Abstract OT2-05-02: International retrospective cohort study of locoregional and systemic therapy in oligometastatic breast cancer (OLIGO-BC1)

S. Imoto, M. Futamura, M. Toi, Y. Fujiwara, T. Ueno, Y. Im, S. Im, S. Ahn, J. Lee, Yong-Hee Park, K. Wang, Y. Kitagawa, M. Nishiyama
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引用次数: 0

Abstract

Breast cancer (BC) is so-called “systemic disease”, because disseminated cancer cells in bone marrow and blood are detected even in early BC patients. Despite adjuvant therapy and postoperative radiation therapy, patients with triple negative BC and Luminal B-like BC often relapse early and systemic therapy is the only way to control disease progression. On the other hand, some BC patients relapse several years later. In such patients, oligometastases are occasionally diagnosed, because metastatic cancer cells are slowly growing and indolent. Oligometastatic BC is defined as low volume metastatic disease with limited number and size of metastatic lesions (up to five and not necessarily in the same organ). This definition is proposed in the Advanced Breast Cancer guidelines that are developed as a joint effort from European School of Oncology and European Society of Medical Oncology. Several retrospective studies demonstrated survival benefit of locoregional therapy in addition to systemic therapy. Locoregional therapy consisted of surgical resection, radiation therapy, ablation therapy, etc. However, it remains unclear about survival benefit of combined therapy in oligometastatic BC. To improve the standard of cancer treatment through the cooperate studies on more effective therapeutic strategies based on drugs, surgery and/or radiotherapy, Federation of Asian Clinical Oncology (FACO) was established in 2012 by Chinese Society of Clinical Oncology (CSCO), Korean Society of Medical Oncology (KSMO) and Japan Society of Clinical Oncology (JSCO). Thus, FACO conducted a retrospective cohort study on oligometastatic BC. The primary endpoint is to compare the estimated 5-year overall survival (OS) of oligometastatic BC patients treated with combined therapy and systemic therapy alone. To hypothesize that combined therapy has more advantage of OS in oligometastatic BC, the 5-year OS rates are expected to be 50% and 40%, respectively. The estimated sample size is calculated to be the number of 698 cases (349 cases in each group) needed to prove the superiority of survival with a two-sided type I error rate of 5% and a statistical power of 80%. Case registry opened in February 2018 and will close in January 2019. We planned to register 700 cases, i.e., 234 cases each from investigators of CSCO, KSMO and JSCO. Update information will be discussed. Citation Format: Imoto S, Futamura M, Toi M, Fujiwara Y, Ueno T, Im Y-H, Im S-A, Ahn SG, Lee JE, Park YH, Wang K, Kitagawa Y, Nishiyama M. International retrospective cohort study of locoregional and systemic therapy in oligometastatic breast cancer (OLIGO-BC1) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-05-02.
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摘要OT2-05-02:低转移性乳腺癌(OLIGO-BC1)局部和全身治疗的国际回顾性队列研究
乳腺癌(BC)被称为“全身性疾病”,因为即使在早期乳腺癌患者中也能检测到骨髓和血液中的弥散性癌细胞。尽管辅助治疗和术后放射治疗,三阴性BC和Luminal b样BC患者经常早期复发,全身治疗是控制疾病进展的唯一途径。另一方面,一些BC患者在几年后复发。在这些患者中,偶尔会诊断出低转移,因为转移癌细胞生长缓慢且惰性。少转移性BC被定义为低体积转移性疾病,转移灶数量和大小有限(最多5个,不一定在同一器官)。这一定义是在晚期乳腺癌指南中提出的,该指南是由欧洲肿瘤学院和欧洲肿瘤医学学会共同制定的。几项回顾性研究表明,除了全身治疗外,局部治疗对生存有好处。局部治疗包括手术切除、放射治疗、消融治疗等。然而,目前尚不清楚联合治疗对低转移性BC的生存益处。为了在药物、手术和/或放疗的基础上,通过合作研究更有效的治疗策略来提高癌症的治疗水平,中国临床肿瘤学会(CSCO)、韩国肿瘤医学学会(KSMO)和日本临床肿瘤学会(JSCO)于2012年成立了亚洲临床肿瘤联合会(FACO)。因此,FACO对低转移性BC进行了回顾性队列研究。主要终点是比较联合治疗和单独全身治疗的低转移性BC患者的估计5年总生存期(OS)。假设联合治疗在低转移性BC中具有更大的OS优势,预计5年OS率分别为50%和40%。估计样本量计算为证明生存优势所需的698例(每组349例),双侧I型错误率为5%,统计能力为80%。案件登记于2018年2月开始,将于2019年1月结束。我们计划登记700例,即CSCO、KSMO和JSCO调查员各234例。将讨论更新信息。引用格式:Imoto S, Futamura M, Toi M, Fujiwara Y, Ueno T, Im YH, Im S- a, Ahn SG, Lee JE, Park YH, Wang K, Kitagawa Y, Nishiyama M.低转移性乳腺癌局部和全身治疗的国际回顾性队列研究(OLIGO-BC1)[摘要]。2018年圣安东尼奥乳腺癌研讨会论文集;2018年12月4-8日;费城(PA): AACR;中国癌症杂志,2019;79(4增刊):OT2-05-02。
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