Hyperthermia as an adjuvant to radiation therapy of recurrent or metastatic malignant melanoma. A multicentre randomized trial by the European Society for Hyperthermic Oncology
Hyperthermia as an adjuvant to radiation therapy of recurrent or metastatic malignant melanoma. A multicentre randomized trial by the European Society for Hyperthermic Oncology
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DOI：
10.3109/02656739609023685
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发表时间：
1996-01-01
影响因子：
3.1
通讯作者：
Bentzen, SM
中科院分区：
文献类型：
--
作者：
Overgaard, J;Gonzalez, DG;Bentzen, SM
ESHO方案3 - 85是一项多中心随机试验，旨在研究热疗作为放射治疗辅助手段在恶性黑色素瘤治疗中的价值。70名患者共134个转移性或复发性恶性黑色素瘤病灶被随机分为两组，一组仅接受放射治疗（8天内进行3次照射），另一组在每次放射治疗后进行热疗（目标是在60分钟内达到43℃）。放射治疗采用高压光子或电子进行。肿瘤根据机构和大小（4厘米及以上或以下）进行分层，并随机分配接受总辐射剂量为24戈瑞或27戈瑞的治疗，同时分别设加用热疗组和不加用热疗组。研究终点是治疗区域的持续完全缓解。68名患者的128个肿瘤可进行评估，观察时间为3至72个月。65个肿瘤被随机分配到仅接受放射治疗组，63个被分配到放射治疗 + 热疗组。分别有60个肿瘤接受24戈瑞剂量，68个肿瘤接受27戈瑞剂量。81个肿瘤大小≤4厘米，47个肿瘤＞4厘米。总体而言，2年实际局部肿瘤控制率为37%。单因素分析显示热疗（仅放疗为28%，放疗 + 热疗为46%，p = 0.008）和辐射剂量（24戈瑞为25%，27戈瑞为56%，p = 0.02）对预后有影响，但肿瘤大小无影响（小肿瘤为42%，大肿瘤为29%，p = 0.21）。Cox多因素回归分析显示最重要的预后参数为：热疗（优势比：1.73（1.07 - 2.78），p = 0.02）、肿瘤大小（优势比：0.91（0.85 - 0.99），p = 0.05）和辐射剂量（优势比：1.17（1.01 - 1.36），p = 0.05）。对热疗质量的分析显示，热疗程度与局部肿瘤反应之间存在显著关系。增加热疗并未显著增加急性或晚期放射反应。患者的总体5年生存率为19%，但如果所有已知疾病得到控制，患者的生存率为38%，而疾病持续活动的患者生存率为8%。
The ESHO protocol 3-85 is a multicentre randomized trial investigating the value of hyperthermia as an adjuvant to radiotherapy in treatment of malignant melanoma. A total of 134 metastatic of recurrent malignant melanoma lesions in 70 patients were randomized to receive radiotherapy alone (3 fractions in 8 days) or each fraction followed by hyperthermia (aimed for 43 degrees C for 60 min). Radiation was given with high voltage photons or electrons. Tumours were stratified according to institution and size (above or below 4 cm) and randomly assigned to a total radiation dose of either 24 or 27 Gy to be given with or without hyperthermia. The endpoint was persistent complete response in the treated area. A number of 128 tumours in 68 patients were evaluable, with an observation time between 3 and 72 months. Sixty-five tumours were randomized to radiation alone and 63 to radiation + heat. Sixty received 24 Gy and 68 tumours received 27 Gy, respectively. Size was less than or equal to 4 cm in 81 and >4 cm in 47 tumours. Overall the 2-year actuarial local tumour control was 37%. Univariate analysis showed prognostic influence of hyperthermia (rad alone 28% versus rad + heat 46%, p = 0.008) and radiation dose (24 Gy 25% versus 27 Gy 56%, p = 0.02), but not of tumour size (small 42% versus large 29%, p = 0.21). A Cox multivariate regression analysis showed the most important prognostic parameters to be: hyperthermia (odds ratio: 1.73 (1.07-2.78), p = 0.02), tumour size (odds ratio: 0.91 (0.85-0.99), p = 0.05) and radiation dose (odds ratio: 1.17 (1.01-1.36), p = 0.05). Analysis of the heating quality showed a significant relationship between the extent of heating and local tumour response. Addition of heat did not significantly increase the acute or late radiation reactions. The overall 5-year survival rate of the patients was 19%, but 38% in patients if all known disease was controlled, compared to 8% in the patients with persistent active disease.