目的:本研究旨在研究低剂量阿帕替尼联合化疗在转移性三阴性乳腺癌(TNBC)患者临床治疗中的有效性和安全性。同时将结果与仅接受化疗的患者进行比较。
方法:本病例系列研究分析了163例转移性TNBC患者的临床资料和治疗结果,这些患者在临床肿瘤内科接受了抢救治疗,福建省肿瘤医院,福建医科大学学院,中国,2011年10月至2023年1月。所有患者均接受单独化疗或阿帕替尼(250mg/天)联合化疗的抢救治疗。该研究的主要结果是无进展生存期(PFS),而次要结局包括总生存期(OS),客观反应率(ORR),疾病控制率(DCR),和安全概况。
结果:该研究旨在比较两组[1]。在参加这项研究的163名TNBC患者中,107人(65.6%)接受了基于化疗的治疗,而56例患者(34.4%)接受了低剂量阿帕替尼(250mg/天)和其他治疗的联合治疗,包括化疗.在倾向得分匹配(PSM)之后,接受阿帕替尼治疗的晚期三阴性乳腺癌(TNBC)患者的客观缓解率(ORR)和疾病控制率(DCR)分别为50.0和90.0%,分别,分别为6.7%和20.0%,分别,化疗组(P<0.001)。与接受化疗的组相比,接受基于阿帕替尼的治疗组的PFS和OS均表现出优异的结果。阿帕替尼组的中位PFS和OS分别为7.8和20.3个月,分别,虽然他们只有2.2个月和9.0个月,分别,对于以化疗为基础的组(P<0.001)[2]。接受组合疗法的患者,包括PD-1抑制剂,被排除在外。总的来说,97例患者单独接受化疗,而34例患者接受阿帕替尼联合化疗治疗。在倾向得分匹配(PSM)之后,接受组合疗法的全组的ORR和DCR分别为44.4%和81.5%,分别,而分别为11.1%和22.2%,分别,对于单独化疗组(P<0.001)。在整个人群的PFS和OS方面,接受阿帕替尼和化疗的组比仅接受化疗的组显着优势。发现PFS为7.8个月,而为2.1个月(P<0.001),OS为21.1个月,而为9.0个月(P<0.001)。阿帕替尼联合化疗致3/4级血液学毒性,包括中性粒细胞减少症(8.8%)和血小板减少症(2.9%)。此外,通常观察到非血液毒性,如手足综合征(35.3%),蛋白尿(26.5%),高血压(61.8%),丙氨酸转氨酶水平较高(26.5%),和疲劳(35.3%)。最常见的非血液学3/4级毒性是手足综合征(2.9%)和高血压(5.9%)。该研究没有报告任何致命的不良反应。
结论:事实证明,低剂量阿帕替尼联合化疗治疗转移性三阴性乳腺癌(TNBC)比单独化疗更有效。此外,与推荐剂量的阿帕替尼相比,3/4级非血液学毒性的发生率显著降低.
OBJECTIVE: This investigation sought to examine the efficacy and safety of low-dose apatinib used alongside chemotherapy in the clinical management of patients with metastatic triple-negative breast cancer (TNBC) within a real-world setting, whilst comparing the outcomes with those treated solely with chemotherapy.
METHODS: This case series study analyzed clinical data and treatment outcomes of 163 patients with metastatic TNBC who underwent rescue treatment at the Medical Oncology Department of Clinical Oncology, Fujian Cancer Hospital, School of Fujian Medical University,
China, between October 2011 and January 2023. All the patients underwent rescue treatment with either chemotherapy alone or apatinib (250 mg/day) combined with chemotherapy. The study\'s primary outcome was progression-free survival (PFS), whereas the secondary outcomes included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety profiles.
RESULTS: The study was designed to compare two groups [1]. Out of the 163 TNBC patients who participated in the study, 107 individuals (65.6%) received treatment based on chemotherapy, whereas 56 patients (34.4%) were given treatment based on a combination of low-dose apatinib (250 mg/day) and other treatments, including chemotherapy. After propensity score matching (PSM), the objective response rate (ORR) and disease control rate (DCR) of patients with advanced triple-negative breast cancer (TNBC) who received apatinib-based treatment were 50.0 and 90.0%, respectively, while they were 6.7 and 20.0%, respectively, for the chemotherapy-based group (P < 0.001). The group that received apatinib-based treatment showed superior results in both PFS and OS compared to the group that received chemotherapy. The median PFS and OS for the apatinib-based group were 7.8 and 20.3 months, respectively, while they were only 2.2 months and 9.0 months, respectively, for the chemotherapy-based group (P < 0.001) [2]. Patients who were administered combo therapies, including PD-1 inhibitors, were excluded. In total, 97 patients received chemotherapy alone, while 34 patients were treated with apatinib in combination with chemotherapy. After propensity score matching (PSM), the ORR and DCR for the total group who received combo therapies were 44.4 and 81.5%, respectively, while they were 11.1 and 22.2%, respectively, for the chemotherapy alone group (P < 0.001). The group receiving both apatinib and chemotherapy displayed notable advantages over the group solely receiving chemotherapy in regards to PFS and OS for the entirety of the population. The PFS was found to be 7.8 months in comparison to 2.1 months (P < 0.001) and the OS was 21.1 months in contrast to 9.0 months (P < 0.001). Apatinib combined with chemotherapy induced grade 3/4 hematological toxicities, including neutropenia (8.8%) and thrombocytopenia (2.9%). Additionally, non-hematological toxicities were commonly observed, such as Hand-foot syndrome (35.3%), proteinuria (26.5%), hypertension (61.8%), higher alanine aminotransferase levels (26.5%), and fatigue (35.3%). The most frequent non-hematological grade 3/4 toxicities were Hand-foot syndrome (2.9%) and hypertension (5.9%). The study did not report any fatal adverse effects.
CONCLUSIONS: The combination of low-dose apatinib with chemotherapy has proven to be more effective than chemotherapy alone in treating metastatic triple-negative breast cancer (TNBC). Additionally, the occurrence of grade 3/4 non-hematologic toxicities was significantly lower compared to the recommended dose of apatinib.