BRENTUXIMAB VEDOTIN + ESHAP (BRESHAP) FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANT: HIGH COMPLETE REMISSION RATE AND LONG-TERM TIME TO TREATMENT FAILURE IN REFRACTORY/RELAPSED HODGKIN LYMPHOMA.
Author(s): ,
R Garcia-Sanz
Affiliations:
Hematology,University Hospital of Salamanca,Salamanca,Spain
,
Anna Sureda
Affiliations:
Hematology,Hospital Duran i Reynals,Barcelona,Spain
,
Fátima De la Cruz
Affiliations:
Hematology,Hospital Virgen del Rocío,Sevilla,Spain
,
Ana Pilar González
Affiliations:
Hematology,Hospital Central de Asturias,Oviedo,Spain
,
Antonia Rodríguez
Affiliations:
Hematology,Hospital 12 de Octubre,Madrid,Spain
,
Blanca Sánchez-González
Affiliations:
Hematology,Hospital del Mar,Barcelona,Spain
,
Eva Domingo
Affiliations:
Hematology,Hospital Duran i Reynals,Barcelona,Spain
,
Miriam Moreno
Affiliations:
Hematology,Hospital Germans Trias i Pujol,Badalona,Spain
,
Javier López
Affiliations:
Hematology,Hopital Ramón y Cajal,Madrid,Spain
,
José Luis Piñana
Affiliations:
Hematology,Hospital Clínico de Valencia,Madrid,Spain
,
Gabriel Rodríguez-Macías
Affiliations:
Hematology,Hospital Gregorio Marañón,Madrid,Spain
,
Miguel Canales
Affiliations:
Hematology,Hospital Universitario la Paz,Madrid,Spain
,
Antonio Gutierrez
Affiliations:
Hematology,Hopsital Son Espases de Mallorca,Palma de Mallorca,Spain
,
María José Rodríguez Salazar
Affiliations:
Hematology,Hospital Universitario de Canarias,Santa Cruz de Tenerife,Spain
,
María Dolores Caballero
Affiliations:
Hematology,University Hospital of Salamanca,Salamanca,Spain
Carmen Martínez
Affiliations:
Hematology,Hospital Clínic i Provincial,Barcelona,Spain
(Abstract release date: 05/17/18) EHA Library. García-Sanz R. 06/15/18; 214506; S113
Prof. Dr. Ramón García-Sanz
Prof. Dr. Ramón García-Sanz
Contributions
Abstract

Abstract: S113

Type: Oral Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 12:15 - 12:30

Location: Room A2

Background
Refractory or Relapsed Hodgkin Lymphoma(RRHL) are treated with Salvage therapy and Autologous Peripheral Blood Stem Cell Transplantation (APBSCT). The addition of brentuximab vedotin (BV) is feasible and increases the CR rate

Aims
To evaluate long-term results of a phase II trial with the combination of BV and ESHAP chemotherapy [BRESHAP] as 2nd line therapy for RRHL prior to APBSCT (ClinicalTrials.gov #NCT02243436).

Methods
Primary efficacy endpoint was complete responses (CR) pre-APBSCT after  BRentuximab vedotin, Etoposide, Solumedrol, High dose AraC and cisPlatin.

Results
Patients with relapsed or refractory classical HL (cHL) after one prior line of therapy were eligible. 66 patients were included in the trial. There were 35 females and 31 males, with a median age of 36 years (18-66). At inclusion, 40 patients were primary refractory, 16 early relapses (CR ≤1 year) and 10 as late relapses (CR >1 year). In this update, all patients have completed all the protocol. During the follow-up, there have been 39 Severe Adverse Events (SAEs) reported in 22 patients (hospitalizations and AEs around transplant were not considered SAEs). Most frequent were fever (n=25, 35% neutropenic), hypomagnesemia and gastrointestinal alterations (n=3). There were 3 SAEs, terminating in death: pneumonia, abdominal sepsis and pulmonary embolism. Apart from APBSCT, there grade 3-4 hematologic toxicity presented in 28 cases: neutropenia (n=21), thrombocytopenia (n=14), and anemia (n=7). Grade 3-4 extra-hematologic adverse events present in ≥5% of cases were non-neutropenic fever (n=13) and hypomagnesemia (n=3). All patients except two underwent stem cell mobilization after the 1st (n=15), 2nd (n=36) or 3rd (n=13) cycle using subcutaneous G-CSF 5 mcg/Kg/12 h. for 5 days. All 64 patients collected >2·10e6/Kg peripheral blood CD34+ cells in all cases (median 5.75, range 2.12-33.4). The number of harvesting procedures was one in 48 patients, two in 13, three in 2 and four in 1. The transplant was done after BRESHAP in 61 patients: all engrafted with a median of 11 & 12 days for neutrophil and platelet recovery, respectively. Four other patients were transplanted after receiving other therapies. No major events were registered during transplant period, except for the patient who died at day +110 due to pneumonia. Overall pre-transplant response was 93%, including a 71% and 22% complete and partial remission rates, respectively. Six patients were considered as non-responders: one who died before any evaluation, two who stable disease and three progressions. Status 3-months after the transplant was CR in 48 patients, PR in 6, SD in 2 and PD in 5. Three doses of BV were given in 50 patients; the remaining 16 patients did not receive the projected consolidation due to toxicity (cytopenias, n=6; neuropathy, n=1), progression (n=6), patient refusal (n=2) and death (n=1). At a mean follow-up of 27 months, 13 patients have progressed and 3 have died without progression, providing 3-year time to treatment failure and progression free survival of 75% and 71%, respectively. Six patients died: 3 due to progression, and the 3 already mentioned. Projected overall survival is 91% at one year.

Conclusion
BRESHAP is a highly effective regimen for remission induction prior to transplant, which maintains it in patients with refractory or relapsed Hodgkin lymphoma. 

Session topic: 17. Hodgkin lymphoma – Clinical

Keyword(s): Hodgkin's Lymphoma, Monoclonal antibody, Refractory, Relapsed lymphoma

Abstract: S113

Type: Oral Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 12:15 - 12:30

Location: Room A2

Background
Refractory or Relapsed Hodgkin Lymphoma(RRHL) are treated with Salvage therapy and Autologous Peripheral Blood Stem Cell Transplantation (APBSCT). The addition of brentuximab vedotin (BV) is feasible and increases the CR rate

Aims
To evaluate long-term results of a phase II trial with the combination of BV and ESHAP chemotherapy [BRESHAP] as 2nd line therapy for RRHL prior to APBSCT (ClinicalTrials.gov #NCT02243436).

Methods
Primary efficacy endpoint was complete responses (CR) pre-APBSCT after  BRentuximab vedotin, Etoposide, Solumedrol, High dose AraC and cisPlatin.

Results
Patients with relapsed or refractory classical HL (cHL) after one prior line of therapy were eligible. 66 patients were included in the trial. There were 35 females and 31 males, with a median age of 36 years (18-66). At inclusion, 40 patients were primary refractory, 16 early relapses (CR ≤1 year) and 10 as late relapses (CR >1 year). In this update, all patients have completed all the protocol. During the follow-up, there have been 39 Severe Adverse Events (SAEs) reported in 22 patients (hospitalizations and AEs around transplant were not considered SAEs). Most frequent were fever (n=25, 35% neutropenic), hypomagnesemia and gastrointestinal alterations (n=3). There were 3 SAEs, terminating in death: pneumonia, abdominal sepsis and pulmonary embolism. Apart from APBSCT, there grade 3-4 hematologic toxicity presented in 28 cases: neutropenia (n=21), thrombocytopenia (n=14), and anemia (n=7). Grade 3-4 extra-hematologic adverse events present in ≥5% of cases were non-neutropenic fever (n=13) and hypomagnesemia (n=3). All patients except two underwent stem cell mobilization after the 1st (n=15), 2nd (n=36) or 3rd (n=13) cycle using subcutaneous G-CSF 5 mcg/Kg/12 h. for 5 days. All 64 patients collected >2·10e6/Kg peripheral blood CD34+ cells in all cases (median 5.75, range 2.12-33.4). The number of harvesting procedures was one in 48 patients, two in 13, three in 2 and four in 1. The transplant was done after BRESHAP in 61 patients: all engrafted with a median of 11 & 12 days for neutrophil and platelet recovery, respectively. Four other patients were transplanted after receiving other therapies. No major events were registered during transplant period, except for the patient who died at day +110 due to pneumonia. Overall pre-transplant response was 93%, including a 71% and 22% complete and partial remission rates, respectively. Six patients were considered as non-responders: one who died before any evaluation, two who stable disease and three progressions. Status 3-months after the transplant was CR in 48 patients, PR in 6, SD in 2 and PD in 5. Three doses of BV were given in 50 patients; the remaining 16 patients did not receive the projected consolidation due to toxicity (cytopenias, n=6; neuropathy, n=1), progression (n=6), patient refusal (n=2) and death (n=1). At a mean follow-up of 27 months, 13 patients have progressed and 3 have died without progression, providing 3-year time to treatment failure and progression free survival of 75% and 71%, respectively. Six patients died: 3 due to progression, and the 3 already mentioned. Projected overall survival is 91% at one year.

Conclusion
BRESHAP is a highly effective regimen for remission induction prior to transplant, which maintains it in patients with refractory or relapsed Hodgkin lymphoma. 

Session topic: 17. Hodgkin lymphoma – Clinical

Keyword(s): Hodgkin's Lymphoma, Monoclonal antibody, Refractory, Relapsed lymphoma

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