BACKGROUND: Single-agent chemotherapy produces partial responses in the range of 7-27% in patients with Stage IV nonsmall cell lung carcinoma (NSCLC). Cisplatin-based combination regimens have achieved higher response rates but with significant toxicity. Two prior studies employing 24-hour infusions of paclitaxel showed responses of 21% and 24%. The purpose of this Phase II study was to determine the effects of paclitaxel administered by short duration infusions on response rate, toxicity, and quality of life (QOL) in patients with NSCLC. METHODS: Twenty patients with histologically proven Stage IV NSCLC were enrolled in this study. All were treated on an outpatient basis with standard premedication followed by paclitaxel 200 mg/m2 infused intravenously over 3 hours. Treatments were repeated every 21 days for a maximum of 6 cycles. RESULTS: The objective response rate was 6/19 (32%; 95% confidence interval, 13-57%). The median duration of response was 6.0 months (range, 2-13 months). The median survival of the entire group was 6.0 months (range, 2-24+ months), and the 1-year survival rate was 22%. Toxicity was mild, with only one hospitalization required for treatment of catheter-related thrombosis. Nonresponding patients were found to have worsening Functional Assessment of Cancer Therapy (FACT)-G and FACT-L scores. Because this was a small clinical study, it did not demonstrate consistent improvement in FACT-G or FACT-L in responding patients. CONCLUSIONS: Paclitaxel given as a 3-hour infusion is a well-tolerated, active single agent in the treatment of Stage IV NSCLC, worthy of further study. Baseline QOL scores predicted those more likely to respond to treatment, but changes in QOL status did not correlate well with objective response status.
BACKGROUND: Single-agent chemotherapy produces partial responses in the range of 7-27% in patients with Stage IV nonsmall cell lung carcinoma (NSCLC). Cisplatin-based combination regimens have achieved higher response rates but with significant toxicity. Two prior studies employing 24-hour infusions of paclitaxel showed responses of 21% and 24%. The purpose of this Phase II study was to determine the effects of paclitaxel administered by short duration infusions on response rate, toxicity, and quality of life (QOL) in patients with NSCLC. METHODS: Twenty patients with histologically proven Stage IV NSCLC were enrolled in this study. All were treated on an outpatient basis with standard premedication followed by paclitaxel 200 mg/m2 infused intravenously over 3 hours. Treatments were repeated every 21 days for a maximum of 6 cycles. RESULTS: The objective response rate was 6/19 (32%; 95% confidence interval, 13-57%). The median duration of response was 6.0 months (range, 2-13 months). The median survival of the entire group was 6.0 months (range, 2-24+ months), and the 1-year survival rate was 22%. Toxicity was mild, with only one hospitalization required for treatment of catheter-related thrombosis. Nonresponding patients were found to have worsening Functional Assessment of Cancer Therapy (FACT)-G and FACT-L scores. Because this was a small clinical study, it did not demonstrate consistent improvement in FACT-G or FACT-L in responding patients. CONCLUSIONS:Paclitaxel given as a 3-hour infusion is a well-tolerated, active single agent in the treatment of Stage IV NSCLC, worthy of further study. Baseline QOL scores predicted those more likely to respond to treatment, but changes in QOL status did not correlate well with objective response status.