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Clinical Trial
. 2012;17(1):64-71.
doi: 10.1634/theoncologist.2011-0276. Epub 2012 Jan 10.

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

Philippe Morice  1 , Philippe Rouanet, Annie Rey, Pascale Romestaing, Gilles Houvenaeghel, Jean Charles Boulanger, Jean Leveque, Didier Cowen, Patrice Mathevet, Jean Pierre Malhaire, Guillaume Magnin, Eric Fondrinier, Jocelyne Berille, Christine Haie-Meder
Affiliations
Clinical Trial

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

Philippe Morice et al. Oncologist. 2012.

Abstract

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).

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Conflict of interest statement

Disclosures

Philippe Morice: None; Philippe Rouanet: None; Annie Rey: None; Pascale Romestaing: None; Gilles Houvenaeghel: None; Jean Charles Boulanger: None; Jean Leveque: None; Didier Cowen: None; Patrice Mathevet: None; Jean Pierre Malhaire: None; Guillaume Magnin: None; Eric Fondrinier: None; Jocelyne Berille: Sanofi (OI); Christine Haie-Meder: None.

Section Editors Dennis Chi: Nycomed (C/A); Peter Harper: sanofi, Roche, ImClone, Pfizer, GlaxoSmithKline, Lilly, Genentech (C/A, advisory boards); Lilly, Novartis, sanofi, Roche (H, commercial symposia).

Reviewer “A”: None.

Figures

Figure 1.
Figure 1.
CONSORT 2010 flow diagram of the GYNECO 02 trial.
Figure 2.
Figure 2.
Kaplan–Meier estimates of the overall survival rate for patients in arm A (hysterectomy) and arm B (no hysterectomy).
Figure 3.
Figure 3.
Kaplan–Meier estimates of the event-free survival rate for patients in arm A (hysterectomy) and arm B (no hysterectomy).
See this image and copyright information in PMC

References

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