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术前 FOLFOX 治疗方案在不适合顺铂治疗的可切除食管鳞癌患者中的安全性和短期疗效。

Safety and short-term efficacy of preoperative FOLFOX therapy in patients with resectable esophageal squamous cell carcinoma who are ineligible for cisplatin.

机构信息

Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

Course of Advanced Clinical Research of Cancer, Juntendo University Graduate School of Medicine, Tokyo, Japan.

出版信息

Esophagus. 2023 Jan;20(1):109-115. doi: 10.1007/s10388-022-00951-4. Epub 2022 Sep 1.

Abstract

BACKGROUND

The standard preoperative treatment for resectable locally advanced esophageal squamous cell carcinoma (LAESCC) in Japan is docetaxel, cisplatin (CDDP), and 5-fluorouracil. However, patients with renal or cardiac dysfunction and elderly patients are ineligible for a CDDP-containing regimen because of toxicities. Oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) therapy has less renal toxicity than CDDP-containing regimens and does not require hydration. However, there are limited data on preoperative FOLFOX therapy in these patients.

METHODS

This retrospective study analyzed patients with resectable LAESCC who were aged ≥ 75 years or had renal or cardiac dysfunction and received preoperative FOLFOX between 2019 and 2021. FOLFOX was administered every 2 weeks for 3 or 4 cycles and was followed by surgery. Adverse events associated with chemotherapy, the complete resection (R0) rate, relative dose intensity (RDI), and histopathological response were evaluated.

RESULTS

Thirty-five patients were eligible. Median age was 77 (range 65-89) years; 68.6% were aged ≥ 75 years, 74.3% had renal dysfunction, and 17.1% had cardiac dysfunction. The RDI was 70.2% and 87.1% for bolus and continuous intravenous 5-fluorouracil, respectively and 85.2% for oxaliplatin. The most common grade ≥ 3 adverse events were neutropenia (60.0%) and leucopenia (28.6%). Two patients (5.7%) had febrile neutropenia and grade 3 pneumonia. Thirty-one patients underwent surgery. The R0 resection rate was 87.1%, and there was no histopathological evidence of residual tumor in 16.1%. There were no treatment-related deaths.

CONCLUSIONS

Preoperative FOLFOX had a manageable safety profile and showed favorable short-term efficacy in patients with resectable LAESCC who were ineligible for CDDP-containing treatment.

摘要

背景

在日本,可切除局部晚期食管鳞状细胞癌(LAESCC)的标准术前治疗是多西紫杉醇、顺铂(CDDP)和 5-氟尿嘧啶。然而,由于毒性作用,患有肾功能或心脏功能障碍的患者以及老年患者不符合含 CDDP 方案的条件。奥沙利铂、亚叶酸和 5-氟尿嘧啶(FOLFOX)治疗比含 CDDP 方案的肾毒性更小,且不需要水化。然而,关于这些患者的术前 FOLFOX 治疗的数据有限。

方法

本回顾性研究分析了 2019 年至 2021 年间接受术前 FOLFOX 治疗的可切除 LAESCC 患者,这些患者年龄≥75 岁或患有肾功能或心脏功能障碍。FOLFOX 每 2 周给药 3 或 4 个周期,然后进行手术。评估与化疗相关的不良事件、完全切除(R0)率、相对剂量强度(RDI)和组织病理学反应。

结果

35 名患者符合条件。中位年龄为 77(范围 65-89)岁;68.6%的患者年龄≥75 岁,74.3%的患者有肾功能障碍,17.1%的患者有心脏功能障碍。FOLFOX 中 5-氟尿嘧啶的推注和持续静脉滴注 RDI 分别为 70.2%和 87.1%,奥沙利铂的 RDI 为 85.2%。最常见的≥3 级不良事件是中性粒细胞减少(60.0%)和白细胞减少(28.6%)。有 2 名患者(5.7%)出现发热性中性粒细胞减少和 3 级肺炎。31 名患者接受了手术。R0 切除率为 87.1%,16.1%的患者无残留肿瘤的组织病理学证据。没有与治疗相关的死亡。

结论

术前 FOLFOX 具有良好的安全性,在不适合含 CDDP 治疗的可切除 LAESCC 患者中显示出良好的短期疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58d5/9813081/de235e099189/10388_2022_951_Fig1_HTML.jpg

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