Bayo Juan, Aviñó Victoria, Toscano Fátima, Jiménez Francisco
Department of Medical Oncology, Complejo Hospitalario de Huelva, Huelva, Spain.
Breast J. 2018 Jul;24(4):462-467. doi: 10.1111/tbj.12927. Epub 2017 Dec 5.
While the docetaxel, carboplatin, and trastuzumab (TCH) regimen is one of the standard treatments in Her2-positive breast cancer, however, acute toxicities, especially those related to the high rate of neutropenia are consistently reported. Primary: To compare the toxicity of TCH in current clinical practice vs the toxicity observed in the pivotal study, comparing the toxicity in patients that received primary prophylaxis (PP) with colony-stimulating factors vs those that did not receive PP. Secondary: To describe the demographic and clinical characteristics of the study sample, as well as the adverse effects and survival. The data regarding 95 patients were analyzed. Observed toxicity (hematological and extra-hematological) was greater compared to the pivotal study, with the exception of neuropathy and neutropenia. Toxicities "PP" vs "no PP": Extra-hematological grade 3-4 toxicities: Significant reduction was observed in the "PP" group vs the "no PP" group referred to fatigue, stomatitis, nausea, and vomiting. Hematological grade 3-4 toxicities: Lesser neutropenia, leukopenia, and febrile neutropenia were observed in the "PP" group. Complications associated to treatment: No grade 3-4 cardiac toxicity, leukemia or deaths were recorded. DFS and OS: After a mean follow-up of 22.9 months, only one bone metastatic relapse was detected (DFS: 98.9%; OS: 100%). The combination TCH is very active and effective as adjuvant and neo-adjuvant therapy in Her2-positive breast cancer, and is currently regarded as standard treatment. However, global toxicity as well as hematological toxicity is elevated. The incorporation of PP to TCH significantly reduces hematological toxicity and some of the global toxicity, thus favoring treatment implementation and lessening the clinical complications. We therefore recommend generalization of PP with colony-stimulating factors in patients receiving TCH.
虽然多西他赛、卡铂和曲妥珠单抗（TCH）方案是Her2阳性乳腺癌的标准治疗方案之一，但一直有急性毒性反应的报道，尤其是与高发生率的中性粒细胞减少相关的毒性反应。主要目的：比较当前临床实践中TCH的毒性与关键研究中观察到的毒性，比较接受集落刺激因子一级预防（PP）的患者与未接受PP的患者的毒性。次要目的：描述研究样本的人口统计学和临床特征，以及不良反应和生存率。分析了95例患者的数据。与关键研究相比，观察到的毒性（血液学和血液外毒性）更大，但神经病变和中性粒细胞减少除外。“PP”组与“无PP”组的毒性：血液外3-4级毒性：在“PP”组中，与“无PP”组相比，疲劳、口腔炎、恶心和呕吐等毒性反应显著降低。血液学3-4级毒性：“PP”组中观察到的中性粒细胞减少、白细胞减少和发热性中性粒细胞减少较少。与治疗相关的并发症：未记录到3-4级心脏毒性、白血病或死亡病例。无病生存期（DFS）和总生存期（OS）：平均随访22.9个月后，仅检测到1例骨转移复发（DFS：98.9%；OS：100%）。TCH联合方案作为Her2阳性乳腺癌的辅助和新辅助治疗非常有效，目前被视为标准治疗方案。然而，总体毒性以及血液学毒性有所升高。在TCH方案中加入PP可显著降低血液学毒性和部分总体毒性，从而有利于治疗的实施并减少临床并发症。因此，我们建议在接受TCH治疗的患者中推广使用集落刺激因子进行一级预防。
