Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER)

Carneiro, Vandré Cabral Gomes; Batista, Thales Paulo; Andrade, Manoel Rodrigues; Barros, Aldo Vieira; Câmara, Luciana Holanda Lima Dornelas; Ramalho, Nathalia Moreira; Lucena, Márcia Angélia de; Fontao, Diogenes; Tancredi, Rodrigo; Júnior, Tyrone César Silva; Bezerra, Artur Lício Rocha; Baiocchi, Glauco

doi:10.1136/ijgc-2022-004092

Cited by 17 publications

(11 citation statements)

References 20 publications

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“…Data on the incidence of surgical complications were derived from four studies ( 10 , 14 , 16 , 17 ). With low heterogeneity observed among these studies ( I 2 < 50%), a fixed-effect model was applied.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety analysis of non-radical surgery for early-stage cervical cancer (IA2 ~ IB1): a systematic review and meta-analysis

Zeng,

Xiao,

et al. 2024

Front. Med.

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ObjectiveRadical hysterectomy has long been considered as the standard surgical treatment for early-stage cervical cancer (IA2 to IB1 stages), according to the 2009 International Federation of Obstetrics and Gynecology. This study aims to conduct an in-depth evaluation of the effectiveness and safety of non-radical surgery as an alternative treatment for patients with early-stage cervical cancer.MethodsA systematic search of online databases including PubMed, Embase, and the Cochrane Library was conducted to identify relevant literature on surgical treatment options for early-stage cervical cancer. Keywords such as “cervical cancer,” “conservative surgery,” “early-stage,” “less radical surgery,” and “simple hysterectomy” were used. Meta-analysis was performed using Stata 15.0 software, which included randomized controlled trials (RCTs) and cohort studies.ResultsThis meta-analysis included 8 eligible articles covering 9 studies, with 3,950 patients in the simple hysterectomy (SH) surgery group and 6,271 patients in the radical hysterectomy (RH) surgery group. The results indicate that there was no significant difference between the two groups in terms of the Overall Survival (OS) (HR = 1.04, 95% CI: 0.86–1.27, p = 0.671; Heterogeneity: I2 = 33.8%, p = 0.170), Disease Free Survival (DFS) (HR = 1.39, 95% CI: 0.59–3.29, p = 0.456; Heterogeneity: I2 = 0.0%, p = 0.374), Cervical Cancer Specific Survival (CCSS) (HR = 1.11, 95% CI: 0.80–1.54, p = 0.519; Heterogeneity: I2 = 11.9%, p = 0.287) and recurrence rate (RR = 1.16, 95% CI: 0.69–1.97, p = 0.583; Heterogeneity: I = 0.0%, p = 0.488). However, the mortality rate (RR = 1.35, 95% CI: 1.10–1.67, p = 0.006; Heterogeneity: I2 = 35.4%, p = 0.158) and the rate of postoperative adjuvant therapy (RR = 1.59, 95% CI: 1.16–2.19, p = 0.004; Heterogeneity: I2 = 92.7%, p < 0.10) were higher in the SH group compared to those in the RH group. On the other hand, the incidence of surgical complications was lower in the SH group (RR = 0.36, 95% CI: 0.21–0.59, p = 0.004; Heterogeneity: I2 = 0.0%, p = 0.857) than that in the RH group. Subgroup analysis revealed that patients in the IB1 stage SH group had a significantly higher mortality rate compared to those in the RH group (RR = 1.59, 95% CI: 1.23–2.07, p < 0.001; Heterogeneity: I2 = 0.0%, p = 0.332). However, there was no significant difference in mortality rates between the two groups for patients at stage IA2 (RR = 0.84, 95% CI: 0.54–1.30, p = 0.428; Heterogeneity: I2 = 26.8%, p = 0.243). In the subgroups positive for Lymphovascular Space Invasion (LVSI), patients in the SH group had a significantly higher mortality rate than those in the RH group (RR = 1.34, 95% CI: 1.09–1.65, p = 0.005; Heterogeneity: I2 = 41.6%, p = 0.128). However, in the LVSI-negative subgroups, there was no significant difference in mortality rates between the two groups (RR = 0.33, 95% CI: 0.01–8.04, p = 0.499).ConclusionFor patients with early-stage cervical cancer patients at IA2 without LVSI involvement, comparisons between the two groups in terms of OS, DFS, CCSS, recurrence rate, and mortality rates revealed no statistically significant differences, indicating that the choice of surgical approach does not affect long-term survival outcomes for this specific patient group. For patients at IB1 and IA2 stages with LVSI involvement, while there were no significant differences between the two groups in OS, DFS, CSS, and recurrence rate, a significant increase in mortality rates was observed in the SH group. This indicates a potential elevated risk of mortality associated with SH in this subset of patients. Notably, the incidence of surgical complications was significantly lower in the SH group compared to the RH group, highlighting the safety profile of SH in this context. Significantly, among patients in the SH group, an increase in the rate of postoperative adjuvant treatment is associated with a higher occurrence of treatment-related complications. To facilitate more precise patient selection for conservative surgical management, future prospective studies of superior quality are imperative to gain deeper insights into this matter.Systematic review registrationPROSPERO (CRD42023451609: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023451609).

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Section: Resultsmentioning

confidence: 99%

Efficacy and safety analysis of non-radical surgery for early-stage cervical cancer (IA2 ~ IB1): a systematic review and meta-analysis

Zeng,

Xiao,

et al. 2024

Front. Med.

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“…Notably, postoperative pathological analysis of microscopic invasion is important. Further, if adequate adjuvant treatment is performed, similar to that indicated in the LESSER trial, extreme parametrium resection might not be needed [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

“…Parametrial involvement is rare in early-stage cervical cancer [ 1 2 3 4 5 ]. Recently, two prospective studies have reported that conization or simple hysterectomy is sufficient for stage IB1 cervical cancer [ 6 7 ]. Many clinicians aim to minimize parametrial resection, considering that severe bladder dysfunction is a frequent complication after radical hysterectomy [ 7 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…Recently, two prospective studies have reported that conization or simple hysterectomy is sufficient for stage IB1 cervical cancer [ 6 7 ]. Many clinicians aim to minimize parametrial resection, considering that severe bladder dysfunction is a frequent complication after radical hysterectomy [ 7 8 ]. Furthermore, even in more invasive cancers, such as IB3/II, there is no clear indication for resection of the parametrium [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Improved bladder function in radical hysterectomy without worsening oncologic outcome: resection of the posterior layer of the vesicouterine ligament with the procedure limited to the vesical veins

Chikazawa,

Imai,

Kuwata

et al. 2024

J Gynecol Oncol

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Objective The classic Okabayashi nerve-sparing radical hysterectomy involves complete resection of the posterior leaf of the vesicouterine ligament, whereas in the simplified nerve-sparing radical hysterectomy, only the vesical veins and some connective tissue of the posterior layer of the vesicouterine ligament are resected. This study aimed to compare bladder function and cervical carcinoma relapse-free survival between these two techniques. Methods We conducted a retrospective, historical control study. All female patients aged >20 years who were diagnosed with cervical cancer stage IB1–IIB and underwent radical hysterectomy with pelvic lymphadenectomy between 2009 and 2022 were enrolled. Patients who had a history of other cancers and those who were treated with non-surgical approaches or non-radical hysterectomy were excluded. The primary outcome was relapse-free survival during the follow-up period. Results A total of 114 patients who underwent curative-intent radical hysterectomy were included in this study. The median follow-up duration was 60 months. No significant difference was observed in relapse-free survival between the two surgical procedures. The simplified nerve-sparing radical hysterectomy was superior in terms of both motor and sensory bladder function outcomes. Conclusion Resection of the posterior layer of the vesicouterine ligament, with the procedure limited to the vesical veins, is an effective and safe method for radical hysterectomy. It may be more useful for preserving the bladder function, without leading to unfavorable oncologic outcomes.

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“…Prospective evidence on this issue is limited. CONCERV1 was a prospective feasibility study, and results of the LESSER2 trial were shared recently. SHAPE trial results (the only sufficiently powered prospective randomized trial on the issue) will be presented this year.…”

mentioning

confidence: 99%

Can simple hysterectomy replace radical hysterectomy as treatment of early-stage cervical cancer?

Obermair

Pareja

2023

Int J Gynecol Cancer

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Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER)

Cited by 17 publications

References 20 publications

Efficacy and safety analysis of non-radical surgery for early-stage cervical cancer (IA2 ~ IB1): a systematic review and meta-analysis

Efficacy and safety analysis of non-radical surgery for early-stage cervical cancer (IA2 ~ IB1): a systematic review and meta-analysis

Improved bladder function in radical hysterectomy without worsening oncologic outcome: resection of the posterior layer of the vesicouterine ligament with the procedure limited to the vesical veins

Can simple hysterectomy replace radical hysterectomy as treatment of early-stage cervical cancer?

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