Early cervical cancers: the international SHAPE study, funded by the PHRC-K, is revolutionizing surgical treatment for the benefit of patients

What are the characteristics of the cervical cancers targeted by the SHAPE study?

In France, three quarters of cervical cancers are diagnosed before the age of 65. Those called “low risk of recurrence”, targeted by our study, are very small tumors, discovered during screening, which do not present symptoms. Their cure rate is very high, and the 5-year survival rate for these patients aged 25 to 45 is between 95 and 98%. [alors qu’il est inférieur à 65 % si l’on considère l’ensemble des cas de cancers du col utérin, NDLR].

However, until recently, the standard treatment consisted of a hysterectomy [retrait de l’utérus, NDLR] called “radical” or “enlarged”: the uterus and its cervix were removed, but also part of the vagina, as well as adjacent tissues, including nerve roots and, in certain cases, the ovaries and fallopian tubes. This treatment has practically not evolved since the 19^e century, whereas today we identify this cancer at early stages, thanks to technical progress and the generalization of screening. However, this is a major and very disabling surgery, which significantly alters the lives of patients who have been cured: difficulty emptying their bladder, recurring constipation problems, pain during sexual intercourse, etc.

Faced with this situation, what were the objectives of the SHAPE study and how was it carried out?

The definition of the population of patients at low risk of recurrence having been established, the issue is now the question of therapeutic de-escalation. This was the starting point for the SHAPE study. Conducted in a prospective, multicenter and randomized manner, it aimed to compare enlarged hysterectomy with a more conservative surgical approach, a “simple” hysterectomy. [retrait de l’utérus et de son col, NDLR], with evaluation of lymph nodes instead of their systematic removal. It was necessary to validate the oncological safety of this surgical practice compared to extended hysterectomy and evaluate its effects on the quality of life of the patients concerned.

This project, initiated in Canada and then expanded to France and other European countries (Germany, Austria, Belgium, Ireland, Norway, the Netherlands and the United Kingdom), was made possible thanks to funding from the PHRC-K [pour sa partie française, NDLR], thus paving the way for a new era in surgical practices. Moreover, at the time we joined the study, Canada had almost closed it for lack of inclusions! France is one of the rare countries where research programs like the PHRC-K make it possible to conduct academic surgical trials. Without this, we would not have been able to reach Canadians and contribute to the improvement of our surgical practices: no manufacturer would have financed a study involving this type of comparison.

In total, the international SHAPE study included 700 patients worldwide from December 2012 to November 2019, including 140 in France spread across 35 centers. The IUCT Oncopole was the promoter. Thanks to the creation of the ARCAGY-GINECO cooperative intergroup, certified and financed by the INCa, we were able to bring together and coordinate several forms of structures (CLCC, CHU, peripheral hospitals, clinics) and gynecological surgeons.

What are the results of the SHAPE study and their impact on the patients concerned? What follow-up has already been given to it?

This study demonstrated that not only is simple hysterectomy as safe as radical hysterectomy, but that it considerably improves patients’ quality of life by reducing their post-operative sequelae, particularly urinary and sexual sequelae. These results were the subject of a publication in the New England Journal of Medicine (NEJM) on February 29, 2024.

These findings have had an immediate impact on surgical practices, with rewritten European recommendations in favor of simple hysterectomy for cervical cancers at low risk of recurrence: the update of the ESGO recommendations [European Society of Gynaecological Oncology, NDLR] is in progress and will be presented at the next congress in 2025 in Rome (Italy). This is a huge step forward for these patients!

In Canada, which was a few years ahead, the SHAPE study also highlighted a positive impact for public health: a Canadian medico-economic study, presented at the ESGO 2024 congress by Dr Janice Kwon and submitted to the Journal of Clinical Oncologyshowed that fewer post-operative after-effects generated fewer medical needs, and therefore less healthcare expenditure.

This study paves the way for less invasive and equally effective surgical practices. Since then, another de-escalation trial on early cervical cancers, SENTICOL III, has been launched to validate the oncological safety of simple hysterectomy. This study is led by Professor Fabrice Lecuru (Institut Curie) and coordinated by ARCAGY-GINECO. This study is now closed for inclusion: it included 988 patients in 12 countries, including almost 500 in France. French participation in this study is also financed by a PHRC-K.