First, 10 hypoxia-positive cases of pathology-diagnosed NSCLC selected from 15 patients were used to determine the normalization window, a period during which RHES improves NSCLC hypoxia. Second, 50 hypoxia-positive cases of pathology-diagnosed NSCLC (Stages I-III) were randomly divided into a RHES plus radiotherapy group (25 cases) and a radiotherapy-alone group (25 cases). Intensity = modulated radiotherapy with a total dose of 60 Gy in 30 fractions for 6 weeks was adopted in the two groups. The target area included primary foci and metastatic lymph nodes. In the RHES plus radiotherapy group, RHES (15 mg/day) was intravenously given during the normalization window.
After RHES administration, the tumor-to=normal tissue radioactivity ratio and capillary permeability surface were first decreased and then increased, with their lowest points on the fifth day compared with the first day (all p < 0.01). Blood flow was first increased and then decreased, with the highest point on the fifth day, compared with the first and tenth day (all p聽< 0.01). In the RHES plus radiotherapy group and the radiotherapy-alone group, the total effective rates (complete response plus partial response) were 80%and 44%(p = 0.009), respectively. The median survival times were 21.1 卤 0.97 months and 16.5 卤 0.95 months (p聽聽= 0.004), respectively. The 1-year and 2-year local control rates were 78.9 卤 8.4%and 68.1 卤 7.8%(p = 0.027) and 63.6 卤 7.2%and 43.4 卤 5.7%(p = 0.022), respectively. The 1-year and 2-year overall survival rates were 83.3 卤 7.2%and 76.6 卤 9.3%(p = 0.247) and 46.3 卤 2.4%and 37.6 卤 9.1%(p = 0.218), respectively.
The RHES normalization window is within about 1 week after administration. RHES combined with radiotherapy within the normalization window has better short-term therapeutic effects and local control rates and no severe adverse reactions in the treatment of NSCLC, but it failed to significantly improve the 1-year and 3-year overall survival rates.