A Phase II Trial of Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-Cell Lymphoma (BENCART): A Consortium for Improving Survival of Lymphoma (CISL) Trial

Abstract

Background There is no standard salvage chemotherapy for relapsed or refractory peripheral T-cell lymphomas (PTCLs). In BETLY trial, which is sole prospective trial for bendamustine in refractory or relapsed T-cell lymphoma, bendamustine showed an encouraging high response rate across the two major PTCL subtypes, independent of age and prior treatment, with acceptable toxicity in refractory or relapsed PTCLs. We planned this trial to investigate the efficacy and toxicity of bendamustine, carboplatin and dexamethasone (BCD) for relapsed or refractory PTCLs, which would be expected to show more promising clinical outcomes than that of bendamustine single therapy.

Patients and Methods Patients with relapsed or refractory PTCLs with more than one previous regimen regardless stem cell transplantation are eligible and totally 30 patients are needed. BCD treatment, which consist of bendamustine 80mg/m2 intravenously (i.v.) on Days 1 and 2, carboplatin AUC 5.0 i.v. on Day 1, and dexamethasone 40 mg orally on Days 1-4, was planned up to six treatment cycles without progressive disease and Peg-GCSF was supported at every cycle. Autologous stem cell transplantation (ASCT) after 3 cycles of BCD could be proceeded for eligible patients.

Results Twenty-eight eligible patients were evaluated for toxicity and response. The diagnoses of participants included 15 cases of PTCL-NOS (54%), five cases of angioimmunoblastic T-cell lymphoma (18%) and four cases of ALK-negative anaplastic large cell lymphoma (14%) among others. The median age of the patients was 59 years (range, 23-75 years). After treatments with BCD, which delivered a median of three BCD cycles, there were 8 patients with complete responses (CR; 30%) and seven with partial responses (PR; 25%). The overall response rate (RR) was 55%. Five patients preceded to ASCT and three patients finally achieved CR. The median progression free survival was 4.8 months with a median follow-up duration of 4.5 months. In a total of 85 cycles of BCD, grade 3 or 4 neutropenia, thrombocytopenia and anemia occurred in 17.6%, 38.8% and 16.5% of cycles, respectively. Only one patients experienced febrile neutropenia.

Conclusions BCD is an effective salvage regimen for relapsed or refractory PTCLs and can be administered with acceptable toxicity.