Dranitsaris G, Beegle N, Kalberer T, Blau S, Cox D, Faria C
Augmentium Pharma Consulting, Toronto, ON, Canada
Cancer Clinics of Excellence, Greenwood Village, CO, USA.
J Oncol Pharm Pract. 2015 Jun;21(3):170-7. doi: 10.1177/1078155214525369. Epub 2014 Mar 11.
Capecitabine (C), gemcitabine (G), and vinorelbine (V) are commonly used as single agents in patients with metastatic breast cancer. Eribulin (E) is one of the most recent cytotoxic agents to gain regulatory approval for metastatic breast cancer in the United States as a single agent. EMBRACE - a large randomized trial demonstrated the safety and overall survival benefit of eribulin in heavily pretreated metastatic breast cancer patients compared to treatment of physician's choice. In this analysis, toxicity and the associated health care resource use were compared between the four agents in a sample of metastatic breast cancer patients treated in a US community oncology setting.
This study identified 411 patients (C=144, G=81, V=96, and E=90) who were treated in 19 community oncology clinics over the preceding two-year period. Data collection included baseline patient and disease characteristics, duration of therapy, use of supportive care drugs, type of dose limiting toxicities, and their impact on overall health care resource use.
The median lines of therapy for C, G, V, and E were second, third, third, and fourth, respectively. Patients were comparable with respect to baseline comorbidities, performance status, serum creatinine, hemoglobin, neutrophil, and platelet counts. The proportion reporting at least one adverse event (any grade) with C, G, V, and E was 45%, 65%, 75%, and 63%. The most commonly reported toxicities (regardless of grade) for C, G, and V were diarrhea (19.4%), anemia (34.6%), and neutropenia (50.0%), respectively. The most common toxicity for E was neutropenia (32.2%). Overall, 5.6%, 19.8%, 22.9%, and 22.2% of patients receiving C, G, V, and E required at least one medical intervention to manage a toxic event. Toxicity was the cause of treatment discontinuation in 25.7%, 8.6%, 11.5%, and 8.9% of C, G, V, and E patients, respectively. The primary cause for treatment discontinuation in all four cohorts was disease progression.
Eribulin demonstrated a comparable patient safety profile to gemcitabine and vinorelbine, even when administered after three lines of prior therapies. Capecitabine was generally used in earlier lines, had less neutropenia and anemia, but more treatment discontinuations due to toxicity.
卡培他滨(C)、吉西他滨(G)和长春瑞滨(V)常用于转移性乳腺癌患者的单药治疗。艾日布林(E)是美国最近获得监管批准用于转移性乳腺癌单药治疗的细胞毒性药物之一。EMBRACE——一项大型随机试验表明,与医生选择的治疗方法相比,艾日布林在经过大量预处理的转移性乳腺癌患者中具有安全性和总生存获益。在本分析中,对美国社区肿瘤环境中接受治疗的转移性乳腺癌患者样本中的四种药物的毒性及相关医疗资源使用情况进行了比较。
本研究确定了在过去两年中于19家社区肿瘤诊所接受治疗的411例患者(C组=144例,G组=81例,V组=96例,E组=90例)。数据收集包括患者基线特征和疾病特征、治疗持续时间、支持性护理药物的使用、剂量限制性毒性类型及其对整体医疗资源使用的影响。
C组、G组、V组和E组的中位治疗线数分别为二线、三线、三线和四线。患者在基线合并症、体能状态、血清肌酐、血红蛋白、中性粒细胞和血小板计数方面具有可比性。报告至少一项不良事件(任何级别)的C组、G组、V组和E组患者比例分别为45%、65%、75%和63%。C组、G组和V组最常报告的毒性(无论级别)分别为腹泻(19.4%)、贫血(34.6%)和中性粒细胞减少(50.0%)。E组最常见的毒性是中性粒细胞减少(32.2%)。总体而言,接受C组、G组、V组和E组治疗的患者中,分别有5.6%、19.8%、22.9%和22.2%需要至少一次医疗干预来处理毒性事件。毒性分别导致C组、G组、V组和E组25.7%、8.6%、11.5%和8.9%的患者停止治疗。所有四个队列中治疗中断的主要原因是疾病进展。
即使在三线先前治疗后给药,艾日布林显示出与吉西他滨和长春瑞滨相当的患者安全性。卡培他滨通常用于早期治疗线,中性粒细胞减少和贫血较少,但因毒性导致的治疗中断较多。