Harrison L B, Franzese F, Gaynor J J, Brennan M F
Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):259-65. doi: 10.1016/0360-3016(93)90236-o.
A prospective randomized trial evaluating adjuvant brachytherapy for soft tissue sarcomas was conducted between July 1982 and July 1987.
One hundred twenty-six patients with soft tissue sarcoma of the extremity or superficial trunk (STS) underwent grossly complete resection with limb-sparing surgery. Intra-operatively, patients were randomized to receive either adjuvant brachytherapy (BRT) or no further therapy (no BRT). BRT consisted of an Iridium-192 implant which delivered 4200-4500 cGy over 4-6 days. Total hospital stay for combined surgery and BRT was 10-14 days. Patients in each group were well matched with respect to age, sex, site, tumor size, depth, histologic type, and grade. Median follow-up is 66.5 months for all living patients.
At 5 years, local control was 82% in the BRT group vs. 67% in the no BRT group (p = .049). When analyzed by histologic grade, high grade tumors had local control of 90% with BRT vs. 65% with no BRT (p = .013). There was no difference in local control in the low grade patients in either arm. At 5 years, the proportion free of distant metastases was approximately 76% in both arms, with no difference between BRT and no BRT. When analyzed by grade, high grade patients had a similar proportion free of distant metastasis in the BRT vs. no BRT arms despite improved local control in those receiving BRT. Similarly, the disease-specific survival for all patients at 5 years was 81% for BRT vs. 80% for no BRT (p = NS). When analyzed by grade, and treatment (BRT vs. no BRT), 5-year disease-specific survival for high grade was the same in both groups.
Adjuvant BRT significantly improves local control in completely resected STS. This improvement is confined to patients with high grade histology. BRT provides excellent local control in this group, and significantly shortens the treatment time when compared to adjuvant external beam radiation. However, the improved local control does not translate into either decreased distant metastasis or increased disease-specific survival.
1982年7月至1987年7月间开展了一项评估软组织肉瘤辅助近距离放疗的前瞻性随机试验。
126例四肢或浅表躯干软组织肉瘤(STS)患者接受了保肢手术且大体切除完全。术中,患者被随机分为接受辅助近距离放疗(BRT)组或不再接受进一步治疗(未行BRT)组。BRT包括植入铱-192,在4至6天内给予4200 - 4500 cGy剂量。手术联合BRT的总住院时间为10 - 14天。每组患者在年龄、性别、部位、肿瘤大小、深度、组织学类型和分级方面匹配良好。所有存活患者的中位随访时间为66.5个月。
5年时,BRT组的局部控制率为82%,未行BRT组为67%(p = 0.049)。按组织学分级分析,高级别肿瘤BRT组的局部控制率为90%,未行BRT组为65%(p = 0.013)。两组低级别患者的局部控制率无差异。5年时,两组远处转移-free比例均约为76%,BRT组与未行BRT组之间无差异。按分级分析,尽管接受BRT的高级别患者局部控制有所改善,但BRT组与未行BRT组的远处转移-free比例相似。同样,所有患者5年的疾病特异性生存率BRT组为81%,未行BRT组为80%(p = 无统计学意义)。按分级和治疗(BRT与未行BRT)分析,两组高级别患者的5年疾病特异性生存率相同。
辅助BRT显著提高了完全切除的STS的局部控制率。这种改善仅限于高级别组织学患者。BRT在该组中提供了出色的局部控制,与辅助外照射相比显著缩短了治疗时间。然而,局部控制的改善并未转化为远处转移减少或疾病特异性生存率提高。