Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer: ARTemis Trial.
Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer: ARTemis Trial.
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DOI：
10.1093/annonc/mdx173
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发表时间：
2017-08-01
期刊：
影响因子：
--
通讯作者：
ARTemis Investigators Group
中科院分区：
文献类型：
--
作者：
Earl HM;Hiller L;Dunn JA;Blenkinsop C;Grybowicz L;Vallier AL;Gounaris I;Abraham JE;Hughes-Davies L;McAdam K;Chan S;Ahmad R;Hickish T;Rea D;Caldas C;Bartlett JMS;Cameron DA;Provenzano E;Thomas J;Hayward RL;ARTemis Investigators Group
ARTemis 试验此前报道，在 HER2 阴性乳腺癌中，在多西紫杉醇 (D) 中添加新辅助贝伐珠单抗 (Bev)，然后添加氟尿嘧啶、表柔比星和环磷酰胺 (D-FEC)，可提高病理完全缓解 (pCR) 率。我们通过中央病理学审查提供无病生存期（DFS）和总生存期（OS）。患者被随机分配接受 3 个周期的 D，随后接受 3 个周期的 FEC (D-FEC)，±4 个周期的 Bev (Bev + D-FEC)。通过治疗和中心病理学审查的 pCR 和残留癌症负担 (RCB) 类别来分析 DFS 和 OS。共有 800 名患者被随机分组[中位随访时间 3.5 年 (IQR 3.2–4.4)]。各治疗组的 DFS 和 OS 相似 [DFS 风险比 (HR)=1.18 (95% CI 0.89–1.57)，P = 0.25； OS HR = 1.26 (95% CI 0.90–1.76)，P = 0.19)。局部病理报告审查和中心组织病理学审查均证实，达到 pCR 的患者的 DFS 和 OS 显着改善 [DFS HR = 0.38 (95% CI 0.23–0.63)，P < 0.001； OS HR = 0.43 (95% CI 0.24–0.75)，P = 0.003]。然而，观察到显着的异质性（P = 0.02）；使用 D-FEC 实现的 pCR 比使用 Bev + D-FEC 实现的 pCR 获得了更大的 DFS 改进。随着 RCB 等级的增加，观察到 DFS 和 OS 显着恶化（趋势 P<0.0001），这种影响在 ER 阴性组中最为明显。在标准化疗中添加短程新辅助 Bev 并未显示出 DFS 或 OS 获益。使用 D-FEC 实现 pCR 与改善 DFS 和 OS 相关，但使用 Bev + D-FEC 实现 pCR 时则不然。因此，目前不建议在早期乳腺癌中使用 Bev。 NCT01093235。
The ARTemis trial previously reported that addition of neoadjuvant bevacizumab (Bev) to docetaxel (D) followed by fluorouracil, epirubicin and cyclophosphamide (D-FEC) in HER2 negative breast cancer improved the pathological complete response (pCR) rate. We present disease-free survival (DFS) and overall survival (OS) with central pathology review. Patients were randomized to 3 cycles of D followed by 3 cycles of FEC (D-FEC), ±4 cycles of Bev (Bev + D-FEC). DFS and OS were analyzed by treatment and by central pathology reviewed pCR and Residual Cancer Burden (RCB) class. A total of 800 patients were randomized [median follow-up 3.5 years (IQR 3.2–4.4)]. DFS and OS were similar across treatment arms [DFS hazard ratio (HR)=1.18 (95% CI 0.89–1.57), P = 0.25; OS HR = 1.26 (95% CI 0.90–1.76), P = 0.19). Both local pathology report review and central histopathology review confirmed a significant improvement in DFS and OS for patients who achieved a pCR [DFS HR = 0.38 (95% CI 0.23–0.63), P < 0.001; OS HR = 0.43 (95% CI 0.24–0.75), P = 0.003]. However, significant heterogeneity was observed (P = 0.02); larger improvements in DFS were obtained with a pCR achieved with D-FEC than a pCR achieved with Bev + D-FEC. As RCB class increased, significantly worse DFS and OS was observed (P for trend <0.0001), which effect was most marked in the ER negative group. The addition of short course neoadjuvant Bev to standard chemotherapy did not demonstrate a DFS or OS benefit. Achieving a pCR with D-FEC is associated with improved DFS and OS but not when pCR is achieved with Bev + D-FEC. At the present time therefore, Bev is not recommended in early breast cancer. NCT01093235.
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影响因子：
45.3
作者：
Sikov, William M.;Berry, Donald A.;Winer, Eric P.
通讯作者：
Winer, Eric P.
DOI：
10.1158/1078-0432.ccr-14-1760
发表时间：
2015-07-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
DeMichele A;Yee D;Berry DA;Albain KS;Benz CC;Boughey J;Buxton M;Chia SK;Chien AJ;Chui SY;Clark A;Edmiston K;Elias AD;Forero-Torres A;Haddad TC;Haley B;Haluska P;Hylton NM;Isaacs C;Kaplan H;Korde L;Leyland-Jones B;Liu MC;Melisko M;Minton SE;Moulder SL;Nanda R;Olopade OI;Paoloni M;Park JW;Parker BA;Perlmutter J;Petricoin EF;Rugo H;Symmans F;Tripathy D;van't Veer LJ;Viscusi RK;Wallace A;Wolf D;Yau C;Esserman LJ
通讯作者：
Esserman LJ
DOI：
10.1056/nejmoa1111097
发表时间：
2012-01-26
期刊：
The New England journal of medicine
影响因子：
--
作者：
Bear HD;Tang G;Rastogi P;Geyer CE Jr;Robidoux A;Atkins JN;Baez-Diaz L;Brufsky AM;Mehta RS;Fehrenbacher L;Young JA;Senecal FM;Gaur R;Margolese RG;Adams PT;Gross HM;Costantino JP;Swain SM;Mamounas EP;Wolmark N
通讯作者：
Wolmark N
影响因子：
82.9
作者：
Willett, CG;Boucher, Y;Jain, RK
通讯作者：
Jain, RK
影响因子：
158.5
作者：
Burger, Robert A.;Brady, Mark F.;Liang, Sharon X.
通讯作者：
Liang, Sharon X.