IDEAL-CRT: A Phase 1/2 Trial of Isotoxic Dose-Escalated Radiation Therapy and Concurrent Chemotherapy in Patients With Stage II/III Non-Small Cell Lung Cancer.

Autor:	Landau DB; Guy's & St. Thomas' NHS Trust, King's College London, London, United Kingdom. Electronic address: david.landau@kcl.ac.uk., Hughes L; Cancer Research UK and UCL Cancer Trials Centre, London, United Kingdom., Baker A; Clatterbridge Cancer Centre, Bebington, United Kingdom., Bates AT; Southampton General Hospital, Southampton, United Kingdom., Bayne MC; Poole Hospital, Poole, United Kingdom., Counsell N; Cancer Research UK and UCL Cancer Trials Centre, London, United Kingdom., Garcia-Alonso A; North Wales Cancer Centre, Rhyl, United Kingdom., Harden SV; Addenbrookes Hospital, Cambridge, United Kingdom., Hicks JD; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom., Hughes SR; Guy's & St. Thomas' NHS Trust, King's College London, London, United Kingdom., Illsley MC; Royal Surrey County Hospital, Guilford, United Kingdom., Khan I; Cancer Research UK and UCL Cancer Trials Centre, London, United Kingdom., Laurence V; Poole Hospital, Poole, United Kingdom., Malik Z; Clatterbridge Cancer Centre, Bebington, United Kingdom., Mayles H; Clatterbridge Cancer Centre, Bebington, United Kingdom., Mayles WPM; Clatterbridge Cancer Centre, Bebington, United Kingdom., Miles E; Mount Vernon Hospital, Middlesex, United Kingdom., Mohammed N; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom., Ngai Y; Cancer Research UK and UCL Cancer Trials Centre, London, United Kingdom., Parsons E; Mount Vernon Hospital, Middlesex, United Kingdom., Spicer J; Guy's & St. Thomas' NHS Trust, King's College London, London, United Kingdom., Wells P; St. Bartholomew's Hospital, London, United Kingdom., Wilkinson D; Mount Vernon Hospital, Middlesex, United Kingdom., Fenwick JD; University of Oxford, Oxford, United Kingdom.
Jazyk:	angličtina
Zdroj:	International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2016 Aug 01; Vol. 95 (5), pp. 1367-1377. Date of Electronic Publication: 2016 Mar 28.
DOI:	10.1016/j.ijrobp.2016.03.031
Abstrakt:	Purpose: To report toxicity and early survival data for IDEAL-CRT, a trial of dose-escalated concurrent chemoradiotherapy (CRT) for non-small cell lung cancer. Patients and Methods: Patients received tumor doses of 63 to 73 Gy in 30 once-daily fractions over 6 weeks with 2 concurrent cycles of cisplatin and vinorelbine. They were assigned to 1 of 2 groups according to esophageal dose. In group 1, tumor doses were determined by an experimental constraint on maximum esophageal dose, which was escalated following a 6 + 6 design from 65 Gy through 68 Gy to 71 Gy, allowing an esophageal maximum tolerated dose to be determined from early and late toxicities. Tumor doses for group 2 patients were determined by other tissue constraints, often lung. Overall survival, progression-free survival, tumor response, and toxicity were evaluated for both groups combined. Results: Eight centers recruited 84 patients: 13, 12, and 10, respectively, in the 65-Gy, 68-Gy, and 71-Gy cohorts of group 1; and 49 in group 2. The mean prescribed tumor dose was 67.7 Gy. Five grade 3 esophagitis and 3 grade 3 pneumonitis events were observed across both groups. After 1 fatal esophageal perforation in the 71-Gy cohort, 68 Gy was declared the esophageal maximum tolerated dose. With a median follow-up of 35 months, median overall survival was 36.9 months, and overall survival and progression-free survival were 87.8% and 72.0%, respectively, at 1 year and 68.0% and 48.5% at 2 years. Conclusions: IDEAL-CRT achieved significant treatment intensification with acceptable toxicity and promising survival. The isotoxic design allowed the esophageal maximum tolerated dose to be identified from relatively few patients. (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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