Overgaard Jens, Dahl Olav, Arcangeli Giorgio
Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.
Department of Oncology and Medical Physics, Haukeland University Hospital, Department of Clinical Science, University of Bergen, Bergen, Norway.
Acta Oncol. 2024 Dec 12;63:943-949. doi: 10.2340/1651-226X.2024.41035.
European Society for Hyperthermic Oncology (ESHO) 2-85 is a multicenter randomized trial investigating hyperthermia (HT) as an adjuvant to radiotherapy (RT) in treatment of locally advanced neck nodes. The trial never fulfilled recruitment and was stopped prematurely, and has not previously been published.
Between January 1987 and February 1993, 64 evaluable neck nodes in 54 patients were included. Tumors were stratified according to institution and nodal size and randomly assigned to receive RT alone (2 Gy/fx, 5 fx/wk) to a total dose of 60-70 Gy, including boost, or the same RT followed once weekly by HT (aimed for 43°C for 60 min). The primary endpoint was persistent complete response (local control).
Sixty-four tumors in 54 patients were evaluable, with a median observation of 17 months. Thirty-four tumors were randomized to RT alone and 30 to RT+HT. Compliance with RT was good. HT was associated with moderate to severe pain and discomfort in 38% of the treatments. In 57% of the heated patients at least one treatment achieved the target temperature. HT did not significantly increase radiation morbidity. The complete response rate was 53% in the RT versus 80% in the RT+HT group, and 3-year persistent local control rate was 32% for RT alone versus 53% for RT+HT; HR: 0.48 [0.23-0.98]. The ESHO 2-85 study demonstrated that addition of a weekly HT treatment to RT of advanced neck nodes significantly enhanced the persistent tumor control. The results substantiate the potential clinical benefit of hyperthermic oncology.
欧洲热疗肿瘤学会（ESHO）2 - 85是一项多中心随机试验，旨在研究热疗（HT）作为放疗（RT）辅助手段治疗局部晚期颈部淋巴结的效果。该试验从未完成招募且提前终止，此前未发表过相关结果。
1987年1月至1993年2月，纳入了54例患者的64个可评估颈部淋巴结。肿瘤根据机构和淋巴结大小进行分层，随机分配接受单纯放疗（2Gy/次，每周5次），总剂量60 - 70Gy（包括增敏剂量），或相同放疗方案后每周进行一次热疗（目标温度43°C，持续60分钟）。主要终点是持续完全缓解（局部控制）。
54例患者的64个肿瘤可评估，中位观察期为17个月。34个肿瘤随机分配至单纯放疗组，30个至放疗 + 热疗组。放疗依从性良好。38%的热疗治疗出现中度至重度疼痛和不适。57%接受热疗的患者至少有一次治疗达到目标温度。热疗未显著增加放疗相关并发症。单纯放疗组完全缓解率为53%，放疗 + 热疗组为80%；3年持续局部控制率单纯放疗组为32%，放疗 + 热疗组为53%；风险比：0.48[0.23 - 0.98]。ESHO 2 - 85研究表明，对晚期颈部淋巴结放疗中每周加用一次热疗可显著提高肿瘤的持续控制率。结果证实了热疗肿瘤学的潜在临床益处。
