Docetaxel plus cisplatin and docetaxel plus irinotecan are active and well-tolerated chemotherapy regimens for advanced non-smallcell lung cancer (NSCLC). A randomised phase II study compared their efficacy and toxicity in 108 patients with stage IIIb/IV NSCLC, who were randomised to receive docetaxel 60 mg m À2 and cisplatin 80 mg m À2 on day 1 (DC; n ¼ 51), or docetaxel 60 mg m À2 on day 8 and irinotecan 60 mg m À2 on day 1 and 8 (DI; n ¼ 57) every 3 weeks. Response rates were 37% for DC and 32% for DI patients. Median survival times and 1-and 2-year survival rates were 50 weeks (95% confidence interval: 34 -78 weeks), 47 and 25% for DC, and 46 weeks (95% confidence interval: 37 -54 weeks), 40 and 18% for DI, respectively. The progression-free survival time was 20 weeks (95% confidence interval: 14 -25 weeks) with DC and 18 (95% confidence interval: 12 -22 weeks) with DI. Significantly more DI than DC patients had grade 4 leucopenia and neutropenia (Po0.01); more DC patients had grade X2 thrombocytopenia (Po0.01). Nausea and vomiting was more pronounced with DC (Po0.01); diarrhoea was more common with DI (P ¼ 0.01). Three treatment-related deaths occurred in DC patients. In conclusion, although the DI and DC regimens had different toxicity profiles, there was no significant difference in survival. Unfortunately, non-small-cell lung cancer (NSCLC) is a member of the group of neoplastic diseases that is relatively chemoresistant. Recent meta-analyses show that cisplatin-based chemotherapy improves survival (Non-Small Cell Lung Cancer Collaborative Group, 1995), and it is considered a standard treatment for NSCLC, Most cisplatin-based regimens have substantial toxicities that require close monitoring and supportive care. Thus, there is a need to develop active and less toxic chemotherapy regimens that include new active compounds with novel mechanisms of action.In the 1990s, several new, active therapies with single-agent response rates of 15 -30% became available for NSCLC, including irinotecan, docetaxel, paclitaxel, vinorelbine, and gemcitabine. Because irinotecan and docetaxel were approved for NSCLC earlier than the other drugs in Japan, development of regimens containing irinotecan or docetaxel is more advanced. Docetaxel 60 mg m À2

Amrubicin is a possible alternative for second-line treatment of advanced NSCLC, although a relevant hematological toxicity is significant, especially with a febrile neutropenia.

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