CISPLATIN, IFOSFAMIDE, AND VINORELBINE COMBINATION CHEMOTHERAPY IN STAGE III-IV NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY

The authors evaluate the combination of three drugs, vinorelbine, ifos famide, and cisplatin, which have been shown to produce good response rates and a significant gain in survival when any two of them are give n together. Seventy-seven untreated patients with inoperable stage III -IV non-small-cell lung cancer from three centers were included. The c ombination consisted of cisplatin 30 mg/m(2) daily, ifosfamide 1,500 m g/m(2) daily, mesna 1,500 mg/m(2) daily on days 1-3, and vinorelbine 2 5 mg/m(2) daily on days 1 and 8. Four cycles were administered every 4 weeks for a total of 267 cycles, before an assessment for toxicity, e ffective dose intensity, response rate, and survival was made. Toxicit y was mainly hematologic (grade 3-4 neutropenia (15.7%), anemia (8.2%) , and thrombopenia (2.6%)) but did not require granulocyte colony-stim ulating factors. Objective response rate was 41.1% (95% confidence int erval, 29.5-52.9%) in 68 patients suitable for assessment. The mean ti me to progression and median survival were 7.7 +/- 1.3 months and 11.6 months, respectively. One-year survival was 47.1%. The effective dose intensity of cisplatin and ifosfamide correlated strongly with surviv al, whereas stage and performance status did not. This study confirms previously reported favorable results for response and survival rates obtained in stage III-IV non-small-cell lung cancer with the vinorelbi ne, ifosfamide, and cisplatin combination. Respect of a scheduled dose intensity has a clear-cut influence on survival and should be evaluat ed routinely in future polychemotherapy trials.