Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.

Methods

In this international, phase 3, randomized trial, we evaluated the omission of chest-wall irradiation in women with "intermediate-risk" breast cancer - defined as cancer that was stage pT1N1, pT2N1, or pT3N0 or stage pT2N0 with a histologic grade of 3, lymphovascular invasion, or both (tumor size: T1, ≤2 cm; T2, >2 cm to 5 cm; or T3, >5 cm) - that was treated with mastectomy, an axillary procedure, and systemic therapy.

在这项国际性的III期随机试验中，我们评估了在“中危”乳腺癌女性中省略胸壁放疗的效果——定义为pT1N1、pT2N1或pT3N0期，或pT2N0期且组织学分级为3级、淋巴血管侵犯或两者兼有的癌症——这些患者接受了乳房切除术、腋窝手术和系统治疗。

Patients were assigned to undergo chest-wall irradiation (40 to 50 Gy; the irradiation group) or not to undergo chest-wall irradiation (the no-irradiation group).

患者被分配接受胸部壁放射治疗（40至50 Gy；放射治疗组）或不接受胸部壁放射治疗（无放射治疗组）。

The primary end point was overall survival, with 10 years of follow-up.

主要终点是总生存，随访时间为10年。

Chest-wall recurrence, regional recurrence, disease-free survival, distant metastasis-free survival, causes of death, and radiation-related adverse events were also assessed.

评估了胸部壁复发、区域复发、无病生存期、远处转移无病生存期、死亡原因以及放射治疗相关的不良事件。

Results

The intention-to-treatpopulation included 808 patients in the irradiation group and 799 in the no-irradiation group.

意向治疗人群包括放射治疗组的808名患者和未接受放射治疗组的799名患者。

The median follow up was 9.6 years.

中位随访时间为9.6年。

Overall survivalwas 81.4% with chest-wall irradiation and 81.9% with no chest-wall irradiation according to 10-year Kaplan-Meier estimates (hazard ratiofor death, 1.04; 95% confidence interval[CI], 0.82 to 1.30; P = 0.80).

根据10年Kaplan-Meier估计，接受胸壁放疗的总生存率为81.4%，未接受胸壁放疗的总生存率为81.9%（死亡风险比为1.04；95%置信区间[CI]，0.82至1.30；P = 0.80）。

A total of 29 patients had a chest-wall recurrence - 9 (1.1%) in the irradiation group and 20 (2.5%) in the no-irradiation group (between-group difference, <2 percentage points; hazard ratio, 0.45; 95% CI, 0.20 to 0.99).

共有29名患者出现胸壁复发 - 其中放疗组有9例（1.1%），未放疗组有20例（2.5%）（两组差异小于2个百分点；风险比，0.45；95%置信区间，0.20至0.99）。

Disease-free survival was 76.2% in the irradiation group and 75.5% in the no-irradiation group (hazard ratiofor recurrence or death, 0.97; 95% CI, 0.79 to 1.18), and distant metastasis-free survival was 78.2% and 79.2%, respectively (hazard ratiofor distant metastasis or death, 1.06; 95% CI, 0.86 to 1.31).

放疗组的无病生存率为76.2%，未放疗组为75.5%（复发或死亡的风险比，0.97；95%置信区间，0.79至1.18），而无远处转移生存率分别为78.2%和79.2%（远处转移或死亡的风险比，1.06；95%置信区间，0.86至1.31）。

Conclusions

In this trial, chest-wall irradiation did not result in higher overall survivalthan no chest-wall irradiation among patients with intermediate-risk, early breast cancer treated with mastectomy and contemporary adjuvant systemic therapy.

在这项试验中，对于接受乳房切除术和当代辅助系统治疗的中危早期乳腺癌患者，胸部壁放疗并未带来比不进行胸部壁放疗更高的总生存率。

(Funded by the Medical Research Council and others; SUPREMO ISRCTN Clinical Study Registry number, 61145589.).

(该研究由医学研究委员会等资助；SUPREMO ISRCTN临床研究注册号为61145589。)