Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable @entity1149 ( XXXX ): Initial analysis of a randomized phase III trial.

@entity1 @entity137 @entity417 @entity1353 @entity3003 @entity2910 @entity1149 @entity1311 @entity1398 @entity489
UNASSIGNED: 7005 Background: Standard therapy for unresectable stage III @entity1149 includes concomitant chemoradiotherapy. In CALGB 39801, we evaluated whether the addition of induction chemotherapy prior to CT/XRT would result in improved survival. METHODS: Between 10/1998 and 5/2002, 366 stage III @entity1 (pts) were randomized to either immediate CT/XRT [ @entity3003 AUC of 2 and @entity1311 50 mg/m(2) each given weekly during 66 Gy chest XRT to; arm 1 (182 pts)] or two cycles of @entity3003 AUC 6 and @entity1311 200 mg/m(2) given q 21 days x 2 cycles followed by identical @entity489 (184 pts). The accrual goal was 360 @entity1 . 290 deaths were required to have 80% power to detect a 40% increase in median survival assuming a one-tailed log-rank test conducted at the 0.025 level of significance. RESULTS: 34% of pts were female, 66% male and 63% were age 60 or older. Grade 3 or 4 @entity137 during induction chemotherapy consisted mainly of @entity1398 (17%/21%). During CT/XRT, grade 3/4 @entity1398 was noted in 11%/4% (arm 1) versus 21%/6% ( @entity489 ), grade 3 @entity417 was 5% vs 11%, grade 3/4 fatigue 16%/1% vs 16%/4%, @entity2910 30%/1% vs 28%/7%, and @entity1353 9%/3% vs 15%/4%. Overall, 4 @entity137 were experienced by 24% of @entity1 on arm 1 versus 41% on @entity489 (p=0.001). With 254 of 290 targeted deaths, median survival on arm 1 is 11.4 months versus 14 months on @entity489 (p=0.154). One year survival estimates are 48% (41%-57%) and 54% (47%-62%) respectively. CONCLUSION: The median survival achieved in each of the treatment groups is low compared to other recent experiences in the literature. The reason(s) for this are uncertain. The addition of induction chemotherapy to immediate concurrent CT/XRT is associated with a 2.6 month increase in median survival. However these findings are not sufficient to reject the null hypothesis of no treatment difference between the two study arms. Further follow up of this data set is required. Our results do not support the use of induction chemotherapy followed by CT/XRT as evidence based standard of care for @entity1 with unresectable stage III @entity1149 . [Table: see text].
