Neoadjuvant chemotherapy in cervical carcinoma stage IIB:: a randomized controlled trial

The aim of this study was to determine the feasibility and role of neoadjuvant chemotherapy (Nch), used before Wertheim Meigs operation (S) and conventional radiotherapy (RT) in Stage IIB cervical carcinoma. Two hundred ninety-five patients were randomized into four groups: first control group (N = 73) received RT of 50 Gy to whole pelvis +35-40 Gy to point A, in one or two brachytherapy applications; the second control group received (N = 75) S + adjuvant RT to whole pelvis (50 Gy) the third group (N = 71) received Nch + RT; the fourth group received (N = 76) Nch + S + RT. The VBP scheme was used (3 courses of vincristine 1 mg/m(2) on day 1, bleomycin 25 mg/m(2) on days 1 to 3, and cisplatinum 50 mg/m(2) on day 1, at 10 day intervals). No differences were found regarding age, tumor volume, parametrial involvement or response to Nch. Disease-free survival (DFS) and overall survival (OS) rates were calculated according to Kaplan-Meier tables and log-rank test. After seven years follow-up, statistically significant differences were found in OS between Nch + S (65%) and RT (48%, P < 0.005) or S (41%, P < 0.001). No differences were obtained comparing both Nch groups, or between Nch + RT (54%) and RT groups (48%). In surgical groups resectability increased from 56% in the S group to 80% in Nch + (P < 0.001). OS was respectively 80% vs 54% in resected patients in Nch + S and S groups (P < 0.001). Also, in the Nch + S group pathological high-risk factors were decreased compared to the S group (lymph nodes metastases, parametrial and vascular space involvement, P < 0.009). OS was improved in surgical groups regardless of initial tumor size; in RT groups OS was only increased in tumors >5 cm from 36% in RT to 66% in Nch + RT (P < 0.05). In both Nch groups no grades 3 or 4 toxicity was observed and OS was statistically better in chemotherapy responders. Nch + S is feasible, with no grades 3 or 4 toxicity. It is an alternative treatment to conventional radiation therapy with an increase in OS.