O'Sullivan Ciara C, Bradbury Ian, Campbell Christine, Spielmann Marc, Perez Edith A, Joensuu Heikki, Costantino Joseph P, Delaloge Suzette, Rastogi Priya, Zardavas Dimitrios, Ballman Karla V, Holmes Eileen, de Azambuja Evandro, Piccart-Gebhart Martine, Zujewski Jo Anne, Gelber Richard D
Ciara C. O'Sullivan and Jo Anne Zujewski, National Cancer Institute, Bethesda, MD; Ian Bradbury, Christine Campbell, and Eileen Holmes, Frontier Science, Inverness-shire, Scotland; Marc Spielmann and Suzette Delaloge, Institut de Cancérologie Gustave Roussy, Villejuif, France; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Heikki Joensuu, Helsinki University Hospital and University of Helsinki, Helsinki, Finland; Joseph P. Costantino and Priya Rastogi, University of Pittsburgh, Pittsburgh, PA; Dimitrios Zardavas, Breast International Group; Karla V. Ballman, Mayo Clinic, Rochester, MN; Evandro de Azambuja and Martine Piccart-Gebhart, Institut Jules Bordet and L'Université Libre de Bruxelles, Brussels, Belgium; and Richard D. Gelber, Harvard Medical School, Harvard T.H. Chan School of Public Health, Dana-Farber Cancer Institute, and Frontier Science and Technology Research Foundation, Boston, MA. ciara.o'
Ciara C. O'Sullivan and Jo Anne Zujewski, National Cancer Institute, Bethesda, MD; Ian Bradbury, Christine Campbell, and Eileen Holmes, Frontier Science, Inverness-shire, Scotland; Marc Spielmann and Suzette Delaloge, Institut de Cancérologie Gustave Roussy, Villejuif, France; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Heikki Joensuu, Helsinki University Hospital and University of Helsinki, Helsinki, Finland; Joseph P. Costantino and Priya Rastogi, University of Pittsburgh, Pittsburgh, PA; Dimitrios Zardavas, Breast International Group; Karla V. Ballman, Mayo Clinic, Rochester, MN; Evandro de Azambuja and Martine Piccart-Gebhart, Institut Jules Bordet and L'Université Libre de Bruxelles, Brussels, Belgium; and Richard D. Gelber, Harvard Medical School, Harvard T.H. Chan School of Public Health, Dana-Farber Cancer Institute, and Frontier Science and Technology Research Foundation, Boston, MA.
J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.
We compared efficacy of trastuzumab versus no trastuzumab in patients with small (≤ 2 cm) human epidermal growth factor receptor 2 (HER2) -positive breast cancer treated in randomized trials.
A meta-analysis was conducted using data from five of the six adjuvant trastuzumab trials. Efficacy end points were disease-free survival (DFS) and overall survival (OS). Separate analyses were prospectively planned for hormone receptor (HR) -positive and HR-negative cohorts. Random effect models and Yusuf-Peto fixed effects models assessed the impact of heterogeneity on baseline hazards and treatment effects across studies. Peto-Pike cumulative incidence estimates were stratified by study and nodal status.
Median follow-up time was 8 years. For 2,263 patients with HR-positive disease, 8-year cumulative incidence rates comparing trastuzumab versus no trastuzumab were 17.3% versus 24.3% (P < .001) for DFS and 7.8% versus 11.6% (P = .005) for OS, respectively; for 1,092 HR-positive patients with zero or one positive lymph nodes, results were 12.7% versus 19.4% (P = .005) for DFS and 5.3% versus 7.4% (P = .12) for OS, respectively. For 1,957 patients with HR-negative disease, 8-year cumulative incidence rates were 24.0% versus 33.4% (P < .001) for DFS and 12.4% versus 21.2% (P < .001) for OS, respectively; for 1,040 HR-negative patients with zero or one positive lymph nodes, results were 20.4% versus 26.3% (P = .05) for DFS and 8.2% versus 12.2% (P = .084) for OS, respectively.
Women with HER2-positive tumors ≤ 2 cm in the randomized trastuzumab trials derived substantial DFS and OS benefit from adjuvant trastuzumab. Trastuzumab-treated patients with HR-positive disease and ≤ one positive lymph node may be candidates for trials assessing less aggressive treatment approaches.
我们比较了在随机试验中接受治疗的小（≤2厘米）人表皮生长因子受体2（HER2）阳性乳腺癌患者中，曲妥珠单抗与不使用曲妥珠单抗的疗效。
使用六项辅助曲妥珠单抗试验中的五项数据进行荟萃分析。疗效终点为无病生存期（DFS）和总生存期（OS）。对激素受体（HR）阳性和HR阴性队列进行了前瞻性计划的单独分析。随机效应模型和Yusuf-Peto固定效应模型评估了异质性对各研究基线风险和治疗效果的影响。Peto-Pike累积发病率估计按研究和淋巴结状态分层。
中位随访时间为8年。对于2263例HR阳性疾病患者，曲妥珠单抗与不使用曲妥珠单抗相比，8年DFS累积发病率分别为17.3%和24.3%（P<.001），OS累积发病率分别为7.8%和11.6%（P=.005）；对于1092例HR阳性且零个或一个阳性淋巴结的患者，DFS结果分别为12.7%和19.4%（P=.005），OS结果分别为5.3%和7.4%（P=.12）。对于1957例HR阴性疾病患者，8年DFS累积发病率分别为24.0%和33.4%（P<.001），OS累积发病率分别为12.4%和21.2%（P<.001）；对于1040例HR阴性且零个或一个阳性淋巴结的患者，DFS结果分别为20.4%和26.3%（P=.05），OS结果分别为8.2%和12.2%（P=.084）。
在随机曲妥珠单抗试验中，HER2阳性肿瘤≤2厘米的女性从辅助曲妥珠单抗中获得了显著的DFS和OS益处。接受曲妥珠单抗治疗的HR阳性疾病且阳性淋巴结≤一个的患者可能是评估侵袭性较小治疗方法试验的候选者。
