Results of an international phase 3 trial comparing radical hysterectomy and simple hysterectomy in patients with low-risk early-stage cervical cancer (LRESCC) show that the two procedures are comparable with fewer surgery related complications and better quality of life with simple hysterectomy. The study was presented at the ongoing 2023 annual meeting of The American Society of Clinical Oncology (ASCO) in Chicago.¹

Marie Plante from the Division of Gynecologic Oncology, Université Laval, Quebec in Canada and coresearchers compared the outcomes of radical hysterectomy and simple hysterectomy in patients with low-risk early-stage cervical cancer defined as stage 1A2 or 1B1 with lesion 2cm or less in size. Both groups also underwent pelvic node dissection as part of the surgery. The study subjects were followed up for a period of 3 years. For this they enrolled 700 women from 12 countries between December 2012 and November 2019 with a median age of 44 years. Majority (91.7%) had stage 1B1 cervical cancer. Half of the hysterectomies were performed laparoscopically, 25% were robotic procedures, while 23% were done abdominally.

In the laparoscopic group, 56% underwent simple hysterectomy, while 44% had radical hysterectomy. In the robotic group, 24% were simple hysterectomies vs 25% radical hysterectomies. And in the abdominal group, 17% were simple hysterectomies vs 29% radical hysterectomies. Less than 5% of patients had lymph node metastasis and 3.1% were also found to have extrauterine extension.

Around 9.2% women who underwent simple hysterectomy and 8.4% in the radical hysterectomy group received post-surgical adjuvant therapy. Eleven women in the simple hysterectomy group and 10 in the radical hysterectomy group had pelvic recurrences over 4.5 years of median follow up.

At 3 years, the primary recurrence rate, which was the primary endpoint of the study, was 2.5% with simple hysterectomy and 2.2% with radical hysterectomy with between-group difference of 0.35% in intention to treat (ITT) analysis. The primary recurrence rate was 2.8% with simple hysterectomy and 2.3% with radical hysterectomy in the per protocol (PP) analysis with between-group difference of 0.42%.

The extrapelvic relapse-free survival (ERFS), overall survival (OS) and quality of life (QoL) were also estimated. At 3 years, the ERFS was 98.1% with simple hysterectomy vs 99.7% with radical hysterectomy. The OS was 99.1% in the simple hysterectomy group vs 99.4% in the radical hysterectomy group. The incidence of surgical complications such as urinary incontinence and urinary retention was higher in women in the radical hysterectomy group compared to those in the simple hysterectomy. A difference in the quality of life was noted between the two groups with results favoring simple hysterectomy.

The study showed that the 3-year pelvic recurrence rate in women who underwent simple hysterectomy for low risk early-stage cervical cancer was comparable to those who underwent radical hysterectomy. They had fewer surgical complications and also a better quality of life. Hence, simple hysterectomy with pelvic node dissection can be a new standard of care in patients with low-risk early-stage cervical cancer.

Reference

1. Plante M, et al. An international randomized phase III trial comparing radical hysterectomy and pelvic node dissection (RH) vs simple hysterectomy and pelvic node dissection (SH) in patients with low-risk early-stage cervical cancer (LRESCC):  A Gynecologic Cancer Intergroup study led by the Canadian Cancer Trials Group (CCTG CX.5-SHAPE). J Clin Oncol. 2023;41(suppl 17):abstr LBA5511. DOI: 10.1200/JCO.2023.41.17_suppl.LBA5511.