摘要 PO3-19-01:乳腺癌寡转移灶转移导向疗法随机对照试验(OLIGAMI 试验;JCOG2110)

IF 3.4 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Toshiyuki Ishiba, I. Nishibuchi, Fumitaka Hara, K. Sasaki, Ryo Sadate, Y. Sekino, R. Machida, Haruhiko Fukuda, Takahiro Kogawa, T. Fujisawa, Y. Sagara, Yoichi Naito, Kaori Terata, Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, C. Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, K. Tamura, Takashi Mizowaki, Michio Yoshimura, N. Shikama, T. Shien, Hiroji Iwata
{"title":"摘要 PO3-19-01:乳腺癌寡转移灶转移导向疗法随机对照试验(OLIGAMI 试验;JCOG2110)","authors":"Toshiyuki Ishiba, I. Nishibuchi, Fumitaka Hara, K. Sasaki, Ryo Sadate, Y. Sekino, R. Machida, Haruhiko Fukuda, Takahiro Kogawa, T. Fujisawa, Y. Sagara, Yoichi Naito, Kaori Terata, Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, C. Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, K. Tamura, Takashi Mizowaki, Michio Yoshimura, N. Shikama, T. Shien, Hiroji Iwata","doi":"10.1158/1538-7445.sabcs23-po3-19-01","DOIUrl":null,"url":null,"abstract":"\n Background: Oligometastases were initially described as a concept bridging localized disease with widespread distant metastases, but a consensus on its definition has yet to be reached. Recently, the term \"metastasis-directed therapy\" (MDT) was coined to encompass local therapy for distant metastases, including surgery and radiation therapy (RT), especially stereotactic body radiation therapy (SBRT). Though OLIGO-BC1 and SABR-COMET have indicated the potential benefits of MDT for oligometastases, NRG-BR002 revealed no significant difference in progression-free survival (PFS). As a definitive conclusion to this clinical question has not been reached, there is an increasing demand for phase III trials focusing on breast cancer (BC). We planned the JCOG2110, also called as OLIGAMI trial . Design: OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negative BC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy dose not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT. Eligibility criteria: OLIGAMI trial will encompass all subtypes of advanced BC. The key criteria of the first registration are as follows: 1) Histologically diagnosed as invasive BC. Biopsy from oligometastases is desirable but not required. 2) Diagnosed with advanced BC with oligometastases by neck to pelvis enhanced CT, FDG-PET, and brain enhanced MRI. 3) Oligometastases defined as: (i) Maximum diameter of each tumor is 3 cm or less. (ii) Total number of 3 or less. (iii) In case of brain metastasis, maximum diameter is 2 cm or less and asymptomatic. 4) The patient with local recurrence is included. 5) De novo stage IV BC is included. The criteria of secondary registration are as follows: 1) The planned number of courses of systemic therapy has been performed. 2) No progression or new distant metastasis by response evaluation. 3) At least one oligometastaseis remains. Specific Aims: OLIGAMI trial aims to confirm the superiority of MDT to systemic therapy for oligometastases of BC. The primary endpoint is overall survival (OS) after randomization, while the secondary endpoints include OS after first registration, PFS, progression site (oligometastases vs. non-oligometastases), PFS specifically related to MDT (restricted arm B), proportion of adverse events and serious adverse events, and the non-progression proportion of health-related quality of life. Statistical methods: The sample size was calculated as 268 to detect 12% of 5-year OS difference with one-sided alpha of 0.05, power of 70%, 3 years of accrual, and 5 years of follow up. Therefore, we assumed the planned sample size for second registration for randomization as 270. We set the number of first registration as 340, assuming that there may be some patients with progression or complete response after the systemic therapy for 12 weeks. Present accrual and target accrual: The patient accrual will start in August 2023. Enrolment of 340 patients for first registration is planned over a 3-year accrual period. Contact information: Principal investigator, Toshiyuki Ishiba, MD. Ph.D. ishiba0313@gmail.com\n Citation Format: Toshiyuki Ishiba, Ikuno Nishibuchi, Fumitaka Hara, Keita Sasaki, Ryo Sadate, Yuta Sekino, Ryunosuke Machida, Haruhiko Fukuda, Takahiro Kogawa, Tomomi Fujisawa, Yasuaki Sagara, Yoichi Naito, Kaori Terata, Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, Chizuko Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, Kenji Tamura, Takashi Mizowaki, Michio Yoshimura, Naoto Shikama, Tadahiko Shien, Hiroji Iwata. A Randomized Controlled Trial of Metastasis-directed Therapy for Oligometastases in Breast Cancer (OLIGAMI trial; JCOG2110) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-01.","PeriodicalId":12,"journal":{"name":"ACS Chemical Health & Safety","volume":"12 15","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Abstract PO3-19-01: A Randomized Controlled Trial of Metastasis-directed Therapy for Oligometastases in Breast Cancer (OLIGAMI trial; JCOG2110)\",\"authors\":\"Toshiyuki Ishiba, I. Nishibuchi, Fumitaka Hara, K. Sasaki, Ryo Sadate, Y. Sekino, R. Machida, Haruhiko Fukuda, Takahiro Kogawa, T. Fujisawa, Y. Sagara, Yoichi Naito, Kaori Terata, Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, C. Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, K. Tamura, Takashi Mizowaki, Michio Yoshimura, N. Shikama, T. Shien, Hiroji Iwata\",\"doi\":\"10.1158/1538-7445.sabcs23-po3-19-01\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n Background: Oligometastases were initially described as a concept bridging localized disease with widespread distant metastases, but a consensus on its definition has yet to be reached. Recently, the term \\\"metastasis-directed therapy\\\" (MDT) was coined to encompass local therapy for distant metastases, including surgery and radiation therapy (RT), especially stereotactic body radiation therapy (SBRT). Though OLIGO-BC1 and SABR-COMET have indicated the potential benefits of MDT for oligometastases, NRG-BR002 revealed no significant difference in progression-free survival (PFS). As a definitive conclusion to this clinical question has not been reached, there is an increasing demand for phase III trials focusing on breast cancer (BC). We planned the JCOG2110, also called as OLIGAMI trial . Design: OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negative BC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy dose not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT. Eligibility criteria: OLIGAMI trial will encompass all subtypes of advanced BC. The key criteria of the first registration are as follows: 1) Histologically diagnosed as invasive BC. Biopsy from oligometastases is desirable but not required. 2) Diagnosed with advanced BC with oligometastases by neck to pelvis enhanced CT, FDG-PET, and brain enhanced MRI. 3) Oligometastases defined as: (i) Maximum diameter of each tumor is 3 cm or less. (ii) Total number of 3 or less. (iii) In case of brain metastasis, maximum diameter is 2 cm or less and asymptomatic. 4) The patient with local recurrence is included. 5) De novo stage IV BC is included. The criteria of secondary registration are as follows: 1) The planned number of courses of systemic therapy has been performed. 2) No progression or new distant metastasis by response evaluation. 3) At least one oligometastaseis remains. Specific Aims: OLIGAMI trial aims to confirm the superiority of MDT to systemic therapy for oligometastases of BC. The primary endpoint is overall survival (OS) after randomization, while the secondary endpoints include OS after first registration, PFS, progression site (oligometastases vs. non-oligometastases), PFS specifically related to MDT (restricted arm B), proportion of adverse events and serious adverse events, and the non-progression proportion of health-related quality of life. Statistical methods: The sample size was calculated as 268 to detect 12% of 5-year OS difference with one-sided alpha of 0.05, power of 70%, 3 years of accrual, and 5 years of follow up. Therefore, we assumed the planned sample size for second registration for randomization as 270. We set the number of first registration as 340, assuming that there may be some patients with progression or complete response after the systemic therapy for 12 weeks. Present accrual and target accrual: The patient accrual will start in August 2023. Enrolment of 340 patients for first registration is planned over a 3-year accrual period. Contact information: Principal investigator, Toshiyuki Ishiba, MD. Ph.D. ishiba0313@gmail.com\\n Citation Format: Toshiyuki Ishiba, Ikuno Nishibuchi, Fumitaka Hara, Keita Sasaki, Ryo Sadate, Yuta Sekino, Ryunosuke Machida, Haruhiko Fukuda, Takahiro Kogawa, Tomomi Fujisawa, Yasuaki Sagara, Yoichi Naito, Kaori Terata, Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, Chizuko Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, Kenji Tamura, Takashi Mizowaki, Michio Yoshimura, Naoto Shikama, Tadahiko Shien, Hiroji Iwata. A Randomized Controlled Trial of Metastasis-directed Therapy for Oligometastases in Breast Cancer (OLIGAMI trial; JCOG2110) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-01.\",\"PeriodicalId\":12,\"journal\":{\"name\":\"ACS Chemical Health & Safety\",\"volume\":\"12 15\",\"pages\":\"\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-05-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Chemical Health & Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1158/1538-7445.sabcs23-po3-19-01\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Chemical Health & Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1158/1538-7445.sabcs23-po3-19-01","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0

摘要

背景:寡转移瘤最初被描述为连接局部疾病和广泛远处转移的一个概念,但对其定义尚未达成共识。最近,"转移灶导向治疗"(MDT)一词被创造出来,以涵盖远处转移的局部治疗,包括手术和放射治疗(RT),尤其是立体定向体放射治疗(SBRT)。虽然 OLIGO-BC1 和 SABR-COMET 表明 MDT 对少转移灶具有潜在的益处,但 NRG-BR002 显示无进展生存期(PFS)没有显著差异。由于对这一临床问题尚未得出明确结论,因此对以乳腺癌(BC)为重点的 III 期试验的需求日益增加。我们计划开展 JCOG2110 试验,也称为 OLIGAMI 试验。设计:OLIGAMI 试验是一项多机构、双臂、开放标签、随机对照的 III 期试验,由日本临床肿瘤学组的 50 家医院参与。首次登记后,所有患者都将接受为期12周的亚型特异性全身治疗,其中包括CDK4/6抑制剂联合激素治疗治疗管腔型BC;多西他赛联合曲妥珠单抗和pertuzumab治疗HER2阳性BC;化疗联合免疫检查点抑制剂治疗表达PD-L1的三阴性BC;奥拉帕利治疗携带BRCA突变的病例。对于其他三阴性 BC,将进行化疗。如果为期12周的系统治疗未导致任何进展或完全反应,患者将进入第二次注册,进行随机分组;A组继续单独接受相同的系统治疗,B组进行MDT,然后接受相同的系统治疗。MDT 将包括 RT 或手术,RT 将主要包括 SBRT,部分包括传统 RT。资格标准:OLIGAMI 试验将包括晚期 BC 的所有亚型。首次登记的主要标准如下:1) 经组织学诊断为浸润性 BC。最好能对少转移灶进行活检,但并非必需。2) 通过颈部至盆腔增强 CT、FDG-PET 和脑增强 MRI 诊断为伴有寡转移灶的晚期 BC。3) 寡转移灶定义为(i) 每个肿瘤的最大直径为 3 厘米或以下。(ii) 肿瘤总数为 3 个或 3 个以下。(iii)脑转移瘤的最大直径为 2 厘米或以下,且无症状。4)包括局部复发的患者。5)包括新发的 IV 期 BC。二次登记的标准如下1) 已完成计划疗程数的系统治疗。2) 通过反应评估无进展或新的远处转移。3) 至少仍有一个寡转移灶。具体目标:OLIGAMI 试验旨在证实 MDT 治疗 BC 少转移灶优于全身治疗。主要终点是随机化后的总生存期(OS),次要终点包括首次登记后的OS、PFS、进展部位(寡转移灶与非寡转移灶)、与MDT特别相关的PFS(限制性B臂)、不良事件和严重不良事件的比例以及健康相关生活质量的非进展比例。统计方法:样本量的计算方法是:在单侧α为 0.05、功率为 70%、累积时间为 3 年、随访时间为 5 年的条件下,268 个样本可检测到 12% 的 5 年 OS 差异。因此,我们假定第二次随机登记的计划样本量为 270 例。我们将首次登记的人数设定为 340 人,假定可能有一些患者在接受系统治疗 12 周后病情进展或完全应答。目前的累积和目标累积:患者注册将于 2023 年 8 月开始。计划在 3 年的注册期内招募 340 名患者进行首次注册。联系信息:主要研究者:Toshiyuki Ishiba, MD.博士 ishiba0313@gmail.com 引用格式:Toshiyuki Ishiba, Ikuno Nishibuchi, Fumitaka Hara, Keita Sasaki, Ryo Sadate, Yuta Sekino, Ryunosuke Machida, Haruhiko Fukuda, Takahiro Kogawa, Tomomi Fujisawa, Yasuaki Sagara, Yoichi Naito, Kaori Terata、Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, Chizuko Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, Kenji Tamura, Takashi Mizowaki, Michio Yoshimura, Naoto Shikama, Tadahiko Shien, Hiroji Iwata.乳腺癌寡转移灶转移导向疗法随机对照试验(OLIGAMI 试验;JCOG2110)[摘要]。在:2023 年圣安东尼奥乳腺癌研讨会论文集;2023 年 12 月 5-9 日;德克萨斯州圣安东尼奥。费城(宾夕法尼亚州):AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-01。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Abstract PO3-19-01: A Randomized Controlled Trial of Metastasis-directed Therapy for Oligometastases in Breast Cancer (OLIGAMI trial; JCOG2110)
Background: Oligometastases were initially described as a concept bridging localized disease with widespread distant metastases, but a consensus on its definition has yet to be reached. Recently, the term "metastasis-directed therapy" (MDT) was coined to encompass local therapy for distant metastases, including surgery and radiation therapy (RT), especially stereotactic body radiation therapy (SBRT). Though OLIGO-BC1 and SABR-COMET have indicated the potential benefits of MDT for oligometastases, NRG-BR002 revealed no significant difference in progression-free survival (PFS). As a definitive conclusion to this clinical question has not been reached, there is an increasing demand for phase III trials focusing on breast cancer (BC). We planned the JCOG2110, also called as OLIGAMI trial . Design: OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negative BC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy dose not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT. Eligibility criteria: OLIGAMI trial will encompass all subtypes of advanced BC. The key criteria of the first registration are as follows: 1) Histologically diagnosed as invasive BC. Biopsy from oligometastases is desirable but not required. 2) Diagnosed with advanced BC with oligometastases by neck to pelvis enhanced CT, FDG-PET, and brain enhanced MRI. 3) Oligometastases defined as: (i) Maximum diameter of each tumor is 3 cm or less. (ii) Total number of 3 or less. (iii) In case of brain metastasis, maximum diameter is 2 cm or less and asymptomatic. 4) The patient with local recurrence is included. 5) De novo stage IV BC is included. The criteria of secondary registration are as follows: 1) The planned number of courses of systemic therapy has been performed. 2) No progression or new distant metastasis by response evaluation. 3) At least one oligometastaseis remains. Specific Aims: OLIGAMI trial aims to confirm the superiority of MDT to systemic therapy for oligometastases of BC. The primary endpoint is overall survival (OS) after randomization, while the secondary endpoints include OS after first registration, PFS, progression site (oligometastases vs. non-oligometastases), PFS specifically related to MDT (restricted arm B), proportion of adverse events and serious adverse events, and the non-progression proportion of health-related quality of life. Statistical methods: The sample size was calculated as 268 to detect 12% of 5-year OS difference with one-sided alpha of 0.05, power of 70%, 3 years of accrual, and 5 years of follow up. Therefore, we assumed the planned sample size for second registration for randomization as 270. We set the number of first registration as 340, assuming that there may be some patients with progression or complete response after the systemic therapy for 12 weeks. Present accrual and target accrual: The patient accrual will start in August 2023. Enrolment of 340 patients for first registration is planned over a 3-year accrual period. Contact information: Principal investigator, Toshiyuki Ishiba, MD. Ph.D. ishiba0313@gmail.com Citation Format: Toshiyuki Ishiba, Ikuno Nishibuchi, Fumitaka Hara, Keita Sasaki, Ryo Sadate, Yuta Sekino, Ryunosuke Machida, Haruhiko Fukuda, Takahiro Kogawa, Tomomi Fujisawa, Yasuaki Sagara, Yoichi Naito, Kaori Terata, Yukinori Ozaki, Akihiko Shimomura, Takehiko Sakai, Chizuko Kanbayashi, Tsuguo Iwatani, Hideo Shigematsu, Kenji Tamura, Takashi Mizowaki, Michio Yoshimura, Naoto Shikama, Tadahiko Shien, Hiroji Iwata. A Randomized Controlled Trial of Metastasis-directed Therapy for Oligometastases in Breast Cancer (OLIGAMI trial; JCOG2110) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-01.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
ACS Chemical Health & Safety
ACS Chemical Health & Safety PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
3.10
自引率
20.00%
发文量
63
期刊介绍: The Journal of Chemical Health and Safety focuses on news, information, and ideas relating to issues and advances in chemical health and safety. The Journal of Chemical Health and Safety covers up-to-the minute, in-depth views of safety issues ranging from OSHA and EPA regulations to the safe handling of hazardous waste, from the latest innovations in effective chemical hygiene practices to the courts'' most recent rulings on safety-related lawsuits. The Journal of Chemical Health and Safety presents real-world information that health, safety and environmental professionals and others responsible for the safety of their workplaces can put to use right away, identifying potential and developing safety concerns before they do real harm.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信