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)

被引：20

作者：

Nutting, Christopher M. ^{[1
]}

Morden, James P. ^{[2
]}

Beasley, Matthew ^{[3
]}

Bhide, Shreerang ^{[1
]}

Cook, Audrey ^{[4
]}

De Winton, Emma ^{[5
]}

Emson, Marie ^{[2
]}

Evans, Mererid ^{[6
]}

Fresco, Lydia ^{[7
]}

Gollins, Simon ^{[8
]}

Gujral, Dorothy ^{[9
,15
]}

Harrington, Kevin ^{[1
]}

Joseph, Mano ^{[10
]}

Lemon, Catherine ^{[11
]}

Luxon, Linda ^{[12
]}

van den Blink, Qurrat ^{[13
]}

Mendes, Ruheena ^{[14
]}

Miah, Aisha ^{[9
,15
]}

Newbold, Kate ^{[1
]}

Prestwich, Robin ^{[16
]}

Robinson, Martin ^{[17
]}

Sanghera, Paul ^{[18
]}

Simpson, Joanna ^{[19
]}

Sivaramalingam, Muthiah ^{[20
]}

Srihari, Narayanan Nair ^{[21
]}

Sydenham, Mark ^{[2
]}

Wells, Emma ^{[22
]}

Witts, Stephanie ^{[2
]}

Hall, Emma ^{[2
]}

机构：

[1] Royal Marsden Hosp, Head & Neck Unit, Fulham Rd, London SW3 6JJ, England

[2] Inst Canc Res, Clin Trials & Stat Unit, London, England

[3] Bristol Canc Inst, Bristol Haematol & Oncol Ctr, Bristol, Avon, England

[4] Cheltenham Gen Hosp, Gloucestershire Oncol Ctr, Cheltenham, Glos, England

[5] Royal United Hosp, Dept Oncol, Bath, Avon, England

[6] Velindre NHS Trust, Clin Oncol, Cardiff, S Glam, Wales

[7] Univ Hosp Coventry & Warwickshire, Dept Oncol, Coventry, W Midlands, England

[8] Glan Clwyd Gen Hosp, Dept Oncol, Rhyl, Wales

[9] Imperial Coll Healthcare NHS Trust, Head & Neck Dept, London, England

[10] Royal Wolverhampton NHS Trust, Oncol & Haematol Directorate, Wolverhampton, W Midlands, England

[11] Mt Vernon Hosp, Dept Oncol, Northwood, Middx, England

[12] UCL, Ear Inst, London, England

[13] Northampton Gen Hosp, Dept Oncol, Northampton, England

[14] Univ Coll Hosp, Dept Oncol, London, England

[15] Royal Marsden Hosp, Sarcoma Unit, Sutton, Surrey, England

[16] St James Univ Hosp, Dept Clin Oncol, Leeds, W Yorkshire, England

[17] Weston Pk Hosp, Dept Clin Oncol, Sheffield, S Yorkshire, England

[18] Univ Hosp Birmingham NHS Fdn Trust, Dept Oncol, Birmingham, W Midlands, England

[19] Royal Sussex Cty Hosp, Dept Oncol, Brighton, E Sussex, England

[20] Royal Preston Hosp, Dept Oncol, Fulwood, England

[21] Royal Shrewsbury Hosp, Dept Oncol, Shrewsbury, Salop, England

[22] Royal Marsden Hosp, QA Phys, London, England

来源：

EUROPEAN JOURNAL OF CANCER | 2018年 / 103卷

关键词：

Radiotherapy; Head and neck cancer; Cochlear-sparing; IMRT; Hearing loss; SENSORINEURAL HEARING-LOSS; MAJOR SALIVARY-GLANDS; POSTOPERATIVE RADIOTHERAPY; NASOPHARYNGEAL CARCINOMA; RADIATION; TUMORS; IRRADIATION; OPTIMIZATION; SURGERY; SYSTEM;

D O I：

10.1016/j.ejca.2018.08.006

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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; 56CS-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. (C) 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

引用

页码：249 / 258

页数：10

共 31 条

[1] THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].

AARONSON, NK ;

AHMEDZAI, S ;

BERGMAN, B ;

BULLINGER, M ;

CULL, A ;

DUEZ, NJ ;

FILIBERTI, A ;

FLECHTNER, H ;

FLEISHMAN, SB ;

DEHAES, JCJM ;

KAASA, S ;

KLEE, M ;

OSOBA, D ;

RAZAVI, D ;

ROFE, PB ;

SCHRAUB, S ;

SNEEUW, K ;

SULLIVAN, M ;

TAKEDA, F .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) :365-376

[2]

[Anonymous], 1980, International classification of impairments, disabilities, and handicaps

[3]

[Anonymous], 1999, J AM ACAD AUDIOL

[4] RADIATION THERAPY AND HEARING LOSS [J].

Bhandare, Niranjan ;

Jackson, Andrew ;

Eisbruch, Avraham ;

Pan, Charlie C. ;

Flickinger, John C. ;

Antonelli, Patrick ;

Mendenhall, William M. .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2010, 76 (03) :S50-S57

[5]

BSA, 2011, PUR TON AIR COND BON

[6]

Chen WC, 1999, ANN OTO RHINOL LARYN, V108, P1159

[7] Comparison of proton therapy techniques for treatment of the whole brain as a component of craniospinal radiation [J].

Dinh, Jeffrey ;

Stoker, Joshua ;

Georges, Rola H. ;

Sahoo, Narayan ;

Zhu, X. Ronald ;

Rath, Smruti ;

Mahajan, Anita ;

Grosshans, David R. .

RADIATION ONCOLOGY, 2013, 8

[8] TOLERANCE OF NORMAL TISSUE TO THERAPEUTIC IRRADIATION [J].

EMAMI, B ;

LYMAN, J ;

BROWN, A ;

COIA, L ;

GOITEIN, M ;

MUNZENRIDER, JE ;

SHANK, B ;

SOLIN, LJ ;

WESSON, M .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1991, 21 (01) :109-122

[9] MALIGNANT SALIVARY-GLAND TUMORS [J].

FITZPATRICK, PJ ;

THERIAULT, C .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1986, 12 (10) :1743-1747

[10] Postoperative radiotherapy for malignant tumors of the parotid gland [J].

Garden, AS ;

ElNaggar, AK ;

Morrison, WH ;

Callender, DL ;

Ang, KK ;

Peters, LJ .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1997, 37 (01) :79-85

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