Phase II study of tamoxifen, ifosfamide, epirubicin and cisplatin combination chemotherapy in patients with non-small cell lung cancer failing previous chemotherapy

We conducted a phase II study of tamoxifen, ifosfamide, epirubicin, and cis platin (TIEP) chemotherapy in patients with Iron-small cell lung cancer (NS CLC) who had failed previous chemotherapy, in order to assess the response and toxicity of TIEP. Between November 1997 and May 1999, 25 patients were treated. Twelve of the 25 patients (48%) had been previously treated with c isplatin-based combination chemotherapy. TIEP doses were tamoxifen 60 mg or al twice daily on days 1-3; ifosfamide 2.4 g/m(2) intravenous infusion (IV) 60 min with mesna on day 2; epirubicin 40 mg/m(2) IV bolus on day 2: and c isplatin 50 mg/m2 IV 60 min on day 2 every 4 weeks for up to six cycles. Se venty one cycles were given to 25 patients, with a median of three cycles ( range one to six cycles). All patients were evaluable for toxicity profile and response rate. As expected, the major toxicity was myelosuppression. Gr ade 3 or 4 neutropenia occurred in 15 patients (60%) during treatment, as w ell as in 31% of the total courses. Febrile neutropenia occurred in two pat ients. No toxic death occurred in this study. Grade 3 thrombocytopenia occu rred in five patients with five cycles. Toxicities other than myelosuppress ion were few and mild in severity. After two cycles of treatment. five of 2 5 patients (20%) had a partial response (95% confidence interval 4.3-35.7%) , Among 12 patients previously treated with cisplatin-based chemotherapy, t hree patients (25%) achieved a partial response. The median time to disease progression was 4.9 months and median survival was 7.7 months. The respons e rate and median survival were better than in our previous study of salvag e chemotherapy with ifosfamide. 5-FU, and leucovorin; and with ifosfamide, epirubicin. 5-FU, and leucovorin. In conclusion, TIEP appears to be an acti ve combination regimen with an acceptable toxicity profile in Chinese patie nts with NSCLC who have failed previous chemotherapy. (C) 2000 Elsevier Sci ence Ireland Ltd. All rights reserved.