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贝伐单抗联合新辅助化疗治疗乳腺癌
Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer


Harry D. Bear ... 肿瘤 • 2012.01.26
相关阅读
• 需要化疗的乳腺癌患者较少 • 贝伐珠单抗作为三阴性乳腺癌的辅助疗法 • 术前化疗后乳腺癌的卡培他滨辅助治疗

摘要


背景

贝伐单抗与抗代谢药物卡培他滨或吉西他滨联合紫杉类的化疗方案可以提高转移性乳腺癌患者的结局。本临床试验的目的,一是在于探索在新辅助化疗中,使用卡培他滨或吉西他滨联合多西他赛,随后使用多柔比星联合环磷酰胺的方案,是否能够使可手术且人表皮生长因子受体2(HER2)阴性的乳腺癌患者达到病理完全缓解率增加;二是研究以上化疗方案中加入贝伐单抗联用能否提高病理完全缓解率。

 

方法

我们将1,206位患者随机分配到各新辅助化疗组,第1组为多西他赛(100 mg/m2身体表面积,第1天),第2组为多西他赛(75 mg/m2,第1天)和卡培他滨(825 mg/m2,每天2次,第1~14天),第3组为多西他赛(75 mg/m2,第1天)和吉西他滨(1,000 mg/m2,第1天和第8天)。所有组的患者分别接受4个周期以上方案治疗后,再进行4个周期的多柔比星联合环磷酰胺化疗。同时,患者随机分组,在前6个化疗周期中接受或不接受贝伐单抗(15 mg/kg体重)治疗。

 

结果

与多西他赛单药治疗相比,多西他赛与卡培他滨或吉西他滨联合方案不能显著提高病理完全缓解率(缓解率分别为29.7% [联合卡培他滨]、31.8% [联合吉西他滨]、32.7%[单药治疗];P=0.69)。卡培他滨和吉西他滨都与毒性反应增加相关,特别是手足综合征、黏膜炎和中性粒细胞减少。加入贝伐单抗能显著提高病理完全缓解率(未使用贝伐单抗为28.2%,使用贝伐单抗为34.5%;P=0.02)。贝伐单抗对病理完全缓解率的影响在激素受体阳性和阴性的患者中并不相同。加入贝伐单抗增加了高血压、左心室收缩异常、手足综合征和黏膜炎的发病率。

 

结论

乳腺癌新辅助化疗中加入贝伐单抗可以显著提高病理完全缓解率,这也是本研究的主要研究终点(由美国国立癌症研究所[National Cancer Institute]等资助;ClinicalTrials.gov注册号为NCT00408408)。





作者信息

Harry D. Bear, M.D., Ph.D., Gong Tang, Ph.D., Priya Rastogi, M.D., Charles E. Geyer, Jr., M.D., André Robidoux, M.D., James N. Atkins, M.D., Luis Baez-Diaz, M.D., Adam M. Brufsky, M.D., Ph.D., Rita S. Mehta, M.D., Louis Fehrenbacher, M.D., James A. Young, M.D., Francis M. Senecal, M.D., Rakesh Gaur, M.D., M.P.H., Richard G. Margolese, M.D., C.M., Paul T. Adams, M.D., Howard M. Gross, M.D., Joseph P. Costantino, Dr.P.H., Sandra M. Swain, M.D., Eleftherios P. Mamounas, M.D., and Norman Wolmark, M.D.
From the National Surgical Adjuvant Breast and Bowel Project (NSABP) (H.D.B., G.T., P.R., C.E.G., A.R., J.N.A., L.B.-D., A.M.B., R.S.M., L.F., J.A.Y., F.M.S., R.G., R.G.M., P.T.A., H.M.G., J.P.C., S.M.S., E.P.M., N.W.); the NSABP Biostatistical Center and the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (G.T., J.P.C.); University of Pittsburgh Cancer Institute, University of Pittsburgh (P.R., A.M.B.); and Allegheny General Hospital (N.W.) — all in Pittsburgh; Medical College of Virginia School of Medicine and the Massey Cancer Center, Virginia Commonwealth University, Richmond (H.D.B.); University of Texas Southwestern Medical Center, Dallas (C.E.G.); Centre Hospitalier de l'Université de Montréal (A.R.) and Jewish General Hospital, McGill University (R.G.M.) — both in Montreal; South East Cancer Control Consortium Community Clinical Oncology Program (CCOP), Goldsboro, NC (J.N.A.); Minority-Based CCOP, San Juan, Puerto Rico (L.B.-D.); University of California at Irvine, Orange (R.S.M.); Kaiser Permanente Oncology Clinical Trials, Northern California, Vallejo, CA (L.F.); Colorado Cancer Research Program, Colorado Springs (J.A.Y.); Northwest Medical Specialties, Tacoma, WA (F.M.S.); CCOP, Kansas City, MO (R.G.); Genesys Regional Medical Center, Grand Blanc, MI (P.T.A.); CCOP, Dayton (H.M.G.), and Aultman Hospital Cancer Center, Canton (E.P.M.) — both in Ohio; and Washington Cancer Institute, Medstar Washington Hospital Center, Washington, DC (S.M.S.). Address reprint requests to Dr. Bear at Box 980011, Division of Surgical Oncology, VCUHS, Richmond, VA 23298-0011, or at hdbear@vcu.edu.

 

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