دورية أكاديمية
Dose-escalated intensity-modulated radiotherapy in patients with locally advanced laryngeal and hypopharyngeal cancers: ART DECO, a phase III randomised controlled trial.
| العنوان: | Dose-escalated intensity-modulated radiotherapy in patients with locally advanced laryngeal and hypopharyngeal cancers: ART DECO, a phase III randomised controlled trial. |
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| المؤلفون: | Nutting CM; The Royal Marsden Hospital, London, UK. Electronic address: chris.nutting@rmh.nhs.uk., Griffin CL; The Institute of Cancer Research, London, UK., Sanghera P; Queen Elizabeth Hospital, Birmingham, UK., Foran B; Weston Park Hospital, Sheffield, UK., Beasley M; Bristol Haematology & Oncology Centre, Bristol, UK., Bernstein D; Department of Physics, The Royal Marsden Hospital, London, UK., Cosgrove V; St James' Hospital, Leeds, UK., Fisher S; University of Leeds, Leeds, UK., West CM; University of Manchester, Manchester, UK., Sibtain A; St Bartholomew's Hospital, London, UK., Palaniappan N; Velindre Hospital, Cardiff, UK., Urbano TG; Guy's and St Thomas' Hospitals, London, UK., Sen M; St James' Hospital, Leeds, UK., Soe W; Glan Clywd, Rhyll, UK., Rizwanullah M; Beatson West of Scotland Cancer Centre, Glasgow, UK., Wood K; Royal Surrey County Hospital, Guildford, UK., Ramkumar S; Southampton General Hospital, Southampton, UK., Junor E; Western General Hospital, Edinburgh, UK., Cook A; Cheltenham General Hospital, Cheltenham, UK., Roques T; Norfolk and Norwich University Hospital, UK., Scrase C; Ipswich Hospital, Ipswich, UK., Bhide SA; The Royal Marsden Hospital, London, UK., Gujral D; The Royal Marsden Hospital, London, UK., Harrington KJ; The Royal Marsden Hospital, London, UK., Mehanna H; The Institute for Head and Neck Studies and Education, University of Birmingham, Birmingham, UK., Miah A; The Royal Marsden Hospital, London, UK., Emson M; The Institute of Cancer Research, London, UK., Gardiner D; The Institute of Cancer Research, London, UK., Morden JP; The Institute of Cancer Research, London, UK., Hall E; The Institute of Cancer Research, London, UK. |
| مؤلفون مشاركون: | ART DECO Trial Management Group |
| المصدر: | European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2021 Aug; Vol. 153, pp. 242-256. Date of Electronic Publication: 2021 Jul 10. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Elsevier Science Ltd Original Publication: Oxford ; New York : Pergamon Press, c1990- |
| مواضيع طبية MeSH: | Hypopharyngeal Neoplasms/*radiotherapy , Laryngeal Neoplasms/*radiotherapy, Aged ; Female ; Humans ; Male ; Middle Aged |
| مستخلص: | Background: Radical (chemo)radiotherapy offers potentially curative treatment for patients with locally advanced laryngeal or hypopharyngeal cancer. We aimed to show that dose-escalated intensity-modulated radiotherapy (DE-IMRT) improved locoregional control. Methods: We performed a phase III open-label randomised controlled trial in patients with laryngeal or hypopharyngeal cancer (AJCC III-IVa/b, TNM 7). Patients were randomised (1:1) to DE-IMRT or standard dose IMRT (ST-IMRT) using a minimisation algorithm, balancing for centre, tumour site, nodal status and chemotherapy use. DE-IMRT was 67.2 gray (Gy) in 28 fractions (f) to the primary tumour and 56Gy/28f to at-risk nodes; ST-IMRT was 65Gy/30f to primary tumour and 54Gy/30f to at-risk nodes. Suitable patients received 2 cycles of concomitant cisplatin and up to 3 cycles of platinum-based induction chemotherapy. The primary end-point was time to locoregional failure analysed by intention-to-treat analysis using competing risk methodology. Findings: Between February 2011 and October 2015, 276 patients (138 ST-IMRT; 138 DE-IMRT) were randomised. A preplanned interim futility analysis met the criterion for early closure. After a median follow-up of 47.9 months (interquartile range 37.5-60.5), there were locoregional failures in 38 of 138 (27.5%) ST-IMRT patients and 42 of 138 (30.4%) DE-IMRT patients; an adjusted subhazard ratio of 1.16 (95% confidence interval: 0.74-1.83, p = 0.519) indicated no evidence of benefit with DE-IMRT. Acute grade 2 pharyngeal mucositis was reported more frequently with DE-IMRT than with ST-IMRT (42% vs. 32%). No differences in grade ≥3 acute or late toxicity rates were seen. Conclusion: DE-IMRT did not improve locoregional control in patients with laryngeal or hypopharyngeal cancer. The trial is registered: ISRCTN01483375. Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: B.F. reports personal fees and other fees from BMS, outside the submitted work. D.B. reports support from National Institute for Health Research during the conduct of the study. E.H. reports grants from Cancer Research UK, during the conduct of the study, grants from Accuray Inc., grants from Varian Medical Systems Inc., grants and non-financial support from Merck Sharp & Dohme, grants and non-financial support from AstraZeneca, grants from Janssen-Cilag, grants and non-financial support from Bayer Healthcare Pharmaceuticals Inc., grants from Kyowa Hakko UK, grants from Alliance Pharma (previously Cambridge Laboratories) and grants from Aventis Pharma Limited (Sanofi), outside the submitted work. H.M. reports personal fees from Warwickshire Head Neck Clinic Ltd, personal fees from AstraZeneca, personal fees from MSD, Sanofi Pasteur and Merck, grants from GSK Biologicals, MSD, Sanofi Pasteur, Silence Therapeutics, GSK PLC and AstraZeneca and other from Sanofi Pasteur, MSD and Merck, outside the submitted work. K.J.H. reports grants and personal fees from AstraZeneca, personal fees from Amgen, personal fees from BMS, grants and personal fees from Boehringer Ingelheim, grants and personal fees from MSD, personal fees from Merck Serono, personal fees from Pfizer and grants and personal fees from Replimune, outside the submitted work. P.S. reports personal fees from advisory board work for AbbVie and non-financial support from Phillips and Accuray, outside the submitted work. The below mentioned authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article: C.M.N., C.L.G., M.B., V.C., S.F., C.M.W., A.S., N.P., T.G.U., M.S., W.S., M.R., K.W., S.R., E.J., A.C., T.R., C.S., S.A.B., Do.G., A.M., M.E., De.G. and J.P.M. (Copyright © 2021. Published by Elsevier Ltd.) |
| معلومات مُعتمدة: | C1491/A15955 United Kingdom CRUK_ Cancer Research UK; 21993 United Kingdom CRUK_ Cancer Research UK; 11570 United Kingdom CRUK_ Cancer Research UK; United Kingdom DH_ Department of Health; 28724 United Kingdom CRUK_ Cancer Research UK; C1491/A9895 United Kingdom CRUK_ Cancer Research UK; C8262/A11570 United Kingdom CRUK_ Cancer Research UK |
| فهرسة مساهمة: | Keywords: Clinical outcomes; Dose escalation; Head and neck cancer; Hypopharynx cancer; IMRT; Larynx cancer; Phase III; Randomised controlled trial; Toxicity |
| سلسلة جزيئية: | ISRCTN ISRCTN01483375 |
| تواريخ الأحداث: | Date Created: 20210713 Date Completed: 20211207 Latest Revision: 20240210 |
| رمز التحديث: | 20240210 |
| DOI: | 10.1016/j.ejca.2021.05.021 |
| PMID: | 34256319 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1879-0852 |
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| DOI: | 10.1016/j.ejca.2021.05.021 |