Abstract P2-15-07: Real-world multicenter, prospective study of the effects ofnab-paclitaxel on clinical outcomes and quality of life of patients with metastatic breast cancer in Greece. The ‘ABReast’ study

A. Koumarianou, P. Makrantonakis, F. Zagouri, C. Papadimitriou, A. Christopoulou, E. Samantas, C. Christodoulou, A. Psyrri, D. Bafaloukos, G. Aravantinos, P. Papakotoulas, S. Baka, C. Andreadis, A. Alexopoulos, I. Bombolaki, K. Kampoli, S. Liori, K. Karvounis, A. Ardavanis
{"title":"Abstract P2-15-07: Real-world multicenter, prospective study of the effects ofnab-paclitaxel on clinical outcomes and quality of life of patients with metastatic breast cancer in Greece. The ‘ABReast’ study","authors":"A. Koumarianou, P. Makrantonakis, F. Zagouri, C. Papadimitriou, A. Christopoulou, E. Samantas, C. Christodoulou, A. Psyrri, D. Bafaloukos, G. Aravantinos, P. Papakotoulas, S. Baka, C. Andreadis, A. Alexopoulos, I. Bombolaki, K. Kampoli, S. Liori, K. Karvounis, A. Ardavanis","doi":"10.1158/1538-7445.sabcs19-p2-15-07","DOIUrl":null,"url":null,"abstract":"Introduction: Nanoparticle albumin-bound (nab)-paclitaxel (nab-P) is approved for the treatment of patients with metastatic breast cancer (MBC) who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Real-world evidence on the effectiveness of nab-P is sparse. From this perspective, this non-interventional study was designed to assess the impact of nab-P on the clinical outcomes and the quality of life of patients with MBC in the routine care of Greece. Materials and methods: This multicenter prospective study enrolled consented females with MBC initiated (≤7 days prior to enrollment) on nab-P according to physicians decision. Clinicopathologic parameters and patient-reported outcomes [Functional Assessment of Cancer Therapy-Breast (FACT-B)] were collected at approximately 9-week intervals during the first 12 months of study participation and approximately every 18 weeks thereafter, until the end of the study observation period (maximum 30 months). Results: Between April 2016 and October 2017, 150 eligible patients (99.3% Caucasian) were enrolled in the study in 16 oncology centers. The patients’ median age was 64.5 years (range: 30.7-84.0) and ECOG performance status was 0 in 66.4% and 1 in 26.2%. 45.3% of patients had ≥1 comorbidity (21.3% cardiovascular diseases). The median time elapsed since MBC diagnosis was 22.4 months, while 36.0% of patients were de novo metastatic. The distribution of hormone receptor (HR)/human epidermal growth factor receptor 2 (HER2) status was 74.6% HR+/HER2-, 11.9% HR-/HER2-, 11.2% HR+/HER2+, and 2.2% HR-/HER2+. Most commonly occurring metastatic sites were the bones (55.3%), lung (50.0%), and liver (40.0%). Prior taxane-based therapy was annotated in 40.0% of patients. Of the patients, 11.3% received nab-P as first, 36.0% as second, 23.3% as third, and 29.3% as fourth or further treatment line. A median of 6 cycles (range: 1-33) was administered; 42.7% of the patients completed >6 and 22.0% >8 cycles. Dose reductions were required for 26.0% of the patients, mainly due to toxicity. The objective response rate was 26.7% and the clinical benefit rate was 44.0%. After a median follow-up of 19.3 months, 92 patients had progressed and 57 had died (14 without progression). The median progression-free survival (PFS) was 6.2 months [95% confidence interval (CI): 5.2-7.3]. The 6- and 12-month PFS rates were 50.6% and 30.5%, respectively. The median overall survival was 21.1 months (95% CI: 17.2-not estimable). Liver [hazard ratio (HR): 1.81; 95% CI: 1.24-2.66] and lung (HR: 1.53; 95% CI: 1.04-2.25) metastases were associated with a higher risk of progression or death. No statistically significant change in the patients’ baseline FACT-B total score (median: 93.0) was observed. The serious and non-serious adverse event (AE) incidence rates were 12.7% and 48.0%, respectively with a total of 37 grade ≥3 AEs (not including disease progression) reported. Conclusion: This study generated real-world evidence on the effectiveness of nab-paclitaxel; no new safety signals emerged. Citation Format: Anna Koumarianou, Paris Makrantonakis, Flora Zagouri, Christos Papadimitriou, Athina Christopoulou, Epaminontas Samantas, Christos Christodoulou, Amanda Psyrri, Dimitris Bafaloukos, Gerasimos Aravantinos, Pavlos Papakotoulas, Sofia Baka, Charalampos Andreadis, Athanasios Alexopoulos, Iliada Bombolaki, Katerina Kampoli, Sofia Liori, Kiki Karvounis, Alexandros Ardavanis. Real-world multicenter, prospective study of the effects of nab-paclitaxel on clinical outcomes and quality of life of patients with metastatic breast cancer in Greece. The ‘ABReast’ study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-07.","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2020-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Poster Session Abstracts","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1158/1538-7445.sabcs19-p2-15-07","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: Nanoparticle albumin-bound (nab)-paclitaxel (nab-P) is approved for the treatment of patients with metastatic breast cancer (MBC) who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Real-world evidence on the effectiveness of nab-P is sparse. From this perspective, this non-interventional study was designed to assess the impact of nab-P on the clinical outcomes and the quality of life of patients with MBC in the routine care of Greece. Materials and methods: This multicenter prospective study enrolled consented females with MBC initiated (≤7 days prior to enrollment) on nab-P according to physicians decision. Clinicopathologic parameters and patient-reported outcomes [Functional Assessment of Cancer Therapy-Breast (FACT-B)] were collected at approximately 9-week intervals during the first 12 months of study participation and approximately every 18 weeks thereafter, until the end of the study observation period (maximum 30 months). Results: Between April 2016 and October 2017, 150 eligible patients (99.3% Caucasian) were enrolled in the study in 16 oncology centers. The patients’ median age was 64.5 years (range: 30.7-84.0) and ECOG performance status was 0 in 66.4% and 1 in 26.2%. 45.3% of patients had ≥1 comorbidity (21.3% cardiovascular diseases). The median time elapsed since MBC diagnosis was 22.4 months, while 36.0% of patients were de novo metastatic. The distribution of hormone receptor (HR)/human epidermal growth factor receptor 2 (HER2) status was 74.6% HR+/HER2-, 11.9% HR-/HER2-, 11.2% HR+/HER2+, and 2.2% HR-/HER2+. Most commonly occurring metastatic sites were the bones (55.3%), lung (50.0%), and liver (40.0%). Prior taxane-based therapy was annotated in 40.0% of patients. Of the patients, 11.3% received nab-P as first, 36.0% as second, 23.3% as third, and 29.3% as fourth or further treatment line. A median of 6 cycles (range: 1-33) was administered; 42.7% of the patients completed >6 and 22.0% >8 cycles. Dose reductions were required for 26.0% of the patients, mainly due to toxicity. The objective response rate was 26.7% and the clinical benefit rate was 44.0%. After a median follow-up of 19.3 months, 92 patients had progressed and 57 had died (14 without progression). The median progression-free survival (PFS) was 6.2 months [95% confidence interval (CI): 5.2-7.3]. The 6- and 12-month PFS rates were 50.6% and 30.5%, respectively. The median overall survival was 21.1 months (95% CI: 17.2-not estimable). Liver [hazard ratio (HR): 1.81; 95% CI: 1.24-2.66] and lung (HR: 1.53; 95% CI: 1.04-2.25) metastases were associated with a higher risk of progression or death. No statistically significant change in the patients’ baseline FACT-B total score (median: 93.0) was observed. The serious and non-serious adverse event (AE) incidence rates were 12.7% and 48.0%, respectively with a total of 37 grade ≥3 AEs (not including disease progression) reported. Conclusion: This study generated real-world evidence on the effectiveness of nab-paclitaxel; no new safety signals emerged. Citation Format: Anna Koumarianou, Paris Makrantonakis, Flora Zagouri, Christos Papadimitriou, Athina Christopoulou, Epaminontas Samantas, Christos Christodoulou, Amanda Psyrri, Dimitris Bafaloukos, Gerasimos Aravantinos, Pavlos Papakotoulas, Sofia Baka, Charalampos Andreadis, Athanasios Alexopoulos, Iliada Bombolaki, Katerina Kampoli, Sofia Liori, Kiki Karvounis, Alexandros Ardavanis. Real-world multicenter, prospective study of the effects of nab-paclitaxel on clinical outcomes and quality of life of patients with metastatic breast cancer in Greece. The ‘ABReast’ study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-07.
摘要P2-15-07:真实世界多中心前瞻性研究nab-紫杉醇对希腊转移性乳腺癌患者临床结局和生活质量的影响。“并排”研究
纳米颗粒白蛋白结合(nab)-紫杉醇(nabp)被批准用于治疗转移性乳腺癌(MBC)患者,这些患者在转移性疾病的一线治疗失败,并且不需要标准的含蒽环类药物治疗。关于nabp有效性的实际证据很少。从这个角度来看,本非介入性研究旨在评估nabp对希腊常规护理中MBC患者临床结局和生活质量的影响。材料和方法:本多中心前瞻性研究纳入经同意的女性MBC患者(入组前≤7天),根据医生决定开始使用nabp。临床病理参数和患者报告的结果[肿瘤治疗-乳腺功能评估(FACT-B)]在参与研究的前12个月大约每9周收集一次,之后大约每18周收集一次,直到研究观察期结束(最多30个月)。结果:2016年4月至2017年10月,16个肿瘤中心的150名符合条件的患者(99.3%为高加索人)入组研究。患者的中位年龄为64.5岁(范围:30.7-84.0),ECOG表现状态为0(66.4%)和1(26.2%)。45.3%的患者有≥1种合并症(21.3%为心血管疾病)。自MBC诊断以来的中位时间为22.4个月,而36.0%的患者为新转移。激素受体(HR)/人表皮生长因子受体2 (HER2)状态分布为HR+/HER2- 74.6%, HR-/HER2- 11.9%, HR+/HER2+ 11.2%, HR-/HER2+ 2.2%。最常见的转移部位是骨(55.3%)、肺(50.0%)和肝(40.0%)。40.0%的患者有既往紫杉烷治疗记录。其中,11.3%的患者第一次接受nabp治疗,36.0%的患者第二次接受nabp治疗,23.3%的患者第3次接受nabp治疗,29.3%的患者第4次或进一步接受nabp治疗。中位数为6个周期(范围:1-33);42.7%的患者完成>6个周期,22.0%的患者完成>8个周期。26.0%的患者需要减少剂量,主要是由于毒性。客观有效率为26.7%,临床获益率为44.0%。中位随访19.3个月后,92例患者进展,57例死亡(14例无进展)。中位无进展生存期(PFS)为6.2个月[95%可信区间(CI): 5.2-7.3]。6个月和12个月的PFS分别为50.6%和30.5%。中位总生存期为21.1个月(95% CI: 17.2,无法估计)。肝脏[危险比(HR): 1.81;95% CI: 1.24-2.66]和肺(HR: 1.53;95% CI: 1.04-2.25)转移与更高的进展或死亡风险相关。患者基线FACT-B总分(中位数:93.0)无统计学意义变化。严重不良事件(AE)和非严重不良事件(AE)发生率分别为12.7%和48.0%,共报告37例≥3级AE(不包括疾病进展)。结论:本研究为nab-紫杉醇的有效性提供了现实证据;没有出现新的安全信号。引用格式:Anna Koumarianou, Paris Makrantonakis, Flora Zagouri, Christos Papadimitriou, Athina Christopoulou, Epaminontas Samantas, Christos Christodoulou, Amanda Psyrri, Dimitris Bafaloukos, Gerasimos Aravantinos, Pavlos Papakotoulas, Sofia Baka, Charalampos Andreadis, Athanasios Alexopoulos, Iliada Bombolaki, Katerina Kampoli, Sofia Liori, Kiki Karvounis, Alexandros Ardavanis。真实世界多中心前瞻性研究nab-紫杉醇对希腊转移性乳腺癌患者临床结局和生活质量的影响。“并排”研究[摘要]。摘自:2019年圣安东尼奥乳腺癌研讨会论文集;2019年12月10日至14日;费城(PA): AACR;中国癌症杂志,2020;31(增刊):02 - 02。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
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:481959085
Book学术官方微信