Arriagada R, Rutqvist L E, Mattsson A, Kramar A, Rotstein S
Institut Gustave-Roussy, Villejuif, France.
J Clin Oncol. 1995 Dec;13(12):2869-78. doi: 10.1200/JCO.1995.13.12.2869.
To analyze different events that determine event-free survival (EFS) in a randomized trial on adjuvant radiotherapy in early breast cancer patients with more than 15 years of follow-up evaluation.
The trial included 960 patients with a unilateral, operable breast cancer. Surgery consisted of a modified radical mastectomy. The trial compared three arms, as follows: preoperative radiotherapy, postoperative radiotherapy, and no adjuvant treatment. Events were analyzed by a competing-risk approach. A proportional hazards multiple regression model was used to analyze the effects of radiotherapy on the risk of distant metastasis. Similar analyses were performed separately for node-negative [N(-)] and node-positive [N(+)] patients in the two groups that did not include preoperative radiotherapy.
Radiotherapy produced a fivefold decrease of the risk of local recurrence (P < .0001). In N(+) patients, postoperative radiotherapy decreased the risk of distant dissemination (relative risk, 0.63). When local recurrence was introduced in the model as a time-dependent covariate, this factor was predictive of distant dissemination (P < .0001) and nullified the effect of postoperative radiotherapy. This finding suggests that the decrease of distant metastases was related to the prevention of local recurrence. A similar effect was found in models that used overall survival as an end point.
This study shows that postmastectomy radiotherapy in N(+) breast cancer patients may decrease the distant metastasis rate by preventing local recurrences and thus avoiding secondary dissemination.
在一项针对早期乳腺癌患者辅助放疗的随机试验中,进行超过15年的随访评估,分析决定无事件生存期(EFS)的不同事件。
该试验纳入了960例单侧可手术乳腺癌患者。手术方式为改良根治性乳房切除术。试验比较了三个治疗组,如下:术前放疗、术后放疗和无辅助治疗。采用竞争风险方法分析事件。使用比例风险多元回归模型分析放疗对远处转移风险的影响。在不包括术前放疗的两组中,分别对淋巴结阴性[N(-)]和淋巴结阳性[N(+)]患者进行了类似分析。
放疗使局部复发风险降低了五倍(P < .0001)。在N(+)患者中,术后放疗降低了远处转移风险(相对风险,0.63)。当将局部复发作为时间依赖性协变量纳入模型时,该因素可预测远处转移(P < .0001),并消除了术后放疗的效果。这一发现表明远处转移的减少与局部复发的预防有关。在以总生存期为终点的模型中也发现了类似的效果。
本研究表明,N(+)乳腺癌患者乳房切除术后放疗可通过预防局部复发从而避免继发转移,降低远处转移率。