曲妥珠单抗和帕妥珠单抗联合不同化疗方案新辅助治疗HER-2阳性乳腺癌真实世界疗效及安全性观察

Neoadjuvant treatment of HER-2 positive breast cancer with trastuzumab plus pertuzumab combined with different chemotherapy regimens in real-world clinical practice: clinical efficacy and safety evaluation

    摘要
  • 摘要:
      目的  比较曲妥珠单抗和帕妥珠单抗（trastuzumab plus pertuzumab，HP）联合紫杉类+铂类（TCbHP）、紫杉类单药（THP）、蒽环类序贯紫杉类（AC-THP）三种化疗方案在真实世界临床实践中新辅助治疗HER-2阳性乳腺癌的疗效、安全性及耐受性。
      方法  回顾性分析2019年6月至2021年12月于保定市第一中心医院等河北省共11家三级甲等医院接受三种方案新辅助治疗并完成后续手术的180例HER-2阳性乳腺癌患者的临床病理资料，其中TCbHP组78例、THP组70例、AC-THP组32例，比较三种治疗方案的疗效、安全性及耐受性，并采用统计学方法分析临床病理因素对总体病理完全缓解（total pathologic complete response，tpCR）率的影响。
      结果  总人群tpCR率为58.9%（106/180）。TCbHP组的tpCR率为64.1%（50/78），高于THP组的54.3%（38/70）和AC-THP组的56.3%（18/32），差异无统计学意义（P=0.454）。TCbHP组的3级及以上不良反应发生率为12.8%（10/78），高于THP组的4.3%（3/70）和AC-THP组的9.4%（3/32），差异无统计学意义（P=0.255）。THP组的既定方案完成率为98.6%（69/70），高于TCbHP组的92.3%（72/78）和AC-THP组的90.6%（29/32），差异无统计学意义（P=0.147)。180例患者中绝经后组与绝经前组的tpCR率分别为65.4%（70/107）与49.3%（36/73），HER-2免疫组织化学法（IHC）3+组与HER-2 IHC2+且荧光原位杂交（FISH）+组的tpCR率分别为65.0%（102/157）与17.4%（4/23），激素受体（HR）阴性组与HR阳性组的tpCR率分别为78.0%（64/82）与42.9%（42/98），白蛋白结合型紫杉醇组与其他紫杉类药物组的tpCR率分别为66.3%（65/98）与50.0%（41/82），组间进行比较差异均具有统计学意义（均P<0.05）。Logistic回归多因素分析表明，HER-2 IHC3+、HR阴性、使用白蛋白结合型紫杉醇为tpCR率的独立影响因素。
      结论  TCbHP、THP、AC-THP方案新辅助治疗HER-2阳性乳腺癌在真实世界临床实践中疗效确切，安全性及耐受性良好。TCbHP方案可考虑作为HER-2阳性乳腺癌新辅助治疗的优选方案。

     

    Abstract:
      Objective  : To evaluate the efficacy, safety, and tolerability of trastuzumab plus pertuzumab (HP) combined with taxane + platinum (TCbHP), taxane (THP), and anthracycline sequential taxane (AC-THP) in the neoadjuvant therapy of HER-2 positive breast cancer in real-world clinical practice.
      Methods  A retrospective investigation was conducted on the clinicopathological data of 180 patients with HER-2 positive breast cancer who received one of the three regimens of neoadjuvant therapy and underwent the follow-up surgeries between June 2019 and December 2021 at 11 3A-grade hospitals, including Baoding NO.1 Central Hospital. Among the patients, 78, 70, and 32 were assigned to the TCbHP, THP, and AC-THP groups, respectively. The effectiveness, safety, and tolerability of the three regimens were compared in addition to examining the influence of clinicopathological factors on the total pathologic complete response (tpCR) rate.
      Results  The overall tpCR rate was 58.9% (106/180). The TCbHP group’s tpCR rate was 64.1% (50/78), which was higher than THP group’s 54.3% (38/70) and AC-THP group’s 56.3% (18/32), with no significant difference (P= 0.454). The incidence of ≥ grade 3 adverse reactions in the TCbHP group was 12.8% (10/78), which was higher than THP group’s 4.3% (3/70) and AC-THP group’s 9.4% (3/32), with no significant difference (P= 0.255). The THP group completed the given approaches at a rate of 98.6% (69/70), which was higher than TCbHP group’s 92.3% (72/78) and AC-THP group’s 90.6% (29/32), with no significant difference (P= 0.147). The tpCR rates of the 180 patients were 65.4% (70/107) and 49.3% (36/73) in the postmenopausal and premenopausal groups, respectively. In the HER-2 immunohistochemistry (IHC) 3+ group and HER-2 IHC2+ fluorescence in situ hybridization+ group, the tpCR rates were 65.0% (102/157) and 17.4% (4/23), respectively. The hormone receptor (HR)-negative and -positive groups had tpCR rates of 78.0% (64/82) and 42.9% (42/98), respectively. The tpCR rates were 66.3% (65/98) and 50.0% (41/82) in the albumin-bound paclitaxel group and other paclitaxel drug group, respectively. The differences between groups were significant (all P<0.05). Multivariate Logistic regression multivariate analysis revealed that HER-2 IHC3+, HR negative, and administered albumin-bound paclitaxel were independent factors affecting the tpCR rate.
      Conclusions  Neoadjuvant TCbHP, THP, and AC-THP therapy for HER-2-positive breast cancer is effective, safe, and well tolerated in real-world clinical practice. The TCbHP regimen can be considered the preferred neoadjuvant treatment for HER-2-positive breast cancer.

     

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