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).

Authors

null

Marie Plante

Division of Gynecologic Oncology, Université Laval, CHU de Quebec, Quebec, QC, Canada

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 , Lois E. Shepherd

Organizations

Division of Gynecologic Oncology, Université Laval, CHU de Quebec, Quebec, QC, Canada, University of British Columbia, Vancouver, BC, Canada, Pincess Margaret Hospital, Torono, ON, Canada, Gynecologic Oncology, Centre Hospitalier de l’Université de Montréal (CHUM), Centre de Recherche de l’Université de Montréal (CRCHUM), Université de Montréal, Montreal, QC, Canada, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France, Gustave Roussy Cancer Center, Villejuif, France, Leiden University Medical Center, Leiden, Netherlands, Netherlands Cancer Institute, Amsterdam, Netherlands, Royal Hallamshire Hospital, Sheffield, United Kingdom, Innsbruck Medical University; Department of Obstetrics and Gynecology, Innsbruck, Austria, Department of Gynecology Medical University Graz, Graz, Austria, Department of Women's Health, Tübingen University Hospital, Tübingen, Germany, CHU de Liege, Liege, Belgium, Oslo University Hospital, Oslo, Norway, Seoul National University College of Medicine, Seoul, South Korea, St James' Hospital, Dublin, Ireland, Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada, The University of British Columbia, Vancouver, BC, Canada

Research Funding

Other
Canadian Institutes of Health Research (CIHR) and Canadian Cancer Society (CCS)

Background: In the last 2 decades, there has been a trend towards less radical surgery in patients with low-risk cervical cancer. Retrospective data suggested that less radical surgery may be safe and associated with less morbidity. The objective of this non-inferiority phase III prospective randomized trial was to compare RH to SH in women with LRESCC. Methods: Women with LRESCC defined as stage 1A2 or 1B1 with lesion ≤ 2cm were randomized to RH or SH after stratification by cooperative group, intended use of sentinel node mapping, stage, histological type, and tumour grade. The primary endpoint was pelvic recurrence rate at 3 years (PRR3). Non-inferiority of SH to RH is claimed when the 95% upper one-sided confidence limit (95% UCL) for the difference in PRR3 of SH to RH (DPRR3), calculated by the Kaplan-Meier method for pelvic-relapse free survival, is lower than or equal to 4%. Primary intention to treat (ITT) analysis included all patients randomized. Per-protocol (PP) analysis included patients eligible at baseline and without evidence of more advanced disease found at the time of surgery or final pathology, based on treatment received. Secondary endpoints included extrapelvic relapse-free survival (ERFS), overall survival (OS), and quality of life (QoL). Results: 700 women (12 countries, 130 centers) were enrolled from December 2012 to November 2019. Patient characteristics were well balanced: median age was 44 (24-80); 91.7% were stage 1B1 and 61.7% had squamous histology. 50% of the hysterectomies were done laparoscopically (56% SH vs. 44% RH), 25% robotically (24% vs. 25%) and 23% abdominally (17% vs. 29%). 4.4% of patients had lymph node metastasis (4.1% SH and 5.1% RH) and 3.1% had extrauterine extension (2.6% SH and 3.7% RH). A total of 8.8% of women received post-surgical adjuvant therapy (9.2% SH and 8.4% RH). With a median follow-up of 4.5 years, 21 pelvic recurrences were identified (11 SH and 10 RH). The PRR3 was 2.5% with SH and 2.2% with RH (DPRR3 0.35% with 95% UCL 2.32%) in ITT analysis; 2.8% with SH and 2.3% with RH (DPRR3 0.42% with 95% UCL 2.56%) in PP analysis. The 3-year ERFS and OS were respectively 98.1% and 99.1% with SH; 99.7% and 99.4% with RH. RH had significantly higher surgery related incidence 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 with significant difference between the two groups over time were all in favor of SH. Conclusions: The pelvic recurrence rate at 3 years in women with low risk early-stage cervical cancer who underwent a simple hysterectomy is not inferior to those who received a radical hysterectomy. Fewer surgical complications and better quality of life were observed with SH. Clinical trial information: NCT01658930.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Clinical Science Symposium

Session Title

Knives Out: Surgical Management of Gynecologic Cancers

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Clinical Trial Registration Number

NCT01658930

Citation

J Clin Oncol 41, 2023 (suppl 17; abstr LBA5511)

DOI

10.1200/JCO.2023.41.17_suppl.LBA5511

Abstract #

LBA5511

Abstract Disclosures