High-dose conformal radiotherapy for treatment of stage IIIA/IIIB XXXX : technical issues and results of a phase I/II trial.

@entity1 @entity137 @entity55 @entity5 @entity3003 @entity2910 @entity1149 @entity1311
PURPOSE: We completed a Phase I/II clinical trial (Lineberger Comprehensive Cancer Center 9603), in which we treated 62 Stage IIIA/IIIB inoperable @entity1149 ( @entity1149 ) @entity1 with two cycles of induction @entity3003 / @entity1311 chemotherapy, followed by concurrent weekly @entity3003 / @entity1311 with radiation doses escalated from 60 to 74 Gy. The median survival of 24 months, 3-year survival rate of 38%, and the high dose of radiation used justified a critical analysis of the technical and clinical components of this trial. METHODS AND MATERIALS: Between 1996 and 1999, 62 sequential @entity1 with inoperable Stage IIIA/IIIB @entity1149 were enrolled and treated with two cycles of induction @entity3003 (area under the concentration curve = 6 using the Calvert equation) and @entity1311 (225 mg/m(2)), followed by an escalating radiation dose of 60-74 Gy with concurrent @entity3003 weekly (area under the concentration curve = 2) and @entity1311 weekly (45 mg/m(2)). The goals of the trial were to determine whether 74 Gy of radiation could be safely delivered under these circumstances and whether @entity1 could potentially benefit in terms of survival. The radiation treatment plans for all 62 @entity1 were reviewed to determine the prechemotherapy and postchemotherapy @entity5 volume, as well as the dose-volume histograms of the normal lung and esophagus. RESULTS: Of the 62 @entity1 who entered the trial, 48 completed the entire course of treatment. At last follow-up, 20 @entity1 were alive (crude survival rate 32%). With a median follow-up of 43 months, the median survival was 24 months. The survival rate was 50% at 2 years and 38% at 3 years. Cox regression analysis showed that survival was best predicted by whether the @entity1 had received radiotherapy (finished the trial), performance status, disease stage, and log postchemotherapy @entity5 volume. The 3-year survival rate for the 48 @entity1 finishing the trial was 45%. Eight @entity1 (13%) suffered locoregional relapse as the only site of failure. Only 1 @entity1 had Grade 2 radiation @entity55 . Five @entity1 (8%) had Radiation Therapy Oncology Group Grade 3 or 4 @entity2910 ; 40 (65%) had a Grade 1 or 2 @entity2910 . @entity137 could be predicted by the length of esophagus receiving 40 or 60 Gy. CONCLUSION: Radiation doses of 74 Gy, when given under the guidelines of the Lineberger Comprehensive Cancer Center 9603, appear to be safe and may possibly contribute to increased survival in @entity1 with inoperable Stage IIIA/IIIB @entity1149 .
