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术前吉西他滨放化疗治疗肾功能不全的胰腺导管腺癌患者。

Preoperative chemoradiotherapy using gemcitabine for pancreatic ductal adenocarcinoma in patients with impaired renal function.

机构信息

Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan.

Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Ube, Japan.

出版信息

Cancer Chemother Pharmacol. 2020 Mar;85(3):537-545. doi: 10.1007/s00280-019-04005-y. Epub 2019 Dec 13.

DOI:10.1007/s00280-019-04005-y
PMID:31834436
Abstract

PURPOSE

Preoperative chemoradiotherapy (CRT) can be a promising treatment for pancreatic ductal adenocarcinoma (PDAC). However, its administration for patients with impaired renal function has not been well investigated, let alone its clinical effect. We previously reported preliminary feasibility of CRT in PDAC patients with renal impairment. Herein, we aimed to investigate the clinical effects of preoperative CRT including safety and long-term prognosis in more PDAC patients with renal impairment as an extension to our previous work.

METHODS

This study enrolled twenty patients harboring resectable PDAC with creatinine clearance level less than 60 ml/min. Patients underwent preoperative CRT with gemcitabine, followed by surgery. The clinical effects of the therapy were evaluated in terms of safety and long-term prognosis.

RESULTS

Preoperative CRT was completed in all 20 patients. Grade 4 leukopenia/neutropenia was identified as an observed toxicity in four cases (20.0%). Renal function was not worsened after CRT. After CRT, 17 cases were judged resectable and underwent laparotomy. Pancreatic resection was performed in 15 of the 17 patients; it was not performed in two patients because of peritoneal dissemination. The 1-/3-/5-year cumulative survival rate from the initiation of CRT for the 20 patients was 88.8%/45.5%/22.8%. In the 15 patients, renal function was not worsened after surgery.

CONCLUSION

Our findings suggest that the clinical effects of preoperative CRT would be favorable in PDAC patients with renal impairment.

摘要

目的

术前放化疗(CRT)可能是治疗胰腺导管腺癌(PDAC)的一种有前途的方法。然而,对于肾功能受损的患者,其应用尚未得到很好的研究,更不用说其临床效果了。我们之前曾报道过肾功能受损的 PDAC 患者接受 CRT 的初步可行性。在此,我们旨在研究术前 CRT 的临床效果,包括更多肾功能受损的 PDAC 患者的安全性和长期预后,这是我们之前工作的延伸。

方法

本研究纳入了 20 名肌酐清除率<60ml/min 的可切除 PDAC 患者。患者接受吉西他滨术前 CRT,然后进行手术。根据安全性和长期预后评估该疗法的临床效果。

结果

20 例患者均完成术前 CRT。4 例(20.0%)出现 4 级白细胞减少/中性粒细胞减少的观察毒性。CRT 后肾功能无恶化。CRT 后,17 例可判断为可切除,并接受剖腹手术。17 例患者中有 15 例行胰腺切除术;因腹膜扩散,2 例患者未行胰腺切除术。20 例患者从 CRT 开始的 1/3/5 年累积生存率分别为 88.8%/45.5%/22.8%。在 15 例患者中,手术后肾功能无恶化。

结论

我们的研究结果表明,术前 CRT 对肾功能受损的 PDAC 患者的临床效果可能是有利的。

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本文引用的文献

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A Prospective, Open-Label, Multicenter Phase 2 Trial of Neoadjuvant Therapy Using Full-Dose Gemcitabine and S-1 Concurrent with Radiation for Resectable Pancreatic Ductal Adenocarcinoma.一项新辅助治疗可切除胰腺导管腺癌的前瞻性、开放标签、多中心 2 期试验:使用全剂量吉西他滨和 S-1 联合放疗。
Ann Surg Oncol. 2019 Dec;26(13):4498-4505. doi: 10.1245/s10434-019-07735-8. Epub 2019 Aug 22.
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吉西他滨新辅助放化疗对比直接手术治疗边界可切除胰腺癌患者的肿瘤学获益:一项前瞻性、随机、开放标签、多中心 2/3 期试验。
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Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01).替吉奥对比吉西他滨用于可切除胰腺癌的辅助化疗:一项 III 期、开放标签、随机、非劣效性试验(JASPAC 01)。
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Feasibility of pre-operative chemoradiotherapy with gemcitabine to treat pancreatic cancer in patients with impaired renal function.吉西他滨术前放化疗治疗肾功能受损的胰腺癌患者的可行性
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