Impact of post-brentuximab vedotin consolidation on relapsed/refractory CD30+ Hodgkin lymphomas: a large retrospective study on 240 patients enrolled in the French Named-Patient Program

Haematologica. 2016 Apr;101(4):466-73. doi: 10.3324/haematol.2015.134213. Epub 2016 Jan 14.

Abstract

Brentuximab vedotin was reported to be effective and safe against refractory/relapsed Hodgkin lymphoma in cohorts of between 12 to 102 patients. Herein we report our retrospective analysis of the French experience with brentuximab vedotin used alone to treat 240 refractory/relapsed Hodgkin lymphoma patients enrolled in a named patient program between 2011 and 2013. All patients had histologically documented CD30+ Hodgkin lymphoma; 74% had refractory disease or early relapses. After a median of 3 lines of chemotherapy, brentuximab vedotin was infused intravenously (1.8 mg/kg every 3 weeks). The primary endpoint was best response. Response at the end of treatment, its duration, survival data and toxicity profile were secondary endpoints. Patients received a median of 6 cycles; 68 underwent a consolidation thereafter. The best response was observed after a median of 4 cycles in 145 (60.4%) patients: 33.8% complete response/unconfirmed complete response, 26.7% partial response. Objective responses were observed as decreased (39.3%) in the 28 patients >60 years. The median response duration was 8.4 months. With median follow-up at 16.1 months, median progression-free survival was 6.8 months and this was significantly longer for patients transplanted after brentuximab vedotin (a median of 18,8 months); median overall survival was not reached. No death has been linked to brentuximab vedotin toxicity. The most common adverse events were peripheral sensory neuropathy (29.3%) and hematological toxicity. The results of this analysis support the previously reported brentuximab vedotin efficacy with manageable toxicity. Because of the short-term responses in most patients, a high-dose therapy with stem cell transplantation for responders should be considered as quickly as possible.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Biomarkers, Tumor / genetics*
  • Brentuximab Vedotin
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Female
  • France
  • Gene Expression
  • Hodgkin Disease / drug therapy*
  • Hodgkin Disease / genetics
  • Hodgkin Disease / mortality
  • Hodgkin Disease / pathology
  • Humans
  • Immunoconjugates / administration & dosage*
  • Immunoconjugates / adverse effects
  • Injections, Intravenous
  • Ki-1 Antigen / genetics
  • Male
  • Middle Aged
  • Nausea / diagnosis
  • Nausea / etiology
  • Nausea / pathology
  • Neoplasm Staging
  • Peripheral Nervous System Diseases / diagnosis
  • Peripheral Nervous System Diseases / etiology
  • Peripheral Nervous System Diseases / pathology
  • Recurrence
  • Remission Induction
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome

Substances

  • Biomarkers, Tumor
  • Immunoconjugates
  • Ki-1 Antigen
  • Brentuximab Vedotin