The role of single-agent gemcitabine in the treatment of non-small-cell lung cancer.

Gemcitabine is a novel antimetabolite which has shown anti-tumor activity against a variety of tumors including non-small-cell lung cancer (NSCLC). Phase I clinical trials with gemcitabine revealed it was well tolerated and several phase II trials were conducted. This report will summarize the data from 15 phase I-II trials conducted in both untreated and treated patients with advanced lung cancer. Overall, single-agent gemcitabine was active with response rates in untreated patients ranging from 14%-33% and 0%-25% in previously treated patients. Grade 4 toxicities were infrequent with neutropenia reported in 2%-6% of patients and grade 4 thrombocytopenia was rate (1%). One randomized phase III trial comparing the efficacy and safety of gemcitabine to best supportive care confirmed the role of gemcitabine as an active agent for the treatment of NSCLC. Furthermore, gemcitabine was shown in several economic models to be cost-effective. In summary single agent gemcitabine is active, minimally toxic, and cost-effective as a treatment regimen for patients with advanced lung cancer. Studies combining gemcitabine with other active agents are underway and have reported promising results. As monotherapy, gemcitabine may make a valuable contribution to those patients with a poor performance status or comorbid diseases desiring treatment studies in this setting should also be considered.