Fodor János, Polgár Csaba, Major Tibor, Németh György
Department of Radiotherapy, National Institute of Oncology, Busdapest, Hungary.
Strahlenther Onkol. 2003 Mar;179(3):197-202. doi: 10.1007/s00066-003-1010-7.
There is insufficient evidence to suggest the routine use of postmastectomy radiotherapy (PMRT) in patients with one to three positive axillary nodes and T1/2 tumors. We have assessed the risk of locoregional recurrence (LRR) with or without RT in this group of patients, and focused on the results in subgroups defined by tumor size.
249 women with T1/2 tumors and one to three positive nodes underwent mastectomy and axillary dissection between 1983 and 1987. Locoregional RT of 50 Gy was given to 175 patients. Chemotherapy or hormonal therapy was administered to 41 and 71 women, respectively. The median follow-up time of survivors was 189 months (range, 167-227 months).
The rates of isolated LRR without or with RT were 16% (12/74) and 8% (14/175), respectively (p = 0.05), and the total (with or without distant relapse) LRR rates 23% and 12%, respectively (p = 0.03). 15-year overall survival amounted to 41% without RT and to 52% with RT (p = 0.2). The rates of isolated LRR for patients treated with chemotherapy or hormonal therapy only were 25% and 12%, respectively. In the absence of RT, age (> 45 vs = 45 years; p = 0.06), tumor size (T1 vs T2; p = 0.07), and extranodal invasion (ENI; absent vs present; p = 0.09) were related to the risk of developing an isolated LRR. On multivariate analysis, only tumor size (relative risk [RR], 3.92; 95% confidence interval [CI], 1.11-15.14) and age (RR, 3.37; 95% CI, 1.03-11.09) emerged as independent significant predictors, whereas ENI (RR, 1.50; 95% CI, 0.81-2.77) did not. In the T1 subgroup, the estimated 15-year isolated LRR rate was 9% (3/36) without and 9% (8/99) with RT (p = 0.9775). 15-year disease-free survival amounted to 62% and 57%, respectively (p = 0.5153). For patients without RT, according to the age groups (= 45 vs > 45 years), the 15-year rates of isolated LRR were 9% and 9%, respectively (p = 0.9910). In the T2 subgroup, the estimated 15-year isolated LRR rate was 30% (9/38) without and 10% (6/76) with RT (RR, 0.33; 95% CI, 0.12-0.92; p = 0.0244). 15-year disease-free survival amounted to 32% and 50%, respectively (p = 0.1213). For patients without RT, according to the age groups (< or = 45 vs > 45 years), the 15-year rates of isolated LRR were 57% and 16%, respectively (p = 0.0049).
Patients with T1 tumor and one to three positive nodes are at low risk of isolated LRR either with or without RT. Patients with T2 tumor and one to three positive nodes are at high risk of isolated LRR without RT. Our findings support the routine use of PMRT in patients with T2 tumor, especially those aged < or = 45 years.
对于腋窝淋巴结1 - 3个阳性且肿瘤为T1/2期的患者，尚无足够证据支持常规使用乳房切除术后放疗（PMRT）。我们评估了该组患者接受或不接受放疗时局部区域复发（LRR）的风险，并重点关注了按肿瘤大小定义的亚组结果。
1983年至1987年间，249例T1/2期肿瘤且腋窝淋巴结1 - 3个阳性的女性接受了乳房切除术和腋窝淋巴结清扫术。175例患者接受了50 Gy的局部区域放疗。分别有41例和71例女性接受了化疗或激素治疗。幸存者的中位随访时间为189个月（范围167 - 227个月）。
未接受放疗和接受放疗的孤立性LRR发生率分别为16%（12/74）和8%（14/175）（p = 0.05），总的（包括或不包括远处复发）LRR发生率分别为23%和12%（p = 0.03）。未接受放疗的15年总生存率为41%，接受放疗的为52%（p = 0.2）。仅接受化疗或激素治疗的患者孤立性LRR发生率分别为25%和12%。在未接受放疗的情况下，年龄（> 45岁与≤ 45岁；p = 0.06）、肿瘤大小（T1与T2；p = 0.07）和结外侵犯（ENI；无与有；p = 0.09）与发生孤立性LRR的风险相关。多因素分析显示，只有肿瘤大小（相对风险[RR]，3.92；95%置信区间[CI]，1.11 - 15.14）和年龄（RR，3.37；95% CI，1.03 - 11.09）是独立的显著预测因素，而ENI（RR，1.50；95% CI，0.81 - 2.77）不是。在T1亚组中，未接受放疗和接受放疗的估计15年孤立性LRR发生率分别为9%（3/36）和9%（8/99）（p = 0.9775）。15年无病生存率分别为62%和57%（p = 0.5153）。对于未接受放疗的患者，按年龄组（≤ 45岁与 > 45岁），15年孤立性LRR发生率分别为9%和9%（p = 0.9910）。在T2亚组中，未接受放疗和接受放疗的估计15年孤立性LRR发生率分别为30%（9/38）和10%（6/76）（RR，0.33；95% CI，0.12 - 0.92；p = 0.0244）。15年无病生存率分别为32%和50%（p = 0.1213）。对于未接受放疗的患者，按年龄组（≤ 45岁与 > 45岁），15年孤立性LRR发生率分别为57%和16%（p = 0.0049）。
T1期肿瘤且腋窝淋巴结1 - 3个阳性的患者，无论接受或不接受放疗，孤立性LRR风险均较低。T2期肿瘤且腋窝淋巴结1 - 3个阳性的患者，未接受放疗时孤立性LRR风险较高。我们的研究结果支持对T2期肿瘤患者，尤其是年龄≤ 45岁的患者常规使用PMRT。
