RBAC (RITUXIMAB BENDAMUSTINE CYTARABINE) IS A FEASIBLE AND SAFE INDUCTION REGIMEN PRIOR TO ASCT IN FRONTLINE MCL: A SINGLE CENTER RETROSPECTIVE REAL LIFE EVALUATION
(Abstract release date: 05/18/17)
EHA Library. Nabergoj M. 05/18/17; 182442; PB1728
Dr. Mitja Nabergoj
Contributions
Contributions
Abstract
Abstract: PB1728
Type: Publication Only
Background
Mantle cell lymphoma (MCL) is an uncommon, still incurable subtype of non Hodgkin lymphoma. The routine use of high dose Cytarabine and high dose chemotherapy followed by autologous stem cell transplant (ASCT) markedly improved the outcome and has become the standard treatment for fit, young (<65 years) patients. Recently, two phase II studies demonstrated that Rituximab, Bendamustine and Cytarabine (RBAC) combination has a remarkable activity with a favorable safety profile both in untreated and relapsed/refractory elderly MCL patients (Visco et al., 2013 and 2017). These studies suggested that RBAC combination (with Cytarabine 800 mg/mq) is safe and effective as a CD34+ stem-cell mobilizing regimen. No data are available on RBAC with Cytarabine 500 mg/mq as mobilizing regimen in transplant-eligible patients.
Aims
To assess the efficacy and safety of RBAC as induction therapy and as a peripheral blood progenitor cell mobilization therapy in combination with granulocyte colony stimulating factor (Lenograstim) in newly diagnosed transplant-eligible mantle cell lymphoma patients.
Methods
From November 2009 to March 2016, 10 newly diagnosed MCL patients (median age 65 years; range 55-72) were treated as induction immunochemotherapy according to RBAC schedule (Rituximab 375 mg/mq day 1, Bendamustine 70 mg/mq day 2-3, Cytarabine 500 mg/mq day 2-3-4) for 4 cycles. 90 % had a stage IV disease; MIPI score was high in one patient (10%), intermediate in 5 patients (50%) and low in 4 patients (40%). Stem cell harvest was performed after 2 cycles. Successful mobilization was defined as achieving physician-determined target PBSC yield which was CD34+ cells >= 2 x 106/Kg. The G-CSF (Lenograstim) infusion started per protocol at day 6 at the dose of 5 umg/kg.
Results
All patients completed the scheduled treatment (4 cycles). The ORR was 90%: CR 90% and PD 10% (1 patient). Overall, the rates of successful mobilization and the proportion of patients achieving a total PBSC yield of ≥2x106/kg were 100%, and the median PBSC yield was 10 x 106/kg (range 3-20x106/kg). The median time to stem cell harvest was 17 days (range 14-19). The median number of apheresis to achieve the PBSC target was 1 and only 1 patient (10%) required a second collection procedure. Plerixafor was not used. 80% of patients underwent high dose chemotherapy according to FEAM protocol (Fotemustine 150 mg/mq on days -7, -6, Etoposide 200 mg/mq) and Cytarabine 400 mg/mq on days -5, -4, -3, -2 and Melphalan 140 mg/mq on day -1) with infusion of at least 5 x106 /Kg of PBSC. The median day for neutrophils and platelet recovery (ANC > 500/mmc, Plts > 50,000/mmc) was 11 and 26 (range 10-29 and 14-34), respectively. There was no engraftment failure. Most frequent adverse events (according to CTCAE grading) during therapy were hematological: neutropenia (100%, all 3-4), thrombocytopenia (100%, 60% G3-4), anemia (100%, 50% G3-4). Among non hematological toxicities, 20% of patients had febrile neutropenia (G3-4), 20% mucositis (G1-2), 20% lung infections (G3), 10% hyperglycemia (G3). After a median follow up of 43 months the OS and PFS were 90% and 80% respectively.
Conclusion
As in the relapsed/refractory setting and in MCL patients ineligible for high dose chemotherapy, RBAC has been proven to be an efficacious induction and mobilization regimen also in transplant eligible MCL patients with an encouraging safety profile. Further investigations are needed to assess the optimal role of RBAC within the standard first line treatments.
Session topic: 20. Aggressive Non-Hodgkin lymphoma - Clinical
Keyword(s): Autologous hematopoietic stem cell transplantation, Mobilization, Mantle cell lymphoma
Abstract: PB1728
Type: Publication Only
Background
Mantle cell lymphoma (MCL) is an uncommon, still incurable subtype of non Hodgkin lymphoma. The routine use of high dose Cytarabine and high dose chemotherapy followed by autologous stem cell transplant (ASCT) markedly improved the outcome and has become the standard treatment for fit, young (<65 years) patients. Recently, two phase II studies demonstrated that Rituximab, Bendamustine and Cytarabine (RBAC) combination has a remarkable activity with a favorable safety profile both in untreated and relapsed/refractory elderly MCL patients (Visco et al., 2013 and 2017). These studies suggested that RBAC combination (with Cytarabine 800 mg/mq) is safe and effective as a CD34+ stem-cell mobilizing regimen. No data are available on RBAC with Cytarabine 500 mg/mq as mobilizing regimen in transplant-eligible patients.
Aims
To assess the efficacy and safety of RBAC as induction therapy and as a peripheral blood progenitor cell mobilization therapy in combination with granulocyte colony stimulating factor (Lenograstim) in newly diagnosed transplant-eligible mantle cell lymphoma patients.
Methods
From November 2009 to March 2016, 10 newly diagnosed MCL patients (median age 65 years; range 55-72) were treated as induction immunochemotherapy according to RBAC schedule (Rituximab 375 mg/mq day 1, Bendamustine 70 mg/mq day 2-3, Cytarabine 500 mg/mq day 2-3-4) for 4 cycles. 90 % had a stage IV disease; MIPI score was high in one patient (10%), intermediate in 5 patients (50%) and low in 4 patients (40%). Stem cell harvest was performed after 2 cycles. Successful mobilization was defined as achieving physician-determined target PBSC yield which was CD34+ cells >= 2 x 106/Kg. The G-CSF (Lenograstim) infusion started per protocol at day 6 at the dose of 5 umg/kg.
Results
All patients completed the scheduled treatment (4 cycles). The ORR was 90%: CR 90% and PD 10% (1 patient). Overall, the rates of successful mobilization and the proportion of patients achieving a total PBSC yield of ≥2x106/kg were 100%, and the median PBSC yield was 10 x 106/kg (range 3-20x106/kg). The median time to stem cell harvest was 17 days (range 14-19). The median number of apheresis to achieve the PBSC target was 1 and only 1 patient (10%) required a second collection procedure. Plerixafor was not used. 80% of patients underwent high dose chemotherapy according to FEAM protocol (Fotemustine 150 mg/mq on days -7, -6, Etoposide 200 mg/mq) and Cytarabine 400 mg/mq on days -5, -4, -3, -2 and Melphalan 140 mg/mq on day -1) with infusion of at least 5 x106 /Kg of PBSC. The median day for neutrophils and platelet recovery (ANC > 500/mmc, Plts > 50,000/mmc) was 11 and 26 (range 10-29 and 14-34), respectively. There was no engraftment failure. Most frequent adverse events (according to CTCAE grading) during therapy were hematological: neutropenia (100%, all 3-4), thrombocytopenia (100%, 60% G3-4), anemia (100%, 50% G3-4). Among non hematological toxicities, 20% of patients had febrile neutropenia (G3-4), 20% mucositis (G1-2), 20% lung infections (G3), 10% hyperglycemia (G3). After a median follow up of 43 months the OS and PFS were 90% and 80% respectively.
Conclusion
As in the relapsed/refractory setting and in MCL patients ineligible for high dose chemotherapy, RBAC has been proven to be an efficacious induction and mobilization regimen also in transplant eligible MCL patients with an encouraging safety profile. Further investigations are needed to assess the optimal role of RBAC within the standard first line treatments.
Session topic: 20. Aggressive Non-Hodgkin lymphoma - Clinical
Keyword(s): Autologous hematopoietic stem cell transplantation, Mobilization, Mantle cell lymphoma
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