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T1-T2 肿瘤且 1-3 个阳性淋巴结的女性乳腺癌根治术后放疗:乳腺国际集团 02-98 试验分析。

Postmastectomy Radiation Therapy in Women with T1-T2 Tumors and 1 to 3 Positive Lymph Nodes: Analysis of the Breast International Group 02-98 Trial.

机构信息

Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon.

Department of Medical Oncology, Fouad Khoury and Makassed General Hospital, Beirut, Lebanon.

出版信息

Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):316-324. doi: 10.1016/j.ijrobp.2018.01.105. Epub 2018 Feb 6.

DOI:
10.1016/j.ijrobp.2018.01.105
PMID:29534902
Abstract

PURPOSE

To analyze the impact of postmastectomy radiation therapy (PMRT) for patients with T1-T2 tumors and 1 to 3 positive lymph nodes enrolled on the Breast International Group (BIG) 02-98 trial.

METHODS AND MATERIALS

The BIG 02-98 trial randomized patients to receive adjuvant anthracycline with or without taxane chemotherapy. Delivery of PMRT was nonrandomized and performed according to institutional preferences. The present analysis was performed on participants with T1-T2 breast cancer and 1 to 3 positive lymph nodes who had undergone mastectomy and axillary nodal dissection. The primary objective of the present study was to examine the effect of PMRT on risk of locoregional recurrence (LRR), breast cancer-specific survival, and overall survival.

RESULTS

We identified 684 patients who met the inclusion criteria and were included in the analysis, of whom 337 (49%) had received PMRT. At 10 years, LRR risk was 2.5% in the PMRT group and 6.5% in the no-PMRT group (hazard ratio 0.29, 95% confidence interval 0.12-0.73; P = .005). Lower LRR after PMRT was noted for patients randomized to receive adjuvant chemotherapy with no taxane (10-year LRR: 3.4% vs 9.1%; P = .02). No significant differences in breast cancer-specific survival (84.3% vs 83.9%) or overall survival (81.7% vs 78.3%) were observed according to receipt of PMRT.

CONCLUSION

Our analysis of the BIG 02-98 trial shows excellent outcomes in women with T1-T2 tumors and 1 to 3 positive lymph nodes found in axillary dissection. Although PMRT improved LRR in this cohort, the number of events remained low at 10 years. In all groups, 10-year rates of LRR were relatively low compared with historical studies. As such, the use of PMRT in women with 1 to 3 positive nodes should be tailored to individual patient risks.

摘要

目的

分析入组乳腺癌国际集团(BIG)02-98 试验的 T1-T2 肿瘤和 1-3 个阳性淋巴结患者接受乳房切除术(PMRT)后的影响。

方法和材料

BIG 02-98 试验随机分配患者接受蒽环类药物联合或不联合紫杉烷化疗的辅助治疗。PMRT 的实施是非随机的,并根据机构偏好进行。本分析针对接受乳房切除术和腋窝淋巴结清扫术的 T1-T2 乳腺癌和 1-3 个阳性淋巴结的患者进行。本研究的主要目的是检查 PMRT 对局部区域复发(LRR)、乳腺癌特异性生存和总生存的影响。

结果

我们确定了 684 名符合纳入标准的患者,并将其纳入分析,其中 337 名(49%)接受了 PMRT。在 10 年时,PMRT 组的 LRR 风险为 2.5%,无 PMRT 组为 6.5%(风险比 0.29,95%置信区间 0.12-0.73;P=0.005)。对于接受无紫杉烷辅助化疗的随机分组患者,PMRT 后 LRR 降低(10 年 LRR:3.4% vs 9.1%;P=0.02)。根据 PMRT 的使用情况,未观察到乳腺癌特异性生存(84.3% vs 83.9%)或总生存(81.7% vs 78.3%)的显著差异。

结论

我们对 BIG 02-98 试验的分析显示,在接受腋窝清扫术的 T1-T2 肿瘤和 1-3 个阳性淋巴结的女性中,结果非常出色。尽管在这组患者中 PMRT 改善了 LRR,但 10 年时的事件数量仍然较低。在所有组中,10 年 LRR 率与历史研究相比相对较低。因此,在 1-3 个阳性淋巴结的女性中使用 PMRT 应根据个体患者的风险进行调整。

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