KEY TAKEAWAYS
- Phase III SHAPE study aimed to compare RH to SH in LRESCC.
- The primary endpoint of the study was the PRR3. Secondary endpoints included ERFS, OS, and QoL.
- The study found SH was non-inferior to RH for LRESCC, with fewer complications and better QoL.
Less radical surgery for low-risk cervical cancer (LRESCC) is gaining popularity due to its safety and lower morbidity. Researchers aimed to compare the radical Hysterectomy (RH) to simple hysterectomy (SH) in LRESCC.
The study enrolled 700 women (from 12 countries and 130 centers) with cervical cancer and randomized with LRESCC 1A2 or 1B1 lesions ≤ 2cm to RH or SH. SH was non-inferior to RH for PRR3 at 3 years, extrapelvic relapse-free survival (ERFS), overall survival (OS), and quality of life(QoL) in the intention-to-treat (ITT) and per-protocol (PP) analyzes.
The median age was 44 (range: 24-80). Most had stage 1B1 (91.7%) and squamous histology (61.7%). Hysterectomies included laparoscopic 50% (56% SH vs. 44% RH), robotic 25% (24% vs. 25%), abdominal 23% (17% vs. 29%). Lymph node metastasis was 4.4% (4.1% SH and 5.1% RH), extrauterine extension was 3.1% (2.6% SH and 3.7% RH). Post-surgical adjuvant therapy was received by 8.8% (9.2% SH and 8.4% RH). Median follow-up was for 4.5 years, and 21 pelvic recurrences were identified (11 SH and 10 RH). In the ITT analysis, PRR3 was 2.5% (SH) and 2.2% (RH), with DPRR3 being 0.35% (95% UCL 2.32%). In the PP analysis, PRR3 was 2.8% (SH) and 2.3% (RH), with DPRR3 being 0.42% (95% UCL 2.56%), 3-year ERFS and OS were 98.1% and 99.1% (SH) and 99.7% and 99.4% (RH), respectively. RH showed higher incidences of urinary incontinence (11.0% vs. 4.7% with SH; P=0.003) and urinary retention (9.9% vs. 0.6% with SH; P<0.0001) during follow-up. QoL scales favored SH, with significant differences between the groups.
The study found SH was non-inferior to RH in LRESCC, with fewer complications and better QoL.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.17_suppl.LBA5511
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT01658930
Marie Plante, Janice S. Kwon, Sarah Ferguson, Vanessa Samouëlian, Gwenael Ferron, Amandine Maulard, Cor de Kroon, Willemien Van Driel, John Tidy, Christian Marth, Karl Tamussino, Stefan Kommoss, Frederic Goffin, Brynhildur Eyjólfsdóttir, Jae-Weon Kim, Noreen Gleeson, Juliana M Ubi, Lori Brotto, Dongsheng Tu, and Lois E. Shepherd. DOI: 10.1200/JCO.2023.41.17_suppl.LBA5511 Journal of Clinical Oncology 41, no. 17_suppl (June 10, 2023) LBA5511-LBA5511.
