A phase II study with vinorelbine, gemcitabine and cisplatin in the treatment of patients with stage IIIb-IV non-small cell lung cancer (NSCLC)

In our phase II study an acceptable and effective agent like cisplatin was used in combination with vinorelbine and gemcitabine in patients with non-s mall cell lung cancer (NSCLC). These two new cytostatic drugs have demonstr ated, when used as a single-agent treatment, effective response rates (vino relbine) and minimum toxicity (gemcitabine). The following schedule was use d: (i) vinorelbine 25 mg/m(2) on days 1 and 8; (ii) gemcitabine 1000 mg/m(2 ) on days 1 and 8; and (iii) cisplatin 75 mg/m(2) on day 8. The schedule wa s repeated every 21 days, with a maximum of six cycles per patient. A total of 31 patients with a mean Karnofsky performance status of 90% were evalua ted and 29 of them were finally eligible. Of the patients, five (16.1%) wer e at stage IIIb and the remainder (83.9%) were at stage IV. The overall res ponse rate was 65% (20 patients); six patients (19.4%) had complete respons e (CR) and 14 (45.2%) had partial response (PR). Two patients (6.5%) had st able disease and seven (22.6%) had progressive disease. The most notable to xicity was hematologic. Leukoneutropenia was mainly revealed after the thir d or fourth cycle and granulocyte-colony stimulating factor (G-CSF) was adm inistered in 24 patients (77.4%). Mild anemia was found in almost all patie nts after the third or fourth cycle (Hb 10-11 g/dl) and eight patients (25. 8%) required erythropoietin (EPO). Thrombocytopenia was more often observed compared with other known chemotherapeutic regimens; six patients (19.4%) had grade I thrombocytopenia and therapy was delayed in another four patien ts (12.9%) due to this complication. Non-hematologic toxicity was mild and well tolerated and consisted of alopecia (54.8%), nausea and vomiting (12.9 %), constipation (12.9%), peripheral neuropathy (9.6%), diarrhea (6.5%), st omatitis (3.2%) and local phlebitis (3.2%). The examined combination provid es us with one of the best overall response rates reported, however at the cost of remarkable hematologic toxicity. Therefore, it would be better appl ied in patients with good performance status. The high response rates give us hope of using this combination as a neoadjuvant regimen. (C) 1999 Elsevi er Science Ireland Ltd. All rights reserved.