High-dose chemotherapy and ASCT using non-cryopreserved stem cells and no G-CSF support is safe and feasible in the treatment of MM under our work conditions in developing countries.
IntroductionIn a developing country like Algeria, such expensive therapy is not available. Alternative approaches are needed to help these adult. In Algeria ‘imatib’ (CIPLA-India) was introduced in 2006; but no study has been published yet in the North Africa region regarding response and outcome of this copy in CML patients. The goal of this multicenter study is to characterize newly adult CML in the western region of Algeria and to assess the effectiveness and safety of imatib (IM, copy) as frontline therapy for patients with CML.Patients and MethodsThe study was carried out in 7 hematology centers in the western Algeria. Patients, who were diagnosed to be suffering from CML between January 1st, 2007 and December 31st, 2014 were selected for data analysis. All patients received a copy preparation, consisting of the alpha crystal form of imatinib, (IM, copy) at an oral dose of 400 mg daily and monitored for tolerance and side effects while on therapy.ResultsBetween January 2007 and December 2014, 355 patients with CML were treated with imatib (Copy). The median follow- up of the study was 46 months (range: 13–107 months). Complete hematological response (CHR) was seen in 83% of patients within 3 months. According to the Sokal score, 72% patients with low, 78% with intermediate and 69% with high risk disease achieved a CHR in 3 months (p=0.26) and according to the EUTOS score, 81% of patients with low and 70% with high risk disease achieved a CHR in 3 months (p=0.08). The major molecular response (MMR) at six months (M6), M9, M12, M18 and M24 was 21%, 38%, 35%, 51% and 67% respectively and 34% of patients achieved a complete molecular response (CMR). The projected 5-year overall survival (OS) rate was 83%. Side effects of imatib (copy) in this study were similar to those reported previously for the entire imatinib mesylate treatment study and only 8% of patients were intolerant to imatib (copy) and treated with a second generation of BCR-ABL inhibitor.ConclusionThis study reflects real world experience treating patients with CML in a developing country and thus sheds light on differences in this population compared to Western countries. In conclusion, imatib (copy) is effective and safe in treating patients with CML in chronic phase and proves to have a durable outcome. To our knowledge this is the first study reporting the response to imatib (copy) in an Algerian population.
Background: The aim of this retrospective study was to analyze early relapse in multiple myeloma (MM) in real life and to evaluate its impact on overall survival (OS) and progression-free survival (PFS). Methods: Two groups of patients were identified according to the date of occurrence of relapse after autologous transplantation, within less than 24 months, defining early relapse (G1), or after more than 24 months, defining late relapse (G2). Results: A total of 307 patients with MM were enrolled, including 93 patients (30%) who had experienced relapse. There were 56 early relapses (18%) and 37 late relapses (12%). In G1 the median follow-up was 19.5 months (3-93), as compared to59 months (24-117) in G2. The median of PFS was 18 months (14.8-21.14) in G1 and was not attained in G2 (p=0.0001). The median of OS was 29 months (18.2-39.7) in G1 and was not attained in G2 (p=0.0001). In a univariate analysis, age>60 years (p=0.003), performance status>1 (p=0.036), LDH>normal (p=0.002), ISS III (p=0.0002) and an absence of maintenance therapy (p=0.002) were found to be predictive factors for early relapse. In a multivariate analysis, only a delay from the initiation of treatment to ASCT of>12 months (p=0.02) and an absence of maintenance therapy (p=0.002) were predictive of early relapse. Conclusion: The predictive factors identified here should allow us to adapt the therapeutic strategy.
Introduction: In a developing country like Algeria, such expensive therapy is not available. Alternative approaches are needed to help these adult. In Algeria 'imatib' (CIPLA-India) was introduced in 2006; but no study has been published yet in the North Africa region regarding response and outcome of this copy in CML patients. The goal of this multicenter study is to characterize newly adult CML in the western region of Algeria and to assess the effectiveness and safety of imatib (IM, copy) as frontline therapy for patients with CML. Patients and Methods: The study was carried out in 7 hematology centers in the western Algeria. Patients, who were diagnosed to be suffering from CML between 1st January, 2007 and 31st December, 2014 were selected for data analysis. All patients received a copy preparation, consisting of the alpha crystal form of imatinib, (IM, copy) at a oral dose of 400 mg daily and monitored for tolerance and side effects while on therapy. Results: Between January 2007 and December 2014, 355 patients with CML were treated with imatib (copy). The median follow- up of the study was 46 months (range: 13-107 months). Complete hematological response (CHR) was seen in 83% of patients within 3 months. According to the Sokal score, 72% patients with low, 78% with intermediate and 69% with high risk disease achieved a CHR in 3 months (p=0.26) and according to the EUTOS score, 81% of patients with low and 70% with high risk disease achieved a CHR in 3 months (p=0.08). The major molecular response (MMR) at six months (M6), M9, M12, M18 and M24 was 21%, 38%, 35%, 51% and 67% respectively and 34% of patients achieved a complete molecular response (CMR). The projected 5-year overall survival (OS) rate was 83%. Side effects of imatib (copy) in this study were similar to those reported previously for the entire imatinib mesylate treatment study and only 8% of patients were intolerant to imatib (copy) and treated with a second generation of BCR-ABL inhibitor. Conclusion: In conclusion, imatib (copy) is effective and safe in treating patients with CML in chronic phase and proves to have a durable outcome. To our knowledge this is the first study reporting the response to imatib (copy) in a Algerian population. Disclosures No relevant conflicts of interest to declare.
INTRODUCTION: Autologous stem cell transplant (ASCT) is the standard of care in transplant-eligible multiple myeloma (MM) patients and is associated witha significant improvement in progression-free survival (PFS), complete remission rates (CR), and overall survival (OS). However, the majority ofpatientsrelapse. This study compares the efficacy of autologous hematopoietic stem cells followed by consolidation bybortezomibbased regimens to the no consolidation therapy in adult patients. PATIENTS AND METHODS: This is a retrospective study over a period of 7 years (2009-2015). All patients less than 65 years with a newly MM diagnosis were included. The protocol used in induction was VD (n=47) treatment whichconsisted of four 3-week cycles of 1.3 mg/m2 bortezomib administered subcutaneously (SC) on days 1, 4, 8, and 11 and 40 mg dexamethasone on days 1Ð4 and 9Ð12. Therapy with VTD was composed of four 3-week cycles of SC bortezomib and dexamethasone at the same doses and schedules as for the VD regimen plus 100 mg/day thalidomide administered orally. Therapy with VCD was composed of four 3-week cycles of SC bortezomib and dexamethasone at the same doses and schedules as for the VD regimen plus 500 mg/m2 cyclophosphamide administered orally on days 1, 8, and 15. Recommended concomitant medications included bisphosphonates, antibiotics, and antiviral prophylaxis. Acetyl salicylic acid was systematically used in the VTD arm. Stem cells were mobilized with 15 or 10 microg/kg G-CSF alone. Leukapheresis to harvest stem cells was performed on day -2 and -1. The grafts were kept in a conventional blood bank refrigerator at 4¡C until reinfusion on day 0. The target yield was 2 x106 CD34+ cells/kg. Following induction therapy, all patients had to proceed to ASCT. The conditioning regimen consisted of melphalan 200 mg/m2 in all patients.The consolidation regimen consisted of two cycles of VD or VCD or VTD after autologous stem- cell transplantation. In our study patients were divided into two groups: Group1 (ASCT plus consolidation) and Group 2 (ASCT alone). The therapeutic evaluation focused on the overall response (CR + VGPR) and progression free survival (PFS) and overall survival (OS) calculated by the Kaplan-Meier method. RESULTS: Over a period of 7 years, 153 patients were collected divided in two group: G1 (n=71) and G2 (n=82). Baseline characteristics are summarized in Table 1. No significant difference was observed between the 2 groups. In terms of CR, 58% of the patients in the G1 achieved a CR after consolidation vs 33% in the G2 after ASCT alone (p=0.007). In terms of VGPR, 31% of the patients in the G1 achieved a least a VGPR vs 17% in the G2 (p=0.04). The relapse rate was significantly lower in the G1 (10%) than the G2 (39%), (p=0.0001). The median follow-up period was 23,4 months. PFS was significantly higher in the G1, median no reached vs 37 months in the G2 (p=0.02) but no significant difference was observed in terms of OS rate between the 2 groups, 91% (G1) versus 82% (G2) at 27 months (p=0.7). CONCLUSION: We conclude thatbortezomib-based regimens as consolidation therapy after ASCT in patients with MM was effective in the improvement of PFS and response rate. Table Patients characteristics. Table. Patients characteristics. Disclosures No relevant conflicts of interest to declare.
Introduction: Intensive chemotherapy followed by autologous stem cell transplantation (ASCT) is currently the treatment of choice in multiple myeloma (MM). Mobilization of hematopoietic stem cell blood (HSCs) can be achieved either by the combination of chemotherapy plus growth factors or by growth factors alone. However, there is no consensus concerning the dose of growth factor alone that should be administered, with ranges varying from 5 microgr to 16 microgr/kg body weight. In this context, we report our experience in mobilization of HSCs using growth factor alone at the dose between 15 microgr /kg and 10 microgr /kg in MM. Patients and methods: A total of 340 ASCT were performed in our center, from May 2009 until June the 31st 2016. These concerned 221 patients with MM. Patients were hospitalized at day -5 on which mobilization started with G-CSF alone (filgrastim) at the dose of 15 microgr /kg/daily subcutaneously for 5 days from May 2009 to October 2012 and at the dose of 10 microgr /kg from November 2012 to June 2016. The white blood cell count was assessed daily. Apheresis was performed at day -2 and day -1 using a Spectra Optia CMN device, and the CD34+ count was assessed by flow cytometry. A single leukapheresis was performed if the number of CD34+ cells was above 2.106/kg. Failure of mobilization was defined as a level of CD34+ less than 2.106/kg, after two leukapheresis. In our study patients were divided into two groups: Group1 (G-CSF=15 microgr /kg) and Group 2 (G-CSF=10 microgr /kg) and the number of CD34+ were divided into three groups: optimal (³5.0 x 106 CD34+ cells/kg), suboptimal (2.0Ð5.0 x 106 CD34+ cells/kg) and poor (<2.0 x 106 CD34+ cells/kg) mobilization. Intensification was done using melphalan 200 mg/m2 on day -1. Results: Patient's characteristics are shown in Table 1. No significant difference was observed between the 2 groups. In this study, we found no significant difference in terms of optimal (p= 0.73), sub-optimal (p= 0.19) or poor (p= 0.11) harvest of stem cells between the 2 groups (table 2). Among the poor mobilizators with G-CSF, only 4 of them had a level of CD34+ harvest less than 0.5 x 106/kg. These patients did not receive an ASCT. 1,3% (4) of all apheresis failed to achieve acceptable harvest level. Conclusion: Our study showed that the mobilization regimen with G-CSF alone at the doses of 10 microgr/kg have the same efficacy as the doses of 15 microgr/kg and is interesting alternative to chemotherapy and G-CSF in patients with MM because it can be administered as an outpatient and is not associated with the risk of febrile neutropenia. Disclosures No relevant conflicts of interest to declare.
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