A Phase II randomized study of paclitaxel plus carboplatin or cisplatin against chemo-naive inoperable non-small cell...

Paclitaxel plus carboplatin (CAR) or cisplatin (CIS) has shown activity in the treatment of advanced non-small cell lung cancer (NSCLC). Our aim was to determine whether paclitaxel plus platinum is an appropriate regimen for chemo-naïve NSCLC in patients aged 70 years or older. Patients were randomized into paclitaxel plus CAR or paclitaxel plus CIS treatment arms. Treatment consisted of paclitaxel 160 mg/m and carboplatin at AUC = 6 (predicted using measured clearances and the Calvert formula) IV infusion on day 1 every 3 weeks, or paclitaxel 160 mg/m and cisplatin 60 mg/m IV on day 1 every 3 weeks. In total, 81 patients were enrolled from September 2000 to February 2005, including 40 who received CAR treatment and 41 who received CIS treatment. In all, 152 cycles of CAR (median, four cycles per patient) and 172 cycles of CIS (median, four cycles per patient) were given. Each arm had one complete response and 15 partial responses to the treatment, with overall response rates of 40% and 39%, respectively. Myelosuppression was mild in both arms, and there was no statistical difference between the two arms. Alopecia (P < 0.001), peripheral neuropathy (P = 0.017), and fatigue (P < 0.001) were more severe in the CIS treatment arm than in the CAR treatment arm. Median time to disease progression was 6.6 months in the CAR arm and 6.9 months in the CIS arm. Median survival time was 10.3 months in the CAR arm and 10.5 months in the CIS arm. In conclusion, paclitaxel plus CAR or CIS treatment is feasible in elderly patients and has similar activity. However, paclitaxel plus CAR had less non-hematological toxicity than paclitaxel plus CIS.