CISPLATIN AND IFOSFAMIDE IN PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE UTERINE CERVIX - A PHASE-II TRIAL

Thirty patients with advanced squamous cell carcinoma of the cervix we re included in a phase II study with cisplatin (DDP) and ifosfamide (I F)/mesna. They received a median of 4 courses of chemotherapy and were all evaluable for response and toxicity. Each cycle consisted of 2 50 0 mg/m(2) IF i.v. days 1-5; mesna 500 mg/m(2) i.v. at hours 0 and 2, a nd 1 000 mg/m(2) per os at hours 6 and 10, days 1-5; DDP 20 mg/m(2) i. v., days 1-5. Cycles were repeated every 4 weeks. One patient obtained CR and 14 PR giving an overall response rate of 50%. Mean duration of response was 21 months. Anemia grade 3 developed in 7 patients, leuko penia grade 3 in 9 patients and grade 4 in one patient; thrombopenia g rade 3 in 2; creatinine clearance grade 3 in one; CNS grade 3 in one a nd cystitis grade 3 in one patient. Overall median survival time was a bout 25+ months (3-63+); after a follow-up of 70 months, 11 patients ( 37%) are still alive with a median survival of 31+ months. IF plus DDP seems to be a good combination for treatment of advanced cervical can cer, with acceptable tolerance and response rate.