A phase II trial of tamoxifen, ifosfamide, epirubicin, and cisplatin combination chemotherapy for inoperable non-small-cell lung cancer

A phase II trial of tamoxifen, ifosfamide, epirubicin, and cisplatin (TIEP) chemotherapy was conducted in patients with chemonaive inoperable non-smal l-cell lung cancer (NSCLC) to assess response and toxicity. From October 19 97 to August 1998, 19 patients were treated. The treatment schema included tamoxifen 60 mg twice daily by mouth on days 1 to 3, ifosfamide 3 g/m(2) in travenous infusion (IV) 60 minutes with mesna on day 2, epirubicin 50 mg/m( 2) IV bolus on day 2, and cisplatin 60 mg/m(2) IV 60 minutes on day 2 every 4 weeks for up to six cycles. All patients were evaluable for response and toxicity. The major toxicity was myelosuppression; grade 3 or 4 leukopenia or neutropenia occurred in 14 of 19 (73.7%) patients during treatment, and 6 patients (31.6%) experienced fever in association with the neutropenia; no toxic deaths occurred. Grade 3 anemia occurred in six patients (31.6%) d uring the treatment. Grade 3 or 4 nausea/vomiting occurred in only one pati ent. Toxicities other than neutropenia and anemia were minimal. After two c ycles of treatment, 9 of 19 patients attained a partial response (47.4%, 95 % confidence interval 24.9%-69.9%) in this study. The median time to diseas e progression was 6 months and median survival time was 12 months. We concl ude that TIEP is an active combination regimen with an acceptable toxicity profile in Chinese patients with inoperable NSCLC.