Results of a multicentre randomised controlled trial of cochlear-sparing intensity-modulated radiotherapy versus conventional radiotherapy in patients with parotid cancer (COSTAR; CRUK/08/004).
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Date
2018-11-01Author
Nutting, CM
Morden, JP
Beasley, M
Bhide, S
Cook, A
De Winton, E
Emson, M
Evans, M
Fresco, L
Gollins, S
Gujral, D
Harrington, K
Joseph, M
Lemon, C
Luxon, L
van den Blink, Q
Mendes, R
Miah, A
Newbold, K
Prestwich, R
Robinson, M
Sanghera, P
Simpson, J
Sivaramalingam, M
Srihari, NN
Sydenham, M
Wells, E
Witts, S
Hall, E
COSTAR Investigators,
Type
Journal Article
Metadata
Show full item recordAbstract
PURPOSE: About 40-60% of patients treated with post-operative radiotherapy for parotid cancer experience ipsilateral sensorineural hearing loss. Intensity-modulated radiotherapy (IMRT) can reduce radiation dose to the cochlea. COSTAR, a phase III trial, investigated the role of cochlear-sparing IMRT (CS-IMRT) in reducing hearing loss. METHODS: Patients (pT1-4 N0-3 M0) were randomly assigned (1:1) to 3-dimensional conformal radiotherapy (3DCRT) or CS-IMRT by minimisation, balancing for centre and radiation dose of 60Gy or 65Gy in 30 daily fractions. The primary end-point was proportion of patients with sensorineural hearing loss in the ipsilateral cochlea of ≥10 dB bone conduction at 4000 Hz 12 months after radiotherapy compared using Fisher's exact test. Secondary end-points included hearing loss at 6 and 24 months, balance assessment, acute and late toxicity, patient-reported quality of life, time to recurrence and survival. RESULTS: From Aug 2008 to Feb 2013, 110 patients (54 3DCRT; 56 CS-IMRT) were enrolled from 22 UK centres. Median doses to the ipsilateral cochlea were 3DCRT: 56.2Gy and CS-IMRT: 35.7Gy (p < 0.0001). 67/110 (61%) patients were evaluable for the primary end-point; main reasons for non-evaluability were non-attendance at follow-up or incomplete audiology assessment. At 12 months, 14/36 (39%) 3DCRT and 11/31 (36%) CS-IMRT patients had ≥10 dB loss (p = 0.81). No statistically significant differences were observed in hearing loss at 6 or 24 months or in other secondary end-points including patient-reported hearing outcomes. CONCLUSION: CS-IMRT reduced the radiation dose below the accepted tolerance of the cochlea, but this did not lead to a reduction in the proportion of patients with clinically relevant hearing loss.
Collections
Subject
COSTAR Investigators
Humans
Parotid Neoplasms
Adult
Aged
Aged, 80 and over
Middle Aged
Female
Male
Radiotherapy, Intensity-Modulated
Young Adult
Research team
Clinical Trials & Statistics Unit
ICR-CTSU Urology and Head and Neck Trials Team
Targeted Therapy
Language
eng
Date accepted
2018-08-02
License start date
2018-11
Citation
European journal of cancer (Oxford, England : 1990), 2018, 103 pp. 249 - 258
Publisher
ELSEVIER SCI LTD