Second-line gemcitabine in refractory stage IV non small-cell lung cancer: a phase II trial.

Two recent trials have suggested that docetaxel improves survival in the second-line treatment of non small-cell lung cancer (NSCLC) refractory to first-line platinum-based regimens. Given this, it is appropriate to continue to address the role of new agents in the second-line treatment of refractory NSCLC. Gemcitabine is a well-tolerated new agent that has been shown to have activity in NSCLC. Thirty-one previously treated patients with NSCLC were entered in this study. Eight patients had responsive disease (defined as response to first-line therapy lasting greater than or equal to 3 months) and 23 had refractory disease (defined as progressive disease on first-line therapy or progression less than 3 months from completing first-line therapy). Gemcitabine (1250 mg/m2) was infused over 30 minutes on days 1, 8, and 15 every 28 days. Quality of life (QOL) was assessed with each cycle using the Functional Assessment Cancer Therapy-Lung (FACT-L) questionnaire. Two patients (6.5%) had a partial response, and nine (29%) had disease stabilization. The most frequent grade 3/4 toxicity was myelosuppression, but this only occurred in 8% of doses delivered. Fifty-two percent of evaluable patients had stable or improved QOL over baseline, 10% had a decline in QOL, and the remainder completed only baseline questionnaires. Twenty-nine patients have died of progressive NSCLC; two patients remain alive. Overall, the 31 patients have a median survival of 5.1 months (95% confidence interval [CI]: 4.2-7.4 months) and 1-year survival rate of 16% (95% CI: 3%-29%). Gemcitabine was well tolerated in this patient population. An objective response rate of 6.5% was observed although a significant proportion of patients (29%) experienced stable disease, which may have impacted on their survival. QOL was improved or maintained in over half of the patients. Given these data, gemcitabine as a single agent is a therapeutic option for patients with refractory NSCLC.