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电子及高剂量率近距离放射治疗用于I-II期乳腺癌保守治疗的增效作用:布达佩斯增效随机试验的初步结果

Electron and high-dose-rate brachytherapy boost in the conservative treatment of stage I-II breast cancer first results of the randomized Budapest boost trial.

作者信息

Polgár Csaba, Fodor János, Orosz Zsolt, Major Tibor, Takácsi-Nagy Zoltán, Mangel László Csaba, Sulyok Zoltán, Somogyi András, Kásler Miklós, Németh György

机构信息

Department of Radiotherapy, National Institute of Oncology, Budapest, Hungary.

出版信息

Strahlenther Onkol. 2002 Nov;178(11):615-23. doi: 10.1007/s00066-002-1053-1.

DOI:10.1007/s00066-002-1053-1
PMID:12426672
Abstract

BACKGROUND AND AIMS

To evaluate the effect of electron and high-dose-rate brachytherapy (HDR BT) boost on local tumor control (LTC), side effects and cosmesis after breast-conserving surgery (BCS) in a prospective randomized study.

PATIENTS AND METHODS

207 women with stage I-II breast cancer who underwent BCS were treated by 50 Gy irradiation to the whole breast and then randomly assigned to receive either a boost to the tumor bed (n = 104) or no further radiotherapy (n = 103). Boost treatments consisted of either 16 Gy electron irradiation (n = 52) or 12-14,25 Gy HDR BT (n = 52). Breast cancer-related events, side effects, and cosmetic results were assessed.

RESULTS

At a median follow-up of 5.3 years, the crude rate of local recurrences was 6.7% (7/104) with and 15.5% (16/103) without boost. The 5-year probability of LTC, relapse-free survival (RFS), and cancer-specific survival (CSS) was 92.7% vs. 84.9% (p = 0.049), 76.6% vs. 66.2% (p = 0.044), and 90.4% vs. 82.1% (p = 0.053), respectively. There was no significant difference in LTC between patients treated with electron or HDR BT boost (94.2% vs. 91.4%; p = 0.74). On multivariate analysis, patient age < 40 years (RR: 4.53), positive margin status (RR: 4.17), and high mitotic activity index (RR: 3.60) were found to be significant risk factors for local recurrence. The incidence of grade 2-3 side effects was higher in the boost arm (17.3% vs. 7.8%; p = 0.03). However, the rate of excellent/good cosmetic results was similar for the two arms (85.6% vs 91.3%; p = 0.14). Cosmesis was rated as excellent/good in 88.5% of patients treated with HDR BT and 82.7% of patients with electron boost (p = 0.29).

CONCLUSIONS

Boost dose significantly improves LTC and RFS in patients treated with BCS and radiotherapy. In spite of the higher incidence of late side effects in the boost arm, boost dose is strongly recommended for patients at high risk for local recurrence. Positive or close margin status, high mitotic activity index, and young patient age should be viewed as absolute indications for tumor bed boost. LTC and cosmesis are excellent and similar to patients boosted with either HDR BT or electrons.

摘要

背景与目的

在一项前瞻性随机研究中,评估电子线和高剂量率近距离放射治疗(HDR BT)加量照射对保乳手术(BCS)后局部肿瘤控制(LTC)、副作用及美容效果的影响。

患者与方法

207例接受BCS的Ⅰ - Ⅱ期乳腺癌女性患者,全乳接受50 Gy照射,然后随机分为瘤床加量组(n = 104)或不再接受进一步放疗组(n = 103)。加量治疗包括16 Gy电子线照射(n = 52)或12 - 14.25 Gy HDR BT(n = 52)。评估乳腺癌相关事件、副作用及美容效果。

结果

中位随访5.3年,加量组局部复发粗发生率为6.7%(7/104),未加量组为15.5%(16/103)。LTC、无复发生存(RFS)及癌症特异性生存(CSS)的5年概率分别为92.7%对84.9%(p = 0.049)、76.6%对66.2%(p = 0.044)、90.4%对82.1%(p = 0.053)。电子线或HDR BT加量治疗患者的LTC无显著差异(94.2%对91.4%;p = 0.74)。多因素分析显示,患者年龄<40岁(RR:4.53)、切缘阳性状态(RR:4.17)及高有丝分裂活性指数(RR:3.60)是局部复发的显著危险因素。加量组2 - 3级副作用发生率更高(17.3%对7.8%;p = 0.03)。然而,两组的优良美容效果率相似(85.6%对91.3%;p = 0.14)。HDR BT治疗患者中88.5%、电子线加量治疗患者中82.7%的美容效果被评为优良(p = 0.29)。

结论

加量剂量显著改善了接受BCS和放疗患者的LTC和RFS。尽管加量组晚期副作用发生率较高,但强烈推荐对局部复发高危患者进行加量剂量照射。切缘阳性或接近阳性状态、高有丝分裂活性指数及年轻患者年龄应被视为瘤床加量的绝对指征。LTC和美容效果良好,且与接受HDR BT或电子线加量治疗的患者相似。

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