triplets for induction treatment in transplant eligible newly diagnosed Multiple Myeloma patients. Objective: To compare response rates and adverse events after induction treatment with Cyclophosphamide Bortezomib and Dexamethasone (CyBorD) or Bortezomib Thalidomide and Dexamethasone (VTD) outside of clinical trials in a Latin American country. Methods: Retrospective multicentric cohort study. All centers participating in the Argentinean Multiple Myeloma Study Group (GAMM) were invited to participate in the study. Eligible patients were 75 years of age or younger, with a diagnosis of Multiple Myeloma according to the IMWG 2014 criteria, transplant eligible, treated with at least one cycle of CyBorD or VTD as induction therapy in the time period from December 2012 until December 2017. Main exclusion criteria were amyloidosis, plasma cell leukemia and previous neuropathy. Patients were identified from local registries at each center and included consecutively in the study database. Epidemiological and clinical data were obtained from medical records and collected in a standardized clinical report form. Patients were followed from diagnosis until death or lost to follow up. Response was evaluated according to IMWG Response Criteria 2016. Adverse events were graded by CTCAE 4.3. Comparisons of response rates were performed using a Chi2 test and differences in rates were expressed as proportions with 95% confidence intervals (CI). Crude odds ratios (OR) and OR adjusted by potential confounders were calculated using a logistic regression model. Kaplan Meier method was used to estimate progression free survival (PFS) and overall survival (OS). Stata 13 software was used. Results: A total of 322 patients from 15 centers in Argentina were included in the study. The median age at diagnosis was 57 years (range 26-74), 52% (167) of the patients were male, 18% (58) had renal failure, 28% (85) ISS 3 , 7% (22) extramedullary disease, and 14% (46) high risk cytogenetics. Median time of follow up was 34 months (IQR 21-58). CyBorD was the most common treatment, indicated as induction therapy in 74% (238) of the cases. The characteristics of the patients were similar in both groups except age and LDH levels. The median number of cycles was 5 (range 1-12). Bortezomib was administered once per week in 85% (272) of the patients and subcutaneously in 86% (276) with no differences between both treatment arms. The median cumulative cyclophosphamide dose per month was 1.5 g (IQR 1.5-2.4) and thalidomide dose per day was 100 mg. In the VTD arm, 72,62% (61) of the patients achieved at least very good partial response (VGPR) vs 53.36% (127) with CyBorD [OR of 2.31 (CI 1.35 - 3.99) p=0.002]. The difference in VGPR was 19.26% (CI 15 - 24). Complete response rate (CR) was 35.92% in patients treated with VTD vs 22.55% with CyBorD [OR of 1.87 (CI 1.04 - 3.35) p=0.03). The difference in CR was 13,37% (CI 9.6 -17.53). There was no difference in overall response rate (ORR) with 94.05% vs 91.18% (p=0.406). Adverse events were more common with VTD (69.05% vs 55.46% p=0.030), especially neuropathy grade 3 - 4 (7.14% vs 1.26% p=0.005) and thrombosis (13.10 % vs 3.36 % p=0.001). Deep venous thrombosis prophylaxis was inadequate in 20.24% of the patients. Hematologic adverse events were more common with CyBorD, especially thrombocytopenia (5.95% vs 16.39% p=0.017). Autologous stem cell transplantation (ASCT) was performed in 78% (249) of patients. There was 5% (17) stem cell mobilization failure, all in the CyBorD arm. Response rates after ASCT with VTD and CyBorD induction treatment were: 76.19 vs 73.11% VGPR (p=0.580) and 48.53% vs 40% CR (p=0.20). Maintenance treatment was indicated in 67.86% (57) and 65.13% (155) patients respectively (p=0.650). The PFS at 24 months was 83% (CI 71-90) with VTD vs 72% (CI 66-78) [(HR 0.92 (CI 0.59 - 1.42) p 0.715] and OS 96% (CI 87-99) vs 91% (86-94) respectively [(HR 1.2 (CI 0.62 - 2.32) p 0.587]. Conclusions: VTD has better CR and VGPR compared to CyBorD. Nevertheless, CyBorD continues to be the preferred induction regimen in Argentina based on safety profile. The optimal number of induction treatment cycles remains to be determined. Disclosures Schutz: Takeda: Honoraria, Research Funding; Sanofi Aventis: Research Funding; Roche: Research Funding; Glaxo: Research Funding; Janssen: Honoraria, Research Funding; Varifarma: Honoraria. Shanley:Brystol Myers Squibb: Consultancy, Honoraria; Takeda: Consultancy, Honoraria. Fantl:Janssen: Consultancy, Honoraria, Research Funding; Varifarma/Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Research Funding; Sanofi: Research Funding; Roche: Research Funding; Tecnofarma: Honoraria; BMS: Consultancy, Honoraria; Glaxo: Research Funding.
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- 2018
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