Tanaka Kenichiro, Watanabe Junichiro, Arai Masami, Kushida Tomoyuki, Ito Tomoaki, Sato Koichi, Saito Mitsue
Department of Surgery, Juntendo University Shizuoka Hospital, Juntendo University School of Medicine, Izunokuni, JPN.
Department of Breast Oncology, Juntendo University Juntendo Hospital, Juntendo University School of Medicine, Tokyo, JPN.
Cureus. 2024 Oct 15;16(10):e71522. doi: 10.7759/cureus.71522. eCollection 2024 Oct.
Background Olaparib is effective in the treatment of metastatic breast cancer (MBC) patients, mainly confirmed by deleterious germline mutations. However, real-world data are scarce. Methodology A total of 10 cases from our institute and 17 cases from the relevant Japanese literature were reviewed. All 27 patients had MBC with confirmed deleterious germline mutations. Tumor reduction, response duration, disease-free interval (DFI), overall survival (OS), and safety were assessed. Additionally, exploratory research was conducted on the characteristics of a subgroup of patients who had a long-term response to olaparib. Results In the 10 cases from two Juntendo hospitals who received olaparib from July 2018 to December 2021, the median age was 48 years (range = 37-63 years). The same numbers of and mutations and the same ratios of luminal and triple negative (TN) breast cancer cases were observed. The metastatic sites, mainly visceral, included the lungs (n = 4), liver (n = 5), and bone (n = 6). The median duration of drug use was four months (range = 1-36 months). The median number of treatment regimens from metastasis to olaparib administration was 2.0 (range = 1-9 regimens). The median DFI was 21 months (range = 0-106 months). The median OS was not reached (range = 16-191 months). In the subgroup analysis of six cases in which olaparib was effective for four months or more, there was a case where DFI was longer than 100 months. Treatment-related toxicities (TRTs) included neutropenia (n = 5; 50%), anemia (n = 4; 40%), thrombocytopenia (n = 2; 20%), nausea (n = 1; 10%), and fatigue (n = 1; 10%). CTCAE (version 5.0) grade ≥3 TRTs included anemia (n = 1; 10%) and neutropenia (n = 5; 50%). On the other hand, neutropenia was previously said to be as low as 27.3%, lower than anemia (40.0%), in a population including various races. We additionally examined another 17 cases from the Japanese literature. Conclusions To our knowledge, this study reports the first real-world data of Japanese patients with MBC and confirmed deleterious germline mutations. Our data showed that olaparib is effective in the real world. The incidence of neutropenia seemed higher in Japanese patients.
奥拉帕尼在转移性乳腺癌（MBC）患者的治疗中有效，主要由有害的种系突变证实。然而，真实世界的数据稀缺。方法：回顾了我院的10例病例和日本相关文献中的17例病例。所有27例患者均为MBC且种系突变有害得到确认。评估了肿瘤缩小情况、反应持续时间、无病间期（DFI）、总生存期（OS）和安全性。此外，对奥拉帕尼长期反应的患者亚组特征进行了探索性研究。结果：在2018年7月至2021年12月接受奥拉帕尼治疗的10例来自两家顺天堂医院的患者中，中位年龄为48岁（范围 = 37 - 63岁）。观察到相同数量的 和 突变以及相同比例的管腔型和三阴性（TN）乳腺癌病例。转移部位主要为内脏，包括肺（n = 4）、肝（n = 5）和骨（n = 6）。药物使用的中位持续时间为4个月（范围 = 1 - 36个月）。从转移到奥拉帕尼给药的治疗方案中位数为2.0（范围 = 1 - 9个方案）。中位DFI为21个月（范围 = 0 - 106个月）。中位OS未达到（范围 = 16 - 191个月）。在奥拉帕尼有效4个月或更长时间的6例亚组分析中，有1例DFI超过100个月。治疗相关毒性（TRT）包括中性粒细胞减少（n = 5；50%）、贫血（n = 4；40%）、血小板减少（n = 2；20%）、恶心（n = 1；10%）和疲劳（n = 1；10%）。CTCAE（第5.0版）≥3级TRT包括贫血（n = 1；10%）和中性粒细胞减少（n = 5；50%）。另一方面，在包括各种种族的人群中，中性粒细胞减少症以前据说低至27.3%，低于贫血（40.0%）。我们还检查了日本文献中的另外17例病例。结论：据我们所知，本研究报告了日本MBC患者且种系突变有害得到确认的首个真实世界数据。我们的数据表明奥拉帕尼在现实世界中有效。日本患者中性粒细胞减少症的发生率似乎更高。
