scholarly journals Bendamustine, Carfilzomib, and Melphalan (BCM) Conditioning Prior to Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: A Feasibility Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4635-4635
Author(s):  
A. Samer Al-Homsi ◽  
Marlee Muilenburg ◽  
Kelli Cole ◽  
Muneer H. Abidi ◽  
Stephanie F. Williams
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Partial Response ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Median Time ◽  
Conditioning Regimen ◽  
Disease Status ◽  
Hematopoietic Stem

Abstract High-dose melphalan (M) followed by autologous hematopoietic stem cell transplantation (AHSCT) remains the standard treatment for multiple myeloma in eligible patients, even in the era of novel agents. However, the majority of patients ultimately relapse and succumb to their disease. Several studies have explored integrating novel agents into the conditioning regimen prior to AHSCT in order to improve complete remission rates and ultimately overall survival. We aimed to assess the feasibility of adding bendamustine (B) and carfilzomib (C) to melphalan (BCM) and performed a phase I dose escalation study. Thirteen patients were enrolled between June 2014 and June 2016. All patients received C at a fixed dose (20 mg/m2) on days (d) -29, -28, -22, -21, -15, -14. The conditioning regimen and doses administered for each cohort were as described in the table below. Due to excessive toxicity, the study was amended after the first 6 patients. Per oversight of a data safety monitoring board, the dose of M was reduced to 140 mg/m2 and C dose on d +6 was omitted. Median age was 58 years (39-68). There were 8 males and 5 females. Performance status was ≥ 80% in all patients. Per the International Staging System (ISS), 3 patients had stage I disease, 5 had stage II, 4 had stage III, and 1 had unknown staging. Three patients had high-risk cytogenetics: 2 with t(4;14) and 1 with deletion 17p. Three patients had received prior AHSCT. Disease status prior to study treatment was stable disease (SD) (n=2), partial response (PR) (n=8), or very good partial response (VGPR) (n=3). Median CD34+ cell dose was 3.24x106/kg (2.23-6.92x106). Median follow-up was 14.2 months (1-24.5). Median time to neutrophil engraftment was 12 d (11-15). One patient died before achieving platelet engraftment. For the remaining patients, median time to platelet engraftment was 16 d (12-20). Non-hematologic toxicities included grade 3 acute mucositis (n=1), lower GI complications (n=6), electrolyte disturbances (n=6), transaminase elevation (n=1) renal insufficiency (n=1), pulmonary edema (n=1), prolonged QTc (n=1), atrial fibrillation (n=1), and elevated troponin (n=1) and grade 4 acute sepsis (n=2), resulting in 1 death in cohort 2 on d +44. Seven patients went on to receive maintenance therapy: 3 with bortezomib, 3 with lenalidomide, and 1 with lenalidomide, dexamethasone, and C. Post-transplant disease status was assessed per protocol by SPEP, SPIF, and serum free light chains and light chain ratio. Nine patients were evaluable on d +100. One patient had SD, 6 had VGPR, and 2 had complete response (CR). Six out of 7 (86%) evaluable patients on d +365 remain disease progression-free. In summary, BCM conditioning prior to AHSCT at the doses described in cohort 3b seems feasible with manageable toxicities. Five additional patients are being enrolled at the same dose level. Table Table. Disclosures No relevant conflicts of interest to declare.

Bortezomib Therapy for Multiple Myeloma in Relapse after Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplantation (RICT).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5399-5399
Author(s):  
Sophie Ducastelle ◽  
Daniela Revesz ◽  
Jacques Troncy ◽  
Samira Mahmoudi ◽  
Xavier Thomas ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
Median Time ◽  
New Drugs ◽  
Hematological Toxicity ◽  
Hematopoietic Stem

Abstract Multiple myeloma (MM) remains incurable and specially of poor prognosis in case of refractory or relapsed disease. However, recent therapeutic advances including the use of new drugs are promising. Although, Bortezomib, new proteasome inhibitor, has proven its efficacy in patients with refractory or relapsed MM, it has not been sufficiently evaluated in the setting of allogeneic hematopoietic stem cell transplantation. Here, we report four cases of MM patients, very heavily pre-treated and all previously transplanted, who received bortezomib associated to dexamethasone for relapse after allogeneic RICT (median time from diagnosis: 68 months, median time from RICT: 41 months). We studied the feasibility, efficacy and safety of bortezomib: two patients achieved a complete remission, one patient a very good partial response, and one had no response. The tolerance was excellent with only one patient who developed a reversible grade 3 hematological toxicity. No GVHD recrudescence was observed. All patients relapsed after completion of bortezomib treatment. This questions about the potential benefit of maintenance therapy with bortezomib. Given the feasibility and the high efficacy of bortezomib combined with dexamethasone in relapsed MM after RICT, our results argue in favour of an immune-modulatory activity of bortezomib. New strategies combining RICT and bortezomib are warranted to increase and maintain an adequate response. Combination RICT and bortezomib regimen are anticipated to further extend survival in relapsed MM.

Faster Registration on International Donor Registries and Shorter Time to Allogeneic Hematopoietic Stem Cell Transplantation After Having Found a Donor Confers Better Outcome In Acute Leukemia Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2371-2371
Author(s):  
Mauricette Michallet ◽  
Mohamad Sobh ◽  
Stephane Morisset ◽  
Xavier Thomas ◽  
Youcef Chelghoum ◽  
...  
Keyword(s):  
Stem Cell ◽  
Molecular Markers ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Acute Leukemia ◽  
Cell Transplantation ◽  
Median Time ◽  
Disease Status ◽  
No Donor ◽  
Hematopoietic Stem

Abstract Abstract 2371 Background: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to offer a potential advantage in terms of event free survival (EFS) and overall survival (OS) in patients with acute leukemia (AL) with bad prognostic factors. The main issue is to find a donor; usually, a patient has 30% chance to find an HLA identical sibling donor (SD) and approximately 40% chance to find a suitable unrelated donor (UD) from international registries. Unfortunately, 40% of registered patients relapse or die before finding a donor. Aim: Our objective was to evaluate the outcome (OS & EFS) in AL patients, whether they had an HLA identical SD, an UD or no donor (ND) after registration on France Greffe de Moelle (FGM) registry, either transplanted later or not. Our secondary objective was to evaluate the impact of interval between, diagnosis and allo-HSCT, donor finding and allo-HSCT, interval registration-allo-HSCT, on OS and EFS. Methods: We have analyzed 251 AL patients diagnosed between January 2000 and December 2008, for whom a search for a donor was initiated for a required allo-HSCT. There were 117 (47%) males and 134 females with a median age at diagnosis of 40 years [16-66], 177 (71%) were AML (prognosis according to cytogenetics & molecular markers: 59 were good, 97 poor and 21 not done) 75 were ALL (prognosis according to cytogenetics & molecular markers: 33 were good, 16 poor and 26 not done). Seventy six (30%) patients had an available SD and received allo-HSCT within a median time of 3.5 months (0.5 – 43) (59 AML & 17 ALL), and 38 (15%) with SD but were not transplanted due to early relapse and/or death. For patients with no available SD, a registration on FGM registry was done. One hundred thirty seven patients were registered after a median interval of 2.3 months (0.4-135) from diagnosis, 33 (13%) patients (24 AML & 9 ALL) did not find any donor, have not been transplanted and they received the standard of care. One hundred and four (41%) patients (62 AML & 42ALL) found an UD or cord blood cell (CBC) unit after a median registration time of 1.6 months (0.3 – 26): 86 with UD of which only 60 have been transplanted within a median time of 2.3 months (0.4 – 14), 18 with CBU of which only 17 were transplanted. Among transplanted patients, 113 (74%) were in complete response (CR) at transplantation, and 40 were in less than CR. Fifty (33%) received peripheral blood (PBSC) (23 UD & 27 SD), 86 (57%) received bone marrow (BM) (37 UD & 49 SD) and 17 (10%) CBC units. For conditioning, 56 (37%) were reduced intensity (29 SD & 27 UD) and 96 standard (47SD & 50 UD). For HLA, there were 45 HLA 10/10, (27BM & 18 PBSC), 14 HLA 9/10 (9BM 5PBSC) 1 HLA 8/10 (BM) and for CBC 14 HLA 4/6 and 3 HLA 5/6. Results: After a median follow-up of 25 months (0.2- 234), the median OS was 78 months (51 – 133) for transplanted patients with SD (3years OS: 68%), it was 33 months (27 – 47) for transplanted patients with UD (3years OS: 44%), 21 months (15 – 37) for not transplanted patients with available SD or UD (3years OS: 34%) and finally it was 31 months (23-221) for patients with ND (3years OS: 45%). The median EFS for the same groups was 38 months (23 – 133), 24 months (17 – 36), 15 months (11-24) and 23 months (14 – 48) respectively. The only factors negatively affecting OS in multivariate analysis (studying age, sex, AL type, cytogenetics, donor or no donor, transplanted or not, UD or SD) were age and allo-transplanted from UD. When adjusting only on transplanted patients, taking into account in addition to previous factors, the time between diagnosis-registration, time between registration-allo-HSCT, disease status at allo-HSCT, stem cell source, conditioning; three significant factors affected OS: disease status (<CR) HR= 2.8 [1.5-5.3] p<0.001; long interval between diagnosis-registration HR= 2 [1.2-3.6] p=0.001 and conditioning (standard) HR=0.27 [0.1-0.8] p=0.02. (3years OS for SD allo-HSCT, UD allo-HSCT late and early registration: 59%, 29% and 47% respectively). Conclusion: The results of our first analysis seemed surprising regarding our knowledge of outcome in allo-HSCT from SD and UD, which led us to investigate on unusual interfering factors. We have explored the relation between the interval diagnosis-registration for a donor search and the interval registration-allo-HSCT that appeared as major factors affecting survival in UD allo-HSCT settings. Disclosures: No relevant conflicts of interest to declare.

Effect of Melphalan 140 Mg/m2 Versus 200 Mg/m2 on Toxicities and Outcomes in Multiple Myeloma Patients Undergoing Single Autologous Stem Cell Transplantation

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1988-1988
Author(s):  
Lakshmikanth Katragadda ◽  
Lindsay McCullough ◽  
Yunfeng Dai ◽  
Jack W Hsu ◽  
John W Hiemenz ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Conflicts Of Interest ◽  
Conditioning Regimen ◽  
Disease Status ◽  
Cox Proportional Hazards Model ◽  
Hematopoietic Stem ◽  
Preparative Regimen

Abstract Introduction: Although melphalan at a dose of 140 mg/m2 (MEL-140) is known to be an effective preparative regimen for autologous hematopoietic stem cell transplantation (ASCT) in multiple myeloma (MM) patients, there are very few studies comparing it to the most commonly used dose of 200 mg/m2 ( MEL-200). Methods: We retrospectively reviewed the records of all myeloma patients who underwent an ASCT between 2001 and 2010 at our institution. We then identified patients who received melphalan as their preparative regimen at doses of 140 mg/m2 or 200 mg/m2. Patients who received any other drug as conditioning regimen or had more than one ASCT or had documented amyloidosis were excluded. Data were collected for variables known to possibly affect prognosis of MM patients. We assessed effect of melphalan dose on toxicities and outcomes. Results: A total of 129 eligible patients were identified, with 33 receiving MEL-140 and 96 receiving MEL-200. As was expected significantly higher percentage of patients in the MEL-140 arm were older than 65 years (P=<0.001) or had cardiac ejection fraction < 50 (P=0.0001) or had Karnofsky score < 80 (P=0.01) or had creatinine > 2 either at diagnosis (P=0.004) or the time of ASCT (P=0.001). Rest of the patient and disease characteristics including Durie-Salmon stage, myeloma subtype and disease status at ASCT were not significantly different between the 2 arms. Patients in MEL-140 needed significantly longer time to ANC engraftment (P=0.037) and also had significantly higher frequency of neutropenic fever (P=0.003). There were no significant differences in mucositis (including grade), nausea, vomiting, diarrhea, bacteremia, or length of hospital stay and frequency of repeat hospitalizations among both groups. There was no treatment related mortality in either group. At a median follow up of 74 months (range, 52-140) from ASCT, there were no significant differences in relapse free survival (RFS) (P=0.4988) and overall survival (OS) (P=0.6936) between the two groups. Five year OS for MEL-140 and MEL-200 is 71.6% and 78.9%, while RFS is 23.9% and 34%, respectively. Proportion of patients whose myeloma status improved to ≥ VGPR at 3 months post ASCT was also not different (P=0.385). Importantly, similar proportions of patients received various post ASCT maintenance therapy (P=0.605). In multivariate cox proportional hazards model only disease status of ≥VGPR at the time of ASCT significantly affected RFS (P=0.024) but did not impact OS (P=0.104). Conclusion: MM patients who received MEL-140 had similar long term outcomes as those who received MEL-200 despite their older age, lower performance status and renal insufficiency. Disclosures No relevant conflicts of interest to declare.

scholarly journals High-dose chemotherapy following autologous hematopoietic stem cell transplantation for multiple myeloma in the real world setting. Single-center experience

2020 ◽  
Vol 22 (2) ◽  
pp. 126-132
Author(s):  
Nikita E. Mochkin ◽  
Vladislav O. Sarzhevskiy ◽  
Julia N. Dubinina ◽  
Elena G. Smirnova ◽  
Denis A. Fedorenko ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Partial Response ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Hematopoietic Stem Cell ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Hematopoietic Stem

Aim. To assess the long-term results of high-dose chemotherapy following autologous hematopoietic stem cell transplantation (autoHSCT) for multiple myeloma (MM) in the real setting and influence of different factors on the results. Materials and methods. From 2006 till 2018 in Pirogovs Center were performed 205 autoHSCT for patients with MM, aged between 3172 years (median 55). 55 (26.8%) autoHSCT were tandem. The study population consisted of 45% men and 55% women. Median follow up was 75 months. For the majority of patients autoHSCT was performed after achieving at least partial response according to the IMWG criteria. For less than 9% patients, autoHSCT was done for chemo refractory disease as a salvage therapy. Most of the patients 179 (87.4%) were treated using melphalan-based conditioning regimens (140 or 200 mg/m2). Initial staging according to ISS was done for less than 30% and to R-ISS less than 5% patients. No transplant-related mortality till D + 100 was registered. 186 patients were included in the final analysis. Results. The 5-year OS and PFS were 73% and 34%, respectively, that corresponds with international data. For patients, younger than 60, 5-year OS was 82%; for patients older than 60, it was 49% (p0.05). For tandem autoHSCT, 5-year PFS was 44%; for single autoHSCT 26% (p0.05). 5-year PFS after autoHSCT was significantly higher in patients with complete and stringent complete response after autoHSCT (44%) in comparison with the group with partial and very good partial response (77%). Sex, response before and after autoHSCT, immunomodulatory drugs in induction, number of prior lines of induction therapy, conditioning regimen and maintenance therapy had no influence on OS. PFS had the same tendencies, except tumor response after autoHSCT. Conclusion. In a real setting, we recommend tandem autoHSCT for all eligible patients with chemosensitive disease, despite the depth of response and induction therapy. Patients younger than 60 and patients with complete of greater response after autoHSCT, benefit from the autoHSCT most. Implementation of total cytogenetic testing according to the R-ISS is of a great value for further development of autoHSCT for MM in Russia.

scholarly journals Hematopoietic Stem Cell Transplantation in Children with Refractory Langerhans Cell Histiocytosis

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4657-4657
Author(s):  
Kazuko Kudo ◽  
Miho Maeda ◽  
Nobuhiro Suzuki ◽  
Hirokazu Kanegane ◽  
Shouichi Ohga ◽  
...  
Keyword(s):  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Median Time ◽  
Langerhans Cell Histiocytosis ◽  
Japanese Society ◽  
Disease Status ◽  
Hematopoietic Stem ◽  
Active Disease

Abstract Introduction Hematopoietic stem cell transplantation (HSCT) is one of the promising treatment strategies for children with refractory Langerhans cell histiocytosis (LCH), because of its immunomodulatory effects.Efficacy and indication of HSCT has been still undetermined. We analyzed the outcomes of HSCT in children with refractory LCH registered in the Transplant Registry Unified Management Program (TRUMP) conducted by the Japanese Society for Hematopoietic Cell Transplantation. Patients and methods Between 1996 and 2014, 30 patients <15 years old with refractory LCH who underwent an allogeneic HSCT were registered in the TRUMP database. Data collected as of March 2017 were analyzed. The histiocyte committee of the Japanese Society of Pediatrc Hematology and Oncology (JSPHO) sent the questionnaires to the institutions where HSCT was done for LCH, and clinical data of 25 patients were collected. Definition of response to initial therapy and disease state at HSCT was described previously. Failures were defined as relapse after HSCT, secondary malignancy, and death from any causes. Results Patients' characteristics The male/female ratio was 18/12. Ages of onset of LCH and at BMT were median 9 months (range 3-23 months) and median 1 years (range 0-11 years), respectively. At diagnosis of LCH, 19 patients were positive for risk organ involvement, 6 were negative. Eleven patients underwent HSCT using myeloablative conditioning (MAC) regimen, whereas 19 patients reduced intensity conditioning (RIC) regimen. Eight patients received total body irradiation (TBI) > 8Gy (10-12Gy) regimen, 3 received full dose busulfan (BU: 16mg/kg po or 17.6mg/kg iv) regimen. Seven received fludarabine (FLU: 125-180mg/m2) + melphalan (MEL: 70-180mg/m2) without TBI and 9 received FLU(120-180mg/m2)+MEL (140-180mg/m2) with low dose irradiation (2-5.1Gy) and the remaining 3 received other RIC regimens. Cyclosporine was used in 13 patients and tacrolimus was used in 16 patients for graft versus host disease (GVHD) prophylaxis. Donor sources were related donor in 9 patients and unrelated in 21 patients (cord blood 19 and bone marrow 2). Four related donors were father or mother and 3 of them were haplo-identical. In these patients, induction therapy at onset achieved a good (5/25), partial (8/25), no (4/25) and progressive (8/25) diseases. In regard to disease status at HSCT, recipients with no active diseae (NAD) were 4/25, active disease-regression (AD-r) 2/25, active disease-stable (AD-s) 4/25 and progressive (AD-p) 15/25. Eight patients received 2-chlorodeoxyadenosine (2-CdA), including 4 patients who received the combination of 2-CdA and high dose Ara-C before HSCT as salvage therapy. At HSCT, 15/23 (65%) patients were in primary induction failure and 8/23 (35%) experienced first or additional relapse, respectively. Transplantation outcomes Neutrophil recovery was observed in 24 patients and the median time to engraftment was 21 days. Platelets engraftment was observed in 17 patients and the median time to engraftment was 52 days. Acute GVHD of grade II - IV, chronic GVHD (cGVHD) were observed in 6 and 4 patients, respectively. Extensive cGVHD was observed in 3 patients who received MAC regimens (p= 0.079). Relapse after HSCT were observed 1 patient in RIC regimens and 2 patients in MAC (P=0.613). With follow-up of median 433 days (range 9-5307days) after HSCT, 17/30 (57%) patients are alive and 13 died. Death occurred within 3 months after HSCT in 8/13. The overall survival (OS) was not different between RIC and MAC (56.8% vs 63.6%, p=0.843). In regard to the correlation of disease status at HSCT and outcome, 6 patients with NAD/ AD-r had better outcome than 19 with AD-s/ AD-p (5-year OS 100% vs 52.1%, p=0.035). The 5-year FFS of the 16 patients who received FLU+ MEL based regimen were 68.8%, and were marginally better than those of the 14 patients who were conditioned with other regimens (68.8% (95%CI: 46.0-91.5) vs 42.9% (95%CI: 16.9-68.8), P=0.209). Discussion In conclusions, of 30 HSCT-recipients for refractory LCH, 17/30 (57%) are alive while post-transplant death occurred in 13/30 (43%). Our study showed that in regard to the correlation of disease status at HSCT and outcome, 6 patients with NAD/ AD-r had better outcome than 19 with AD-s/ AD-p (5-year OS 100% vs 52.1%, p=0.035). Novel bridging measures, such as targeted inhibition of the MAPK pathway, are required to stabilize the disease activity before HSCT. Disclosures No relevant conflicts of interest to declare.

Clinical and Epidemiological Characteristics of Multiple Myeloma (MM): Comparison Between Hematopoietic Stem Cell Transplantation (HSCT) and Conventional Chemotherapy,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4166-4166
Author(s):  
Gemma Ramirez ◽  
Consuelo Gonzalez Garcia ◽  
Ma Sol Durán ◽  
Javier De La Rubia ◽  
Alfons Soler ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Survival Rate ◽  
Hematopoietic Stem Cell Transplantation ◽  
Partial Response ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Complete Response ◽  
Conventional Chemotherapy ◽  
Hematopoietic Stem

Abstract Abstract 4166 INTRODUCTION: The purpose of this epidemiological retrospective study was to describe the natural history, clinical features, treatment and outcome of a wide population of multiple myeloma (MM) patients during a 2-year period. MATERIALS AND METHODS: Data from 338 patients' files from 37 Spanish centers were collected during 2009. Included patients had ISS stage II-III MM and started first line treatment according to daily practice between Sep'03-Aug'05. Response rate (RR) following IMWG criteria and survival from diagnosis are analyzed in patients either with or without hematopoietic stem cell transplantation (HSCT). Because immunotechniques were not always available back then, stringent complete response is categorized as complete response (CR) and very good partial response as partial response (PR). Statistics on survival are calculated using univarite Cox analyses, and Chi-square and Fisher exact test are used for categorical results; valid percentages are presented. RESULTS: Patients had a median of 66 (21–88) years of age at the time of diagnosis, good to moderate ECOG performance status (0–1, 50%; 2, 25%), and 1:1 ratio male:female. Besides staging II (42%) or III (58%) MM, most (95%) exhibited secretory disease, and bone lesions were common (73%). Anemia (hemoglobin <12 g/dl) was present initially in 80% of patients, hypercalcemia (calcium level ≥11 mg/dl) in 26%, and a serum creatinine level of 2 mg/dl or more in 27%. Of the 167 candidates to HSCT, 39 patients did not receive the therapy, mainly due to progression after induction (n=12), patient's decision (n=6), HSC mobilization failure (n=4), or death (n=4). Reasons for not being HSCT candidate included older age (n=112) and concomitant diseases (n=12). Table 1 resumes treatment regimens, efficacy, toxicity and survival of transplanted (T) and non-transplanted (NT) cohorts. Indution mainly consisted of conventional chemotherapy as new anti-myeloma therapies were not available during the study period. Most patients (93%) undergoing HSCT had melphalan conditioning; subsequent maintenance was given to 61 patients: interferon (75%), prednisone+/−interferon (10%), thalidomide (5%), and bortezomib (3%). Only 35 patients (9 in the T cohort) were given a second line of treatment. Objective RR (ORR=CR+PR) was higher in T than NT patients (95% vs 53%), even when both received similar chemotherapy combination, VBDA/VBMCP (94% vs 71%). When compared to this regimen, MP and VAD were significantly less effective in NT patients (ORR, 50% and 39%). Toxicity was manageable with few severe hematological events, more oftenly occurring after polychemotherapy administration. Particularly, groups of patients taking alkylator-containing regimens (either MP or VBDA/VBMCP) presented relatively higher frequency of drug-related events (46% in each group) than VAD (25%). Global median survival was 50 months (IC95%, 43– 57) and 3-year survival rate was 64% (IC95%, 57–69). In accordance to the greater efficacy, superior 3-year survival rate was achieved when receiving HSCT (85% vs 52%; p<0.001). CONCLUSION: Results of this Spanish nation-wide epidemiological study confirmed previous findings in other countries (Kyle, 2003; Conte, 2007). As expected, efficacy varied depending on patient's characteristics and treatment. No safety issues were noted. Survival rate was enhanced by HSCT. Further reports on the outcomes sorted by treatment regimen, as well as potential prognostic factors, will be presented. Disclosures: López: Celgene: Employment. Baquero:Celgene: Employment.

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