{"title":"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)。","authors":"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","doi":"10.1007/s10120-023-01453-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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/m<sup>2</sup>, day 1), oxaliplatin (100 mg/m<sup>2</sup>, 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":null,"pages":null},"PeriodicalIF":6.0000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10896774/pdf/","citationCount":"0","resultStr":"{\"title\":\"Short-term outcomes of preoperative chemotherapy with docetaxel, oxaliplatin, and S-1 for gastric cancer with extensive lymph node metastasis (JCOG1704).\",\"authors\":\"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\",\"doi\":\"10.1007/s10120-023-01453-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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/m<sup>2</sup>, day 1), oxaliplatin (100 mg/m<sup>2</sup>, 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":12684,\"journal\":{\"name\":\"Gastric Cancer\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.0000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10896774/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gastric Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10120-023-01453-7\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/5 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastric Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10120-023-01453-7","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/5 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
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。
Short-term outcomes of preoperative chemotherapy with docetaxel, oxaliplatin, and S-1 for gastric cancer with extensive lymph node metastasis (JCOG1704).
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.
期刊介绍:
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