{"title":"双周伊立替康加顺铂与单用伊立替康治疗先行或未行胃切除术的晚期胃癌二线疗效的差异。","authors":"Kazuhiro Nishikawa, Wasaburo Koizumi, Akira Tsuburaya, Motoko Suzuki, Satoshi Morita, Kazumasa Fujitani, Yusuke Akamaru, Ken Shimada, Hisashi Hosaka, Ken Nishimura, Takaki Yoshikawa, Toshimasa Tsujinaka, Junichi Sakamoto","doi":"10.1007/s10147-024-02661-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Biweekly irinotecan plus cisplatin combination therapy (BIRIP) and irinotecan monotherapy (IRI) are both expectable second-line chemotherapy (SLC) options for treating advanced gastric cancer (AGC). Although many patients receiving SLC have undergone gastrectomy, the impact of gastrectomy on SLC remains unclear, and the impact of gastrectomy may vary from regimen to regimen.</p><p><strong>Patients and methods: </strong>A total of 290 eligible patients registered in two randomized phase III trials evaluating BIRIP (IRI, 60 mg/m<sup>2</sup>; CDDP, 30 mg/m<sup>2</sup>, q2w) or IRI (150 mg/m<sup>2</sup>, q2w) for patients with AGC was classified into the prior gastrectomy subgroup (PGG) or the no gastrectomy subgroup (NGG). We performed a subgroup analysis to evaluate the impact of gastrectomy on second-line BIRIP and IRI.</p><p><strong>Results: </strong>The BIRIP demonstrated significantly longer OS (11.1 vs. 6.8 months; HR 0.64; P = 0.026) and PFS (3.7 vs. 2.3 months; HR 0.54; P = 0.003) than the IRI, as well as better ORR (23.5% vs. 7.1%, P = 0.046) and DCR (74.5% vs. 47.6%, P = 0.010) in NGG. Although in PGG, the BIRIP failed to demonstrate differences in OS (13.8 vs. 13.8 months; HR 0.94; P = 0.722), PFS (4.9 vs. 4.5 months; HR 0.82; P = 0.194), ORR (18.3% vs. 20.5%) and DCR (70.4% vs. 65.1%). The incidence of grade 3 or worse adverse events did not differ except for a high incidence of anemia in the BIRIP group in PGG.</p><p><strong>Conclusions: </strong>BIRIP was an effective treatment option that may improve survival outcomes among patients with AGC without previous gastrectomy.</p><p><strong>Clinical trial registration: </strong>UMIN000025367.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"320-329"},"PeriodicalIF":2.4000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan alone in second-line treatment of advanced gastric cancer with or without prior gastrectomy.\",\"authors\":\"Kazuhiro Nishikawa, Wasaburo Koizumi, Akira Tsuburaya, Motoko Suzuki, Satoshi Morita, Kazumasa Fujitani, Yusuke Akamaru, Ken Shimada, Hisashi Hosaka, Ken Nishimura, Takaki Yoshikawa, Toshimasa Tsujinaka, Junichi Sakamoto\",\"doi\":\"10.1007/s10147-024-02661-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Biweekly irinotecan plus cisplatin combination therapy (BIRIP) and irinotecan monotherapy (IRI) are both expectable second-line chemotherapy (SLC) options for treating advanced gastric cancer (AGC). Although many patients receiving SLC have undergone gastrectomy, the impact of gastrectomy on SLC remains unclear, and the impact of gastrectomy may vary from regimen to regimen.</p><p><strong>Patients and methods: </strong>A total of 290 eligible patients registered in two randomized phase III trials evaluating BIRIP (IRI, 60 mg/m<sup>2</sup>; CDDP, 30 mg/m<sup>2</sup>, q2w) or IRI (150 mg/m<sup>2</sup>, q2w) for patients with AGC was classified into the prior gastrectomy subgroup (PGG) or the no gastrectomy subgroup (NGG). We performed a subgroup analysis to evaluate the impact of gastrectomy on second-line BIRIP and IRI.</p><p><strong>Results: </strong>The BIRIP demonstrated significantly longer OS (11.1 vs. 6.8 months; HR 0.64; P = 0.026) and PFS (3.7 vs. 2.3 months; HR 0.54; P = 0.003) than the IRI, as well as better ORR (23.5% vs. 7.1%, P = 0.046) and DCR (74.5% vs. 47.6%, P = 0.010) in NGG. Although in PGG, the BIRIP failed to demonstrate differences in OS (13.8 vs. 13.8 months; HR 0.94; P = 0.722), PFS (4.9 vs. 4.5 months; HR 0.82; P = 0.194), ORR (18.3% vs. 20.5%) and DCR (70.4% vs. 65.1%). The incidence of grade 3 or worse adverse events did not differ except for a high incidence of anemia in the BIRIP group in PGG.</p><p><strong>Conclusions: </strong>BIRIP was an effective treatment option that may improve survival outcomes among patients with AGC without previous gastrectomy.</p><p><strong>Clinical trial registration: </strong>UMIN000025367.</p>\",\"PeriodicalId\":13869,\"journal\":{\"name\":\"International Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"320-329\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10147-024-02661-6\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/11/25 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10147-024-02661-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/25 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：双周伊立替康加顺铂联合疗法（BIRIP）和伊立替康单药疗法（IRI）都是治疗晚期胃癌（AGC）的二线化疗（SLC）方案。尽管许多接受SLC的患者都接受了胃切除术，但胃切除术对SLC的影响仍不明确，而且胃切除术的影响可能因治疗方案而异：在两项随机Ⅲ期试验中，共有290名符合条件的患者登记参加了评估BIRIP（IRI，60 mg/m2；CDDP，30 mg/m2，q2w）或IRI（150 mg/m2，q2w）治疗AGC患者的试验，这些患者被分为曾接受胃切除术亚组（PGG）或未接受胃切除术亚组（NGG）。我们进行了一项亚组分析，以评估胃切除术对二线BIRIP和IRI的影响：结果：在 NGG 中，BIRIP 的 OS（11.1 个月 vs. 6.8 个月；HR 0.64；P = 0.026）和 PFS（3.7 个月 vs. 2.3 个月；HR 0.54；P = 0.003）明显长于 IRI，ORR（23.5% vs. 7.1%，P = 0.046）和 DCR（74.5% vs. 47.6%，P = 0.010）也优于 IRI。尽管在 PGG 中，BIRIP 未显示出 OS（13.8 个月 vs. 13.8 个月；HR 0.94；P = 0.722）、PFS（4.9 个月 vs. 4.5 个月；HR 0.82；P = 0.194）、ORR（18.3% vs. 20.5%）和 DCR（70.4% vs. 65.1%）方面的差异。3级或更严重不良事件的发生率没有差异，只是在PGG中BIRIP组贫血发生率较高：BIRIP是一种有效的治疗方案，可改善既往未接受过胃切除术的AGC患者的生存预后：临床试验注册：UMIN000025367。
Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan alone in second-line treatment of advanced gastric cancer with or without prior gastrectomy.
Background: Biweekly irinotecan plus cisplatin combination therapy (BIRIP) and irinotecan monotherapy (IRI) are both expectable second-line chemotherapy (SLC) options for treating advanced gastric cancer (AGC). Although many patients receiving SLC have undergone gastrectomy, the impact of gastrectomy on SLC remains unclear, and the impact of gastrectomy may vary from regimen to regimen.
Patients and methods: A total of 290 eligible patients registered in two randomized phase III trials evaluating BIRIP (IRI, 60 mg/m2; CDDP, 30 mg/m2, q2w) or IRI (150 mg/m2, q2w) for patients with AGC was classified into the prior gastrectomy subgroup (PGG) or the no gastrectomy subgroup (NGG). We performed a subgroup analysis to evaluate the impact of gastrectomy on second-line BIRIP and IRI.
Results: The BIRIP demonstrated significantly longer OS (11.1 vs. 6.8 months; HR 0.64; P = 0.026) and PFS (3.7 vs. 2.3 months; HR 0.54; P = 0.003) than the IRI, as well as better ORR (23.5% vs. 7.1%, P = 0.046) and DCR (74.5% vs. 47.6%, P = 0.010) in NGG. Although in PGG, the BIRIP failed to demonstrate differences in OS (13.8 vs. 13.8 months; HR 0.94; P = 0.722), PFS (4.9 vs. 4.5 months; HR 0.82; P = 0.194), ORR (18.3% vs. 20.5%) and DCR (70.4% vs. 65.1%). The incidence of grade 3 or worse adverse events did not differ except for a high incidence of anemia in the BIRIP group in PGG.
Conclusions: BIRIP was an effective treatment option that may improve survival outcomes among patients with AGC without previous gastrectomy.
期刊介绍：
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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