PRELIMINARY-RESULTS OF A PHASE-III TRIAL OF SPONTANEOUS ANIMAL TUMORS TO HEAT AND OR RADIATION - EARLY NORMAL TISSUE-RESPONSE AND TUMOR VOLUME INFLUENCE ON INITIAL RESPONSE
PRELIMINARY-RESULTS OF A PHASE-III TRIAL OF SPONTANEOUS ANIMAL TUMORS TO HEAT AND OR RADIATION - EARLY NORMAL TISSUE-RESPONSE AND TUMOR VOLUME INFLUENCE ON INITIAL RESPONSE
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DOI：
10.1016/0360-3016(82)90455-2
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发表时间：
1982-01-01
影响因子：
7
通讯作者：
SIM, DA
中科院分区：
文献类型：
--
作者：
DEWHIRST, MW;CONNOR, WG;SIM, DA
启动了一项III期随机试验，在宠物[犬和猫]中使用自发性恶性肿瘤检测单独热疗、单独辐射和热疗加辐射的相对疗效。单独加热劣于其他2个治疗组，表现为无应答率显著较高和应答持续时间较短。对于肿瘤> 10 cm 3的患者，热加放疗与单纯放疗的完全缓解率（CR）或热相对风险（TRR）比< 10 cm 3的患者更高（TRR分别为4.8和1.4）。完全缓解的总体TRR为2.3。联合治疗组的CR数据表明，对于小肿瘤，热疗和放疗之间至少存在累加效应，但在较大肿瘤组中很可能存在协同效应。根据目前可用的数据，尽管联合治疗存在不显著的优势，但在2个放疗组之间未观察到反应持续时间的显著差异。正常组织效应通过辐照体积内的完全湿脱屑、晚期纤维化和骨坏死的发生率进行评价。由于辐射皮肤剂量取决于所使用的技术，因此可以通过逻辑回归模型估计在50%的动物中实现潮湿脱屑的剂量（DD 50）为3728 ± 0.05。344拉德的辐射。没有观察到在辐射中加入热量会显著降低DD50。加热完整皮肤的患者数量较少，无法对效果进行准确分析。
A phase III randomized trial was initiated to test the relative efficacies of heat alone, radiation alone and heat plus radiation using spontaneous malignancies in pet animals [dogs and cats]. Heat alone was inferior to the other 2 treatment arms as demonstrated by a significantly higher non-response rate and shorter response duration. The ratio of complete response rates (CR) for heat plus radiation to radiation alone or the thermal relative risk (TRR) was greater for tumors > 10 cm3 as compared to those < 10 cm3 (TRR = 4.8 and 1.4, respectively). The overall TRR for complete responses was 2.3. The CR data for the combined therapy arm indicate at least an additive effect between heat and radiation for small tumors but most likely a synergistic effect in the larger tumor group. Based on the data currently available, no significant difference in response duration is observed between the 2 radiation arms, although a nonsignificant advantage to the combination therapy exists. Normal tissue effects were evaluated by incidence of full moist desquamation within the irradiated volume, late fibrosis and bone necrosis. Since the radiation skin dose depended upon the technique being used, it was possible to estimate the dose to achieve moist desquamation in 50% of the animals (DD50) by a logistic regression model as being 3728 .+-. 344 rad for radiation alone. Significant lowering of the DD50 was not observed for the addition of heat to radiation. Low patient numbers where intact skin was heated prevented an accurate analysis of the effect.