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多西他赛、顺铂和氟尿嘧啶联合方案对比双药化疗作为晚期鳞状肛管癌一线治疗的多中心倾向评分匹配研究

DCF versus doublet chemotherapy as first-line treatment of advanced squamous anal cell carcinoma: a multicenter propensity score-matching study.

作者信息

Kim Stefano, Vendrely Véronique, Saint Angélique, André Thierry, Vaflard Pauline, Samalin Emmanuelle, Pernot Simon, Bouché Oliver, Zubir Mustapha, Desrame Jérôme, de la Fouchardière Christelle, Smith Denis, Ghiringhelli François, Vienot Angélique, Jacquin Marion, Klajer Elodie, Nguyen Thierry, François Éric, Taieb Julien, Le Malicot Karine, Vernerey Dewi, Meurisse Aurélia, Borg Christophe

机构信息

Clinical Investigational Center, INSERM CIC-1431, Centre Hospitalier Universitaire de Besançon, Besançon, France.

INSERM Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.

出版信息

Exp Hematol Oncol. 2023 Jul 21;12(1):63. doi: 10.1186/s40164-023-00413-2.

Abstract

Triplet DCF (docetaxel, cisplatin and 5-flurouracil) and doublet CP/CF (carboplatin and paclitaxel/cisplatin and 5-fluorouracil) regimens were prospectively evaluated in advanced squamous anal cell carcinoma (SCCA), and validated as standard treatments. Even though the high efficacy and good tolerance of DCF regimen were confirmed in 3 independent prospective trials, doublet CP regimen is still recommended in several guidelines based in its better safety profile with similar efficacy compared to CF regimen. We performed a propensity score-adjusted method with inverse probability of treatment weighted (IPTW) and matched case control (MCC) comparison among patients with metastatic or non-resectable locally advanced recurrent SCCA, treated with chemotherapy as first line regimen. The primary endpoint was the overall survival (OS), and the secondary endpoint was the progression-free survival (PFS). 247 patients were included for analysis. 154 patients received DCF and 93 patients received a doublet regimen. The median OS was 32.3 months with DCF and 18.3 months with doublet regimens (HR 0.53, 95%CI 0.38-0.74; p = 0.0001), and the median PFS was 11.2 months with DCF versus 7.6 months with doublet regimens (HR 0.53, 95%CI 0.39-0.73; p < 0.0001). The hazard ratios by IPTW and MCC analyses were 0.411 (95% CI, 0.324-0.521; p < 0.0001) and 0.406 (95% CI, 0.261-0.632; p < 0.0001) for OS, and 0.466 (95% CI, 0.376-0.576; p < 0.0001) and 0.438 (95% CI, 0.298-0.644; P < 0.0001) for PFS. The triplet DCF regimen provides a high and significant benefit in OS and PFS over doublet regimens, and should be considered as upfront treatment for eligible patients with advanced SCCA.

摘要

三联体DCF(多西他赛、顺铂和5-氟尿嘧啶)和双联体CP/CF(卡铂和紫杉醇/顺铂和5-氟尿嘧啶)方案在晚期鳞状肛管癌(SCCA)中进行了前瞻性评估,并被确认为标准治疗方案。尽管DCF方案的高效性和良好耐受性在3项独立的前瞻性试验中得到了证实,但由于双联体CP方案与CF方案疗效相似但安全性更好,因此在一些指南中仍被推荐。我们采用倾向评分调整方法,对接受化疗作为一线方案的转移性或不可切除的局部晚期复发性SCCA患者进行了逆概率加权处理(IPTW)和匹配病例对照(MCC)比较。主要终点是总生存期(OS),次要终点是无进展生存期(PFS)。纳入247例患者进行分析。154例患者接受DCF方案,93例患者接受双联体方案。DCF方案组的中位OS为32.3个月,双联体方案组为18.3个月(风险比0.53,95%置信区间为0.38-0.74;p = 0.0001),DCF方案组的中位PFS为11.2个月,双联体方案组为7.6个月(风险比0.53,95%置信区间为0.39-0.73;p < 0.0001)。通过IPTW和MCC分析得出的OS风险比分别为0.411(95%置信区间为0.324-0.521;p < 0.0001)和0.406(95%置信区间为0.261-0.632;p < 0.0001),PFS风险比分别为0.466(95%置信区间为0.376-0.576;p < 0.0001)和0.438(95%置信区间为0.298-0.644;p < 0.0001)。三联体DCF方案在OS和PFS方面比双联体方案具有显著更高的获益,对于符合条件的晚期SCCA患者应考虑作为一线治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b0f6/10362607/c4bec61ae1cf/40164_2023_413_Fig1_HTML.jpg

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