Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma

Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma
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DOI:
10.1200/jco.1996.14.3.859
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发表时间:
1996-03-01
影响因子:
45.3
通讯作者:
Brennan, MF
Brennan, MF
中科院分区:
医学1区
文献类型:
--
作者:
Pisters, PWT;Harrison, LB;Brennan, MF

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目的:本试验旨在评估辅助近距离放射治疗对软组织肉瘤患者局部和全身复发率的影响。患者和方法:在一项单机构前瞻性随机试验中,164例患者在肢体或浅表躯干软组织肉瘤完全切除后,随机接受术中辅助近距离放射治疗(BRT)或不接受进一步治疗(无BRT)。辅助放射治疗采用铱-192植入治疗,剂量为42 ~ 45戈伊,持续4 ~ 6天。两个研究组的患者和肿瘤因素分布相似,包括年龄、性别、肿瘤部位、肿瘤大小、组织学类型和分级。结果:中位随访时间为76个月,BRT组和非BRT组的5年精算局部控制率分别为82%和69%(P = 0.04)。高级别病变患者的局部控制率为89%(BRT)和66%(无BRT)(P = 0.0025),BRT对低级别病变患者的局部控制没有影响(P = 0.49)。BRT组和非BRT组的5年无远处复发率分别为83%和76%(P = 0.60)。尽管高级别病变患者的局部控制有所改善,但按组织学分级进行的分析并未显示BRT对远处转移的影响。BRT组和非BRT组的5年疾病特异性生存率分别为84%和81%(P = .65),无论肿瘤分级如何,BRT均无影响。结论:辅助近距离放射治疗可改善软组织肉瘤完全切除后的局部控制。这种局部控制的改善仅限于具有高级别组织病理学的患者。高级别病变患者局部复发的减少与远处转移的显著减少或疾病特异性生存率的改善无关。
Purpose: This trial was performed to evaluate the impact of adjuvant brachytherapy on local and systemic recurrence rates in patients with soft tissue sarcoma,Patients and Methods: In a single-institution prospective randomized trial, 164 patients were randomized intraoperatively to receive either adjuvant brachytherapy (BRT) or no further therapy (no BRT) after complete resection of soft tissue sarcomas of the extremity or superficial trunk. The adjuvant radiation was administered by iridium-192 implant, which delivered 42 to 45 Gy over 4 to 6 days. The two study groups had comparable distributions of patient and tumor factors, including age, sex, tumor site, tumor size, and histologic type and grade,Results: With a median follow-up time of 76 months, the 5-year actuarial local control rates were 82% and 69% in the BRT and no BRT groups (P = .04), respectively. Patients with high-grade lesions had local control rates of 89% (BRT) and 66% (no BRT) (P = .0025), BRT had no impact on local control in patients with low-grade lesions (P = .49). The 5-year freedom-from-distant-recurrence rates were 83% and 76% in the BRT and no BRT groups (P = .60), respectively, Analysis by histologic grade did not demonstrate an impact of BRT on the development of distant metastasis, despite the improvement in local control noted in patients with high-grade lesions. The 5-year disease-specific survival rates for the BRT and no BRT groups were 84% and 81% (P = .65), respectively, with no impact of BRT regardless of tumor grade.Conclusion: Adjuvant brachytherapy improves local control after complete resection of soft tissue sarcomas. This improvement in local control is limited to patients with high-grade histopathology. The reduction in local recurrence in patients with high-grade lesions is not associated with a significant reduction in distant metastasis or improvement in disease-specific survival.