Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy for Esophageal Cancer.
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BACKGROUND: Longitudinal quality of life (QoL) was compared for patients with esophageal cancer receiving definitive chemoradiotherapy (CRT) with conventional-dose (CD) vs. high-dose (HD) radiotherapy as used in the RTOG phase III 94-05 trial (Intergroup 0123). METHODS: Between June 12, 1995, and July 1, 1999, 236 patients with cT1-4NxM0 esophageal cancer were randomized to CD CRT (50.4 Gy and concurrent 5-fluorouracil and cisplatin) vs. HD CRT (64.8 Gy and the same chemotherapy). QoL was assessed using the Functional Assessment of Cancer Therapy, Head & Neck (version 2) at baseline, after CRT, at 8 months from the start of CRT, and at 1 year. RESULTS: Of 218 eligible patients, 166 participated in pretreatment QoL assessments (82 HD, 84 CD). Patients with ≥10% weight loss and Karnofsky Performance Status 60-80 were less likely to participate (P = .02 and P = .002, respectively). Pretreatment characteristics for participating patients were similar in both arms. At CRT completion, 96 patients completed QoL (46 HD, 50 CD) assessment. Total mean QoL was significantly lower in the HD arm (P = .02) and remained lower at 8 and 12 months after the start of CRT, but these values did not reach statistical significance. Change in mean QoL from baseline to each of the three subsequent assessment time points did not differ significantly between the two treatment arms. CONCLUSIONS: For patients treated with definitive CRT for esophageal cancer, radiation dose escalation to 64.8 Gy does not significantly improve QoL. These results provide additional evidence that radiotherapy to 50.4 Gy should remain the standard of care.