{"title":"Neo-Peaks研究(JBCRG-20子研究)中同时混合输注曲妥珠单抗和帕妥珠单抗的临床经验。","authors":"Hiroko Bando, Hiroyuki Yasojima, Kazushige Ishida, Kokoro Kobayashi, Hiroi Kasai, Masahiro Kashiwaba, Shinji Ohno, Satoshi Morita, Masakazu Toi, Norikazu Masuda","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Dual human epidermal growth factor receptor 2(HER2)blockade with trastuzumab(H)and pertuzumab(P)combined with docetaxel and carboplatin(TCb)is a standard neoadjuvant therapy for HER2-positive breast cancer patients. We conducted this sub-study using data from the investigator-initiated randomized phase 2 JBCRG-20(Neo-peaks)study to evaluate the safety of simultaneous mixed HP infusion in Japanese patients, as there have been no data to date. A total of 204 patients in groups A-C received TCbHP, TCbHP followed by trastuzumab emtansine(T-DM1)+P, and T-DM1+P, respectively. Of the 103 patients in groups A and B who received H and P by sequential infusion in cycle 1, the 17(median age 59; range 29-69 years)who did not experience an infusion reaction(IF)received these agents as a mixed, single-bag infusion from cycle 2 onwards. No cases of IF were observed, thus 71 mixed doses were safely administered. Administration time was reduced to 60 min from cycle 3 onwards. Furthermore, in the group B patients, mixed HP infusion did not affect their subsequent treatment(i. e. 4 cycles of T-DM1+P). Simultaneous administration of H and P enables a reduced administration time, which would benefit both patients and healthcare providers.</p>","PeriodicalId":35588,"journal":{"name":"Japanese Journal of Cancer and Chemotherapy","volume":"51 9","pages":"925-930"},"PeriodicalIF":0.0000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Experience with Simultaneous Mixed Infusion of Trastuzumab and Pertuzumab in the Neo-Peaks Study (JBCRG-20 Sub-Study).\",\"authors\":\"Hiroko Bando, Hiroyuki Yasojima, Kazushige Ishida, Kokoro Kobayashi, Hiroi Kasai, Masahiro Kashiwaba, Shinji Ohno, Satoshi Morita, Masakazu Toi, Norikazu Masuda\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Dual human epidermal growth factor receptor 2(HER2)blockade with trastuzumab(H)and pertuzumab(P)combined with docetaxel and carboplatin(TCb)is a standard neoadjuvant therapy for HER2-positive breast cancer patients. We conducted this sub-study using data from the investigator-initiated randomized phase 2 JBCRG-20(Neo-peaks)study to evaluate the safety of simultaneous mixed HP infusion in Japanese patients, as there have been no data to date. A total of 204 patients in groups A-C received TCbHP, TCbHP followed by trastuzumab emtansine(T-DM1)+P, and T-DM1+P, respectively. Of the 103 patients in groups A and B who received H and P by sequential infusion in cycle 1, the 17(median age 59; range 29-69 years)who did not experience an infusion reaction(IF)received these agents as a mixed, single-bag infusion from cycle 2 onwards. No cases of IF were observed, thus 71 mixed doses were safely administered. Administration time was reduced to 60 min from cycle 3 onwards. Furthermore, in the group B patients, mixed HP infusion did not affect their subsequent treatment(i. e. 4 cycles of T-DM1+P). Simultaneous administration of H and P enables a reduced administration time, which would benefit both patients and healthcare providers.</p>\",\"PeriodicalId\":35588,\"journal\":{\"name\":\"Japanese Journal of Cancer and Chemotherapy\",\"volume\":\"51 9\",\"pages\":\"925-930\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Japanese Journal of Cancer and Chemotherapy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese Journal of Cancer and Chemotherapy","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
摘要
曲妥珠单抗(H)和百妥珠单抗(P)联合多西他赛和卡铂(TCb)的双重人类表皮生长因子受体 2(HER2)阻断疗法是 HER2 阳性乳腺癌患者的标准新辅助疗法。我们利用研究者发起的随机 2 期 JBCRG-20(Neo-peaks)研究的数据开展了这项子研究,以评估在日本患者中同时混合输注 HP 的安全性,因为迄今为止还没有相关数据。A-C组共204名患者分别接受了TCbHP、TCbHP后曲妥珠单抗(T-DM1)+P和T-DM1+P治疗。A组和B组的103名患者在第一周期接受了H和P的序贯输注,其中17名患者(中位年龄59岁;范围29-69岁)未出现输注反应(IF),他们从第二周期起接受了这些药物的混合单袋输注。没有观察到 IF 病例,因此安全地使用了 71 种混合剂量。从第 3 个周期开始,给药时间缩短至 60 分钟。此外,在 B 组患者中,混合输注 HP 不会影响其后续治疗(即 4 个周期的 T-DM1+P 治疗)。同时输注 H 和 P 可以缩短给药时间,这对患者和医护人员都有好处。
Clinical Experience with Simultaneous Mixed Infusion of Trastuzumab and Pertuzumab in the Neo-Peaks Study (JBCRG-20 Sub-Study).
Dual human epidermal growth factor receptor 2(HER2)blockade with trastuzumab(H)and pertuzumab(P)combined with docetaxel and carboplatin(TCb)is a standard neoadjuvant therapy for HER2-positive breast cancer patients. We conducted this sub-study using data from the investigator-initiated randomized phase 2 JBCRG-20(Neo-peaks)study to evaluate the safety of simultaneous mixed HP infusion in Japanese patients, as there have been no data to date. A total of 204 patients in groups A-C received TCbHP, TCbHP followed by trastuzumab emtansine(T-DM1)+P, and T-DM1+P, respectively. Of the 103 patients in groups A and B who received H and P by sequential infusion in cycle 1, the 17(median age 59; range 29-69 years)who did not experience an infusion reaction(IF)received these agents as a mixed, single-bag infusion from cycle 2 onwards. No cases of IF were observed, thus 71 mixed doses were safely administered. Administration time was reduced to 60 min from cycle 3 onwards. Furthermore, in the group B patients, mixed HP infusion did not affect their subsequent treatment(i. e. 4 cycles of T-DM1+P). Simultaneous administration of H and P enables a reduced administration time, which would benefit both patients and healthcare providers.