Phase I-II pilot of whole abdominal radiation and concomitant XXXX as an adjuvant in @entity694 : a Southwest Oncology Group Study.

@entity1 @entity137 @entity5 @entity3052 @entity694 @entity1487
Thirty-eight @entity1 with Stage B2, C1 or C2 @entity694 (Astler-Coller Modification of Dukes) received 3000 rads whole abdominal radiation and concomitant intermittent bolus @entity1487 as part of a phase I-II adjuvant trial. @entity1 whose @entity5 penetrated the serosa (B2 or C2) in addition received a 1600 rad boost to the @entity5 bed. @entity1487 was administered only during radiation. It was given at a dose of 300 mg/m2 days 1-5 and 28-32 in 21 @entity1 (Group A) and day 1-3 and 28-31 in 17 @entity1 (Group B). Median follow-up time for Group A is 44 months. Group A @entity1 have a disease-free survival of 66% and overall survival of 73% at 44 months. The 16 C2 @entity1 in Group A have a disease-free survival of 54% and overall survival of 65% at 44 months. There was a 26% incidence of moderate to severe acute @entity137 in Group A but no long term bowel, liver, or hematologic @entity137 . One @entity1 developed @entity3052 2 years after treatment. Group B @entity1 had only a 6% incidence of moderate to severe @entity137 , but had a disease-free survival of 60% and overall survival of 100% at median follow-up of 23 months. Group B Stage C2 @entity1 had a disease-free survival of 53% and overall survival of 100% at this same follow-up period. Disease-free and overall survival in Group A Stage C2 @entity1 is superior to that in several published trials. Given the manageable @entity137 , adjuvant whole abdominal radiation with concomitant @entity1487 and @entity5 bed boost should be tested in a randomized fashion for possible therapeutic benefits.
