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

The aim of this study was to determine the feasibility and role of neoadjuv ant chemotherapy (Nch), used before Wertheim Meigs operation (S) and conven tional radiotherapy (RT) in Stage IIB cervical carcinoma. Two hundred ninety-five patients were randomized into four groups: first co ntrol group (N = 73) received RT of 50 Gy to whole pelvis +35-40 Gy to poin t A, in one or two brachytherapy applications; the second control group rec eived (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. Th e VBP scheme was used (3 courses of vincristine 1 mg/m(2) on day 1, bleomyc in 25 mg/m(2) on days 1 to 3, and cisplatinum 50 mg/m(2) on day 1, at 10 da y intervals). No differences were found regarding age, tumor volume, parame trial involvement or response to Nch. Disease-free survival (DFS) and overa ll survival (OS) rates were calculated according to Kaplan-Meier tables and log-rank test. After seven years follow-up, statistically significant diff erences 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 resectabi lity 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 decre ased compared to the S group (lymph nodes metastases, parametrial and vascu lar space involvement, P < 0.009). OS was improved in surgical groups regar dless 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 gr ades 3 or 4 toxicity was observed and OS was statistically better in chemot herapy responders. Nch + S is feasible, with no grades 3 or 4 toxicity. It is an alternative treatment to conventional radiation therapy with an incre ase in OS.