Results of the GYNECO 02 Study, an FNCLCC Phase III Trial Comparing Hysterectomy with No Hysterectomy in Patients with a (Clinical and Radiological) Complete Response After Chemoradiation Therapy for Stage IB2 or II Cervical Cancer

Abstract

Learning Objectives After completing this course, the reader will be able to: Evaluate the therapeutic impact of hysterectomy after chemoradiation therapy in locally advanced cervical cancer. Evaluate the rate of histologic residual disease in patients with complete clinical and radiologic response after chemoradiation therapy. This article is available for continuing medical education credit at http://CME.TheOncologist.com Background. Concomitant chemoradiation (CRT) (including brachytherapy) is considered the standard management for stage IB2 or II cervical cancer in many countries. Nevertheless, some of them discuss completion surgery (hysterectomy [HT]) after CRT. The aim of this study was to investigate the therapeutic impact of such surgery. Methods. A randomized trial was opened in France in 2003 to evaluate the interest in HT after CRT. Inclusion criteria were: (a) stage IB2 or II cervical cancer without extrapelvic disease on conventional imaging; (b) pelvic external radiation therapy (45 Gy with or without parametrial or nodal boost) with concomitant cisplatin chemotherapy (40 mg/m2 per week) followed by uterovaginal brachytherapy (15 Gy to the intermediate risk clinical target volume); and (c) complete clinical and radiological response 6–8 weeks after brachytherapy. Patients were randomized between HT (arm A) and no HT (arm B). Unfortunately this trial was closed because of poor accrual: 61 patients were enrolled (in 2003–2006) and are reported on here. Results. Thirty one and 30 patients were enrolled, respectively, in arm A and arm B. Twelve patients recurred (five of them died): respectively, eight and four in arm A and arm B. The 3‐year event‐free survival rates were 72% (standard error [SE], 9%) and 89% (SE, 6%) (not significant [NS]) in arm A and arm B, respectively. The 3‐year overall survival rates were 86% (SE, 6%) and 97% (SE, 3%) (NS) in arm A and arm B, respectively. Conclusions. Results of the current trial seem to suggest that completion HT had no therapeutic impact in patients with clinical and radiological complete response after CRT (but this conclusion is limited by the lack of power).

Risk assessment model for overall survival in patients with locally advanced cervical cancer treated with definitive concurrent chemoradiotherapy

“…Recently, Duenas-Gonzalez et al reported the results of a phase III trial that showed that gemcitabine plus cisplatin chemoradiotherapy followed by adjuvant gemcitabine/cisplatin chemotherapy improved survival outcomes [24]. Hysterectomy may also be considered as an adjunctive treatment option for high-risk patients after CCRT, although this possibility is only supported by limited evidence [25][26][27].…”

Impact of treatment time and dose escalation on local control in locally advanced cervical cancer treated by chemoradiation and image-guided pulsed-dose rate adaptive brachytherapy

“…After completion of a randomized study, evaluating the role of systematic hysterectomy in patients with complete clinical and radiologic remission (GYNECO 02), this strategy was abandoned [7], and hysterectomy was considered as a salvage treatment, and therefore limited to patients with histologically proven incomplete local response. The inclusion period started from the abandon of post radiation hysterectomy until 2011.…”

Clinical outcome of recurrent locally advanced cervical cancer (LACC) submitted to primary multimodality therapies

“…proctitis, cystitis, hydronephrosis) resulted lower compared to exclusive CTRT probably because of replacement of utero-vaginal brachytherapy with completion surgery [4]. Among major criticisms raised against CTRT followed by radical surgery are the potential higher risk of long-term complications together with the potential depletion of all available treatment modalities for the recurrent disease [4][5][6]. Indeed, the treatment choice for recurrent disease is primarily dependent on previous therapy and secondarily on the site of the recurrent tumor together with the patient's performance status [7,8].…”