卡巴他赛在加拿大接受或未接受过阿比特龙治疗的转移性去势抵抗性前列腺癌患者中的疗效、生活质量及安全性
Efficacy, quality of life, and safety of cabazitaxel in Canadian metastatic castration-resistant prostate cancer patients treated or not with prior abiraterone.
作者信息
Saad Fred, Winquist Eric, Hubay Stacey, Berry Scott, Assi Hazem, Levesque Eric, Aucoin Nathalie, Czaykowski Piotr, Lattouf Jean-Baptiste, Alloul Karine, Stewart John, Sridhar Srikala S
机构信息
CRCHUM/Université de Montréal, Montreal, QC, Canada;
London Health Sciences Centre, London, ON, Canada;
出版信息
Can Urol Assoc J. 2016 Mar-Apr;10(3-4):102-9. doi: 10.5489/cuaj.3470.
INTRODUCTION
In the TROPIC study, cabazitaxel improved overall survival in abiraterone-naïve metastatic castration-resistant prostate cancer (mCRPC) patients post-docetaxel. To evaluate cabazitaxel in routine clinical practice, an international, single-arm trial was conducted. Efficacy, safety, and quality of life (QoL) data were collected from Canadian patients enrolled. Overall survival and progression-free survival were not collected as part of this study. Importantly, prior abiraterone use was obtained and its impact on clinical parameters was examined.
METHODS
Sixty-one patients from nine Canadian centres were enrolled, with prior abiraterone use known for 60 patients. Prostate-specific antigen (PSA) response rate, safety, and impact on QoL life were analyzed as a function of prior abiraterone use.
RESULTS
Overall, 92% of patients were ECOG 0/1, 88% had bone metastases, and 25% visceral metastases. Patients treated without prior abiraterone (NoPriorAbi) (n=35, 58%) and with prior abiraterone (PriorAbi) (n=25, 42%) had similar baseline characteristics, except for age and prior cumulative docetaxel dose. Median number of cabazitaxel cycles received was similar between groups (NoPriorAbi=6, PriorAbi=7), as was PSA response rate (NoPriorAbi=36.4%, PriorAbi=45.0%, p=0.54). Almost one-third (31%) of patients received prophylactic granulocyte colony-stimulating factors. Most frequent Grade 3/4 toxicities were neutropenia (14.8%); anemia, febrile neutropenia, fatigue (each at 9.8%); and diarrhea (8.2%). No treatment-related adverse event leading to death was observed. QoL and pain were improved with no difference seen between groups. Treatment discontinuation was mainly due to disease progression (45.9%) and adverse events (32.8%).
CONCLUSIONS
In routine clinical practice, cabazitaxel's risk-benefit ratio in mCRPC patients previously treated with docetaxel seems to be maintained independent of prior abiraterone use.
引言
在TROPIC研究中，卡巴他赛改善了多西他赛治疗后初治的转移性去势抵抗性前列腺癌（mCRPC）患者的总生存期。为了评估卡巴他赛在常规临床实践中的效果，开展了一项国际单臂试验。收集了入组的加拿大患者的疗效、安全性和生活质量（QoL）数据。本研究未收集总生存期和无进展生存期数据。重要的是，记录了患者先前是否使用过阿比特龙，并研究了其对临床参数的影响。
方法
招募了来自加拿大9个中心的61名患者，其中60名患者有先前使用阿比特龙的记录。根据先前是否使用过阿比特龙，分析前列腺特异性抗原（PSA）缓解率、安全性及对生活质量的影响。
结果
总体而言，92%的患者ECOG评分为0/1，88%有骨转移，25%有内脏转移。未使用过阿比特龙（NoPriorAbi）（n = 35，58%）和使用过阿比特龙（PriorAbi）（n = 25，42%）的患者基线特征相似，但年龄和先前多西他赛累积剂量除外。两组接受卡巴他赛治疗周期的中位数相似（NoPriorAbi = 6，PriorAbi = 7），PSA缓解率也相似（NoPriorAbi = 36.4%，PriorAbi = 45.0%，p = 0.54）。近三分之一（31%）的患者接受了预防性粒细胞集落刺激因子治疗。最常见的3/4级毒性为中性粒细胞减少（14.8%）；贫血、发热性中性粒细胞减少、疲劳（均为9.8%）；腹泻（8.2%）。未观察到导致死亡的治疗相关不良事件。生活质量和疼痛得到改善，两组之间无差异。治疗中断主要是由于疾病进展（45.9%）和不良事件（32.8%）。
结论
在常规临床实践中，对于先前接受多西他赛治疗的mCRPC患者，卡巴他赛的风险效益比似乎不受先前是否使用过阿比特龙的影响。
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