[ASCO2016]中国研究:卡培他滨加入三阴性乳腺癌辅助治疗疗效

发布时间:2016-05-23 浏览次数:452次 来源: 作者:

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2016年美国临床肿瘤学会(ASCO)年会将于6月3日至7日在美国芝加哥举行。大会将以壁报形式公布一项由我国复旦大学附属肿瘤医院邵志敏教授团队进行的将卡培他滨加入三阴性乳腺癌辅助治疗的疗效和安全性研究(摘要号1012)。研究详情如下:


三阴性乳腺癌的标准辅助化疗方案包含紫杉烷和蒽环类药物。为了测定将卡培他滨加入三阴性乳腺癌的辅助治疗的疗效和安全性,复旦大学附属肿瘤医院邵志敏团队在中国的35家医疗机构开展了一项随机、开放标签的3期试验,招募了术后的早期三阴性乳腺癌女性。入组患者按1:1比例随机接受3个疗程的卡培他滨、多西他赛(TX),及随后三个疗程的环磷酰胺、表柔比星和卡培他滨(XEC),或接受三个疗程的多西他赛(T),及随后三个疗程的环磷酰胺、表柔比星和氟尿嘧啶(FEC)。研究的首要终点为无疾病生存(DFS)。


在2012年6月和2013年11月间,研究人员共评估了585例患者,卡培他滨组的288例患者及对照组的273例纳入了疗效和安全性意向治疗分析。两组的临床和病理特征相平衡。这两种方案的耐受性良好,最常见毒性为中性粒细胞减少,秃头症,神经病和手足综合征。卡培他滨组87.15%的患者及对照组89.75%的患者完成了6个疗程的化疗。38.89%的患者减少了卡培他滨的剂量。


在中位随访30个月后,两组的无疾病生存没有显著差异(90.58% vs 86.8%; p=0∙23)。然而,卡培他滨方案显示出更好的无复发生存(92.73% vs 87.84%, p=0.049),无远端转移生存(94.29% vs 89.27%, p=0.019)和总生存(97.4% vs 95.61%, p=0.063)。



研究结果表明,将卡培他滨加入标准化疗方案可减少三阴性乳腺癌的复发。临床试验信息:NCT01642771


摘要原文:


Cbcsg-10: Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for triple negative breast cancer.


Background: Standard adjuvant chemotherapy regimens for triple-negative breast cancer (TNBC) contain taxane and anthracycline. We aimed to investigate the efficacy and safety of integrate capecitabine in the adjuvant treatment of triple-negative patients.


Methods: For this randomized, open-label, phase 3 trial undertaken at 35 institutions or hospitals in China, we recruited women with early TNBC after surgery. Eligible patients were randomly assigned (1:1) using a central patient screening and randomization system to either three cycles of capecitabine and docetaxel (TX) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (XEC), or to three cycles of docetaxel (T) followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (FEC). The primary endpoint was disease-free survival (DFS). This trial is registered with ClinicalTrials.gov, number NCT01642771. 


Results: Between Jun, 2012, and Nov, 2013, 585 patients were assessed for eligibility and randomized. 288 patients in capecitabine group and 273 in control group were included in the intention-to-treat analysis for efficacy and safety. The clinical and pathological features were well balanced in two groups. Both regimen were well tolerated, the most common toxicities were neutropenia, alopecia, neuropathy and hand-foot-syndrome, 87.15% patients in the capecitabine group and 89.75% patients in the control group completed 6 cycles of chemotherapy. 38.89% patients had capecitabine dose reduction. After a median follow-up of 30 months, disease-free survival was not significantly different between the groups, (90.58% vs 86.8%; p=0∙23). However, capecitabine regimen showed better recurrence-free survival (92.73% vs 87.84%, p=0.049), distant-disease free survival (94.29% vs 89.27%, p=0.019) and overall survival (97.4% vs 95.61%, p=0.063). 


Conclusions: Integration of capecitabine into standard chemotherapy regimen reduced recurrence in TNBC. Clinical trial information: NCT01642771