早期乳腺癌患者保乳手术＋靶向治疗后对区域淋巴结放疗的获益不大
早期乳腺癌患者保乳手术＋靶向治疗后对区域淋巴结放疗的获益不大...
2017年8月1日，牛津大学出版社旗下美国《国家癌症研究所杂志》将正式发表加拿大蒙特利尔圣心医院、英国苏格兰前沿科学、比利时布鲁塞尔自由大学、加拿大迈松内夫罗斯蒙特医院、瑞士诺华、以色列特拉维夫索拉斯基医疗中心、挪威奥斯陆大学、意大利克雷莫纳医院、奥地利维也纳医科大学、美国国家癌症研究所、华盛顿大学、约翰斯霍普金斯大学、凯斯西储大学、梅奥医院的研究报告，
该研究回顾分析了入组拉帕替尼和/或曲妥珠单抗辅助治疗优化（ALTTO）Ⅲ期研究并接受保乳手术治疗的1664例淋巴结阳性乳腺癌患者，其中878例（52.8%）接受了腋窝、锁骨上和/或内乳淋巴结RNI，检查了RNI对无病生存（DFS）的影响。针对阳性淋巴结数量、肿瘤大小和分级、年龄、激素受体状态、有否宏转移、治疗分组、化疗时间等影响因素，进行校正多变量比例风险模型（cox）回归分析，以调查RNI与DFS之间的相关性。
结果发现，RNI组患者淋巴结阳性率较高且肿瘤大于2cm较多。中位随访4.5年，RNI组、未RNI组的DFS率（84.3%、88.3%）、区域复发率（0.9%比0.6%）或总生存率（93.6%、95.3%）无显著差异。经多变量分析校正后，RNI与DFS无相关性（风险比：0.96，95%置信区间：0.71～1.29）。
因此，该分析未发现RNI对于保乳手术后接受辅助HER2靶向疗法的HER2阳性、淋巴结阳性患者有DFS获益。由于这是研究回顾分析，并非前瞻随机研究，接受RNI的患者可能病情本来相对较差，故有必要进一步随机临床研究检验RNI对HER2阳性乳腺癌的益处。
J Natl Cancer Inst. 2017 Aug 1;109(8):djw331.
Regional Nodal Irradiation After Breast Conserving Surgery for Early HER2-Positive Breast Cancer: Results of a Subanalysis From the ALTTO Trial.
Gingras I, Holmes E, De Azambuja E, Nguyen DH, Izquierdo M, Anne Zujewski J, Inbar M, Naume B, Tomasello G, Gralow JR, Wolff AC, Harris L, Gnant M, Moreno-Aspitia A, Piccart MJ, Azim HA Jr.
Hopital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada; Frontier Science (Scotland) Ltd., Kincraig, UK; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada; Novartis Pharma AG, Basel, Switzerland; National Cancer Institute, Bethesda, MD; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Oslo University Hospital, Oslo, Norway; University of Oslo, Oslo, Norway; Azienda Istituti Ospitalieri, Cremona, Italy; Seattle Cancer Care Alliance, University of Washington, Seattle, WA; Johns Hopkins University School of Medicine, Baltimore, MD; Case Western Reserve University, Cleveland, OH; Medical University of Vienna, Vienna, Austria; Mayo Clinic, Jacksonville, FL.
BACKGROUND: Two randomized trials recently demonstrated that regional nodal irradiation (RNI) could reduce the risk of recurrence in early breast cancer; however, these trials were conducted in the pretrastuzumab era. Whether these results are applicable to human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients treated with anti-HER2-targeted therapy is unknown.
METHODS: This retrospective analysis was performed on patients with node-positive breast cancer who were enrolled in the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization phase III adjuvant trial and subjected to BCS. The primary objective of the present study was to examine the effect of RNI on disease-free survival (DFS). A multivariable cox regression analysis adjusted for number of positive lymph nodes, tumor size, grade, age, hormone receptors status, presence of macrometastatis, treatment arm, and chemotherapy timing was carried out to investigate the relationship between RNI and DFS.
RESULTS: One thousand six hundred sixty-four HER2-positive breast cancer patients were included, of whom 878 (52.8%) had received RNI to the axillary, supraclavicular, and/or internal mammary lymph nodes. Patients in the RNI group had higher nodal burden and more frequently had tumors larger than 2 cm. At a median follow-up of 4.5 years, DFS was 84.3% in the RNI group and 88.3% in the non-RNI group. No differences in regional recurrence (0.9 % vs 0.6 %) or in overall survival (93.6% vs 95.3%) were observed between the two groups. After adjustment in multivariable analysis, there was no statistically significant association between RNI and DFS (hazard ratio=0.96, 95% confidence interval=0.71 to 1.29).
CONCLUSIONS: Our analysis did not demonstrate a DFS benefit of RNI in HER2-positive, node-positive patients treated with adjuvant HER2-targeted therapy. The benefit of RNI in HER2-positive breast cancer needs further testing within randomized clinical trials.
PMID: 28376188
DOI: 10.1093/jnci/djw331
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