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多西他赛、顺铂和5-氟尿嘧啶新辅助治疗局部晚期食管鳞状细胞癌的真实世界安全性和疗效

Real-world safety and efficacy of neoadjuvant docetaxel, cisplatin, and 5-fluorouracil therapy for locally advanced esophageal squamous cell carcinoma.

作者信息

Tamba Mikako, Osumi Hiroki, Ogura Mariko, Fukuoka Shota, Okamura Akihiko, Kanamori Jun, Imamura Yu, Yoshino Koichiro, Udagawa Shohei, Wakatsuki Takeru, Shinozaki Eiji, Watanabe Masayuki, Yamaguchi Kensei, Chin Keisho, Ooki Akira

机构信息

Department of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.

出版信息

BMC Cancer. 2025 Apr 8;25(1):636. doi: 10.1186/s12885-025-14011-4.

Abstract

BACKGROUND

Neoadjuvant chemotherapy with docetaxel, cisplatin plus 5-FU (DCF) has become the new standard of care for locally advanced esophageal squamous cell carcinoma (ESCC). In a real-world setting, the efficacy, recurrence, and adverse events (AEs) remain unclear.

METHODS

This retrospective cohort study included 86 patients who received neoadjuvant DCF followed by esophagectomy for resectable ESCC.

RESULTS

Following neoadjuvant DCF treatment, 75 patients underwent R0 curative resection. At the median follow-up of 19.2 months, the median disease-free survival (DFS)/recurrence-free survival (RFS) was not yet reached, with estimated 3-year DFS/RFS rates of 65.2%, respectively. The incidence of primary tumor regression grading (TRG) grade 1a and pathological complete response (pCR) were 21.3% (16/75) and 14.7% (11/75), respectively. The estimated 1-year DFS/RFS rates were 93.8% for primary TRG grade 1a and 100% for pCR. Baseline elevated serum SCC-antigen levels were inversely associated with achieving primary TRG grade 1a or pCR. In 64 patients who did not achieve pCR, residual tumor cells in the lymph nodes (ypN; HR, 16.96; 95% CI, 2.11-136.12; P < 0.01) and Glasgow prognostic score (GPS; HR, 8.34; 95% CI, 1.73-40.31; P < 0.01) were independent predictors of shorter DFS/RFS. The most common grade ≥ 3 AEs were neutropenia (61.6%) and febrile neutropenia (26.7%), which were not associated with clinicopathological factors. The most common non-hematological AEs were appetite loss (9.3%), pulmonary embolism (8.1%), diarrhea (7.0%), and nausea (2.3%). Nine patients discontinued neoadjuvant DCF due to toxicities.

CONCLUSIONS

Neoadjuvant DCF was effective and well-tolerated in real-world ESCC patients. Primary TRG grade 1a or pCR showed a favorable DFS/RFS, while positive ypN and GPS were independent risk factors for worse DFS/RFS.

摘要

背景

多西他赛、顺铂联合5-氟尿嘧啶(DCF)的新辅助化疗已成为局部晚期食管鳞状细胞癌(ESCC)的新治疗标准。在实际临床环境中,其疗效、复发情况及不良事件(AE)仍不明确。

方法

这项回顾性队列研究纳入了86例接受新辅助DCF治疗后行食管切除术的可切除ESCC患者。

结果

新辅助DCF治疗后,75例患者接受了R0根治性切除。在中位随访19.2个月时,中位无病生存期(DFS)/无复发生存期(RFS)尚未达到,估计3年DFS/RFS率分别为65.2%。原发肿瘤退缩分级(TRG)1a级和病理完全缓解(pCR)的发生率分别为21.3%(16/75)和14.7%(11/75)。原发TRG 1a级的估计1年DFS/RFS率为93.8%,pCR为100%。基线血清鳞状细胞癌抗原水平升高与达到原发TRG 1a级或pCR呈负相关。在64例未达到pCR的患者中,淋巴结残留肿瘤细胞(ypN;HR,16.96;95%CI,2.11 - 136.12;P < 0.01)和格拉斯哥预后评分(GPS;HR,8.34;95%CI,1.73 - 40.31;P < 0.01)是DFS/RFS缩短的独立预测因素。最常见的≥3级AE为中性粒细胞减少(61.6%)和发热性中性粒细胞减少(26.7%),与临床病理因素无关。最常见的非血液学AE为食欲减退(9.3%)、肺栓塞(8.1%)、腹泻(7.0%)和恶心(2.3%)。9例患者因毒性反应中断新辅助DCF治疗。

结论

新辅助DCF在实际临床ESCC患者中有效且耐受性良好。原发TRG 1a级或pCR显示出良好的DFS/RFS,而ypN阳性和GPS是DFS/RFS较差的独立危险因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07db/11980314/98299d2d1306/12885_2025_14011_Fig1_HTML.jpg

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