A simple hysterectomy is considered a safe option for low-risk early-stage cervical cancer patients and improves quality of life.

The results of the CX5/SHAPE clinical trial, published today in the New England Journal of Medicine (NEJM), conclude that a simple hysterectomy is a safe treatment option for women with low-risk early-stage cervical cancer. The Phase III international trial compared radical hysterectomy and pelvic node dissection with simple hysterectomy and pelvic node dissection.

“These results are important because they demonstrate, for the first time, that a simple hysterectomy is a safe option for women with carefully selected low-risk early-stage cervical cancer,” said Dr. Marie Plante, the CX5 study lead and a gynecologic oncologist at CHU de Quebec, Laval University. “These results will likely be practice-changing with the new standard-of-care treatment being a simple hysterectomy instead of radical hysterectomy.”

For this patient population, the current standard treatment is a radical hysterectomy, a far more invasive surgery. Although it is a highly effective treatment, there are more risks of long-term surgical side effects including compromised bladder, bowel, and sexual function. 
The trial results indicate fewer surgical urological complications for patients who received a simple hysterectomy. The radical hysterectomy group had three times more bladder injuries, nearly twice as many ureteral injuries and statistically more adverse events within four weeks of surgery. In addition, the simple hysterectomy trial participants had an overall better quality of life as there was a significant toxicity associated with radical surgery on sexual health with a high proportion of patients having sustained sexual-vaginal dysfunction and sexual distress.
This study has potential implications in parts of the world where cervical cancer is endemic. Cervical cancer is the fourth most common cancer in women globally (according to the WHO), and unfortunately more common in less affluent countries.  

“The global impact of these results is important to note as surgical de-escalation may allow women in low and middle-income countries easier access to less radical surgical interventions,” say Dr. Lois Shepherd the CX5 Senior Investigator and a Queen’s University Professor in the Department of Pathology & Molecular Medicine.
 
About the study

The study included 700 women who came from 12 different countries and 130 centers with low-risk, early-stage cervical cancer, defined as stage 1A2 or 1B1 disease, grade 1, 2, or 3, with lesions less than or equal to 2 centimeters and limited cervical stromal invasion. Of note, 186 or 26% of all patients were recruited from Canadian centers. The pelvic recurrence rate at 3-years was 2.52% for the Simple Hysterectomy group and 2.17% for the women receiving a Radical Hysterectomy with a difference of 0.35% and one-sided 95% confidence limit of 2.32%. Secondary endpoints included extra pelvic relapse-free survival, relapse-free survival, overall survival (OS), and quality of life.

CX5/SHAPE was an academic study led by the Canadian Cancer Trials Group (CCTG) and directly funded by the Canadian Institute of Health Research (CIHR) and in part by the Canadian Cancer Society (CCS). The study is an international collaboration with The Gynecological Cancer InterGroup (GCIG) that includes partners : Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Dutch Gynecologic Oncology Group (DGOG), National Cancer Research Institute (NCRI), Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO Studiengruppe), Belgium Gynecologic Oncology Group (BGOG), Arbeitsgemeinschaft Gynaekologische, Onkologie Austria (AGO Austria), Oslo University Hospital - The Norwegian Radium Hospital, Korean Gynecologic Oncology Group (KGOG), and All Ireland Cooperative Oncology Research Group (ICORG).

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