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

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 24 21-day cycles of G (1000mg/m², days 1 and 8), C (AUC5, day 1), D (40mg, daily days 14), and R (375mg/m², day 8 for CD20-positive disease) and were evaluable for response. Characteristics included: median age 58 yeas (1979 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] 5480) and 31 (95 CI 1944), respectively, with activity seen in a broad variety of histologies. Responses occurred in 16 of 17 (94, 95 CI 83100) transplant-eligible patients and 15 of 28 (54, 95 CI 3471) with chemoresistant disease. The median CD34 yield in patients attempting peripheral blood stem cell (PBSC) collection following this regimen was 10.9×10⁶ CD34 cells/kg (range 5.024.1×10 ⁶). Hematologic toxicity was common, but febrile neutropenia (2.5) and grade 4 non-hematologic adverse events (n2) were rare, with no treatment-related deaths. GCD(R) is a safe and effective outpatient regimen for relapsed lymphoma, and successfully mobilizes PBSCs.