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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/m2, days 1 and 8), C (AUC = 5, day 1), D (40 mg, daily days 1–4), and R (375 mg/m2, day 8 for CD20-positive disease) and were evaluable for response. Characteristics included: median age 58 yeas (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 × 106 CD34+ cells/kg (range 5.0–24.1 × 106). 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.
Acknowledgements
Special thanks are given to Tina Bogne, Mark Brockman, Britt Kammerer, Nancy Knudsen, RN, Jennifer Roden, Greg Whitman, the additional Puget Sound Oncology Consortium (PSOC) investigators who contributed to this study (Drs. Albert Brady, Eric Chen, Vijajayakrishna Gadi, Robert Gersh, John Hansen, Peter Jiang, Theodore Kim, Kirk Lund, Sareena Malhi, David Maloney, Daniel Martin, Robert McCroskey, Vivian Oehler, Shushma Pant, Nanette Robinson, William Rubin, Peter Schelgel, Gerald Segal, Howard West, and Robert Witham), and the patients who participated.
Declaration of interest: Research was supported by: Eli Lilly Incorporated, NIH grants P01CA44991, R01CA76287, R01CA109663, K23CA85479, and K08CA095448, Lymphoma Research Foundation Mantle Cell Lymphoma Research Initiative, SCOR Grant 7040 from the Leukemia and Lymphoma Society, the Mary A. Wright Memorial Research Fund, and a donation from Frank and Betty Vandermeer. A.K.G. received Eli Lilly research funding, and is a Scholar in Clinical Research of the Leukemia and Lymphoma Society.