A phase 2 multicenter study of irinotecan and cisplatinum as neoadjuvant treatment in patients with locally advanced cervical cancer.

Hypothesis: To evaluate efficacy and safety of a neoadjuvant treatment with irinotecan and cisplatin [cis-diamminedichloroplatinum(II); CDDP] in patients with locally advanced cervical cancer. Methods: A phase 2 study was conducted at 13 centers located in Italy. Eighty-seven were enrolled between 2000 and 2003. Patients received irinotecan 175 mg/m2 on day 1 every 3 weeks followed by CDDP 80 mg/m2. Each patient was to receive 3 cycles of treatment. Tumor response was to be evaluated by magnetic resonance imaging 3 weeks after the end of the third cycle. At the end of therapy, all patients were to be examined for radical surgery. Results: Of 71 patients included in the primary analysis, 9 (12.7%) showed a complete response; and 43 (60.6%), a partial response for an overall response rate of 73.2% (95% confidence interval [CI], 61.4%-83.1%). Complete pathological responses were observed in 13.6% of the patients (95% CI, 7.0%-23.0%). Overall survival rate at 4 years was 87.0% (95% CI, 79.5%-94.5%). There were no study-related deaths. Most common adverse events were alopecia in 76 patients (87.4%) and gastrointestinal disorders in 79 patients (90.8%). Serious adverse events were vomiting in 18 patients (20.7%), nausea in 14 (16.1%), diarrhea in 8 (9.2%), and neutropenia in 50 (57.5%). A total of 3 patients (3.4%) were discontinued from the study owing to the occurrence of 1 or more serious adverse event. Conclusions: Irinotecan and CDDP as neoadjuvant chemotherapy in locally advanced cervical cancer showed a promising response rate. These data warrant confirmation with a phase 3 study.