Amichetti M, Graiff C, Fellin G, Pani G, Bolner A, Maluta S, Valdagni R
Divisione di Radioterapia Oncologica, Ospedale S. Chiara, Trento, Italy.
Int J Radiat Oncol Biol Phys. 1993 Aug 1;26(5):801-7. doi: 10.1016/0360-3016(93)90495-h.
Hyperthermia is now being widely used to treat clinical malignancies especially combined with radiotherapy and more rarely with chemotherapy. The combination of heat, radiation, and chemotherapy (trimodality) can lead to potent interaction. The present Phase I-II study was conducted to evaluate the feasibility and acute toxicity of a combination of cisplatin, hyperthermia, and irradiation in the treatment of superficial cervical nodal metastases from head and neck cancer.
Eighteen patients with measurable neck metastases from previously untreated squamous cell head and neck tumors were entered into the trial. Therapy consisted of a conventional irradiation (total dose 70 Gy, 2 Gy five times a week) combined with a weekly administration of 20 mg/m2 iv of cisplatin and a total of two sessions of local external microwave hyperthermia (desired temperature of 42.5 degrees C for 30 min).
Feasibility of the treatment was demonstrated. Acute local toxicity was mild; no thermal blisters or ulcerations were reported and only two patients experienced local pain during hyperthermia. Cutaneous toxicity appeared greater than in our previous studies with irradiation plus hyperthermia and irradiation plus cisplatin. Systemic toxicity was moderate with major toxic effects observed in three patients (World Health Organization (WHO) grade 3 anaemia). Even though it was not an aim of the study to evaluate the nodal response, we observed a complete response rate of 72.2% (95% confidence interval 51-93.4%), 16.6% of partial response and 11.1% of no change.
The study confirms the feasibility of the combination of cisplatin, heat, and radiation with an acceptable toxicity profile. The trimodal therapy deserves further evaluation as a way to enhance the efficacy of irradiation in the treatment of nodal metastases from head and neck tumors.
热疗目前正广泛应用于临床恶性肿瘤的治疗，尤其是与放疗联合使用，与化疗联合使用的情况则较少。热疗、放疗和化疗（三联疗法）相结合可产生强效相互作用。本I-II期研究旨在评估顺铂、热疗和放疗联合治疗头颈部癌颈部浅表淋巴结转移的可行性和急性毒性。
18例先前未经治疗的头颈部鳞状细胞肿瘤且颈部转移灶可测量的患者进入该试验。治疗方案包括常规放疗（总剂量70 Gy，每周5次，每次2 Gy），联合每周静脉注射20 mg/m²顺铂，以及总共两次局部体外微波热疗（目标温度为42.5℃，持续30分钟）。
证明了该治疗方法的可行性。急性局部毒性较轻；未报告有热水泡或溃疡，只有两名患者在热疗期间出现局部疼痛。皮肤毒性似乎比我们之前放疗加 热疗以及放疗加顺铂的研究更大。全身毒性为中度，三名患者出现主要毒性反应（世界卫生组织（WHO）3级贫血）。尽管评估淋巴结反应并非本研究的目的，但我们观察到完全缓解率为72.2%（95%置信区间51-93.4%），部分缓解率为16.6%，病情无变化率为11.1%。
该研究证实了顺铂、热疗和放疗联合使用具有可接受的毒性特征，是可行的。三联疗法作为提高头颈部肿瘤淋巴结转移放疗疗效的一种方法，值得进一步评估。
