Radiochemotherapy with short daily infusion of low-dose @entity901 , @entity4181 , and XXXX in T3-T4 unresectable @entity5 : a phase II IATTGI study.

@entity901 @entity1 @entity4181 @entity137 @entity295 @entity882 @entity5 @entity294 @entity15114 @entity1398 @entity1431 @entity14 @entity204 @entity159 @entity1487
PURPOSE: @entity901 ( @entity15114 )/ @entity1487 ( @entity1487 ) have confirmed their preclinical synergy in advanced @entity14 @entity1 . Chemoradiotherapy with @entity1487 + @entity4181 (LV) is considered the standard treatment in unresectable @entity5 @entity1 . The objective was to evaluate @entity15114 with @entity1487 + LV and concurrent radiotherapy in unresectable @entity5 @entity1 . @entity1 AND METHODS:                 <AbstractText Label="TREATMENT" NlmCategory="METHODS"> @entity15114 25 mg/m(2)/day in 30-min infusions, followed by bolus LV 20 mg/m(2)/day and bolus @entity1487 375 mg/m(2)/day. All drugs were given on 4 days during Weeks 1 and 5 of a standard radiotherapy cycle (50.4 Gy). A single @entity15114 dose (50 mg/m(2)) was also given on the third week of radiotherapy. A cycle of @entity15114 with @entity1487 + LV was administered 4 weeks after chemoradiotherapy, with surgery planned 4 weeks later. RESULTS: Between March 1998 and April 2000, 22 @entity1 with T3-T4 unresectable @entity5 were accrued. @entity1 characteristics included the following: 11 females, 11 males, median age 58 (range: 18-76). @entity159 ( @entity159 ) 0: 2 @entity1 , @entity159 1: 7 @entity1 , and @entity159 2: 13 @entity1 . The following RTOG Grade 3-4 @entity137 were reported: @entity294 , 6 @entity1 ; cutaneous, 3 @entity1 ; @entity1398 - @entity1431 , 2 @entity1 ; and @entity882 , 1 @entity1 ; 1 treatment-related @entity204 resulted ( @entity1398 - @entity295 after chemoradiotherapy). Only 1 @entity1 had neurosensory Grade 2 ( @entity15114 -specific Levi's scale) @entity137 . Nine @entity1 had @entity159 worsening during treatment. Five @entity1 had chemoradiotherapy delay (median: 6 days). Of 22 @entity1 , 16 underwent surgery (without serious surgical complications); 12/16 had a complete resection (5/12 had sphincter preservation). Pathologic examination revealed 3/12 complete remissions, 2/12 minimal microscopic residual disease, 2/12 T2N0, 1/12 T3N0, and 4/12 positive nodes; 4/16 had unresectable disease. Median follow-up was 15 months (range: 3.0-43.4 months), median time to progression was 15.7 months (CI 95%, 0, 31.7), and median overall survival was 19.5 months (CI 95%, 18.0, 21). CONCLUSIONS: Outpatient treatment with low-dose, 30-min daily @entity15114 infusion was feasible and very active, with acceptable @entity137 .
