RANDOMIZED TRIAL OF CISPLATIN VERSUS CISPLATIN PLUS MITOLACTOL VERSUSCISPLATIN PLUS IFOSFAMIDE IN ADVANCED SQUAMOUS CARCINOMA OF THE CERVIX - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

Purpose: Cisplatin, mitolactol (dibromodulcitol), and ifosfamide have been the most active single agents in squamous carcinoma of the cervix identified so far by the Gynecologic Oncology Group (GOG). Combinatio ns of cisplatin plus ifosfamide and cisplatin plus mitolactol are pros pectively compared with cisplatin alone. Patients and Methods: patient s were randomized to receive cisplatin 50 mg/m(2) or the some dose of cisplatin plus mitolactol (C + M) 180 mg/m(2) orally on days 2 to 6, o r cisplatin plus ifosfamide (CIFX) 5 g/m(2) given as a 24-hour infusio n plus mesna 6 g/m(2) during and for 12 hours after the ifosfamide inf usion, every 3 weeks for up to six courses. Of 454 patients entered, 4 38 were eligible and analyzed for response and survival. Results: CIFX held ct higher response rate (31.1% v 17.8%, P = .004) and longer pro gression-free survival (PFS) time (P = .003) compared with cisplatin a lone, The median times to progression or death were 4.6 and 3.2 months , respectively, C + M showed no significant improvement in these param eters compared with cisplatin alone, Survival was associated with init ial performance score (PS; 0 was more favorable; P < .001) and with ag e (younger was unfavorable, P = .025). There was no significant differ ence in overall survival between cisplatin and either of the combinati ons. Leukopenia, renal toxicity, peripheral neurotoxicity, and CNS tox icity were more frequent with CIFX (P < .05). Conclusion: CIFX improve d the response rate and PFS duration in advanced cervix cancer compare d with cisplatin alone, but at the cost of greater toxicity and with n o improvement in survival. (C) 1997 by American Society of Clinical On cology.