STOCKHOLM – Whether or not a woman had a hysterectomy made no impact on survival in a small phase III trial among patients with a complete response after chemoradiation, including brachytherapy, for early-stage ovarian cancer.
The primary end point of the event-free survival rate at 3 years was 72% in women who underwent extrafascial hysterectomy and 89% among those who did not (P = .17). Overall survival rates were also similar at 86% with hysterectomy and 97% without (P = .15), Dr. Philippe Morice reported at the European Multidisciplinary Cancer Congress.
Dr. Philippe Morice
"Even if our conclusion is diminished by the insufficient accrual of patients, in the analysis of 61 patients, we don’t observe any effect of completion hysterectomy on the overall and event-free survival of patients," said Dr. Morice, with the Institût de Cancérologie Gustave Roussy, Villejuif, France.
"With the development of new radiation and brachytherapy that increase the rate of local control, the place of the hysterectomy in this context is very probably disappearing during the next years," he added.
The National Federation of Cancer Campaign Centers GYNECO 02 trial was stopped in 2006 due to poor accrual after randomizing 31 women to hysterectomy after chemoradiotherapy (CRT) and 30 to CRT alone.
The two arms were well balanced, although 11 women in the hysterectomy arm had histologic residual disease in the cervix. Most of the cases were isolated cells, with three other cases having residual disease less than 1 cm and two having disease more than 1 cm, he said.
After a median follow-up of 3.8 years, 11 patients relapsed including 8 randomized to hysterectomy after CRT and 3 randomized to CRT alone.
In the CRT-alone arm, the site of first recurrence was centropelvic alone in two patients and distant without pelvic or nodal involvement in one, he said.
In the hysterectomy arm, the site of recurrence for one patient each was centropelvic alone, centropelvic plus nodal, pelvic node and distant, paraaortic nodes alone, and distant without pelvic or nodal, with three patients having paraaortic nodal involvement and distant recurrence.
"For the patient that undergoes complete treatment with chemoradiation and brachytherapy, we can see in this trial that the problem is not the local control of the disease, but the metastatic control," he said.
"More isn’t always better," observed discussant Dr. Nicholas Reed, a consultant clinical oncologist with Beatson Oncology Centre, Gartnavel General Hospital Glasgow, Scotland.
He suggested that positron emission tomography/computed tomography and other newer imaging modalities have a role in identifying select patients in whom hysterectomy could be avoided. If hysterectomy does not have a central role to play in early ovarian cancer, he suggested that modern imaging techniques and faster computer software systems can improve radiation quality by optimizing the tumor volume to be treated and the dose to organs at risk.
The GYNECO 02 trial asked whether surgery could reduce the risk of local or locoregional relapse in women with stage IB2/II cervical cancer and no extra-pelvic disease treated with pelvic external radiation therapy at 45-50 Gy and concomitant cisplatin 40 mg/m2 per week, followed by utero-vaginal brachytherapy at 15 Gy.
A parametrial or nodal boost of 10-15 Gy was possible in cases of parametrial involvement with insufficient regression at the time of brachytherapy or in those with pelvic node involvement on initial imaging, said Dr. Morice. All women had a complete clinical and radiological response, based on magnetic resonance imaging, 6 to 8 weeks after brachytherapy.
The joint congress was sponsored by the European Cancer Organization, the European Society for Medical Oncology, and the European Society for Radiotherapy and Oncology.
The study was funded by the Federation Nationale des Centres de Lutte Contre le Cancer.