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對(duì)于早期三陰性乳腺癌患者，目前標(biāo)準(zhǔn)的術(shù)后輔助化療方案包括多西他賽等紫杉類藥物和表柔比星等蒽環(huán)類藥物，如果同時(shí)加入口服三步酶鏈轉(zhuǎn)換靶向化療藥物卡培他濱可能提高療效。不過，既往研究數(shù)據(jù)主要來自歐美晚期患者，缺乏有說服力的中國早期患者研究數(shù)據(jù)。 2020年4月10日，美國臨床腫瘤學(xué)會(huì)《臨床腫瘤學(xué)雜志》在線發(fā)表復(fù)旦大學(xué)附屬腫瘤醫(yī)院李俊杰、余科達(dá)、莫淼、邵志敏、哈爾濱醫(yī)科大學(xué)附屬第三醫(yī)院龐達(dá)、吉林省腫瘤醫(yī)院王長青、重慶西南醫(yī)院姜軍、甘肅省腫瘤醫(yī)院楊碎勝、河北醫(yī)科大學(xué)第四醫(yī)院劉運(yùn)江、浙江大學(xué)醫(yī)學(xué)院附屬第一醫(yī)院傅佩芬、上海長海醫(yī)院盛湲、汕頭大學(xué)醫(yī)學(xué)院附屬腫瘤醫(yī)院張國君、南昌市第三醫(yī)院曹亞麗、中國福利會(huì)國際和平婦幼保健院何奇、河南省腫瘤醫(yī)院崔樹德、西安交通大學(xué)第二附屬醫(yī)院王西京、重慶醫(yī)科大學(xué)附屬第一醫(yī)院任國勝、山西省腫瘤醫(yī)院李炘正、蘇州市立醫(yī)院俞士尤、廣東省中醫(yī)院劉鵬熙、首都醫(yī)科大學(xué)附屬北京友誼醫(yī)院屈翔、江蘇省腫瘤醫(yī)院唐金海、溫州醫(yī)科大學(xué)附屬第一醫(yī)院王甌晨、吉林大學(xué)第一醫(yī)院范志民、蘇州大學(xué)第二附屬醫(yī)院蔣國勤、天津醫(yī)科大學(xué)腫瘤醫(yī)院張瑾、解放軍總醫(yī)院王建東、復(fù)旦大學(xué)附屬中山醫(yī)院張宏偉、江蘇省人民醫(yī)院王水、哈爾濱醫(yī)科大學(xué)附屬第二醫(yī)院張建國、中國醫(yī)科大學(xué)附屬第一醫(yī)院金鋒、中山大學(xué)孫逸仙紀(jì)念醫(yī)院饒南燕、新疆醫(yī)科大學(xué)附屬腫瘤醫(yī)院馬斌林、上海市第六人民醫(yī)院何萍青、中國醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院徐兵河、上海市第一婦嬰保健院莊志剛、上海市第一人民醫(yī)院王建豐、北京協(xié)和醫(yī)院孫強(qiáng)等學(xué)者的中國乳腺癌臨床研究協(xié)作組CBCSG010研究5年隨訪結(jié)果，探討了將卡培他濱加入中國早期三陰性乳腺癌患者術(shù)后標(biāo)準(zhǔn)輔助化療方案的有效性和安全性。 CBCSG010 (Comparative Study on Two Post-operative Adjuvant Chemotherapy Regimens for Treating Triple-negative Breast Cancer): A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer (NCT01642771) 該全國多中心前瞻非盲隨機(jī)對(duì)照三期臨床研究于2012年6月～2013年12月從全國35家醫(yī)院入組早期三陰性乳腺癌手術(shù)切除后女性患者585例，按1∶1的比例隨機(jī)分為兩組：
隨機(jī)分組集中進(jìn)行，未行分層。主要研究終點(diǎn)為無病生存，次要研究終點(diǎn)包括無復(fù)發(fā)生存、無遠(yuǎn)處病變生存、總生存。 結(jié)果，中位隨訪67個(gè)月，卡培他濱組與標(biāo)準(zhǔn)化療組相比：
亞組分析表明，無論是否絕經(jīng)、淋巴結(jié)是否轉(zhuǎn)移、腫瘤大小、TNM分期高低、分級(jí)高低、增殖指數(shù)Ki-67高低，卡培他濱組與標(biāo)準(zhǔn)化療組相比，無病生存比例都較高。 總體而言，38.89%的患者卡培他濱減量，8.42%的患者報(bào)告≥3級(jí)手足綜合征。藥物安全數(shù)據(jù)符合卡培他濱已知安全特征，并且兩組患者大致相似?？ㄅ嗨麨I組與標(biāo)準(zhǔn)化療組相比，發(fā)生率最高的≥3級(jí)血液毒性反應(yīng)：
因此，該研究結(jié)果表明，對(duì)于早期三陰性乳腺癌術(shù)后患者，紫杉類＋蒽環(huán)類標(biāo)準(zhǔn)輔助化療方案±口服卡培他濱相比，5年無病生存比例顯著較高，而且未發(fā)生新的安全問題。  相關(guān)鏈接 J Clin Oncol. 2020 Apr 10. [Epub ahead of print] Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial. Li J, Yu K, Pang D, Wang C, Jiang J, Yang S, Liu Y, Fu P, Shen Y, Zhang G, Cao Y, He Q, Cui S, Wang X, Ren G, Li X, Yu S, Liu P, Qu X, Tang J, Wang O, Fan Z, Jiang G, Zhang J, Wang J, Zhang H, Wang S, Zhang J, Jin F, Rao N, Ma B, He P, Xu B, Zhuang Z, Wang J, Sun Q, Guo X, Mo M, Shao Z; CBCSG Study Group. Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Medical College, Fudan University, Shanghai, China; The Third Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China; Jilin Cancer Hospital and Institute, Changchun, Jilin, China; Southwest Hospital, Chongqing, Chongqing, China; Gansu Cancer Hospital, Lanzhou, Gansu, China; The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, China; The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Changhai Hospital of Shanghai, Shanghai, China; Cancer Hospital of Shantou Medical College, Shantou, Guangdong, China; The Third Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China; The International Peace Maternity and Child Health Hospital of China, Welfare Institute, Shanghai, China; Henan Cancer Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China; Medical College, The Second Affiliated Hospital of Xi'An Jiaotong University, Xi'an, Shanxi, China; The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China; Shanxi Cancer Hospital, Taiyuan, Shanxi, China; Eastern Hospital of Suzhou Municipal Hospital, Suzhou, Jiangsu, China; Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China; Beijing Friendship Hospital, Capital Medical University, Beijing, China; Jiangsu Cancer Hospital, Suzhou, Jiangsu, China; The First Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, China; The First Hospital of Jilin University, Changchun, Jilin, China; The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Tianjin Medical University Cancer Institute and Hospital, Tianjin, China; The General Hospital of the People's Liberation Army, Beijing, China; Zhongshan Hospital, Fudan University, Shanghai, China; Jiangsu Province Hospital, Suzhou, Jiangsu, China; The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China; The First Hospital of China Medical University, Shenyang, Liaoning, China; The Second Affiliated Hospital of Zhongshan University, Guangzhou, Guangdong, China; Xinjiang Cancer Hospital, Wulumuqi, Xinjiang, China; Shanghai Sixth People's Hospital, Shanghai, China; Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China; Shanghai First Maternity and Infant Hospital Corporation, Shanghai, China; Shanghai General Hospital, Shanghai, China; Peking Union Medical College Hospital, Beijing, China; Continuing Education and Technology Services Department, Chinese Anti-Cancer Association, Tianjin, China.
PURPOSE: Standard adjuvant chemotherapy for triple-negative breast cancer (TNBC) includes a taxane and an anthracycline. Concomitant capecitabine may be beneficial, but robust data to support this are lacking. The efficacy and safety of the addition of capecitabine into the TNBC adjuvant treatment regimen was evaluated. PATIENTS AND METHODS: This randomized, open-label, phase III trial was conducted in China. Eligible female patients with early TNBC after definitive surgery were randomly assigned (1:1) to either capecitabine (3 cycles of capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide). Randomization was centralized without stratification. The primary end point was disease-free survival (DFS). RESULTS: Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585 were randomly assigned to treatment (control, 288; capecitabine, 297). Median follow-up was 67 months. The 5-year DFS rate was higher for capecitabine than for control treatment (86.3% v 80.4%; hazard ratio, 0.66; 95% CI, 0.44 to 0.99; P = 0.044). Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%). Overall, 39.1% of patients had capecitabine dose reductions, and 8.4% reported grade ≥ 3 hand-foot syndrome. The most common grade ≥ 3 hematologic toxicities were neutropenia (capecitabine, 136 [45.8%]; control, 118 [41.0%]) and febrile neutropenia (capecitabine, 50 [16.8%]; control, 46 [16.0%]). Safety data were similar to the known capecitabine safety profile and generally comparable between arms. CONCLUSION: Capecitabine when added to 3 cycles of docetaxel followed by 3 cycles of a 3-drug anthracycline combination containing capecitabine instead of fluorouracil significantly improved DFS in TNBC without new safety concerns. PMID: 32275467 DOI: 10.1200/JCO.19.02474
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