[Combination of cisplatin and vinorelbin in the neoadjuvant treatment of locally advanced cervical carcinoma. Phase II study]. FT Associazione di cisplatino e vinorelbina nel trattamento neoadiuvante del cancro cervicale localmente avanzato. Studio di fase II.

BACKGROUND: Aim of this phase II study is to evaluate the cytoreductive efficacy and the toxicity of a regimen consisting of cisplatin and vinorelbine as neoadjuvant chemotherapy for three cycles every 21 days in patients with locally-advanced cervical carcinoma. METHODS: Between April 1996 and December 1998, 33 untreated patients with locally-advanced cervical carcinoma received neoadjuvant chemotherapy with cisplantino 80 mg/m2 (day 1) plus vinorelbine 25 mg/m2 (day 1 and 8). Within 28 days from completion of chemotherapy patients in complete or partial response were submitted to radical hysterectomy plus pelvic lymphadenectomy. RESULTS: Twenty-six patients (79%) were submitted to radical surgery; four patients were not submitted to surgery because of poor response to treatment, two for anesthesiological contraindications and one refused surgery. The combination of cisplatin plus vinorelbine in this phase II study induced a clinical overall response rate of 90%, with 8 pathologic complete response (24%). CONCLUSIONS: The association of cisplatin and vinorelbine as neoadjuvant chemotherapy in locally-advanced cervical carcinoma showed to be safe and effective with a low cost and poor toxicity.