A randomised trial of cisplatin and vindesine versus supportive care only in advanced non-small cell lung cancer.

摘要: The value of chemotherapy in advanced non-small cell lung cancer (NSCLC) remains contentious. Because this two separate but very similar trials were set up Australia and Southampton (UK). Two hundred one patients with stage IIIb or IV NSCLC randomly assigned to cisplatin 120 mg m-2 on days 1 29 vindesine 3 weekly x 6 no chemotherapy. Both groups eligible receive radiotherapy other palliative treatment as required. Of 188 evaluable patients, 97 received 91 the control arm. Response was assessed between 42 49. Responders continued at same doses though being given 4 2 12. overall response rate 28%; there significant differences according major prognostic criteria. Although survival group (median 27 weeks) longer than that 17 not statistically (log rank P = 0.33). For without dissemination (IIIb), median 45 weeks arm 26 non-chemotherapy 0.075). Toxicity universal frequently severe: discontinuing after cycle, 13 did so because unacceptable toxicity. This cannot be recommended routine treatment. Further phase III studies should continue use a also attempt measure quality life, an issue addressed effectively recent trials.