A multicenter phase 2 study of risk-adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma

Abstract

BACKGROUND. Administration of salvage chemotherapy to patients with relapsed or refractory lymphoma is associated with significant toxicity. Vinorelbine and gemcitabine are novel chemotherapeutic agents with minimal overlapping toxicity. We present a phase 2 study of vinorelbine and gemcitabine with or without ifosfamide administered in an ambulatory care setting for relapsed or refractory lymphoma. METHODS. Ninety patients were enrolled. Group 1 comprised patients with "good" risk disease, Group 2 comprised patients with "high" risk disease, and Group 3 comprised patients relapsing after prior stem cell transplant. Patients in Group 1 and Group 3 received vinorelbine and gemcitabine with filgrastim support (VGF); those in Group 2 received the above regimen with ifosfamide (FGIV). We incorporated a standardized interim evaluation with dose escalation for patients with suboptimal response after 2 cycles. RESULTS. Toxicities were acceptable. Febrile neutropenia was uncommon: 7% after VGF (7 of 107 cycles) and 19% for FGIV (26 of 148 cycles). Unplanned admissions occurred in 23 of 107 cycles (21%) after VGF and 50 of 148 (34%) after FGIV. Overall response for Groups 1, 2 and 3, respectively was 76%, 39% and 50%, with median overall survival of 28, 9 and 30 months. CONCLUSIONS. Vinorelbine-based and gemcitabine-based chemotherapy is effective in the salvage setting against lymphoma and can be administered in an ambulatory setting. © 2008 American Cancer Society.