Docetaxel in combination with either cisplatin or gemcitabine in unresectable non-small cell lung carcinoma: a randomized phase II study by the Japan Lung Cancer Cooperative Clinical Study Group.

Purpose To evaluate whether cisplatin-free chemotherapy (docetaxel and gemcitabine [DG]) provides a comparable alternative to cisplatin-based chemotherapy (docetaxel and cisplatin [DC]) as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC). Patients and Methods Patients ( n = 133) with stage IIIB to IV NSCLC were randomly assigned to receive DG (docetaxel 60 mg/m 2 , day 8 + gemcitabine 800 mg/m 2 , days 1 and 8, every 3 weeks; n = 65) or DC (docetaxel 60 mg/m 2 , day 1 + cisplatin 80 mg/m 2 , day 1, every 3 weeks; n = 68). The primary end point of the study was overall response rate. No prophylactic use of human recombinant granulocyte colony stimulating factor was allowed. Results The planned patient number was 150. However, an unexpectedly high incidence of grade 3 interstitial lung disease (11.1%) was identified in the DG arm, so the study was closed early. The overall response rates of the DG and DC arms were 27% and 23.5%, respectively, which demonstrated that the DG treatment was not inferior to the DC arm. Gastrointestinal toxicities were less frequent in the DG arm than in DC arm. Interstitial lung disease was exclusively observed in seven of 63 patients in the DG arm (11.1%). Median survival and 1-year survival rate were comparable between the two arms (median survival, DG 13.7 months versus DC 11.4 months; 1-year survival, DG 56.6% versus DC 47.7%). Conclusion The DG regimen has a response rate and survival rate comparable to those of the DC regimen and can therefore be considered from an efficacy point of view to be comparable. However, the DG regimen may have induced pulmonary toxicity in 11% of the patients exposed and therefore should be used cautiously among patients with advanced NSCLC.