紫杉醇新辅助化疗单周方案对比密集方案用于乳腺癌的疗效和安全性评价

Therapeutic efficacy and safety evaluation of weekly regimen versus intensive regimen of paclitaxel neoadjuvant chemotherapy in breast cancer

目的比较紫杉醇新辅助化疗单周方案与密集方案用于乳腺癌的疗效与安全性。方法回顾性分析2017年1月至2020年12月北京大学肿瘤医院乳腺癌预防治疗中心收治的249例乳腺癌患者资料,采用倾向性匹配评分后,按紫杉醇不同给药频次分为单周方案组(91例)和密集方案组(91例)。单周方案组患者给予注射用盐酸表柔比星90~100 mg/m^(2),静脉推注,d_(1)+注射用环磷酰胺600 mg/m^(2),静脉推注,d_(1),14 d为1周期;4个周期后序贯紫杉醇注射液80 mg/m^(2),静脉滴注,d_(1),每周1次,共12周。密集方案组患者给予注射用盐酸表柔比星(用法用量同单周方案组)+注射用环磷酰胺(用法用量同单周方案组),4个周期后序贯紫杉醇注射液175 mg/m^(2),静脉滴注,d_(1),14 d为1周期,共4个周期。化疗后24 h给予聚乙二醇化重组人粒细胞刺激因子注射液6 mg或化疗第4、6、8、10天给予人粒细胞刺激因子注射液0.3 mg。比较两组患者的临床疗效、病理完全缓解率(pCR)和不良反应发生情况。结果两组患者的有效率、无效率及pCR比较,差异均无统计学意义(P>0.05)。单周方案组年龄≥50岁、已绝经、人表皮生长因子受体2阴性患者的pCR均显著高于密集方案组(P<0.05)。密集方案组患者3级及以上中性粒细胞减少发生率显著低于单周方案组(P<0.05),两组患者的血红蛋白减少发生率、转氨酶升高发生率、周围神经毒性发生率比较,差异均无统计学意义(P>0.05)。结论在人表皮生长因子受体2阴性、年龄≥50岁及绝经后的乳腺癌患者中,紫杉醇单周化疗方案的pCR较高,但由于该方案的化疗间隔时间较短,未预防性使用升高白细胞的药物,故3级及以上中性粒细胞减少发生率较高。

OBJECTIVE To compare the efficacy and safety of weekly regimen versus intensive regimen of paclitaxel neoadjuvant chemotherapy for breast cancer.METHODS The data of 249 patients with breast cancer admitted to Breast Cancer Prevention and Treatment Center of Peking University Cancer Hospital from January 2017 to December 2020 were retrospectively analyzed.After matching with the propensity score matching method,they were divided into single-week regimen group(91 cases)and intensive regimen group(91 cases)according to the different administration frequencies of paclitaxel.The patients in single-week regimen group were given Epirubicin hydrochloride for injection 90-100 mg/m^(2),intravenous bolus,d_(1)+Cyclophosphamide for injection 600 mg/m^(2),intravenous bolus,d_(1),14 days as a cycle;after four cycles,they were given sequential injection of Paclitaxel injection 80 mg/m^(2),intravenous drip,d_(1),once a week,for 12 weeks.The patients in intensive regimen group were given Epirubicin hydrochloride for injection(same usage and dosage as single-week regimen group)+Cyclophosphamide for injection(same usage and dosage as single-week regimen group),after 4 cycles they were given sequential injection of Paclitaxel injection 175 mg/m^(2),intravenous drip,d_(1),14 days as a cycle,a total of 4 cycles;they were also given Polyethylene glycol recombinant human granulocyte stimulating factor injection 6 mg 24 hours after chemotherapy or 0.3 mg on the 4th,6th,8th and 10th day after chemotherapy.The clinical efficacy,pathologic complete remission rate(pCR)and the occurrence of adverse drug reactions were compared between two groups.RESULTS There were no significant difference in effective rate,ineffective rate and pCR between the two groups(P>0.05).The pCR of patients over 50 years old,menopause and negative for human epidermal growth factor receptor 2 in singleweek regimen group was significantly higher than intensive regimen group(P<0.05).The incidence of neutropenia of grade 3 and above in intensive regimen group was significantly lower than single-week regimen group(P<0.05).There was no significant difference in the incidence of decreased hemoglobin,increased transaminase and peripheral neurotoxicity between the two groups(P>0.05).CONCLUSIONS Among the breast cancer patients with negative for human epidermal growth factor receptor 2,over 50 years old and menopause,the pCR of single-week regimen of paclitaxel is high.However,because the chemotherapy interval of this scheme is short and the drugs that increase leukocytes are not used prophylactically,the incidence of neutropenia of grade 3 and above is high.