Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher E R, Wickerham D L, Deutsch M, Margolese R, Dimitrov N, Kavanah M
National Surgical Adjuvant Breast and Bowel Project Operations and Statistical Centers, USA.
J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.
In 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after lumpectomy concluded that the combination was more beneficial than lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings.
Women (N = 818) with localized DCIS were randomly assigned to lumpectomy or lumpectomy plus radiation (50 Gy). Tissue was removed so that resected specimen margins were histologically tumor-free. Mean follow-up time was 90 months (range, 67 to 130). Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment. Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented.
The benefit of lumpectomy plus radiation was virtually unchanged between 5 and 8 years of follow-up and was due to a reduction in invasive and noninvasive ipsilateral breast tumors (IBTs). Incidence of locoregional and distant events remained similar in both treatment groups; deaths were only infrequently related to breast cancer. Incidence of noninvasive IBT was reduced from 13.4% to 8.2% (P = .007), and of invasive IBT, from 13.4% to 3.9% (P < .0001). All cohorts benefited from radiation regardless of clinical or mammographic tumor characteristics.
Through 8 years of follow-up, our findings continue to indicate that lumpectomy plus radiation is more beneficial than lumpectomy alone for women with localized, mammographically detected DCIS. When evaluated according to the mammographic characteristics of their DCIS, all groups benefited from radiation.
1993年，一项国家乳腺与肠道外科辅助治疗项目（NSABP）旨在评估乳房肿瘤切除术之后进行放射治疗价值的试验结果表明，对于局限性导管原位癌（DCIS），联合治疗比单纯乳房肿瘤切除术更有益。本报告扩展了这些研究结果。
818例局限性DCIS女性被随机分配接受乳房肿瘤切除术或乳房肿瘤切除术加放射治疗（50 Gy）。切除组织以使切除标本边缘在组织学上无肿瘤。平均随访时间为90个月（范围67至130个月）。肿瘤检测的大小和方法由中央临床、乳腺X线摄影和病理评估确定。给出了无事件生存率和生存率的生命表估计值、特定事件的年均发生率、特定事件终点的相对风险以及构成无事件生存的特定事件的累积概率。
在随访5至8年期间，乳房肿瘤切除术加放射治疗的益处基本未变，这归因于同侧侵袭性和非侵袭性乳腺肿瘤（IBT）的减少。两个治疗组局部和远处事件的发生率保持相似；死亡很少与乳腺癌相关。非侵袭性IBT的发生率从13.4%降至8.2%（P = 0.007），侵袭性IBT的发生率从13.4%降至3.9%（P < 0.0001）。无论临床或乳腺X线摄影肿瘤特征如何，所有队列均从放射治疗中获益。
通过8年的随访，我们的研究结果继续表明，对于经乳腺X线摄影检测出的局限性DCIS女性，乳房肿瘤切除术加放射治疗比单纯乳房肿瘤切除术更有益。根据其DCIS的乳腺X线摄影特征进行评估时，所有组均从放射治疗中获益。
