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多西他赛化疗联合雄激素剥夺治疗在中国转移性激素敏感性前列腺癌高容量疾病患者中的疗效和安全性分析。

Docetaxel chemotherapy plus androgen-deprivation therapy in high-volume disease metastatic hormone-sensitive prostate cancer in Chinese patients: an efficacy and safety analysis.

机构信息

Department of Urology, Minhang Hospital, Fudan University, Shanghai, China.

Department of Urology, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

Eur J Med Res. 2022 Aug 11;27(1):148. doi: 10.1186/s40001-022-00773-1.

DOI:10.1186/s40001-022-00773-1
PMID:35953852
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9367054/
Abstract

OBJECTIVE

To investigate the efficacy and safety of docetaxel chemotherapy combined with androgen-deprivation therapy for patients with high-volume disease metastatic hormone-sensitive prostate cancer.

METHODS

153 cases of high-volume disease metastatic hormone-sensitive prostate cancer in Minhang Hospital between January 2018 and December 2019 were analyzed retrospectively, including the number of patients, age, initial PSA level, Gleason score, TNM stage and ECOG score. 90 patients in the endocrine therapy group received continuous ADT, and 63 patients in the combined chemotherapy group received docetaxel plus ADT. The progression-free survival time (time from initiation of prostate cancer treatment to progression to CRPC), PSA response rate, and adverse reactions were compared between the two groups.

RESULTS

All 153 cases were closely followed up for a period of 12.3-35.3 months, with a median follow-up time of 23.5 months. The median time to reach the lowest point of PSA in the two groups was 6.3 months and 7.9 months (P = 0.018) in the combination chemotherapy group and the ADT group alone, with 27 (42.9%) and 12 (13.3%) cases in the two groups Within 12 months of treatment, PSA decreased to below 0.2 ng/ml (P = 0.02), and progression-free survival was 16.9 months (6.5-28.5 months) and 11.2 months (4.3-22.7 months) in the two groups. (P < 0.001). There were 18 cases (28.6%) and 54 cases (60%) in the two groups with disease progression (P < 0.001). There were 6 cases (9.5%) and 15 cases (16.7%) in the combination chemotherapy group and the ADT group died of prostate cancer and related complications, respectively. All 63 cases in the combined chemotherapy group completed 6 cycles of chemotherapy. 39 (61.9%) cases experienced varying degrees of neutropenia, of which 12 (19%) experienced grade 3-4 neutropenia, with 6 cases (9.5%) developed febrile neutropenia. 30 cases (47.6%) had toxic reactions in the digestive system, and 3 case (4.3%) had grade 3 liver dysfunction. 27 cases (42.8%) had skin and mucosal toxicity. 9 cases (14.3%) had mild fluid retention. No blood and digestive toxicity were observed in the ADT group. 33 cases (52.4%) and 48 (53.3%) of the two groups had symptoms of afternoon hot flashes and fatigue, (P = 0.961).

CONCLUSION

Docetaxel chemotherapy combined with endocrine therapy could be one of effective treatments for delaying castration resistance of HVD-mHSPC, which could prolong PFS effectively and obtain a higher PSA response rate, high safety under close monitoring, and controllable adverse reactions.

摘要

目的

探讨多西他赛化疗联合去势治疗对大体积转移性激素敏感前列腺癌(HVD-mHSPC)患者的疗效和安全性。

方法

回顾性分析 2018 年 1 月至 2019 年 12 月闵行医院收治的 153 例 HVD-mHSPC 患者的临床资料,包括患者数量、年龄、初诊 PSA 水平、Gleason 评分、TNM 分期和 ECOG 评分。内分泌治疗组 90 例患者接受持续 ADT,联合化疗组 63 例患者接受多西他赛+ADT。比较两组患者的无进展生存期(从前列腺癌治疗开始到进展为 CRPC 的时间)、PSA 缓解率和不良反应。

结果

153 例患者均密切随访 12.3-35.3 个月,中位随访时间 23.5 个月。两组患者 PSA 最低值的中位时间分别为 6.3 个月和 7.9 个月(P = 0.018),联合化疗组和 ADT 组分别有 27(42.9%)和 12(13.3%)例患者在治疗 12 个月内 PSA 下降至低于 0.2ng/ml(P = 0.02),两组患者的无进展生存期分别为 16.9 个月(6.5-28.5 个月)和 11.2 个月(4.3-22.7 个月)(P < 0.001)。两组患者分别有 18 例(28.6%)和 54 例(60%)发生疾病进展(P < 0.001)。联合化疗组和 ADT 组分别有 6 例(9.5%)和 15 例(16.7%)患者死于前列腺癌及相关并发症。联合化疗组 63 例患者均完成 6 周期化疗。39(61.9%)例患者发生不同程度的中性粒细胞减少症,其中 12(19%)例患者发生 3-4 级中性粒细胞减少症,6(9.5%)例患者发生发热性中性粒细胞减少症。30(47.6%)例患者发生消化系统毒性反应,3 例(4.3%)例患者发生 3 级肝功能障碍。27(42.8%)例患者发生皮肤和黏膜毒性。9(14.3%)例患者发生轻度体液潴留。ADT 组未观察到血液和消化系统毒性。两组患者分别有 33(52.4%)例和 48(53.3%)例出现午后潮热和乏力症状(P = 0.961)。

结论

多西他赛化疗联合内分泌治疗可能是延缓 HVD-mHSPC 去势抵抗的有效治疗方法之一,可有效延长 PFS,获得更高的 PSA 缓解率,在密切监测下具有较高的安全性,且不良反应可控制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44da/9367054/94ff369050e5/40001_2022_773_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44da/9367054/94ff369050e5/40001_2022_773_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44da/9367054/94ff369050e5/40001_2022_773_Fig1_HTML.jpg

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