Single agent Gemcitabine in Refractory or Relapsed Small-Cell Lung Cancer. Phase II Study

Abstract

Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC.Patients and Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. Patients were required to have performance status of 0 to 2 and adequate organ function. Treatment consisted of gemcitabine 1,000 mg/m2 on days 1, 8 and 15 of a 28-day cycle. Patients were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). Results: Twenty eight patients were enrolled onto this study (12 refractory and 16 sensitive patients). Twenty eight were assessable for response, survival and toxicity. Median patient age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic toxicities included neutropenia (28.6%) and thrombocytopenia (25%). The main grade 3/4 non-hematologic toxicities were pulmonary (7.1%) and neurologic toxicity (14.3%). Objective responses occurred in 14.3% of patients overall, including one patient with refractory SCLC (8.3%) and three patients with sensitive SCLC (18.8%). Median survival for the overall group was 7.1 months. Survival was not significantly different for patients with refractory versus sensitive disease.Conclusion: Gemcitabine has modest activity in previously treated SCLC patients. The favorable toxicity profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds