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根治性子宫切除术范围与早期宫颈癌生存相关:监测宫颈癌(SCCAN)合作研究的亚分析。

Survival associated with extent of radical hysterectomy in early-stage cervical cancer: a subanalysis of the Surveillance in Cervical CANcer (SCCAN) collaborative study.

机构信息

Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.

Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.

出版信息

Am J Obstet Gynecol. 2023 Oct;229(4):428.e1-428.e12. doi: 10.1016/j.ajog.2023.06.030. Epub 2023 Jun 17.

Abstract

BACKGROUND

International guidelines recommend tailoring the radicality of hysterectomy according to the known preoperative tumor characteristics in patients with early-stage cervical cancer.

OBJECTIVE

This study aimed to assess whether increased radicality had an effect on 5-year disease-free survival in patients with early-stage cervical cancer undergoing radical hysterectomy. The secondary aims were 5-year overall survival and pattern of recurrence.

STUDY DESIGN

This was an international, multicenter, retrospective study from the Surveillance in Cervical CANcer (SCCAN) collaborative cohort. Patients with the International Federation of Gynecology and Obstetrics 2009 stage IB1 and IIA1 who underwent open type B/C1/C2 radical hysterectomy according to Querleu-Morrow classification between January 2007 and December 2016, who did not undergo neoadjuvant chemotherapy and who had negative lymph nodes and free surgical margins at final histology, were included. Descriptive statistics and survival analyses were performed. Patients were stratified according to pathologic tumor diameter. Propensity score match analysis was performed to balance baseline characteristics in patients undergoing nerve-sparing and non-nerve-sparing radical hysterectomy.

RESULTS

A total of 1257 patients were included. Of note, 883 patients (70.2%) underwent nerve-sparing radical hysterectomy, and 374 patients (29.8%) underwent non-nerve-sparing radical hysterectomy. Baseline differences between the study groups were found for tumor stage and diameter (higher use of non-nerve-sparing radical hysterectomy for tumors >2 cm or with vaginal involvement; P<.0001). The use of adjuvant therapy in patients undergoing nerve-sparing and non-nerve-sparing radical hysterectomy was 27.3% vs 28.6%, respectively (P=.63). Five-year disease-free survival in patients undergoing nerve-sparing vs non-nerve-sparing radical hysterectomy was 90.1% (95% confidence interval, 87.9-92.2) vs 93.8% (95% confidence interval, 91.1-96.5), respectively (P=.047). Non-nerve-sparing radical hysterectomy was independently associated with better disease-free survival at multivariable analysis performed on the entire cohort (hazard ratio, 0.50; 95% confidence interval, 0.31-0.81; P=.004). Furthermore, 5-year overall survival in patients undergoing nerve-sparing vs non-nerve-sparing radical hysterectomy was 95.7% (95% confidence interval, 94.1-97.2) vs non-nerve-sparing 96.5% (95% confidence interval, 94.3-98.7), respectively (P=.78). In patients with a tumor diameter ≤20 mm, 5-year disease-free survival was 94.7% in nerve-sparing radical hysterectomy vs 96.2% in non-nerve-sparing radical hysterectomy (P=.22). In patients with tumors between 21 and 40 mm, 5-year disease-free survival was 90.3% in non-nerve-sparing radical hysterectomy vs 83.1% in nerve-sparing radical hysterectomy (P=.016) (no significant difference in the rate of adjuvant treatment in this subgroup, P=.47). This was confirmed after propensity match score analysis (balancing the 2 study groups). The pattern of recurrence in the propensity-matched population did not demonstrate any difference (P=.70).

CONCLUSION

For tumors ≤20 mm, no survival difference was found with more radical hysterectomy. For tumors between 21 and 40 mm, a more radical hysterectomy was associated with improved 5-year disease-free survival. No difference in the pattern of recurrence according to the extent of radicality was observed. Non-nerve-sparing radical hysterectomy was associated with better 5-year disease-free survival than nerve-sparing radical hysterectomy after propensity score match analysis.

摘要

背景

国际指南建议根据早期宫颈癌患者术前已知的肿瘤特征来调整根治性子宫切除术的彻底性。

目的

本研究旨在评估早期宫颈癌患者接受根治性子宫切除术时增加根治性是否对 5 年无病生存率有影响。次要目的是 5 年总生存率和复发模式。

研究设计

这是一项来自国际、多中心、回顾性 SCCAN 协作队列研究。纳入了 2009 年国际妇产科联合会(FIGO)分期为 IB1 和 IIA1 期、接受开放式 B/C1/C2 根治性子宫切除术(根据 Querleu-Morrow 分类)、未接受新辅助化疗且最终组织学检查淋巴结阴性且手术切缘无肿瘤的患者。进行了描述性统计和生存分析。根据病理肿瘤直径对患者进行分层。对行神经保留和非神经保留根治性子宫切除术的患者进行倾向评分匹配分析,以平衡基线特征。

结果

共纳入 1257 例患者。值得注意的是,883 例(70.2%)患者行神经保留根治性子宫切除术,374 例(29.8%)患者行非神经保留根治性子宫切除术。研究组之间存在肿瘤分期和直径的基线差异(对于直径>2cm 或有阴道受累的肿瘤,非神经保留根治性子宫切除术的使用率更高;P<.0001)。行神经保留和非神经保留根治性子宫切除术的患者中,分别有 27.3%和 28.6%接受辅助治疗(P=.63)。神经保留和非神经保留根治性子宫切除术患者的 5 年无病生存率分别为 90.1%(95%置信区间,87.9-92.2)和 93.8%(95%置信区间,91.1-96.5)(P=.047)。多变量分析显示,非神经保留根治性子宫切除术与全队列的无病生存率独立相关(风险比,0.50;95%置信区间,0.31-0.81;P=.004)。此外,神经保留和非神经保留根治性子宫切除术患者的 5 年总生存率分别为 95.7%(95%置信区间,94.1-97.2)和 96.5%(95%置信区间,94.3-98.7)(P=.78)。肿瘤直径≤20mm 的患者中,神经保留根治性子宫切除术的 5 年无病生存率为 94.7%,而非神经保留根治性子宫切除术为 96.2%(P=.22)。肿瘤直径在 21-40mm 的患者中,非神经保留根治性子宫切除术的 5 年无病生存率为 90.3%,神经保留根治性子宫切除术为 83.1%(P=.016)(该亚组中辅助治疗的发生率无显著差异,P=.47)。这在倾向评分匹配分析后得到了证实(平衡了 2 个研究组)。倾向匹配人群的复发模式没有显示出任何差异(P=.70)。

结论

对于直径≤20mm 的肿瘤,更彻底的根治性子宫切除术并未提高生存率。对于直径在 21-40mm 的肿瘤,更彻底的根治性子宫切除术与提高 5 年无病生存率相关。根据根治性的程度,复发模式没有差异。倾向评分匹配分析后,非神经保留根治性子宫切除术与神经保留根治性子宫切除术相比,5 年无病生存率更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8ab/10966343/7ffdfbdb19ed/nihms-1973095-f0001.jpg

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