Abstract
In a prospective study 160 untreated patients with clinical stage IIIb and IV NSCLC were randomized to receive vindesin-mitomycin C-cisplatin or vindesin-mitomycin C—CBDCA (at fixed dose of 500 mgsqm). The drug free interval was 4 wks and patients were supposed to receive 6–8 cycles. CBDCA group obtained an response rate of 38% with median survival 6.2 mo. and experienced relatively mild toxicity. Received dose intensity (DI) for CBOCA was calculated to be 91% of planned DI. The treatment outcome was analyzed by the influence of CBDCA DI in respect of optimal individual dose calculated by Egorin, Calvert and Chatelut (ESMO Lisbon) formulas. Coefficients of variation between the dose of CBDCA based on body surface area and individual dose obtained by Calvert and Egorin formula were 30 and 40% respectively. Patients with PD received approximately 15% less of optimal dose compared to the patients with CR only, but small numbers of CRs do not allow firm conclusion. Due to broad range of pretreatment platelet count, Calvert formula might not be suitable for optimal dose finding in NSCLC patients. It is concluded that DI-outcome correlations are not consistent for CBDCA in NSCLC. It is of questionable value to test this hypothesis in a prospective manner due to lack of sensitivity of NSCLC to chemotherapy agents available.
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