Falconer Henrik, Norberg-Hardie Anna, Salehi Sahar, Alfonzo Emilia, Weydandt Laura, Dornhöfer Nadja, Wolf Benjamin, Höckel Michael, Aktas Bahriye
Department of Pelvic Cancer, Karolinska University Hospital and the Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.
EClinicalMedicine. 2024 Jun 20;73:102696. doi: 10.1016/j.eclinm.2024.102696. eCollection 2024 Jul.
According to international guidelines, standard treatment (ST) with curative intent in cervical cancer (CC) comprises radical hysterectomy and pelvic lymphadenectomy in early stages (International Federation of Gynecology and Obstetrics (FIGO) 2009 IB1, IIA1), adjuvant chemoradiation is recommended based on risk factors upon final pathology. Definitive chemoradiation is recommended in locally advanced stages (FIGO 2009 IB2, IIA2, IIB). Total mesometrial resection (TMMR) with therapeutic lymph node dissection (tLND) without adjuvant radiation has emerged as a promising treatment. Here we compare oncologic outcome by TMMR + tLND or ST.
In this observational cohort study, women treated according to international guidelines were identified in the population-based registries from Sweden and women treated with TMMR were identified in the Leipzig Mesometrial Resection (MMR) Study Database (DRKS 0001517) 2011-2020. Relevant clinical and tumour related variables were extracted. Recurrence-free survival (RFS) and overall survival (OS) by ST or TMMR was analysed with log-rank test, cumulative incidence function and proportional hazard regression yielding hazard ratios (HR) with 95% confidence intervals (CI), adjusted for relevant confounders.
Between 2011 and 2020, 1007 women were included in the final analysis. 733 women were treated according to ST and 274 with TMMR. RFS at five years was 77.9% (95% CI 74.3-81.1) and 82.6% (95% CI 77.2-86.9) for the ST and TMMR cohorts respectively (p = 0.053). In early-stage CC, RFS was higher after TMMR as compared to ST, 91.2% 81.8% (p = 0.002). In the adjusted analysis, TMMR was associated with a lower hazard of recurrence (HR 0.39; 95% CI 0.22-0.69) and death (HR 0.42; 95% CI 0.21-0.86) compared to ST. The absolute difference in risk of recurrence at 5 years was 9.4% (95% CI 3.2-15.7) in favor of TMMR. In locally advanced CC, no significant differences in RFS or OS was observed.
Compared to ST, TMMR without radiation therapy was associated with superior oncologic outcomes in women with early-stage cervical cancer whereas no difference was observed in locally advanced disease. Our findings together with previous evidence suggest that TMMR may be considered the primary option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment.
This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden).
根据国际指南，宫颈癌（CC）的根治性标准治疗（ST）包括早期（国际妇产科联盟（FIGO）2009年IB1、IIA1期）行根治性子宫切除术和盆腔淋巴结清扫术，根据最终病理结果的危险因素推荐辅助放化疗。局部晚期（FIGO 2009年IB2、IIA2、IIB期）推荐根治性放化疗。全子宫系膜切除术（TMMR）联合治疗性淋巴结清扫术（tLND）且不进行辅助放疗已成为一种有前景的治疗方法。在此，我们比较TMMR + tLND与ST的肿瘤学结局。
在这项观察性队列研究中，从瑞典基于人群的登记处确定按照国际指南接受治疗的女性，在莱比锡子宫系膜切除术（MMR）研究数据库（DRKS 0001517）中确定2011年至2020年接受TMMR治疗的女性。提取相关的临床和肿瘤相关变量。采用对数秩检验、累积发病率函数和比例风险回归分析ST或TMMR的无复发生存期（RFS）和总生存期（OS），得出风险比（HR）及95%置信区间（CI），并对相关混杂因素进行校正。
2011年至2020年，1007名女性纳入最终分析。733名女性接受ST治疗，274名接受TMMR治疗。ST组和TMMR组的5年RFS分别为77.9%（95%CI 74.3 - 81.1）和82.6%（95%CI 77.2 - 86.9）（p = 0.053）。在早期宫颈癌中，TMMR后的RFS高于ST，分别为91.2%和81.8%（p = 0.002）。在多因素分析中，与ST相比，TMMR与较低的复发风险（HR 0.39；95%CI 0.22 - 0.69）和死亡风险（HR 0.42；95%CI 0.21 - 0.86）相关。5年复发风险的绝对差异为9.4%（95%CI 3.2 - 15.7），有利于TMMR。在局部晚期宫颈癌中，未观察到RFS或OS的显著差异。
与ST相比，不进行放疗的TMMR在早期宫颈癌女性中具有更好的肿瘤学结局，而在局部晚期疾病中未观察到差异。我们的研究结果与先前的证据表明，TMMR可被视为局限于苗勒管区域的早期和局部晚期宫颈癌的主要选择。
本研究得到瑞典南曼兰临床研究中心和瑞典斯德哥尔摩地区的资助。
