Ajani JA et al. – Both arms of RTOG 0113 were associated with high morbidity; the study did not meet its 1-year survival end point Methods
Comparison of 2 nonoperative approaches (with/without fluorouracil) using induction chemotherapy and then definitive chemoradiotherapy in 84 localized esophageal cancer (LEC) pts with unresectable cancer who were poor surgical candidates
Primary end point: determination of whether either approach achieved ≥ 77.5% 1-yr survival rate, surpassing the historical 66% of Radiation Therapy Oncology Group (RTOG) protocol 9405
Randomization: Arm A (41 pts: induction with fluorouracil, cisplatin, paclitaxel; then fluorouracil + paclitaxel with radiation, 50.4 Gy) or Arm B (43: induction with paclitaxel + cisplatin; then the same chemotherapy with radiation, 50.4 Gy)
Results
Assessable pts: 72 total; A=37; B=35
Median survival: A=28.7 mo; B=14.9 mo (RTOG 9405=18.8 mo)
1-yr survival: 75.7% in arm A approached the 77.5% goal
2-year survival: A=56%; B=37%
Frequent toxicities: grade 3 in A=54%; B=43% and grade 4 in A=27%; B=40%
See all
