Figo IV 卵巢癌初次细胞减灭术与间期细胞减灭术 (SOFI-4) 的生存结果:全国范围内基于人群的目标试验模拟。
Survival Outcomes of Primary versus Interval Cytoreductive Surgery for FIGO IV Ovarian Cancer (SOFI-4): a Nationwide Population-based Target Trial Emulation.
发表日期:2024 Aug 05
作者:
Floriane Jochum, Élise Dumas, Paul Gougis, Anne-Sophie Hamy, Denis Querleu, Lise Lecointre, Thomas Gaillard, Fabien Reyal, Fabrice Lecuru, Enora Laas, Cherif Akladios
来源:
Am J Obstet Gynecol
摘要:
初次细胞减灭手术与间期细胞减灭手术对FIGO IV卵巢癌结局的影响仍不确定,并且可能因分期和腹膜外转移位置而异。通过因果评估结合倾向评分调整来模拟目标试验已成为使用观察数据评估干预措施的主要方法。使用目标试验评估初次细胞减灭术与间期细胞减灭术对FIGO IV卵巢癌患者无进展生存期和总生存期的影响利用综合的法国国家健康保险数据库,我们模拟了一项目标试验,以探讨初次与间期细胞减灭术对FIGO IV卵巢癌预后的因果影响(卵巢癌手术FIGO 4:SOFI-4)。使用具有审查权重逆概率的克隆方法来调整信息审查并平衡各组之间的基线特征。根据FIGO分期和腹膜外转移部位进行亚组分析。该研究纳入了2014年1月1日至2022年12月31日期间被诊断患有FIGO IV卵巢癌的75岁以下、健康状况良好的患者。主要和次要结局分别是五年无进展生存期和七年无进展生存期。年总生存期。在该研究纳入的 2,772 名患者中,948 名患者 (34.2%) 在纳入时被归类为 Figo IVA,1,824 名患者 (65.8%) 被归类为 Figo IVB。 1,182 名患者(42.6%)接受了初次细胞减灭术,1,590 名患者(57.4%)接受了间期细胞减灭术。初次细胞减灭术的中位进展生存期为 19.7 个月(四分位距 [IQR]:19.3-20.1),而接受间隔细胞减灭术的患者的中位进展生存期为 15.7 个月(IQR:15.7-16.1)。初次细胞减灭术的中位总生存期为 63.1 个月 [IQR:61.7-65.4],而间隔细胞减灭术的中位总生存期为 55.6 个月 [IQR:53.8-56.3]。我们的研究结果表明,初次肿瘤细胞减灭术与五年无进展生存期延长 5.0 个月相关(95% 置信区间 [CI]:3.8-6.2),七年总体生存期延长 3.9 个月生存率(95% CI:1.9-6.2)。在FIGO IVA 和IVB 亚组中均观察到初次间期细胞减灭术的这些生存获益。对于胸膜、膈上或腹外淋巴结转移的患者,初次细胞减灭术显示出改善的无进展生存率和总生存率。SOFI-4 主张对于FIGO IV 卵巢患者,初次细胞减灭术优于间期细胞减灭术。癌症,表明腹膜外转移(如膈上或腹外淋巴结)不应自动排除合适患者的初次细胞减灭手术考虑。版权所有 © 2024。由 Elsevier Inc. 出版。
The effect of primary cytoreductive surgery versus interval cytoreductive surgery on FIGO IV ovarian cancer outcomes remains uncertain, and may vary depending on the stage and the extraperitoneal metastasis location. Emulating target trials through causal assessment combined with propensity score adjustment has become a leading method for evaluating interventions using observational data.To assess the effect of primary versus interval cytoreductive surgery on progression-free and overall survival in patients with FIGO IV ovarian cancer using target trial emulation.Utilizing the comprehensive French national health insurance database, we emulated a target trial to explore primary versus interval cytoreductive surgery causal impacts on FIGO IV ovarian cancer prognosis (Surgery for Ovarian cancer FIGO 4: SOFI-4). The clone method with inverse probability of censoring weighting was used to adjust for informative censoring and balance baseline characteristics between the groups. Subgroup analyses were conducted based on FIGO stages and extraperitoneal metastasis locations. The study included patients under 75 years of age, in good health condition, diagnosed with FIGO IV ovarian cancer between January 1, 2014, and December 31, 2022. The primary and secondary outcomes were respectively five-year progression-free survival and seven-year overall survival.Among the 2,772 patients included in the study, 948 (34.2%) were classified as FIGO IVA and 1,824 (65.8%) as FIGO IVB at inclusion. Primary cytoreductive surgery was performed on 1,182 patients (42.6%), while interval cytoreductive surgery was conducted on 1,590 patients (57.4%). The median progression survival for primary cytoreductive surgery was 19.7 months (interquartile range [IQR]: 19.3-20.1), compared to 15.7 months (IQR: 15.7-16.1) for those who underwent interval cytoreductive surgery. The median overall survival was 63.1 months [IQR: 61.7-65.4] for primary cytoreductive surgery, in comparison to 55.6 months [IQR: 53.8-56.3] for interval cytoreductive surgery. The findings of our study indicate that primary cytoreductive surgery is associated with a 5.0-month increase in five-year progression-free survival (95% Confidence Intervals [CI]: 3.8-6.2) and a 3.9-month increase in seven-year overall survival (95% CI: 1.9-6.2). These survival benefits of primary over interval cytoreductive surgery were observed in both the FIGO IVA and IVB subgroups. Primary cytoreductive surgery demonstrated improved progression-free survival and overall survival in patients with pleural, supra-diaphragmatic, or extra-abdominal lymph node metastasis.SOFI-4 advocates for the benefits of primary cytoreductive surgery over interval cytoreductive surgery for patients with FIGO IV ovarian cancer, suggesting extraperitoneal metastases like supra-diaphragmatic or extra-abdominal lymph nodes should not automatically preclude primary cytoreductive surgery consideration in suitable patients.Copyright © 2024. Published by Elsevier Inc.