Notice to SGO Members: Emerging data on the surgical approach for radical hysterectomy in the treatment of women with cervical cancer (November 2018)

CHICAGO, IL (Nov. 13, 2018)— Gynecologic oncologists should be aware of the emerging data on minimally invasive surgery (MIS) for cervical cancer so that a thorough discussion can be undertaken with patients and shared decision making used when choosing the surgical approach for radical hysterectomy. To make sure our members are aware recently published data, we are providing the following informational statement from the SGO Clinical Practice Committee and approved by the SGO Executive Committee.

The recently published prospective randomized Phase 3 Laparoscopic Approach to Cervical Cancer (LACC) trial and the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database study in the New England Journal of Medicine, both noting inferior oncologic outcomes for patients treated with minimally invasive surgery (MIS) in early stage cervical cancer, have led to increased public attention to the issue of MIS for cervical cancer.

In the multicenter, international LACC trial, stage IA1 (+ LVSI), IA2, and IBI cervical cancers were randomized to MIS radical hysterectomy (n = 319) versus open radical hysterectomy (n = 312). (1) This was designed as a non-inferiority trial where the primary outcome was rate of disease-free survival (DFS) at 4.5 years. MIS radical hysterectomy was associated with a DFS rate at 4.5 years of 86.0%, compared to 96.5% with open radical hysterectomy, a difference of -10.6% (95% confidence interval [CI], ?16.4 to ?4.7). It is important to note that this study was closed prematurely due to an imbalance in deaths between the 2 groups. The difference in survival remained after adjustment for age, body-mass index, stage of disease, lymphvascular invasion, lymph-node involvement, and ECOG performance-status score. Over 90% of tumors were stage IB1; microscopic, early-stage low risk cervical cancers (FIGO stage IA) were underrepresented in the LACC trial and these data may not necessarily be applicable to such patients.

In Melamed et al.’s 2-part epidemiologic study utilizing the National Cancer Database, 1225 of 2461 patients with IA2 and IB1 cervical cancer underwent MIS radical hysterectomy; those undergoing MIS radical hysterectomy were more often white, privately insured, and of higher socioeconomic status than those who underwent open radical hysterectomy. (2) The 4-year mortality was 9.1% among women who underwent minimally invasive radical hysterectomy and 5.3% among those who underwent open radical hysterectomy (hazard ratio, 1.65; 95% confidence interval [CI], 1.22 to 2.22; P=0.002 by the log-rank test). In part 2 utilizing the SEER database, the authors showed a decrease in survival of 0.8% per year after 2006 which coincided with the introduction of MIS. In both studies, the reasons for these outcomes are unclear from the available data.

Gynecologic oncologists are encouraged to consider all available data as they counsel individual patients to determine the most appropriate surgical approach. We anticipate additional data to emerge on this important topic. A dedicated session focused on the surgical approach for radical hysterectomy in cervical cancer is planned for the 2019 SGO Annual Meeting on Women’s Cancer. As a scientific community we will continue to assess current and emerging data pertaining to this issue as we make shared decisions regarding surgical approach with our patients on an individualized basis.

References

1. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. DOI: 10.1056/NEJMoa1806395.

2. Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. DOI: 10.1056/NEJMoa1804923.