Locoregional radiation therapy in patients with high-risk breast cancer receiving adjuvant chemotherapy: 20-year results of the British Columbia randomized trial
Locoregional radiation therapy in patients with high-risk breast cancer receiving adjuvant chemotherapy: 20-year results of the British Columbia randomized trial
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DOI：
10.1093/jnci/djh297
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发表时间：
2005-01-19
影响因子：
10.3
通讯作者：
Manji, M
中科院分区：
文献类型：
--
作者：
Ragaz, J;Olivotto, IA;Manji, M
背景资料：不列颠哥伦比亚省随机放射试验旨在确定局部放射治疗对经改良根治性乳腺切除术和辅助化疗治疗的绝经前淋巴结阳性乳腺癌患者生存率的影响。318例患者被分配接受不进一步治疗或放射治疗（37.5戈伊，16次）。先前的15年随访分析显示，放射治疗与乳腺癌生存率的统计学显著改善相关，但总生存率的改善仅具有边缘统计学意义。我们报告了20年随访数据的分析。方法：生存分析采用Kaplan-Meier法。通过比例风险回归模型的Wald检验计算相对风险估计值。所有统计学检验均为双侧检验。结果如下：20年随访时（存活患者的中位随访时间：249个月）与单纯化疗相比，化疗和放疗在所有分析的终点（包括无孤立局部复发的生存率）方面均具有统计学显著性改善（分别为74%和90%;相对风险[RR] = 0.36，95%置信区间[CI] = 0.18至0.71; P = 0.002），全身无复发生存率（31% vs 48%; RR = 0.66，95% CI = 0.49 - 0.88; P = 0.004），乳腺癌无瘤生存率（48% vs 30%; RR 0.63，95% CI = 0.47 - 0.83; P = .001），无事件生存期（35% vs 25%; RR = 0.70，95% CI = 0.54 - 0.92; P = 0.009），乳腺癌特异性生存期（53%对38%; RR = 0.67，95%CI = 0.49至0.90; P = 0.008），与15年随访结果相反，总生存率（47%对37%; RR = 0.73，95%CI = 0.55至0.98; P = 0.03）。两组的长期毒性，包括心源性死亡（1.8% vs 0.6%）均极轻微。结论：对于接受改良根治性乳房切除术治疗的高危乳腺癌患者，放射治疗（16次）和辅助化疗的治疗比单纯化疗的生存结局更好，耐受性良好，长期毒性可接受。
Background: The British Columbia randomized radiation trial was designed to determine the survival impact of locoregional radiation therapy in premenopausal patients with lymph node-positive breast cancer treated by modified radical mastectomy and adjuvant chemotherapy. Three hundred eighteen patients were assigned to receive no further therapy or radiation therapy (37.5 Gy in 16 fractions). Previous analysis at the 15-year follow-up showed that radiation therapy was associated with a statistically significant improvement in breast cancer survival but that improvement in overall survival was of only borderline statistical significance. We report the analysis of data from the 20-year follow-up. Methods: Survival was analyzed by the Kaplan-Meier method. Relative risk estimates were calculated by the Wald test from the proportional hazards regression model. All statistical tests were two-sided. Results: At the 20 year follow up (median follow up for live patients: 249 months) chemotherapy and radiation therapy, compared with chemotherapy alone, were associated with a statistically significant improvement in all end points analyzed, including survival free of isolated locoregional recurrences (74% versus 90%, respectively; relative risk [RR] = 0.36, 95% confidence interval [CI] = 0.18 to 0.71; P = .002), systemic relapse-free survival (31% versus 48%; RR = 0.66, 95% CI = 0.49 to 0.88; P = .004), breast cancer-free survival (48% versus 30%; RR 0.63, 95% CI = 0.47 to 0.83; P = .001), event-free survival (35% versus 25%; RR = 0.70, 95% CI = 0.54 to 0.92; P = .009), breast cancer-specific survival (53% versus 38%; RR = 0.67, 95% CI = 0.49 to 0.90; P = .008), and, in contrast to the 15-year follow-up results, overall survival (47% versus 37%; RR = 0.73, 95% CI = 0.55 to 0.98; P = .03). Long-term toxicities, including cardiac deaths (1.8% versus 0.6%), were minimal for both arms. Conclusion: For patients with high-risk breast cancer treated with modified radical mastectomy, treatment with radiation therapy (schedule of 16 fractions) and adjuvant chemotherapy leads to better survival outcomes than chemotherapy alone, and it is well tolerated, with acceptable long-term toxicity.