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Randomized Phase II Study of Physiologic MRI-Directed Adaptive Radiation Boost in Poor Prognosis Head and Neck Cancer

Authors :
Michelle L. Mierzwa
Madhava Aryal
Choonik Lee
Matthew Schipper
Monica VanTil
Krystal Morales
Paul L. Swiecicki
Keith A. Casper
Kelly M. Malloy
Matthew E. Spector
Andrew G. Shuman
Steven B. Chinn
Mark E.P. Prince
Chaz L. Stucken
Andrew J. Rosko
Theodore S. Lawrence
J. Chad Brenner
Benjamin Rosen
Caitlin A. Schonewolf
Jennifer Shah
Avraham Eisbruch
Francis P. Worden
Yue Cao
Source :
Clin Cancer Res
Publication Year :
2022
Publisher :
American Association for Cancer Research (AACR), 2022.

Abstract

Purpose: We conducted a randomized phase II multicenter clinical trial to test the hypothesis that physiologic MRI-based radiotherapy (RT) dose escalation would improve the outcome of patients with poor prognosis head and neck cancer. Patients and Methods: MRI was acquired at baseline and at RT fraction 10 to create low blood volume/apparent diffusion coefficient maps for RT boost subvolume definition in gross tumor volume. Patients were randomized to receive 70 Gy (standard RT) or 80 Gy to the boost subvolume (RT boost) with concurrent weekly platinum. The primary endpoint was disease-free survival (DFS) with significance defined at a one-sided 0.1 level, and secondary endpoints included locoregional failure (LRF), overall survival (OS), comparison of adverse events and patient reported outcomes (PRO). Results: Among 81 randomized patients, neither the primary endpoint of DFS (HR = 0.849, P = 0.31) nor OS (HR = 1.19, P = 0.66) was significantly improved in the RT boost arm. However, the incidence of LRF was significantly improved with the addition of the RT boost (HR = 0.43, P = 0.047). Two-year estimates [90% confidence interval (CI)] of the cumulative incidence of LRF were 40% (27%–53%) in the standard RT arm and 18% (10%–31%) in the RT boost arm. Two-year estimates (90% CI) for DFS were 48% (34%–60%) in the standard RT arm and 57% (43%–69%) in the RT boost arm. There were no significant differences in toxicity or longitudinal differences seen in EORTC QLQ30/HN35 subscales between treatment arms in linear mixed-effects models. Conclusions: Physiologic MRI-based RT boost decreased LRF without a significant increase in grade 3+ toxicity or longitudinal PRO differences, but did not significantly improve DFS or OS. Additional improvements in systemic therapy are likely necessary to realize improvements in DFS and OS.

Details

ISSN :
15573265 and 10780432
Volume :
28
Database :
OpenAIRE
Journal :
Clinical Cancer Research
Accession number :
edsair.doi.dedup.....52549d5286e81439619ff39cea8b28ec
Full Text :
https://doi.org/10.1158/1078-0432.ccr-22-1522