Short-term outcomes of preoperative chemotherapy with docetaxel, oxaliplatin, and S-1 for gastric cancer with extensive lymph node metastasis (JCOG1704).

IF 6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gastric Cancer Pub Date : 2024-03-01 Epub Date: 2024-01-05 DOI:10.1007/s10120-023-01453-7
Yukinori Kurokawa, Yuichiro Doki, Ryo Kitabayashi, Takaki Yoshikawa, Takashi Nomura, Kunihiro Tsuji, Masahiro Goto, Haruhiko Cho, Jun Hihara, Naoki Hiki, Souya Nunobe, Junki Mizusawa, Narikazu Boku, Masanori Terashima
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引用次数: 0

Abstract

Background: The prognosis for marginally resectable gastric cancer with extensive lymph node metastasis (ELM) remains unfavorable, even after R0 resection. To assess the safety and efficacy of preoperative docetaxel, oxaliplatin, and S-1 (DOS), we conducted a multicenter phase II trial.

Methods: Eligibility criteria included histologically proven HER2-negative gastric adenocarcinoma with bulky nodal (bulky N) involvement around major branched arteries or para-aortic node (PAN) metastases. Patients received three cycles of docetaxel (40 mg/m2, day 1), oxaliplatin (100 mg/m2, day 1), and S-1 (80-120 mg/body, days 1-14), followed by gastrectomy with D2 plus PAN dissection. Subsequently, patients underwent postoperative chemotherapy with S-1 for 1 year. The primary endpoint was major (grade ≥ 2a) pathological response rate (pRR) according to the Japanese Classification of Gastric Carcinoma criteria.

Results: Between October 2018 and March 2022, 47 patients (bulky N, 20; PAN, 17; both, 10) were enrolled in the trial. One patient was ineligible. Another declined any protocol treatments before initiation. Among the 45 eligible patients who initiated DOS chemotherapy, 44 (98%) completed 3 cycles and 42 (93%) underwent R0 resection. Major pRR and pathological complete response rates among the 46 eligible patients, including the patient who declined treatment, were 57% (26/46) and 24% (11/46), respectively. Common grade 3 or 4 toxicities were neutropenia (24%), anorexia (16%), febrile neutropenia (9%), and diarrhea (9%). No treatment-related deaths occurred.

Conclusions: Preoperative chemotherapy with DOS yielded favorable pathological responses with an acceptable toxicity profile. This multimodal approach is highly promising for treating gastric cancer with ELM.

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多西他赛、奥沙利铂和 S-1 术前化疗治疗广泛淋巴结转移的胃癌的短期疗效(JCOG1704)。
背景:即使进行了R0切除,伴有广泛淋巴结转移(ELM)的可微切除胃癌的预后仍然不佳。为了评估术前多西他赛、奥沙利铂和 S-1(DOS)的安全性和有效性,我们开展了一项多中心 II 期试验:入选标准包括经组织学证实的HER2阴性胃腺癌,且主要分支动脉周围或主动脉旁结节(PAN)转移累及大结节(bulky N)。患者接受三个周期的多西他赛(40 毫克/平方米,第 1 天)、奥沙利铂(100 毫克/平方米,第 1 天)和 S-1(80-120 毫克/体,第 1-14 天)治疗,然后进行 D2 加 PAN 切开的胃切除术。随后,患者接受为期一年的S-1术后化疗。根据日本胃癌分类标准,主要终点为主要(≥2a级)病理反应率(pRR):2018年10月至2022年3月期间,47名患者(大块N型20人;PAN型17人;两者均为10人)入组试验。一名患者不符合条件。另一名患者在开始治疗前拒绝接受任何方案治疗。在 45 名符合条件并开始 DOS 化疗的患者中,44 人(98%)完成了 3 个周期的治疗,42 人(93%)接受了 R0 切除术。包括一名拒绝治疗的患者在内,46名符合条件的患者的主要pRR和病理完全反应率分别为57%(26/46)和24%(11/46)。常见的3级或4级毒性反应为中性粒细胞减少(24%)、厌食(16%)、发热性中性粒细胞减少(9%)和腹泻(9%)。没有发生与治疗相关的死亡病例:使用DOS进行术前化疗可获得良好的病理反应,且毒性可接受。这种多模式方法在治疗ELM胃癌方面前景广阔。
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来源期刊
Gastric Cancer
Gastric Cancer 医学-胃肠肝病学
CiteScore
14.70
自引率
2.70%
发文量
80
审稿时长
6-12 weeks
期刊介绍: Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.
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