哌柏西利联合内分泌治疗晚期激素受体阳性乳腺癌的真实世界研究

A real-world study of the efficacy and safety of Palbociclib combined with endocrine therapy for advanced hormone receptor-positive breast cancer

目的评价哌柏西利联合内分泌治疗HR+/HER2−晚期乳腺癌患者的疗效及安全性。方法回顾性分析2018年9月15日至2020年10月30日本中心83例采用哌柏西利联合内分泌治疗的HR+/HER2−晚期乳腺癌患者的临床资料,评估其临床疗效、无进展生存期(PFS)及不良反应。结果共纳入的83例HR+/HER2-晚期乳腺癌患者,中位随访时间为15.5个月,一线(n=25)和二线(n=38)采用哌柏西利联合内分泌治疗患者的ORR高于多线治疗患者(n=20),但差异无统计学意义(48.0%vs 44.7%vs 30.0%,P=0.466),3组患者的疾病控制率差异也无统计学意义(96.0%vs 89.5%vs 80.0%,P=0.337)。哌柏西利联合组全人群mPFS为13.0个月(95%CI:11.4~14.6个月),一线/二线治疗患者的mPFS较多线治疗患者延长(20.0个月vs 14.0个月vs 5.0个月,P<0.001),仅有骨转移的患者mPFS优于非骨转移患者(未达到vs 13.0个月;HR=0.42,95%CI:0.22~0.84,P=0.01);无内脏转移患者的mPFS优于存在内脏转移患者,但差异无统计学意义(20.0个月vs 13.0个月;HR=0.65,95%CI:0.35~1.22,P=0.38)。依维莫司联合内分泌治疗耐药患者应用哌柏西利治疗仍可获益(mPFS=5个月)。83例患者采用哌柏西利联合治疗后常见和严重的不良反应均为中性粒细胞减少,其中12例因不良反应下调剂量。结论哌柏西利联合内分泌治疗HR+/HER2-晚期乳腺癌患者的临床疗效显著,尤其是一/二线治疗取得较好疗效,安全性良好。

ObjectiveTo evaluate the efficacy and safety of Palbociclib combined with endocrine therapy for HR+/HER2-advanced breast cancer(ABC).MethodsThe clinical data of 83 patients with HR+/HER2-ABC in our center from September 15,2018 to October30,2020 were retrospectively analyzed to evaluate the clinical efficacy,progression-free survival(PFS)and adverse effects of Palbociclib combined with endocrine therapy.ResultsA total of 83 patients with HR+/HER2-ABC were enrolled and the median follow-up time was 15.5 months.The ORR of the first-line patients(n=25)and the second-line patients(n=38)received Palbociclib combined with endocrine therapy were higher than those of the multi-line patients(n=20),but the difference was not statistically significant(48.0%vs 44.7%vs30.0%,P=0.466),and there was no statistically significant difference in DCR among the three groups(96.0%vs 89.5%vs 80.0%,P=0.337).The median progression-free survival(mPFS)in the Palbociclib combined group was 13.0 months(95%CI:11.4 to 14.6 months),the firstline/the second-line patients had longer mPFS than the multi-line patients(20.0 months vs 14.0 months vs 5.0 months,P<0.001),and only the bone metastases patients had better mPFS than patients without bone metastases(NR months vs 13.0 months;HR=0.42,95%CI:0.22-0.84,P=0.01);mPFS in patients without visceral metastasis was better than those with visceral metastasis,but the difference was not statistically significant(20.0 months vs 13.0 months;HR=0.65,95%CI:0.35-1.22,P=0.38).Patients who were resistant to Everolimus combined with endocrine therapy still benefited from Palbociclib(mPFS=5 months).The most common and serious adverse effects of 83 patients received Palbociclib combined were neutropenia,among which 12 patients were dose-reduced due to adverse effects.ConclusionsPalbociclib combined with endocrine therapy for HR+/HER2-ABC patients has a significant clinical efficacy and good safety,especially the first-line/the second-line treatment has achienved good efficacy.