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Best Practice in Advanced Esophageal Cancer: A Report on Trans-Tasman Radiation Oncology Group TROG 03.01 and NCIC CTG ES.2 Multinational Phase 3 Study in Advanced Esophageal Cancer (OC) Comparing Quality of Life (QOL) and Palliation of Dysphagia in Patients Treated With Radiation Therapy (RT) or Chemoradiation Therapy (CRT)

2014; Elsevier BV; Volume: 90; Issue: 1 Linguagem: Inglês

10.1016/j.ijrobp.2014.06.021

1879-355X

Michael Penniment, Jennifer A. Harvey, Rebecca Wong, Sonya Stephens, H. Au, Chris O’Callaghan, Andrew Kneebone, Samuel Y. Ngan, Iain Ward, Rajarshi Roy, Thomas Sullivan, Tirath Nijjar, James Biagi, Liam Mulroy,

Gastric Cancer Management and Outcomes

RT is known to relieve dysphagia of advanced esophageal cancer; there is no data from randomized phase III trials determining response, toxicity, or role of palliative CRT. Aims (1) to establish effective and least toxic treatment for symptom relief of advanced OC; (2) determine effects of common cancer treatments on QOL and end of life care; and (3) establish an evidence base for patient decision making regarding the optimal management for incurable OC. Two hundred twenty patients were randomized to receive a course of palliative RT [35 Gy in 15 fractions in Australia and New Zealand, (n = 115) or 30 Gy in 10 fractions (n = 105) in Canada and United Kingdom], or concomitant CRT with Cisplatin and 5-FU (D1-4) (n = 111). Dysphagia was measured using the Mellow score, toxicity using CTCAE v2, and QOL using EORTC QLQ30 and esophagus module (OES-18). The primary end point was the proportion of patients with improved dysphagia as measured at week 9 and maintained until week 13. The patients receiving radiation therapy alone showed a dysphagia response (at any point) of 67.89% compared to chemotherapy response in 73.87% (p = 0.343). There was increased gastro-intestinal toxicity in patients receiving CRT (nausea: p = 0.0019 and vomiting: p = 0.0072). The median survival was 210 days for CRT and 203 days for RT alone. The baseline parameters of both groups were well matched at randomization and although the results of the trial showed equally poor survival prognosis in both arms, there were some patients (n = 21) still alive at 2 years post treatment. CRT was associated with increased gastro-intestinal toxicity without any significant improvement in dysphagia response or median survival. Further analysis of QOL, toxicity and durable palliative response will be published. This multicenter trial reflects practice in several countries. RT alone remains an excellent tool for palliation of patients with advanced OC and should remain the standard of care.