Marco Colleoni and Aron Goldhirsch, European Institute of Oncology and International Breast Cancer Study Group, Milan; Lorenzo Gianni, Ospedale degli Infermi and Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Rimini, Italy; Zhuoxin Sun, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center and Frontier Science and Technology Research Foundation; Zhuoxin Sun and Richard D. Gelber, Harvard T.F. Chan School of Public Health; Richard D. Gelber, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; Per Karlsson, Institute of Selected Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, Gothenburg, Sweden; John F. Forbes, Australia and New Zealand Breast Cancer Trials Group, University of Newcastle, Newcastle Mater Hospital, Newcastle; Alan S. Coates, International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia; Beat Thürlimann, Breast Center Kantonsspital, St Gallen, and Swiss Group for Clinical Cancer Research; and Monica Castiglione, International Breast Cancer Study Group, Bern, Switzerland.
J Clin Oncol. 2016 Mar 20;34(9):927-35. doi: 10.1200/JCO.2015.62.3504. Epub 2016 Jan 19.
PURPOSE: Predicting the pattern of recurrence can aid in the development of targeted surveillance and treatment strategies. We identified patient populations that remain at risk for an event at a median follow-up of 24 years from the diagnosis of operable breast cancer. PATIENTS AND METHODS: International Breast Cancer Study Group clinical trials I to V randomly assigned 4,105 patients between 1978 and 1985. Annualized hazards were estimated for breast cancer-free interval (primary end point), disease-free survival, and overall survival. RESULTS: For the entire group, the annualized hazard of recurrence was highest during the first 5 years (10.4%), with a peak between years 1 and 2 (15.2%). During the first 5 years, patients with estrogen receptor (ER)--positive disease had a lower annualized hazard compared with those with ER-negative disease (9.9% v 11.5%; P = .01). However, beyond 5 years, patients with ER-positive disease had higher hazards (5 to 10 years: 5.4% v 3.3%; 10 to 15 years: 2.9% v 1.3%; 15 to 20 years: 2.8% v 1.2%; and 20 to 25 years: 1.3% v 1.4%; P < .001). Among patients with ER-positive disease, annualized hazards of recurrence remained elevated and fairly stable beyond 10 years, even for those with no axillary involvement (2.0%, 2.1%, and 1.1% for years 10 to 15, 15 to 20, and 20 to 25, respectively) and for those with one to three positive nodes (3.0%, 3.5%, and 1.5%, respectively). CONCLUSION: Patients with ER-positive breast cancer maintain a significant recurrence rate during extended follow up. Strategies for follow up and treatments to prevent recurrences may be most efficiently applied and studied in patients with ER-positive disease followed for a long period of time.
目的：预测复发模式有助于制定针对监测和治疗策略。我们确定了在可手术乳腺癌诊断后中位随访 24 年时仍存在事件风险的患者人群。
患者和方法：国际乳腺癌研究组临床试验 I 至 V 于 1978 年至 1985 年期间随机分配了 4105 名患者。估计了乳腺癌无复发生存期（主要终点）、无病生存率和总生存率的年化风险。
结果：对于整个组，复发的年化风险在最初 5 年最高（10.4%），在 1 至 2 年之间达到峰值（15.2%）。在最初 5 年内，与 ER 阴性疾病相比，ER 阳性疾病患者的年化风险较低（9.9%比 11.5%；P =.01）。然而，超过 5 年后，ER 阳性疾病患者的风险更高（5 至 10 年：5.4%比 3.3%；10 至 15 年：2.9%比 1.3%；15 至 20 年：2.8%比 1.2%；20 至 25 年：1.3%比 1.4%；P<.001）。在 ER 阳性疾病患者中，即使对于无腋窝受累（10 至 15 年分别为 2.0%、2.1%和 1.1%；15 至 20 年分别为 3.0%、3.5%和 1.5%；20 至 25 年分别为 1.3%、1.4%和 1.1%）和 1 至 3 个阳性淋巴结的患者，复发的年化风险仍然较高且相对稳定。
结论：ER 阳性乳腺癌患者在长期随访中保持着显著的复发率。在长期随访的 ER 阳性疾病患者中，随访和预防复发的治疗策略的应用和研究可能最为有效。
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