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根治性子宫切除术不能提高宫颈癌且术中检测到淋巴结受累患者的生存率:ABRAX 国际回顾性队列研究。

Completion of radical hysterectomy does not improve survival of patients with cervical cancer and intraoperatively detected lymph node involvement: ABRAX international retrospective cohort study.

机构信息

Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Prague, Czech Republic.

Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Prague, Czech Republic.

出版信息

Eur J Cancer. 2021 Jan;143:88-100. doi: 10.1016/j.ejca.2020.10.037. Epub 2020 Dec 5.

Abstract

BACKGROUND

The management of cervical cancer patients with intraoperative detection of lymph node involvement remains controversial. Since all these patients are referred for (chemo)radiation after the surgery, the key decision is whether radical hysterectomy should be completed as originally planned, taking into account an additional morbidity associated with extensive surgical dissection prior to adjuvant treatment. The ABRAX study investigated whether completing a radical uterine procedure is associated with an improved oncological outcome of such patients.

PATIENTS AND METHODS

We performed retrospective analyses of 515 cervical cancer patients (51 institutions, 19 countries) who were referred for primary curative surgery between 2005 and 2015 (stage IA-IIB, common tumour types) in whom lymph node involvement was detected intraoperatively. Patients were stratified according to whether the planned uterine surgery was completed (COMPL group, N = 361) or abandoned (ABAND group, N = 154) to compare progression-free survival. Definitive chemoradiation was given to 92.9% patients in the ABAND group and adjuvant (chemo)radiation or chemotherapy to 91.4% of patients in the COMPL group.

RESULTS

The risks of recurrence (hazard ratio [HR] 1.154, 95% confidence intervals [CI] 0.799-1.666, P = 0.45), pelvic recurrence (HR 0.836, 95% CI 0.458-1.523, P = 0.56), or death (HR 1.064, 95% CI 0.690-1.641, P = 0.78) were not significantly different between the two groups. No subgroup showed a survival benefit from completing radical hysterectomy. Disease-free survival reached 74% (381/515), with a median follow-up of 58 months. Prognostic factors were balanced between the two groups. FIGO stage and number of pelvic lymph nodes involved were significant prognostic factors in the whole study cohort.

CONCLUSION

We showed that the completion of radical hysterectomy does not improve survival in patients with intraoperatively detected lymph node involvement, regardless of tumour size or histological type. If lymph node involvement is confirmed intraoperatively, abandoning uterine radical procedure should be considered, and the patient should be referred for definitive chemoradiation.

CLINICAL TRIALS IDENTIFIER

NCT04037124.

摘要

背景

对于术中检测到淋巴结受累的宫颈癌患者的管理仍存在争议。由于所有这些患者在手术后都被转介接受(化疗)放疗,因此关键决策是是否应按原计划完成根治性子宫切除术,同时考虑到在辅助治疗前广泛手术解剖相关的额外发病率。ABRAX 研究调查了完成根治性子宫手术是否与此类患者的肿瘤学结局改善相关。

患者和方法

我们对 2005 年至 2015 年间(IA-IIB 期,常见肿瘤类型)因术中检测到淋巴结受累而接受初次根治性手术的 515 例宫颈癌患者(51 个机构,19 个国家)进行了回顾性分析。根据计划的子宫手术是否完成(完成组,N=361)或放弃(放弃组,N=154),对患者进行分层,以比较无进展生存率。92.9%的放弃组患者接受了确定性放化疗,91.4%的完成组患者接受了辅助(化疗)放疗或化疗。

结果

复发风险(风险比 [HR] 1.154,95%置信区间 [CI] 0.799-1.666,P=0.45)、盆腔复发(HR 0.836,95%CI 0.458-1.523,P=0.56)或死亡(HR 1.064,95%CI 0.690-1.641,P=0.78)在两组之间无显著差异。没有亚组显示完成根治性子宫切除术有生存获益。无病生存率达到 74%(381/515),中位随访时间为 58 个月。预后因素在两组之间平衡。FIGO 分期和盆腔淋巴结受累数量是整个研究队列的显著预后因素。

结论

我们表明,无论肿瘤大小或组织学类型如何,术中检测到淋巴结受累的患者完成根治性子宫切除术并不能提高生存率。如果术中确认淋巴结受累,应考虑放弃子宫根治性手术,并将患者转介接受确定性放化疗。

临床试验标识符

NCT04037124。

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