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
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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