PHASE-II STUDY OF PATIENTS WITH METASTATIC NONSMALL CELL-CARCINOMA OFTHE LUNG TREATED WITH PACLITAXEL BY 3-HOUR INFUSION

BACKGROUND. Single-agent chemotherapy produces partial responses in th e range of 7-27% in patients with Stage IV nonsmall cell lung carcinom a (NSCLC). Cisplatin-based combination regimens have achieved higher r esponse rates but with significant toxicity. Two prior studies employi ng 24-hour infusions of paclitaxel showed responses of 21% and 24%. Th e purpose of this Phase II study was to determine the effects of pacli taxel administered by short duration infusions on response rate, toxic ity, and quality of life (QOL) in patients with NSCLC. METHODS. Twenty patients with histologically proven Stage IV NSCLC were enrolled in t his study. All were treated on an outpatient basis with standard preme dication followed by paclitaxel 200 mg/m(2) infused intravenously over 3 hours, Treatments were repeated every 21 days for a maximum of 6 cy cles. RESULTS. The objective response rate was 6/19 (32%; 95% confiden ce 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 m onths (range, 2-24+ months), and the 1-year survival rate was 22%. Tox icity was mild, with only one hospitalization required for treatment o f catheter-related thrombosis. Nonresponding patients were found to ha ve worsening Functional Assessment of Cancer Therapy (FACT)-G and FACT -L scores. Because this was a small clinical study, it did not demonst rate consistent improvement in FACT-G or FACT-L in responding patients . CONCLUSIONS. Paclitaxel given as a 3-hour infusion is a well-tolerat ed, active single agent in the treatment of Stage IV NSCLC, worthy of further study. Baseline QOL scores predicted those more likely to resp ond to treatment, but changes in QOL status did not correlate well wit h objective response status. (C) 1997 American Cancer Society.