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辅助放疗对仅具有中危因素的早期宫颈癌患者肿瘤学结局的影响:一项倾向评分匹配分析

The effect of adjuvant radiotherapy on oncological outcomes in patients with early-stage cervical carcinoma with only intermediate-risk factors: a propensity score matching analysis.

作者信息

Turkmen Osman, Kilic Fatih, Tokalioglu Abdurrahman Alp, Cakir Caner, Yuksel Dilek, Kilic Cigdem, Boran Nurettin, Kimyon Comert Gunsu, Turan Taner

机构信息

Department of Gynecologic Oncology, Etlik Zubeyde Hanim Women's Health Training and Research Hospital, Faculty of Medicine, University of Health Sciences, Ankara, Turkey.

出版信息

J Obstet Gynaecol. 2022 Oct;42(7):3204-3211. doi: 10.1080/01443615.2022.2109406. Epub 2022 Aug 12.

DOI:10.1080/01443615.2022.2109406
PMID:35959796
Abstract

We aimed to evaluate whether adjuvant radiotherapy had a survival benefit for patients with early-stage cervical carcinoma with intermediate-risk factors. This study included patients who underwent radical hysterectomy and lymphadenectomy according to Wertheim-Okabayashi for stage IB1-IIA2 cervical carcinoma. Each patient had at least one intermediate-risk factor including tumour diameter ≥4 cm, deep stromal invasion, and positive lymphovascular space invasion (LVSI). Patients with lymph node metastasis, parametrial invasion, and positive surgical margins according to the final paraffin section were excluded. In total, 183 patients were included. Seventy-three (39.9%) patients had one, 85 (46.4%) had two, and 25 (13.7%) had three intermediate risk factors. Sixty-seven (36.6%) patients received adjuvant radiotherapy. There was a statistically significant difference in terms of stage, LVSI, and endometrial/uterine invasion between the groups that did and did not receive adjuvant radiotherapy ( = .024,  = .018, and  = .001, respectively). These two groups were homogenised by performing propensity score matching (PSM) analysis. In the new matched cohort ( = 134), 5-year disease-free survival (DFS) was 89.5% in the group that received adjuvant radiotherapy and 82% in the group that did not (HR: 0.484, 95% CI: [0.171-1.369];  = .171). Also, receiving adjuvant radiotherapy was not associated with an improvement in oncologic outcomes in patients with one, two, or more intermediate risk factors. In univariate analysis, none of the risk factors was associated with DFS. In conclusion, adjuvant radiotherapy had no favourable effect on survival outcomes in patients with early-stage cervical carcinoma with only intermediate risk factors.IMPACT STATEMENT Radiotherapy after radical hysterectomy in cervical carcinoma is accepted as the standard of care when high-risk factors - positive surgical margins, lymph node metastasis, and parametrial involvement - are found in the surgical specimen. However, the necessity of adjuvant radiotherapy in patients with intermediate-risk factors - deep stromal invasion, positive LVSI, tumour diameter ≥4 cm - is controversial. We compared patients who received adjuvant radiotherapy and those who did not. No significant difference was found between the two groups in terms of oncologic outcomes. There was no difference between the two groups in terms of pelvic and extrapelvic recurrence rates. The number of positive intermediate-risk factors did not affect survival. Moreover, age, tumour type, stage, number of removed lymph nodes, grade, bilateral salpingo-oophorectomy, and endometrial/uterine invasion were not associated with DFS among patients with stage IB-IIA cervical carcinoma with only intermediate-risk factors. Debate remains over the prognostic factors and the adjuvant treatment options in patients with early-stage cervical carcinoma who possess intermediate-risk factors. Adjuvant radiotherapy can be ignored if initial adequate surgery has been performed in this patient group.

摘要

我们旨在评估辅助放疗对具有中度风险因素的早期宫颈癌患者是否具有生存获益。本研究纳入了根据Wertheim-Okabayashi术式接受根治性子宫切除术和淋巴结清扫术的IB1-IIA2期宫颈癌患者。每位患者至少有一项中度风险因素,包括肿瘤直径≥4 cm、深层间质浸润和阳性淋巴管间隙浸润(LVSI)。根据最终石蜡切片有淋巴结转移、宫旁浸润和手术切缘阳性的患者被排除。总共纳入了183例患者。73例(39.9%)患者有一项中度风险因素,85例(46.4%)有两项,25例(13.7%)有三项中度风险因素。67例(36.6%)患者接受了辅助放疗。接受和未接受辅助放疗的两组患者在分期、LVSI以及子宫内膜/子宫浸润方面存在统计学显著差异(分别为P = 0.024、P = 0.018和P = 0.001)。通过倾向评分匹配(PSM)分析使这两组达到同质化。在新的匹配队列(n = 134)中,接受辅助放疗组的5年无病生存率(DFS)为89.5%,未接受辅助放疗组为82%(风险比:0.484,95%置信区间:[0.171 - 1.369];P = 0.171)。此外,接受辅助放疗与具有一项、两项或更多中度风险因素的患者的肿瘤学结局改善无关。在单因素分析中,没有风险因素与DFS相关。总之,辅助放疗对仅具有中度风险因素的早期宫颈癌患者的生存结局没有有利影响。

影响声明

当手术标本中发现高危因素——手术切缘阳性、淋巴结转移和宫旁受累时,宫颈癌根治术后放疗被视为标准治疗。然而,对于具有中度风险因素——深层间质浸润、阳性LVSI、肿瘤直径≥4 cm——的患者,辅助放疗的必要性存在争议。我们比较了接受辅助放疗和未接受辅助放疗的患者。两组在肿瘤学结局方面未发现显著差异。两组在盆腔和盆腔外复发率方面没有差异。中度风险因素阳性的数量不影响生存。此外,对于仅具有中度风险因素的IB-IIA期宫颈癌患者,年龄、肿瘤类型、分期、切除淋巴结数量、分级、双侧输卵管卵巢切除术以及子宫内膜/子宫浸润与DFS无关。对于具有中度风险因素的早期宫颈癌患者的预后因素和辅助治疗选择仍存在争议。如果对该患者群体进行了初始充分的手术,则可以不考虑辅助放疗。

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