Whelan T, Clark R, Roberts R, Levine M, Foster G
OCTRF, Hamilton Regional Cancer Centre, Ontario, Canada.
Int J Radiat Oncol Biol Phys. 1994 Aug 30;30(1):11-6. doi: 10.1016/0360-3016(94)90513-4.
To determine whether ipsilateral breast tumor recurrence (IBTR) postlumpectomy was independently predictive of distant relapse and mortality in women with node negative breast cancer.
A randomized trial was conducted in Ontario between 1984 and 1989, in which 837 women with node negative disease who had undergone lumpectomy and axillary dissection were randomized to either postoperative radiation (40 Gy in 16 fractions to the whole breast, followed by a boost of 12.5 Gy in five fractions to the primary site), or no further treatment. A Cox proportional hazards regression analysis was performed for the endpoints mortality and distant relapse using the fixed covariates, treatment, age, tumor size, estrogen receptor status, progesterone receptor status, and nuclear grade; and the time dependent variable IBTR.
The analysis was based on 799 patients for which all fixed covariate data was available. Median follow-up was 66 months. The cumulative rate of IBTR at 5 years was significantly greater for the no treatment group compared to the radiation group; 30% vs. 8% respectively (p < 0.0001). No difference was detected in overall survival between the treatment groups (p = 0.45). Significant independent predictors for mortality were nuclear grade, high vs. medium or low (relative risk (RR) = 2.28, p = 0.0001); and tumor size > or = 2 cm. vs. < 2 cm. (RR = 1.64, p = 0.01). In addition, IBTR predicted increased mortality (RR = 2.18, p < 0.0006). Similar results were observed for distant relapse. An IBTR within 1 year of surgery was associated with a higher risk of distant relapse and mortality.
Local breast recurrence following lumpectomy is associated with an increased risk of distant relapse and death.
确定保乳手术后同侧乳腺肿瘤复发（IBTR）是否能独立预测无淋巴结转移乳腺癌女性的远处复发和死亡率。
1984年至1989年在安大略省进行了一项随机试验，837例接受保乳手术和腋窝清扫的无淋巴结转移疾病女性被随机分为术后放疗组（全乳16次分割照射40 Gy，随后对原发部位5次分割追加照射12.5 Gy）或不进行进一步治疗组。使用固定协变量（治疗、年龄、肿瘤大小、雌激素受体状态、孕激素受体状态和核分级）以及时间依赖性变量IBTR，对死亡率和远处复发终点进行Cox比例风险回归分析。
分析基于799例可获得所有固定协变量数据的患者。中位随访时间为66个月。未治疗组5年时IBTR的累积发生率显著高于放疗组；分别为30%和8%（p < 0.0001）。治疗组之间总生存率无差异（p = 0.45）。死亡率的显著独立预测因素为核分级，高分级与中分级或低分级相比（相对风险（RR）= 2.28，p = 0.0001）；以及肿瘤大小≥2 cm与<2 cm相比（RR = 1.64，p = 0.01）。此外，IBTR可预测死亡率增加（RR = 2.18，p < 0.0006）。远处复发也观察到类似结果。术后1年内发生IBTR与远处复发和死亡风险较高相关。
保乳术后局部乳腺复发与远处复发和死亡风险增加相关。
