ESTRO 2024 - Abstract Book

S1200

Clinical - Head & neck

ESTRO 2024

481

Proffered Paper

OPRAH: Phase 3 trial of optimum radiation dose for palliation in head and neck carcinoma

Supriya Mallick 1 , Abhilash Dagar 1 , Adrija Ghosh 1 , Sangeeta Hazarika 1 , Jaswin Raj 1 , Aman Sharma 1 , Akash Kumar 2 , Jyoti Sharma 3 , Smriti Panda 4 , Dayanand Sharma 1 1 National Cancer Institute, Radiation Oncology, New Delhi, India. 2 National Cancer Institute, Medical Oncology, New Delhi, India. 3 National Cancer Institute, Surgical Oncology, New Delhi, India. 4 National Cancer Institute, ENT Oncology, New Delhi, India

Purpose/Objective:

Radiation forms the backbone of palliation in patients not suitable for curative treatment in Head and Cancer (HNC). However, randomized data on optimum dose fractionation is lacking. The aim of the study was to evaluate whether a higher dose regimen would lead to an improvement in progression-free survival (PFS) with acceptable toxicity.

Material/Methods:

Three hundred and five patients with non-metastatic loco-regionally advanced HNC not amenable to curative treatment, between the ages 18-79 years with ECOG PS 0-2 were randomized 1:1 into a standard arm (20Gy/5#/1 wk) and an experimental arm (30Gy/5#/1wk). Radiation therapy was delivered using 6-MV photons (Dose rate= 600MU/min) (Acuros-XB Algorithm Version 15.6.05. At the completion of radiotherapy, 1-month, and thereafter at 3 monthly intervals post-radiotherapy, patients were evaluated via clinical examination, physician-reported Radiation Therapy Oncology Group (RTOG) scores, and patient-reported Quality of life (QOL) scores using HN QLQ 43. Cross sectional imaging was performed at 3-monthly intervals post-treatment. PFS was calculated from the date of diagnosis to the date of either clinical or radiological progression. At progression, patients were discussed in a multidisciplinary board as per which they received palliative chemotherapy, oral metronomic therapy, or best supportive care. Between 2020 and 2023, a total of 305 patients eligible for the trial were enrolled (152 in the standard Arm; and 153 in the Experimental arm). The cohort had a median age of 52 years (ranging from 28 to 81 years), with a median smoking history of 15 pack years. 44.6% of patients had an ECOG PS≥2. The oral cavity was the most common site, accounting for 52.8% of cases. 77.5% of patients had T4 disease, 50.8% had N3 disease, and 31.1% had both T4 and N3 disease. Baseline patient characteristics were similar between the groups, except for age (p-value: 0.06), Ryle's Tube requirement (p-value: 0.039), and oral cavity primary (p-value: 0.048). 94.1% of patients completed radiotherapy, with 86.1% attending at least the first follow-up. At a median follow-up of 5.33 months, the entire cohort had a median PFS of 6.2 months and a median OS of 7.8 months. The PFS was 6.48 months (ranging from 16 to 1,106 days) and 5.87 months (ranging from 1 to 1,166 days) (p-value = 0.470) between the two groups. The OS was 8.45 months (ranging from 26 to 1,106 days) and 7.1 months (ranging from 8 to 1,166 days) (p-value = 0.477) between the two groups. Results: