Alagizy H A, Shehata M A, Hashem T A, Abdelaziz K K, Swiha M M
Clinical Oncology Department, Faculty of Medicine, Menofia University, Egypt.
Clinical Oncology Department, Faculty of Medicine, Menofia University, Egypt.
Hematol Oncol Stem Cell Ther. 2015 Mar;8(1):22-7. doi: 10.1016/j.hemonc.2014.11.003. Epub 2014 Nov 26.
High interest in triple-negative breast cancers is not surprising as this category of patients benefits neither from hormonal therapies nor from anti HER2 treatments. Blockade of angiogenesis by metronomic chemotherapy as well as other antiangiogenics might improve outcomes in this group of patients. This study aims to evaluate the tolerability and efficacy of metronomic capecitabine as extended adjuvant treatment for women with triple-negative breast cancer.
This is a prospective phase II study that included 41 patients diagnosed with triple-negative breast cancer and who were indicated for adjuvant chemotherapy. They received capecitabine 500mg PO twice daily and continuously for six months after finishing six cycles of adjuvant FEC100±postoperative radiotherapy.
Forty-one patients were enrolled in this study between June 2010 and December 2013. Median age was 50years ranging from 27 to 67years. Treatment was well tolerated. Adverse effects were grade 1 palmar-plantar erythrodysesthesia in 13 patients (31.7%); grade 1 diarrhea in five patients (12.2%); and grade 1 vomiting in two patients (4.9%). Estimated median follow-up duration was 34 months. Estimated mean disease-free survival (DFS) was 42.4months (95% CI, 39.02-45.79), while median DFS was not reached. Estimated mean overall survival was 44.34months (95% CI 41.9-46.9).
Extended adjuvant metronomic capecitabine is well tolerated with patient compliance. These results need to be compared in a study with control arm, larger sample, as well as longer follow-up.
三阴性乳腺癌备受关注并不奇怪，因为这类患者既无法从激素疗法中获益，也无法从抗HER2治疗中获益。节拍化疗以及其他抗血管生成药物对血管生成的阻断作用可能会改善这类患者的预后。本研究旨在评估节拍性卡培他滨作为三阴性乳腺癌女性患者延长辅助治疗的耐受性和疗效。
这是一项前瞻性II期研究，纳入了41例被诊断为三阴性乳腺癌且适合接受辅助化疗的患者。在完成六个周期的辅助FEC100±术后放疗后，他们接受卡培他滨500mg口服，每日两次，持续六个月。
2010年6月至2013年12月期间，41例患者纳入本研究。中位年龄为50岁，范围在27至67岁之间。治疗耐受性良好。不良反应包括13例患者（31.7%）出现1级手足红斑感觉异常；5例患者（12.2%）出现1级腹泻；2例患者（4.9%）出现1级呕吐。估计中位随访时间为34个月。估计平均无病生存期（DFS）为42.4个月（95%CI，39.02 - 45.79），而中位DFS未达到。估计平均总生存期为44.34个月（95%CI 41.9 - 46.9）。
延长辅助性节拍性卡培他滨耐受性良好，患者依从性高。这些结果需要在一项设有对照组、样本量更大且随访时间更长的研究中进行比较。
