Ang K K, Peters L J, Weber R S, Morrison W H, Frankenthaler R A, Garden A S, Goepfert H, Ha C S, Byers R M
Department of Radiotherapy, University of Texas M. D. Anderson Cancer Center, Houston 77030.
Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):795-8. doi: 10.1016/0360-3016(94)90351-4.
To assess the efficacy and toxicity of elective-adjunctive radiotherapy given in five 6-Gy fractions to patients with cutaneous melanoma of the head and neck at high risk for local-regional relapse.
From 1983 to August 1992, 174 patients (132 men and 42 women) were enrolled. The ages ranged from 16 to 89 years (median: 54 years). One group (n = 79) received elective irradiation after wide local excision of lesions > or = 1.5 mm thick, or Clark's level IV-V, a second group (n = 32) received adjunctive irradiation after excision of primary lesions plus limited neck dissection, and a third group (n = 63) received irradiation after neck dissection for nodal relapse. Each group had a projected local-regional recurrence rate of approximately 50%. The radiotherapy consisted of five fractions of 6 Gy each, specified at Dmax, delivered twice a week, to a total dose of 30 Gy in 2.5 weeks. Electron beams of appropriate energies were used whenever possible. Junction lines between adjoining fields were moved twice to minimize dose heterogeneity. Patients were seen at regular intervals to assess disease status and therapy-related complications. Patients who relapsed were treated as indicated by the clinical status.
With a median follow-up of 35 months, 111 of 174 patients were alive. The disease recurred above the clavicles only in six patients, at distant sites in 58 patients, and both local-regionally and at distant sites in nine patients. The actuarial 5-year local-regional control (LRC) and survival rates for the whole group were 88% and 47%, respectively. The thickness of the primary lesion, presence of more than three positive nodes, and extracapsular extension did not influence the LRC rate after radiotherapy (range: 85-92%). However, lesion thickness strongly affected the 5-year survival rate of group 1 patients (i.e., 100% for < or = 1.5 mm thick, but Clark's level IV, 72% for > 1.5-4 mm, and 30% for > 4 mm). In groups 2 and 3, the 5-year survival rate of patients with > three involved nodes was lower than that of patients with one to three positive nodes (23% vs. 39%). The acute tolerance to adjunctive radiotherapy was excellent. Late radiation complications were observed in only three patients. These were moderate neck fibrosis, mild ipsilateral hearing impairment, and transient exposure of external auditory canal cartilage.
The safety of this hypofractionated radiotherapy regimen in the management of cutaneous melanoma was established in this study. The overall 5-year actuarial LRC rate of 88% was much higher than that of our historical group and that reported in the literature (50%). The survival rate of patients with lesion of 1.5-4 mm thickness was also higher than that observed in other series. Based on these results a prospective randomized study to further define the role of adjunctive postoperative radiotherapy is planned.
评估对头颈部皮肤黑色素瘤局部区域复发高危患者给予五 6 戈瑞分次的选择性辅助放疗的疗效和毒性。
1983 年至 1992 年 8 月，纳入 174 例患者（132 例男性和 42 例女性）。年龄范围为 16 至 89 岁（中位数：54 岁）。一组（n = 79）在广泛局部切除厚度≥1.5 毫米或克拉克分级为 IV - V 级的病变后接受选择性放疗，第二组（n = 32）在切除原发性病变加有限颈部清扫术后接受辅助放疗，第三组（n = 63）在颈部清扫治疗淋巴结复发后接受放疗。每组预计局部区域复发率约为 50%。放疗由每次 6 戈瑞，共五次组成，规定在 Dmax，每周两次，2.5 周内总剂量达 30 戈瑞。尽可能使用合适能量的电子束。相邻野之间的交界线移动两次以尽量减少剂量不均匀性。定期对患者进行检查以评估疾病状态和与治疗相关的并发症。复发患者根据临床情况进行相应治疗。
中位随访 35 个月，174 例患者中有 111 例存活。仅 6 例患者锁骨上方复发，58 例远处复发，9 例局部区域和远处均复发。全组 5 年精算局部区域控制（LRC）率和生存率分别为 88%和 47%。原发性病变厚度、三个以上阳性淋巴结的存在以及包膜外扩展对放疗后的 LRC 率无影响（范围：85% - 92%）。然而，病变厚度强烈影响第 1 组患者的 5 年生存率（即厚度≤1.5 毫米但克拉克分级为 IV 级的患者为 100%，厚度＞1.5 - 4 毫米的患者为 72%，厚度＞4 毫米的患者为 30%）。在第 2 组和第 3 组中，三个以上受累淋巴结患者的 5 年生存率低于一至三个阳性淋巴结患者（23%对 39%）。辅助放疗的急性耐受性良好。仅 3 例患者出现晚期放疗并发症。分别为中度颈部纤维化、轻度同侧听力障碍和外耳道软骨短暂暴露。
本研究证实了这种低分割放疗方案在皮肤黑色素瘤治疗中的安全性。总体 5 年精算 LRC 率 88%远高于我们的历史组及文献报道（50%）。厚度为 1.5 - 4 毫米病变患者的生存率也高于其他系列观察到的结果。基于这些结果，计划进行一项前瞻性随机研究以进一步明确辅助术后放疗的作用。
