Phase II study of patients with metastatic nonsmall cell carcinoma of the lung treated with paclitaxel by 3-hour infusion

✍ Scribed by William J. Tester; Pamela Y. Jin; Deborah H. Reardon; Jeffrey B. Cohn; Martin H. Cohen

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 77 KB
• Volume: 79
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19970215)79:4<724::aid-cncr9>3.0.co;2-d

✦ Synopsis

METHODS.

Twenty patients with histologically proven Stage IV NSCLC were en-Pennsylvania.

rolled in this study. All were treated on an outpatient basis with standard premedication followed by paclitaxel 200 mg/m 2 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.