COMPARATIVE ACTIVITY OF NAVELBINE, NAVELB INE PLUS CISPLATIN, AND VINDESINE PLUS CISPLATIN IN THE THERAPY OF UNRESECTABLE NON-SMALL-CELL LUNG-CARCINOMA - RESULTS OF A MULTICENTRIC EUROPEAN RANDOMIZED TRIAL INCLUDING 612 PATIENTS

The results are reported of three chemotherapy schedules in a multicen tric, international, randomized trial of the therapy of unresectable n on small cell lung carcinoma which included 612 patients. The antitumo ral efficiency of the cisplatin + vindesine combination (200 patients) was compared with that of navelbine (206 patients), a recently availa ble vinca alkaloid, and with a third therapeutical leg with cisplatin + navelbine (206 patients). After a very thorough response evaluation the combination cisplatin + navelbine obtained a response rate higher than the other combination (30% vs. 19%; p=0.02) and also than navelbi ne (30% vs. 14%; p<0.001). The median response durations were 9.3, 9.9 , and 7.8 months for the combination with navelbine, vindesine and the new vinca alkaloid alone, respectively. After a median follow-up peri od of 26 months the combination cisplatin + navelbine achieved a highe r survival rate than the combination cisplatin + vindesine (40 vs. 32 weeks) and navelbine (40 vs 31 weeks; p=0.045). The most important tox icity with the combination cisplatin + navelbine was neutropenia, whic h although relevant in number was not of long duration. In summary, na velbine is an active agent in the therapy of non small cell lung carci noma. In this trial the therapeutic superiority of its combination wit h cisplatin over the combination cisplatin + vindesine was observed; l ikewise, it was also more efficient than monotherapy with navelbine.