Quality of life in a phase III study of prospective radiation therapy (IMRT) +/- cetuximab for locally advanced resected head and neck cancer: NRG/RTOG 0920.

11123 Background: We tested the primary question whether the addition of cetuximab to postoperative radiotherapy (IMRT) results in poorer patient reported outcomes (PROs) at 12 months compared to IMRT alone. We also examined changes in PROs over time. Methods: Randomized and eligible patients who consented to quality of life (QOL) assessment completed PROs measured by 5 instruments, prior to treatment (baseline) and at 3, 12, and 24 months after IMRT. Instruments included: 1) Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN), a multidimensional QOL instrument for use with head and neck cancer patients; 2) University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) covering mouth/throat dryness and its impact on oral health-related QOL; 3) Dermatology Life Quality Index (DLQI) for skin-related changes; 4) EuroQol (EQ-5D-3L) covering usual activities and perceived current health state; 5) Performance Status Scale for Head and Neck Cancer (PSS-HN) assessing normalcy of diet, public eating, and understandability of speech. Higher scores on XeQOLS and DLQI indicate worse QOL; otherwise higher scores indicate better QOL for other measures. For FACT-HN, XeQOLS, DLQI, and EQ-5D-3L, changes from baseline were compared by Van Elteren test, and for PSS-HN, the % ≤ 50 was compared by Z test. 158 patients per arm provided 80% power to test the difference between IMRT + cetuximab and IMRT alone. Changes in PROs over time were evaluated using mixed models. Two-sided tests were used with α=0.05. Results: 499 of 577 eligible patients (86%) consented to QOL. There were no significant differences between treatment arms (IMRT vs. IMRT + cetuximab) for all PRO measures in change from baseline to 3 or 12 months post-IMRT (see table). At 24 months, the change from baseline was significantly different for DLQI (p=0.02), but the difference was not clinically meaningful; other PROs were not significantly different. There were no significant differences between treatment arms for PSS-HN diet, eating, or speech at any time point (see table). Regarding treatment effect over time, in both treatment groups, all PRO measures showed greatest decline at 3 months followed by improvement towards baseline by 24 months. Conclusions: Treatment with IMRT + cetuximab was not associated with worse PROs compared to IMRT alone. Furthermore, findings demonstrate important recovery trends in QOL with return to baseline for most measures in both study arms. Clinical trial information: NCT00956007 . Results at 12 months. Instrument (score range) IMRT IMRT+Cetuximab p-value FACT-HN (0-148) n 122 132 Mean change -0.41 1.31 0.94 XeQOLS (0-4) n 105 114 Mean change 0.52 0.46 0.99 DLQI (0-30) n 121 133 Mean change -0.07 0.44 0.23 EQ-5D-3L (0-1) n 108 117 Mean change 0.01 0.02 0.87 PSS-HN diet (0-100) n 130 141 % ≤ 50 37.7 39.7 0.73 PSS-HN eating (0-100) n 130 141 % ≤ 50 20.0 15.6 0.34 PSS-HN speech (0-100) n 131 140

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