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卡巴他赛联合泼尼松龙化疗用于转移性去势抵抗性前列腺癌的有效性和安全性:通过卡巴他赛同情用药项目获得的韩国患者数据。

Effectiveness and safety of cabazitaxel plus prednisolone chemotherapy for metastatic castration-resistant prostatic carcinoma: data on Korean patients obtained by the cabazitaxel compassionate-use program.

作者信息

Lee Jae-Lyun, Park Se Hoon, Koh Su-Jin, Lee Se Hoon, Kim Yu Jung, Choi Yoon Ji, Lee Jihye, Lim Ho Yeong

机构信息

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil Songpa-gu, Seoul, 138-736, Korea,

出版信息

Cancer Chemother Pharmacol. 2014 Nov;74(5):1005-13. doi: 10.1007/s00280-014-2579-5. Epub 2014 Sep 6.

Abstract

PURPOSE

To report the efficacy and safety of using cabazitaxel plus prednisolone chemotherapy to treat Korean patients with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy.

METHODS

This cohort study enrolled 26 mCRPC patients. Treatment consisted of 25 mg/m(2) cabazitaxel that was intravenously administered every 3 weeks, in addition to twice-daily 5 mg prednisolone.

RESULTS

The median patient age was 67 years (range = 53-82), median Eastern Cooperative Oncology Group performance status was 1 (range = 0-2), Gleason score was ≥ 8 in 25 patients (96 %), and median serum prostate-specific antigen (PSA) was 95.3 ng/mL (interquartile range = 9.1-297.7). A total of 180 treatment cycles were administered, and a median of five cycles were administered per patient (range = 1-23). A PSA response was observed in 32 % of evaluable patients. Tumor response was evaluated in eight patients, and three and four patients achieved partial response and stable disease, respectively. Over a median follow-up duration of 23.4 months (95 % CI 11.1-35.6), median time to treatment failure was 4.2 months (95 % CI 1.8-6.6) and median time to progression was 8.5 months (95 % CI 3.0-13.1). Median overall survival was 16.5 months (95 % CI 12.1-20.9). Grade 3 or worse febrile neutropenia developed in eight patients (31 %) and neutropenic infection in four patients (15 %).

CONCLUSION

Cabazitaxel plus prednisolone chemotherapy can be used to treat Korean mCRPC patients. Prophylactic growth factor support should be considered for patients at high risk of neutropenic fever or infection.

摘要

目的

报告多西他赛治疗后使用卡巴他赛联合泼尼松化疗治疗韩国转移性去势抵抗性前列腺癌(mCRPC)患者的疗效和安全性。

方法

本队列研究纳入了26例mCRPC患者。治疗方案为每3周静脉注射25mg/m²卡巴他赛,此外每日两次口服5mg泼尼松。

结果

患者中位年龄为67岁(范围53 - 82岁),东部肿瘤协作组(ECOG)中位体能状态为1(范围0 - 2),25例患者(96%)的 Gleason评分≥8,血清前列腺特异性抗原(PSA)中位值为95.3ng/mL(四分位间距 = 9.1 - 297.7)。共进行了180个治疗周期,每位患者中位接受5个周期治疗(范围1 - 23)。32%的可评估患者观察到PSA反应。对8例患者评估了肿瘤反应,分别有3例和4例患者达到部分缓解和病情稳定。在中位随访23.4个月(95%CI 11.1 - 35.6)期间,中位治疗失败时间为4.2个月(95%CI 1.8 - 6.6),中位进展时间为8.5个月(95%CI 3.0 - 13.1)。中位总生存期为16.5个月(95%CI 12.1 - 20.9)。8例患者(31%)发生3级或更严重的发热性中性粒细胞减少,4例患者(15%)发生中性粒细胞减少性感染。

结论

卡巴他赛联合泼尼松化疗可用于治疗韩国mCRPC患者。对于有中性粒细胞减少性发热或感染高风险的患者,应考虑预防性生长因子支持治疗。

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