Concurrent chemoradiation therapy with @entity900 and @entity1311 for locally advanced XXXX : long-term follow-up of a phase I trial.

@entity1 @entity1143 @entity137 @entity2910 @entity1149 @entity900 @entity1311 @entity134 @entity1398 @entity358
The purpose of this trial was to evaluate the feasibility of concurrent @entity1311 / @entity900 and conventional thoracic irradiation in locally advanced @entity1149 ( @entity1149 ). Ambulatory @entity1 with medically inoperable or unresectable stage II-III @entity1149 , and performance status 0-2 were eligible. @entity1 were not excluded from this trial if they had lost more than 5% of their body weight during the preceding 3 months, and/or if they had small ipsilateral @entity1143 . The initial dose of @entity1311 / @entity900 was 110 and 50 mg/m(2), and was escalated through five dose levels. Four cycles of chemotherapy were planned; the first two cycles were given concurrently with radiotherapy (4 weeks apart), followed by two additional cycles (every 3 weeks). Conventional chest radiotherapy to a total dose of 60 Gy (2 Gy per day) was delivered in 6 weeks. Forty-three @entity1 were enrolled of which 38 were evaluable for response. Dose-limiting @entity137 were grade 4 @entity1398 (43% of @entity1 ) and grade 3 @entity2910 (26% of @entity1 ) during the chemoradiotherapy phase. Grade > or = 2 acute and late @entity358 occurred in 10 and 68% of the @entity1 , respectively. In most @entity1 , prompt symptomatic and radiologic improvement was observed with early @entity134 administration. The volume of lung receiving 15-30 Gy was correlated with late @entity358 . The overall response was 84% with ten complete and 22 partial responses. The median survival was 16.5 months (95% confidence interval, 9.5 to 25) for those @entity1 evaluable for response. After a median follow-up of 70 months, 5 (13%) @entity1 are alive without evidence of disease. The maximum tolerated dose (MTD) of @entity1311 and @entity900 with concurrent radiotherapy is at dose level 3 @entity1311 (135 mg/m(2)) and @entity900 (75 mg/m(2)). @entity137 , although significant, was manageable in the great majority of the @entity1 . The activity observed with this regimen is particularly noteworthy when considering the advanced nature of these @entity1 , and the fact that @entity1 (N=18) with poor risk factors were included in the study.
