Follow-up in a long-term randomized trial with neoadjuvant chemotherapy for squamous cell cervical carcinoma.

Objective: To assess the role of neoadjuvant chemotherapy to achieve radical surgery in a larger number of patients with locally advanced/or bulky Stage IB cervical carcinoma. We conducted a trial to determine whether neoadjuvant chemotherapy would improve disease-free survival and overall survival in Stage IB-III cervical cancer.

Design: Prospective randomized clinical study with long-term follow-up.

Setting: Department of Gynecology, Perinatology and Child Health, II Faculty University of Rome "La Sapienza".

Methods: 288 patients with squamous cell carcinoma of the uterine cervix, FIGO Stage IB-IIIB were randomized to one of the following treatments: three courses of neoadjuvant chemotherapy with cisplatin, vincristine, bleomycin (NACT arm; n = 159); conventional surgery or exclusive radiotherapy (CONV arm; n = 129). There was no difference in age, FIGO stage, tumor size and lymph node involvement between the two groups (p = ns). Two hundred and thirty-four patients in Stage IB-IIb (n = 129 NACT arm and n = 105 CONV arm) and 24 patients in Stage III (NACT arm) who proved to be chemosensitive underwent radical hysterectomy. Six Stage III patients, non responders to chemotherapy, and 24 patients, Stage III of the CONV arm, underwent radiotherapy. Follow-up extended for seven years.

Results: The study was performed on disease-free survival related to several prognostic factors: age, FIGO stage, tumor size, grading, parametrial involvement, lymph node status and surgical margins. Recurrence of disease occurred in 49 (32.1%) patients of the NACT arm (n = 153) and in 39 (37.1%). patients of the CONV arm (n = 105). Statistically significant differences in the recurrence of the disease were related to FIGO stage (p < 003), grading (p < .05), parametrial involvement (p < .002) lymph node status (p < .0001) and tumor size (p <.002). No statistical significance was related to age and surgical margins (p = ns). Disease-free and overall survival in the two groups were, respectively, 65.4% vs 53.5% (p = ns) and 70.4% 65.9% (p = ns).