Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget Sound Oncology Consortium.

Publication Type:

Journal Article

Source:

Leukemia & lymphoma, Volume 51, Issue 8, p.1523-9 (2010)

Keywords:

2010, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Murine-Derived, Antibody Development Core Facility, Antineoplastic Combined Chemotherapy Protocols, Biologics Production Core Facility, Carboplatin, Cell Processing Core Facility, Center-Authored Paper, Clinical Research Division, Combined Modality Therapy, Comparative Medicine Core Facility, Deoxycytidine, Dexamethasone, Drug Resistance, Neoplasm, Female, Flow Cytometry Core Facility, Genomics Core Facility, Hematopoietic Stem Cell Mobilization, Humans, Lymphoma, Male, Middle Aged, Neoplasm Recurrence, Local, Peripheral Blood Stem Cell Transplantation, Prospective Studies, Proteomics Core Facility, Remission Induction, Research Trials Office Core Facility - Biostatistics Service, Salvage Therapy, Shared Resources, Survival Rate, Treatment Outcome, Young Adult

Abstract:

We conducted a multi-center phase II trial of gemcitabine (G), carboplatin (C), dexamethasone (D), and rituximab (R) in order to examine its safety and efficacy as an outpatient salvage regimen for lymphoma. Fifty-one patients received 2-4 21-day cycles of G (1000 mg/m(2), days 1 and 8), C (AUC = 5, day 1), D (40 mg, daily days 1-4), and R (375 mg/m(2), day 8 for CD20-positive disease) and were evaluable for response. Characteristics included: median age 58 years (19-79 years), stage III/IV 88%, elevated LDH 33%, median prior therapies 2, prior stem cell transplant 12%, chemoresistant 62%, median prior remission duration 2.5 months. The overall and complete response rates were 67% (95% confidence interval [CI] 54-80%) and 31% (95% CI 19-44%), respectively, with activity seen in a broad variety of histologies. Responses occurred in 16 of 17 (94%, 95% CI 83-100%) transplant-eligible patients and 15 of 28 (54%, 95% CI 34-71%) with chemoresistant disease. The median CD34 yield in patients attempting peripheral blood stem cell (PBSC) collection following this regimen was 10.9 x 10(6) CD34+ cells/kg (range 5.0-24.1 x 10(6)). Hematologic toxicity was common, but febrile neutropenia (2.5%) and grade 4 non-hematologic adverse events (n = 2) were rare, with no treatment-related deaths. GCD(R) is a safe and effective outpatient regimen for relapsed lymphoma, and successfully mobilizes PBSCs.