醋酸阿比特龙联合多西他赛治疗转移性激素敏感性前列腺癌的疗效观察

Efficacy of abiraterone acetate combined with docetaxel in patients with metastatic hormone-sensitive prostate cancer

目的探讨醋酸阿比特龙(ABI)联合多西他赛(DOC)治疗转移性激素敏感性前列腺癌(mHSPC)患者的疗效与安全性。方法分析郑州大学附属肿瘤医院2019年1月至2021年6月收治的44例mHSPC患者的临床资料。根据治疗方式的不同将患者分为两组,在雄激素剥夺治疗(ADT)的基础上,30例患者接受ABI治疗(ABI组),14例患者接受ABI联合DOC治疗(ABI+DOC组)。比较两组患者无进展生存期(PFS)及前列腺特异性抗原(PSA)相关指标。应用Mann-Whitney、χ^(2)检验及Cox回归进行数据分析。结果44例患者中位随访时间为21.5个月,ABI+DOC组患者DOC化疗2~8个周期,平均5.4个周期。ABI+DOC组患者中位PFS指标高于ABI组(35个月比26个月,χ^(2)=4.978,P<0.05),相对于单用ABI,ABI联合DOC化疗降低患者73%疾病进展风险(风险比0.27,95%置信区间0.08~0.96,P<0.05)。ABI和ABI+DOC组分别有18例(60.0%)和11例(78.6%)患者12个月内PSA<0.2 ng/ml,两组差异无统计学意义(χ^(2)=0.755,P>0.05)。治疗2个月ABI+DOC组患者达到PSA90比例高于ABI组(85.7%比53.3%,χ^(2)=4.325,P<0.05)。ABI及ABI+DOC组患者中位PSA最低值分别为0.08 ng/ml和0.07 ng/ml,达到最低值的中位时间分别为7个月和9.5个月,两组间差异无统计学意义(Z=-1.328、-1.509,P>0.05)。两组患者均未发生导致患者死亡的严重不良事件。ABI及ABI+DOC组患者3~4级不良事件发生率分别为30.0%和35.7%,两组间差异无统计学意义(χ^(2)=0.001,P>0.05)。结论ABI与DOC联用延长mHSPC患者PFS,提高治疗2个月达到PSA90患者比例,且不增加3~4级不良事件发生率。

Objective To investigate the efficacy and safety of abiraterone acetate(ABI)combined with docetaxel(DOC)in patients with metastatic hormone-sensitive prostate cancer(mHSPC).Methods The clinical data of 44 patients with mHSPC from Jan.2019 to Jun.2021 in Affiliated Cancer Hospital of Zhengzhou University were analyzed.According to different treatment methods,the patients were divided into two groups.All patients received androgen deprivation therapy(ADT).Among them,30 patients received ABI(ABI group)and 14 patients received ABI combined with DOC(ABI+DOC group).Progression-free survival(PFS)and prostate specific antigen(PSA)related outcomes were compared between the two groups.Mann-Whitney test,Chi-square test and Cox regression analysis were used for data analysis.Results The median follow-up time for the patients was 21.5 months,and the chemotherapy cycle of ABI+DOC group was 2-8 cycles,with an average of 5.4 cycles.The median PFS in ABI+DOC group was longer than that in ABI group(35 months vs.26 months,χ^(2)=4.978,P<0.05).Compared with ABI,ABI combined with DOC significantly reduced the risk of progression by 73%(hazard ratio 0.27,95%confidence interval 0.08-0.96,P<0.05).At 12 months,60.0%receiving ABI and 78.6%receiving ABI+DOC achieved PSA<0.2 ng/ml,with no significant difference between the two groups(χ^(2)=0.755,P>0.05).A significantly higher proportion of patients receiving ABI+DOC achieved a PSA90 response than those receiving ABI after two-monthtreatment(85.7%vs.53.3%,χ^(2)=4.325,P<0.05).The median PSA nadir values and time to PSA nadir were 0.08 ng/ml and 7 months in the ABI group and 0.07 ng/ml and 9.5 months in the ABI+DOC group respectively,with no significant difference between the two groups(Z=-1.328,-1.509,P>0.05).No serious adverse events leading to patient death occurred in either group.The incidence of grade 3-4 adverse events was 30.0%and 35.7%in ABI and ABI+DOC groups respectively,with no significant difference between the two groups(χ^(2)=0.001,P>0.05).Conclusion The combination of ABI and DOC prolonged PFS and increased the ratio of PSA90 significantly after two-month treatment in mHSPC patients,without increasing the incidence of grade 3-4 adverse events.