KEY TAKEAWAYS
- This Phase III trial compared RH to SH in women with LRESCC.
- The study’s primary endpoint was PRR3. Secondary endpoints included ERFS, OS, and QoL.
- The PRR3 for SH was not inferior to RH in LRESCC, but SH had fewer surgical complications and better QoL.
This Phase III non-inferiority trial aimed to evaluate the effectiveness of radical hysterectomy (RH) versus simple hysterectomy (SH) in women diagnosed with low-risk early-stage cervical cancer (LRESCC).
Women with stage 1A2 or 1B1 LRESCC with lesions ≤ 2cm were randomized into either the RH or SH groups for the study. Stratification was based on several factors, such as cooperative group, the intended use of sentinel node mapping, cancer stage, histological type, and tumor grade. The primary endpoint was pelvic recurrence rate at 3 years (PRR3). Non-inferiority would be established if the upper 95% confidence limit for the difference in PRR3 between SH and RH was less than or equal to 4%.
The analysis was conducted in two ways: intention to treat (ITT), which included all participants initially randomized, and per-protocol (PP), which only included those eligible at the baseline and did not have more advanced disease discovered during or after surgery. Secondary endpoints were extrapelvic relapse-free survival (ERFS), overall survival (OS), and quality of life (QoL).
The study enrolled 700 women from December 2012 to November 2019 across 12 countries and 130 centers. The patient demographics were well balanced, with a median age of 44, ranging from 24 to 80. Most (91.7%) were at stage 1B1, and 61.7% had squamous histology. As for the surgical methods, 50% were performed laparoscopically (56% SH and 44% RH), 25% using robotic assistance (24% SH and 25% RH), and 23% abdominally (17% SH and 29% RH). Lymph node metastasis was found in 4.4% of the patients (4.1% in SH and 5.1% in RH), while extrauterine extension occurred in 3.1% (2.6% SH and 3.7% RH). Post-surgical adjuvant therapy was administered to 8.8% of the participants (9.2% in SH and 8.4% in RH).
After a median follow-up period of 4.5 years, 21 cases of pelvic recurrence were noted (11 in SH and 10 in RH). The ITT analysis reported a PRR3 of 2.5% for SH and 2.2% for RH, with a DPRR3 of 0.35% and a 95% UCL of 2.32%. The PP analysis showed similar results. The 3-year ERFS and OS rates were 98.1% and 99.1% for SH, and 99.7% and 99.4% for RH. Importantly, RH was linked to a significantly higher rate of surgery-related urinary incontinence (11.0% compared to 4.7% in SH, p=0.003) and urinary retention (9.9% compared to 0.6% in SH, p<0.0001) during follow-up. QoL metrics showed that significant differences over time favored SH.
The PRR3 for women with low-risk early-stage cervical cancer who underwent an SH was not inferior to those who underwent an RH. Additionally, SH was associated with fewer surgical complications and better QoL.
Source: https://meetings.asco.org/abstracts-presentations/219845
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT01658930
Plante, M., Kwon, J.S., Ferguson, S., Samouëlian, V., Ferron, G., Maulard, A., Kroon, C.d., Driel, W.V., Tidy, J., Marth, C., Tamussino, K., Kommoss, S., Goffin, F., Eyjólfsdóttir, B., Kim, J-W., Gleeson, N., Ubi, J.M., Brotto, L., Tu, D., Shepherd, L.E. PID: BO1-1 – SHAPE Trial: 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).
