Contributions
Abstract: PB2444
Type: Publication Only
Background
Hematopoietic progenitor cell transplantation (HSCT) represents a potentially curative therapy for certain hematological diseases. Improving conditioning regimen (CR)efficacy and safety is the major variable for results and is an important area of research . Also the world shortage and expense of carmustine has promoted the use of alternative conditioning regimens to the classical BEAM/CBV. Recently at MD Anderson Cancer Center, Dr. Nieto demonstrated that GEMBUMEL improves PFS and OS in patients with HL R/R. GEMBUMEL combines the alkylating activity with the inhibition of DNA repair, producing an additive or synergistic effect. We present here a comparative study of the CR: BUCY, BEAM-BEAC and GEMBUMEL in patients (P) with diagnosis of Lymphoma subjected to autologous HSCT.
Aims
To evaluate the safety and efficacy of these regimens in our experience.
Methods
Retrospective, observational and descriptive work. Patients with diagnosis of Hodgkin's Lymphoma (HL) and non-Hodgkin's Lymphoma (NHL) undergoing autologous HSCT in the 2010-2017 period were included. CR were (all the medication was done intravenous) : BEAC (Carmustine 300 mg/m2 , Etoposide 1200 mg/m2, Cytarabine 800 mg/m2 Cyclophosphamide 140 mg/kg IV) BEAM (Carmustine 300 mg/m2, Etoposide 800 mg/m2, Cytarabine 1600 mg/m2, Melphalan 140 mg/m2) BUCY (Busulfan 12.8 mg/kg Cyclophosphamide 120 mg/kg) GEMBUMEL (Busulfan 420mg/m2, Melphalan 120 mg/m2, Gemcitabine 5500mg/m2). Safety was analyzed assessing: toxicity (according to CTCAE), haematological recovery and transfusional requirement. Progression Free Survival (PFS) and Overall Survival (OS) was evaluated for the efficacy analysis. Descriptive statistics were used for the numerical variables, ANOVA for the categorical ones, Chi-Square test for comparison of proportions and the analysis of PFS and OS by Kaplan Meier curves. A p <0.05 was considered statistically significant.
Results
We analyzed 70 P, with the following distribution according to CR: 1-BUCY (n = 16), 2-BEAM / BEAC (n = 35) and 3-GEMBUMEL (n = 19). Only a statistically significant difference was observed in the relationship between men and women, within their baseline. When grade III-IV of Toxicity was evaluated between the groups, there were statistically significant with p <0.001, mucositis (50% vs54.2% vs100%), hepatitis (0% vs0% vs73.7%) and dermatitis ( 0% vs0% 36.8%), with no difference in transplantation related mortality. When Efficacy was compared, neutrophil recovery was achieved with a mean of 13, 13.8 and 11 days (p 0.169) and platelets 33, 20 and 18 days (p 0.008), and there were no differences in transfusion requirements. The 12-month PFS was 75, 80 and 78.95% and the OS at 12 months was 87, 94.2 and 94.7%, with no significant statistical differences. The comparison according to disease (HL vs NHL) also showed no difference in terms of OS.
Conclusion
GEMBUMEL CR presented more toxicity, evidencing a higher incidence of mucositis, hepatitis and dermatitis, while BUCY showed late recovery of platelets. There were no differences in PFS or OS between the CR.
Session topic: 23. Stem cell transplantation - Clinical
Keyword(s): Conditioning, lymphoma, Transplant
Abstract: PB2444
Type: Publication Only
Background
Hematopoietic progenitor cell transplantation (HSCT) represents a potentially curative therapy for certain hematological diseases. Improving conditioning regimen (CR)efficacy and safety is the major variable for results and is an important area of research . Also the world shortage and expense of carmustine has promoted the use of alternative conditioning regimens to the classical BEAM/CBV. Recently at MD Anderson Cancer Center, Dr. Nieto demonstrated that GEMBUMEL improves PFS and OS in patients with HL R/R. GEMBUMEL combines the alkylating activity with the inhibition of DNA repair, producing an additive or synergistic effect. We present here a comparative study of the CR: BUCY, BEAM-BEAC and GEMBUMEL in patients (P) with diagnosis of Lymphoma subjected to autologous HSCT.
Aims
To evaluate the safety and efficacy of these regimens in our experience.
Methods
Retrospective, observational and descriptive work. Patients with diagnosis of Hodgkin's Lymphoma (HL) and non-Hodgkin's Lymphoma (NHL) undergoing autologous HSCT in the 2010-2017 period were included. CR were (all the medication was done intravenous) : BEAC (Carmustine 300 mg/m2 , Etoposide 1200 mg/m2, Cytarabine 800 mg/m2 Cyclophosphamide 140 mg/kg IV) BEAM (Carmustine 300 mg/m2, Etoposide 800 mg/m2, Cytarabine 1600 mg/m2, Melphalan 140 mg/m2) BUCY (Busulfan 12.8 mg/kg Cyclophosphamide 120 mg/kg) GEMBUMEL (Busulfan 420mg/m2, Melphalan 120 mg/m2, Gemcitabine 5500mg/m2). Safety was analyzed assessing: toxicity (according to CTCAE), haematological recovery and transfusional requirement. Progression Free Survival (PFS) and Overall Survival (OS) was evaluated for the efficacy analysis. Descriptive statistics were used for the numerical variables, ANOVA for the categorical ones, Chi-Square test for comparison of proportions and the analysis of PFS and OS by Kaplan Meier curves. A p <0.05 was considered statistically significant.
Results
We analyzed 70 P, with the following distribution according to CR: 1-BUCY (n = 16), 2-BEAM / BEAC (n = 35) and 3-GEMBUMEL (n = 19). Only a statistically significant difference was observed in the relationship between men and women, within their baseline. When grade III-IV of Toxicity was evaluated between the groups, there were statistically significant with p <0.001, mucositis (50% vs54.2% vs100%), hepatitis (0% vs0% vs73.7%) and dermatitis ( 0% vs0% 36.8%), with no difference in transplantation related mortality. When Efficacy was compared, neutrophil recovery was achieved with a mean of 13, 13.8 and 11 days (p 0.169) and platelets 33, 20 and 18 days (p 0.008), and there were no differences in transfusion requirements. The 12-month PFS was 75, 80 and 78.95% and the OS at 12 months was 87, 94.2 and 94.7%, with no significant statistical differences. The comparison according to disease (HL vs NHL) also showed no difference in terms of OS.
Conclusion
GEMBUMEL CR presented more toxicity, evidencing a higher incidence of mucositis, hepatitis and dermatitis, while BUCY showed late recovery of platelets. There were no differences in PFS or OS between the CR.
Session topic: 23. Stem cell transplantation - Clinical
Keyword(s): Conditioning, lymphoma, Transplant