Scott R, Gillespie B, Perez C A, Hornback N B, Johnson R, Emami B, Bauer M, Pakuris E
Cancer Consult, Torrance, CA 90505.
Int J Radiat Oncol Biol Phys. 1988 Sep;15(3):711-6. doi: 10.1016/0360-3016(88)90316-1.
Between August 1981 and April 1986, 133 patients with superficial malignant tumors not previously treated with radiotherapy were entered on a Phase I/II RTOG study evaluating hyperthermia plus definitive radiotherapy. Eligible patients included those with superficial epithelial or mesenchymal tumors less than 4 cm in depth. Protocol radiotherapy specified a tumor dose of 60 Gy delivered in 1.8-2.0 Gy fractions 5 times/week with a boost of 5-10 Gy through reduced portals to residual tumor. Protocol hyperthermia, delivered twice weekly, was to start within 15 minutes following irradiation and to consist of 60 minutes of heat to a tumor temperature of 43 degrees C. Sixteen patients were excluded. Of the 117 eligible patients, the treated lesions had site/histologies which were 35% head & neck/squamous, 46% breast/adenocarcinoma, and 19% other site/histologies. Lesions were 3 cm or larger for 77% of patients. Of the 41 patients with head & neck/squamous lesions, skin or subcutaneous necrosis occurred within 6 months for 2% of the patients; 12% experienced thermal blisters. Fourteen patients were followed for 6 months or more following start of treatment; none of these experienced late toxicities more severe than telangiectasis. Complete responses were observed in 51% of these patients. Of the 54 patients with breast/adenocarcinoma lesions, skin or subcutaneous necrosis occurred within 6 months for 13% of the patients; 17% experienced thermal blisters. Thirty-seven patients were followed for 6 months or more following start of treatment; complications observed during this period included 13% with ulceration and one case of skin necrosis. Complete responses were observed in 85% of these patients. Local control was maintained at nearly this level for at least 2 years. Logistic regression analyses showed site/histology, greatest tumor diameter and average tumor temperature to be significantly related to response. Based on these promising findings, the RTOG has instituted a randomized Phase III study evaluating radiation therapy with or without hyperthermia in this patient population.
1981年8月至1986年4月期间，133例未曾接受过放射治疗的浅表恶性肿瘤患者进入了放射肿瘤学组（RTOG）的一项I/II期研究，该研究旨在评估热疗联合根治性放疗的效果。符合条件的患者包括那些深度小于4厘米的浅表上皮或间叶组织肿瘤患者。方案规定的放疗是给予肿瘤剂量60 Gy，每周5次，每次1.8 - 2.0 Gy，通过缩小照射野对残留肿瘤追加5 - 10 Gy的剂量。方案规定的热疗每周进行两次，在放疗后15分钟内开始，持续60分钟，使肿瘤温度达到43摄氏度。16例患者被排除。在117例符合条件的患者中，所治疗的病变部位/组织学类型为：35%为头颈部/鳞状细胞癌，46%为乳腺/腺癌，19%为其他部位/组织学类型。77%的患者病变直径为3厘米或更大。在41例头颈部/鳞状细胞癌病变患者中，2%的患者在6个月内发生皮肤或皮下坏死；12%的患者出现热疱。14例患者在开始治疗后随访6个月或更长时间；这些患者中无一例出现比毛细血管扩张更严重的晚期毒性反应。这些患者中有51%观察到完全缓解。在54例乳腺/腺癌病变患者中，13%的患者在6个月内发生皮肤或皮下坏死；17%的患者出现热疱。37例患者在开始治疗后随访6个月或更长时间；在此期间观察到的并发症包括13%的患者出现溃疡和1例皮肤坏死。这些患者中有85%观察到完全缓解。局部控制在至少2年内维持在接近这一水平。逻辑回归分析显示，病变部位/组织学类型、最大肿瘤直径和平均肿瘤温度与缓解显著相关。基于这些有前景的发现，放射肿瘤学组开展了一项随机III期研究，评估在该患者群体中放疗联合或不联合热疗的效果。
