Evaluation of the optimal duration of chemotherapy in phase II trials for inoperable non-small-cell lung cancer (NSCLC)

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Abstract
To determine the optimal duration of chemotherapy in phase II trials for patients with non-small-cell lung cancer (NSCLC). The time from start of treatment until achievement of response according to WHO criteria was determined retrospectively in 8 phase II trials. Response to chemotherapy consisting of 4 complete and 39 partial remissions was registered in 43 of 333 patients. The median time from treatment start to response was 54 days. On day 84 on-study, 35 of the responding patients (81%) had achieved the response. Forty-three responses (98%) had occurred by day 168 and only one patient (2%) accomplished a response after 168 days of treatment. The responses had a median duration of 151 days (range 28-1559 days). The data indicate that patients with NSCLC included in phase II trials who have not yet achieved a response to chemotherapy after 168 days on study have a low likelihood (2%) of a subsequent response. Hence, treatment cessation at this point should be considered for non-responding patients. Continuation of treatment from day 84 to day 168 resulted in response in only 7 patients out of the total of 43 responses noted (16%). Thus, the toxic effects of the chemotherapy in addition to the inconvenience of hospital visits renders it questionable whether it is worthwhile to continue treatment in patients with inoperable non-small-cell lung cancer beyond day 84 in the absence of response.