Pilot study of an outpatient-based approach for advanced lymphoma using vinorelbine, gemcitabine and filgrastim

Vinorelbine and gemcitabine have demonstrable single-agent activity against lymphoma, show differing toxicity profiles and can be given in an outpatient setting.

We have evaluated the feasibility of an outpatient-based combination of vinorelbine and gemcitabine with filgrastim support (VGF) in patients with advanced lymphoma.

An open-label, single-arm study of 40 consecutive patients with relapsed (n = 24) or refractory (n = 16) lymphoma was undertaken. The median number of prior regimens was three (range 1-11) and 12 had undergone prior stem cell transplantation. Patients received vinorelbine 25 mg/m(2) and gemcitabine 1000 mg/m(2) on days 1 and 8 of each 21-day cycle. Patients showing no response after two cycles (early response) were offered alternative therapy. Responding patients received two more cycles. Primary end-points were the early and overall response rates.

One hundred and sixteen cycles of therapy were delivered. Hospital admissions were required following 27 treatment cycles (24%), predominantly following cycle 1. Febrile neutropenia followed 6% of cycles. The early and overall response rates on an intention-to-treat basis were 60 and 53%, respectively. Responses for peripheral T-cell lymphoma and Hodgkin lymphoma were particularly encouraging, 70 and 75%, respectively. With a median follow up of 34 months overall survival for the entire cohort at 2 years is 50%. Furthermore, for the 23 patients who did not receive high-dose consolidative therapy 2-year survival was 35%.

Vinorelbine and gemcitabine with filgrastim support can be safely delivered in an outpatient setting and shows clinically meaningful activity against a range of advanced lymphoma subtypes.