■这项研究的目的是比较在先前接受过蒽环类和紫杉烷治疗的转移性乳腺癌患者中,utidelone联合卡培他滨用于一线或二线以上治疗的疗效和安全性。同时,我们比较了依替德隆联合卡培他滨与长春瑞滨联合顺铂一线治疗转移性乳腺癌的疗效.
■回顾性队列研究了11例转移性乳腺癌患者,这些患者此前曾接受过蒽环类和紫杉烷(包括新辅助和辅助疗法)治疗,并接受了utidelone联合卡培他滨的一线治疗,32例二线或以上患者,收集了2011年10月至2022年8月期间接受长春瑞滨加顺铂治疗的60例患者.第1组和第2组均采用依替德隆联合卡培他滨治疗,第三组采用长春瑞滨加顺铂治疗。主要终点是无进展生存期(PFS),次要终点是总生存期(OS),客观反应率(ORR),和治疗安全。
■到2023年3月31日,在晚期一线治疗中,utidelone加卡培他滨组的中位PFS达到11.70个月(95%CI0.093-0.141),与二线或以上治疗的5.60个月(95%CI0.025-0.079)相比[HR0.42,(95%CI0.226-0.787),P=0.0077]。在utidelone加卡培他滨中,在先进的一线治疗中未达到中位OS,平均总生存期为23.16个月(95%CI0.198-0.265);而二线或以上治疗的中位OS为19.50个月(95%CI0.083-0.307),平均总生存期为16.89个月(95%CI0.136-0.202)[HR0.26,(95%CI0.098-0.678),P=0.0495]。晚期一线治疗的ORR为27.27%(95CI0.060,0.610),二线及以上治疗的ORR为15.63%(95CI0.053,0.328)。在先进的一线治疗中,依替德隆联合卡培他滨优于长春瑞滨联合顺铂,中位PFS为6.12个月(95%CI0.051-0.072)[HR0.49,(95%CI0.286-0.839),P=0.0291]。与依替隆加卡培他滨相比,长春瑞滨加顺铂晚期一线治疗组的中位OS为35.37个月(95%CI0.258-0.449),平均总生存期为40.79个月(95%CI0.315-0.501)[HR0.54,(95%CI0.188-1.568),P=0.2587]。长春瑞滨加顺铂的ORR为18.33%(95%CI0.095,0.304)。我们研究中最常见的不良事件是神经毒性,手足综合征,血液学毒性,胃肠道毒性,肝肾功能异常.在依替德隆加卡培他滨治疗期间,没有因不良反应而死亡。
■在MBC中,utidelone联合卡培他滨的一线治疗可获得更有利的PFS,操作系统,和ORR比二线或以上治疗。在先进的一线治疗中,utidelone联合卡培他滨的PFS较好,和ORR与长春瑞滨加顺铂相比。这项研究得出结论,在晚期一线MBC中,utidelone加卡培他滨是更有价值的化疗方案。
UNASSIGNED: The purpose of this
study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and
vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer.
UNASSIGNED: A retrospective cohort of 11 patients with metastatic breast cancer previously treated with anthracycline and taxane (including neoadjuvant and adjuvant therapies) for advanced first-line with utidelone plus capecitabine, 32 patients treated with second-line or above, and 60 patients with vinorelbine plus cisplatin between October 2011 and August 2022 was collected. The first and second groups were treated with utidelone plus capecitabine, and the third group was treated with vinorelbine plus cisplatin. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), objective response rate (ORR), and treatment safety.
UNASSIGNED: By 03/31/2023, median PFS reached 11.70 months (95 % CI 0.093-0.141) in utidelone plus capecitabine group in the advanced first-line therapy, compared to 5.60 months (95 % CI 0.025-0.079) in the second-line or above therapy [HR 0.42, (95 % CI 0.226-0.787), P = 0.0077]. In utidelone plus capecitabine, the median OS was not reached in the advanced first-line therapy, with a mean overall survival of 23.16 months (95 % CI 0.198-0.265); whereas the median OS in the second-line or above therapy was 19.50 months (95 % CI 0.083-0.307), with a mean overall survival of 16.89 months (95 % CI 0.136-0.202) [HR 0.26, (95 % CI 0.098-0.678), P = 0.0495]. The ORR for advanced first-line therapy was 27.27 % (95%CI 0.060, 0.610) compared with 15.63 % (95%CI 0.053, 0.328) for second-line or above. In advanced first-line therapy, utidelone plus capecitabine was superior to vinorelbine plus cisplatin with a median PFS of 6.12 months (95 % CI 0.051-0.072) [HR 0.49, (95 % CI 0.286-0.839), P = 0.0291]. Compared with utidelone plus capecitabine, the median OS in vinorelbine plus cisplatin advanced first-line therapy group was 35.37 months (95 % CI 0.258-0.449), and the mean overall survival was 40.79 months (95 % CI 0.315-0.501) [HR 0.54, (95 % CI 0.188-1.568), P = 0.2587]. The ORR for
vinorelbine plus cisplatin was 18.33 % (95 % CI 0.095, 0.304). The most common adverse events in our
study were neurological toxicity, hand-foot syndrome, hematological toxicity, gastrointestinal toxicity, and hepatic and renal function abnormalities. There were no deaths due to adverse effects during the utidelone plus capecitabine treatment period.
UNASSIGNED: In MBC, advanced first-line therapy with utidelone plus capecitabine resulted in more favorable PFS, OS, and ORR than second-line or above therapy. In advanced first-line therapy, utidelone plus capecitabine had superior PFS, and ORR compared with vinorelbine plus cisplatin. This
study concludes that utidelone plus capecitabine is a more valuable chemotherapy option in advanced first-line MBC.