Treatment of inoperable non-small cell lung carcinoma stage IIIb and IV with cisplatin, epidoxorubicin, vindesine and lonidamine: A phase II study

Aims and background: The polychemotherapeutic regimen PEV (cisplatin, epido xorubicin and vindesine) + lonidamine proved to be valid in terms of activi ty and efficacy in the treatment of patients with advanced, previously untr eated non-small cell lung carcinoma, The goal of the study was to verify wh ether a different dose of lonidamine, together with an increase in cisplati n and epidoxorubicin compared to the standard regimen, is able to improve t he activity and efficacy of PEV without increasing toxicity. Patients and methods: Thirty-one patients were treated with cisplatin (80 m g/m(2)/iv), epidoxorubicin (70 mg/m(2)/iv) and vindesine (3 mg/m(2)/iv) eve ry 28 days for 6 courses in combination with lonidamine (600 mg/day on days 1 and 2 of each course followed by 450 mg/day until progression of disease or intolerance). All the patients were monitored for clinical response, me dian duration of response and survival and for toxicity. Results: The clinical response in the 29 assessable patients was: 41.4% par tial remission, 48.3% stable disease, and 10.3% progression of disease. The median duration of response was 8.5 months (range, 4-26+) and median survi val was 12 months (range, 4-26+), Survival was above the median in 15 stage IIIb patients, and 2 patients were long survivors at 26+ months. The toxic ity of PEV + lonidamine was mild; there were no toxic deaths nor acute toxi city of grade 4 according to the WHO scoring system. Conclusions: Our polychemotherapeutic regimen proved to be valid in terms o f activity and efficacy, and a further dose increase in single chemotherape utic agents as well as lonidamine could therefore be justified.