. Ahead of Print: TJOD-67279

A critical review of the shape trial

Polat Dursun1, Murat Gultekin2
1Ufuk University School Of Medicine, Gynecologic Oncology, Ankara, Turkiye
2Hacettepe University School Of Medicine, Gynecologic Oncology, Ankara, Turkiye

An international randomized trial comparing radical hysterectomy and(RH)vs simple hysterectomy(SH) in patients with low-risk early-stage cervical cancer recently published in NEJM by Plante et al. and we read it with great interest. Although the literature does not include any relevant randomized trials, early-stage cervical cancers are traditionally treated using the radical hysterectomy (RH) technique pioneered by Ernst Wertheim and others >100 years ago. Nowadays, efforts to reduce the complications and morbidity associated with RH, and improve patient quality of life post surgery are ongoing; therefore, we appreciate the SHAPE Trial researchers’ efforts to improve our knowledge of this topic and improve patient outcomes. The SHAPE Trial researchers performed a non-inferiority trial that included 130 centers in 12 countries, comparing simple hysterectomy (SH) and RH in patients with low-risk cervical cancer (lesions ≤2 cm with limited stromal invasion). They noted that, “SH was not inferior to RH with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention”. It is well known that each year almost 600,000 cases of cervical cancer occur worldwide, of which nearly 80% are in undeveloped or developing countries. Although the researchers wrote that their results cannot be generalized to developing countries, as practicing gynecologic oncologists from a developing country we also think that some patients with cervical tumors <2 cm might benefit from and urgently need less radical surgery, especially in low resource settings in which there is limited or no screening or radiotherapy facilities, nor operative infra-structure or trained gynecologic oncologists. In contrast to what was written, we strongly think that clinicians in developing and undeveloped countries can make good use of the SHAPE Trial findings; however, before we can reach a definitive conclusion, we have some criticisms and concerns about the Trial, as detailed below, that we think must be addressed.

Keywords: cervical cancer, type 1 hysterectomy, radical hysterectomy


A critical review of the shape trial

Polat Dursun1, Murat Gultekin2
1Ufuk Üniversitesi Tıp Fakültesi, Jinekolojik Onkoloji, Ankara, Türkiye
2Hacettepe Üniversitesi Tıp Fakültesi, Jinekolojik Onkoloji, Ankara, Türkiye

An international randomized trial comparing radical hysterectomy and(RH)vs simple hysterectomy(SH) in patients with low-risk early-stage cervical cancer recently published in NEJM by Plante et al. and we read it with great interest. Although the literature does not include any relevant randomized trials, early-stage cervical cancers are traditionally treated using the radical hysterectomy (RH) technique pioneered by Ernst Wertheim and others >100 years ago. Nowadays, efforts to reduce the complications and morbidity associated with RH, and improve patient quality of life post surgery are ongoing; therefore, we appreciate the SHAPE Trial researchers’ efforts to improve our knowledge of this topic and improve patient outcomes. The SHAPE Trial researchers performed a non-inferiority trial that included 130 centers in 12 countries, comparing simple hysterectomy (SH) and RH in patients with low-risk cervical cancer (lesions ≤2 cm with limited stromal invasion). They noted that, “SH was not inferior to RH with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention”. It is well known that each year almost 600,000 cases of cervical cancer occur worldwide, of which nearly 80% are in undeveloped or developing countries. Although the researchers wrote that their results cannot be generalized to developing countries, as practicing gynecologic oncologists from a developing country we also think that some patients with cervical tumors <2 cm might benefit from and urgently need less radical surgery, especially in low resource settings in which there is limited or no screening or radiotherapy facilities, nor operative infra-structure or trained gynecologic oncologists. In contrast to what was written, we strongly think that clinicians in developing and undeveloped countries can make good use of the SHAPE Trial findings; however, before we can reach a definitive conclusion, we have some criticisms and concerns about the Trial, as detailed below, that we think must be addressed.

Anahtar Kelimeler: Serviks kanseri, tip1 histerektomi, radikal histerektomi, Shape trial,




Corresponding Author: Polat Dursun, Türkiye


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