Quality of life and two-year results of a randomized phase III study of dysphagia-optimized intensity modulated radiotherapy (DO-IMRT) versus standard IMRT (S-IMRT) in head and neck cancer.

Authors

null

Christopher Nutting

Royal Marsden NHS Foundation Trust, London, United Kingdom

Christopher Nutting , Keith Rooney , Bernadette Foran , Laura Pettit , Matthew Beasley , Laura Finneran , Justin Roe , Justine Tyler , Tom Roques , Audrey Cook , Imran Petkar , Shree Bhide , Devraj Srinivasan , Cheng Boon , Emma De Winton , Robert Frogley , Mark Adrian Sydenham , Marie Emson , Emma Hall

Organizations

Royal Marsden NHS Foundation Trust, London, United Kingdom, Belfast City Hospital, Belfast, United Kingdom, Weston Park Cancer Centre, Sheffield, United Kingdom, Royal Shrewsbury Hospital, Shrewsbury, United Kingdom, Bristol Haematology and Oncology Centre, Bristol, United Kingdom, Institute of Cancer Research, London, United Kingdom, The Royal Marsden NHS Foundation Trust, London, United Kingdom, The Royal Marsden Hospital, London, United Kingdom, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, United Kingdom, Cheltenham General Hospital, Cheltenham, United Kingdom, Guys and St Thomas NHS Foundation Trust, London, United Kingdom, The Royal Marsden Hospital and the Institute of Cancer Research, London, United Kingdom, Edinburgh Cancer Centre, Edinburgh, United Kingdom, Worcestershire Royal Hospital, Worcester, United Kingdom, Royal United Hospital, Bath, United Kingdom, Patient Advocate, London, United Kingdom, Institute of Cancer Research Clinical Trials and Statistics Unit, Sutton, United Kingdom, The Institute of Cancer Research, London, United Kingdom

Research Funding

Other

Background: Most newly diagnosed oro- & hypopharngeal cancers (OPC, HPC) are treated with (chemo)RT with curative intent but at the consequence of adverse effects on quality of life. We investigated if using DO-IMRT to reduce RT dose to the dysphagia/aspiration related structures (DARS) improved swallowing function compared to S-IMRT. Methods: Patients with T1-4, N0-3, M0 OPC/HPC were randomised 1:1 to S-IMRT (65 Gray (Gy)/30 fractions (f) to primary & nodal tumour; 54Gy/30f to remaining pharyngeal subsite & nodal areas at risk of microscopic disease) or DO-IMRT. The volume of the superior & middle pharyngeal constrictor muscle (PCM) (OPC) or inferior PCM (HPC) lying outside the high-dose target volume was set a mandatory mean dose constraint in DO-IMRT. Treatment allocation was by minimisation balanced by centre, use of induction/concomitant chemotherapy, tumour site & AJCC stage. Primary endpoint was mean MD Anderson Dysphagia Inventory (MDADI) composite score 12 months after RT. Secondary endpoints included University of Washington (UW)-Qol, Performance Status Scale Head & Neck (PSS-HN) domain scores (range: 0-100), swallow volume, swallow capacity and local control. Results: 112 patients (56 S-IMRT, 56 DO-IMRT) were randomised from 22 UK & Ireland centres from 06/2016 - 04/2018. 111/112 had RT doses as prescribed (1 patient died before RT). Outcome measures at 12 and 24 months are summarised below. DO-IMRT had higher MDADI scores at 12 (p = 0.04) and 24 (p = 0.07) months. Clinically important improvements in swallowing function were seen in patients receiving DO-IMRT using PSS-HN domains and the UW-QoL tool. Conclusions: DO-IMRT improved patient reported swallowing function compared with S-IMRT. Improvements were seen in overall MDADI as well as functional scores in both PSS-HN and UW-QoL. Clinical trial information: 25458988.


12 months
24 months

S-IMRT (n = 54)
DO-IMRT (n = 55)
p-value
S-IMRT (n = 51)
DO-IMRT (n = 54)
p-value
MDADI Mean score (SD)
70.6 (17.3)
77.7 (16.1)
0.04
73 (17.4)
79.6 (16.5)
0.07
PSS-HN Normalcy of diet score > 50
58% (25/43)
71% (36/51)
0.50
73% (30/41)
81% (38/47)
0.55
PSS-HN Eating in public score > 50
74% (32/43)
84% (43/51)
0.35
85% (35/41)
92% (43/47)
0.57
UW-QoL “Able to swallow as well as ever”
15% (7/46)
40% (21/52)
0.01
20% (8/41)
40% (19/47)
0.04
UW-QoL “Saliva of normal consistency”
7% (2/29)
8% (3/39)
0.67
4% (1/26)
6% (2/36)
0.61
UW-QoL “Can taste food normally”
11% (5/45)
23% (12/52)
0.04
24% (10/41)
33% (16/48)
0.02
Median UW-QoL Physical subscale score (IQR)
74 (66-85)
83 (76-88)
0.02
78 (70-85)
85 (77-90)
0.02
Median UW-QoL Social-Emotional subscale score (IQR)
83 (70-92)
83 (74-92)
0.82
87 (78-95)
88 (80-96)
0.33

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Local-Regional Disease

Clinical Trial Registration Number

25458988

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 6065)

DOI

10.1200/JCO.2022.40.16_suppl.6065

Abstract #

6065

Poster Bd #

57

Abstract Disclosures