CHICAGO – Low-risk cervical cancer can be cured with a simple Hysterectomy with the same rate of cancer control as standard radical hysterectomy, and the de-escalated surgery has significantly fewer adverse side effects, researchers for the SHAPE clinical trial reported here.

For the primary non-inferiority endpoint of pelvic recurrence at 3 years, the incidence was 2.52% among 350 women who underwent the simple hysterectomy, compared with 2.17% among another 350 women randomized to the more extensive radical hysterectomy, said Marie Plante, MD, ob/gyn specialist at Laval University in Montreal, Quebec.

The difference of 0.35% fulfilled the prespecified criteria to conclude the simplified procedure was non-inferior to the radical hysterectomy, she said at a press conference on late-breaking abstracts at the annual meeting of the American Society of Clinical Oncology (ASCO).

“These results are important because it demonstrates, for the first time, that a simple hysterectomy is a safe option for women with carefully selected early-stage low-risk cervical cancer,” said Plante. “This trial will likely be practice-changing, with the new standard-of-care treatment for patients with low-risk disease being a simple hysterectomy instead of radical hysterectomy.”

In performing a radical hysterectomy, surgeons remove the uterus, cervix, upper vagina, and the tissue around the cervix. In a simplified hysterectomy, the surgeon removes only the uterus and cervix.

Plante emphasized that the simplified hysterectomy only would apply to women diagnosed with early stage cervical cancer – Stage 1A2 or Stage 1B1. She also noted that the simplified procedure is a less technically difficult surgery than radical hysterectomy, so that the application of the study could have wide-ranging impact, especially in lower income countries where the heaviest burden of cervical cancer exists.

Plante reported that the 700 SHAPE participants had low-risk, early-stage squamous cell, adenocarcinoma, and adenosquamous carcinoma and all underwent a pelvic lymph node dissection to exclude the presence of lymph node metastasis. The cancers also had to have less than a 10-mm stromal invasion and measure no more than 20 mm to be eligible for the international multicenter study.

“The SHAPE trial shows that among carefully selected tumors and patients, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasively procedures,” said Kathleen Moore, MD, gynecologic oncologist at the Stephenson Cancer Center, Oklahoma City, the study discussant at the ASCO press conference.

“You can do this without loss of oncologic control and importantly, with reduction in surgical complications,” Moore said. “From the moment this is presented, this will be the new standard of care. It represents a huge step forward in the care of women with early stage cervical cancer and honestly, the de-escalation may allow these women in low and middle income countries better access now that we understand what it does take to cure these early tumors. These results have broad implications on the global scale.”

In addition to non-inferiority, Plante said the study also found that the simpler surgery translated into fewer complications, stressing that radical hysterectomy was associated with significant excesses in urinary incontinence (19 vs eight women, P=0.048) and urinary retention (38 vs two women, P

Additionally, bladder injuries rose to nine cases with radical hysterectomy and three in the simple hysterectomy group, and urethral injuries reached five vs three cases, both differences not reaching statistical significance. There were seven deaths in each arm of the study.

Plante said that when women were questioned regarding sexual health and quality of life, the simple hysterectomy patients had more positive scores than the women who had radical surgery.