Phase 2 Randomized Controlled Trial of Radiation Therapy Plus Concurrent Interferon-Alpha and XXXX Versus @entity900 for @entity5 .

@entity1 @entity137 @entity5 @entity900 @entity10211 @entity1968 @entity4020 @entity204 @entity3027
PURPOSE: Because a combination of @entity1968 , interferon-alpha, and radiation therapy demonstrated synergistic action and effectiveness to treat @entity5 in earlier studies, we designed this randomized phase 2 open-label trial to assess efficacy and safety of @entity4020 ( @entity3027 ) and @entity10211 (RA) administered concomitantly with radiation therapy ( @entity3027 -RA-radiation) to treat @entity5 . METHODS AND MATERIALS: Stage III cervical @entity5 @entity1 were randomized to study and control groups in a 1:1 ratio. All @entity1 were treated with radiation therapy; study arm @entity1 received @entity3027 (3  *  10(6) IU subcutaneously) 3 times a week for 4  weeks and daily RA (40  mg orally) for 30  days starting on day 1 of radiation, whereas control arm @entity1 received weekly @entity900 (40  mg/m(2)) for 5  weeks during radiation. @entity1 were followed for 3  years. The primary endpoint was overall survival at 3  years. RESULTS: @entity1 in the study (n=104) and control (n=105) groups were comparable for clinicopathological characteristics, radiation therapy-related variables and treatment response. Proportions of disease-free @entity1 in the study and control groups were 38.5% and 44.8%, respectively, after median follow-up of 29.2  months. Hazard ratios were 0.67 (95% confidence interval [CI]: 0.44-1.01) and 0.69 (95% CI: 0.44-1.06) for overall and disease-fee survival, respectively, comparing the study group to control, and demonstrated an inferior outcome with RA- @entity3027 -radiation, although differences were statistically nonsignificant. Kaplan-Meier curves of disease-free and overall survival probabilities also showed inferior survival in the study group compared to those in the control. Acute @entity137 of chemoradiation were significantly higher with 2 acute @entity137 -related @entity204 . CONCLUSIONS: Treatment with RA- @entity3027 -radiation did not demonstrate survival advantage over chemoradiation despite being less toxic. The trends predicted an inferior outcome with the RA- @entity3027 combination.
