A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.

11116 Background: The randomized, double-blind, phase 3 KEYNOTE-412 study (NCT03040999) investigated pembrolizumab (pembro) + chemoradiation therapy (CRT) versus placebo + CRT for locally advanced head and neck squamous cell carcinoma (LA HNSCC). Descriptive PRO analysis may provide important insight to better understand patient (pt) experiences. This analysis evaluated pt experience by examining item-level PRO scores. Methods: Adults with LA HNSCC were randomly assigned 1:1 to pembro 200 mg IV Q3W or placebo + CRT. PROs included the EORTC QLQ-C30 and EORTC QLQ-H&N35. Responses to each item of the QLQ-C30 and H&N35 were analyzed descriptively based on treatment group combined data. Each item was evaluated overall, and then for the H&N35 by tumor location and by clinical event (death, distant progressive disease [PD], local regional PD, local PD, and distant metastasis or histologically persistent/residual disease). Symptom burden was defined as responses of “a little,” “quite a bit,” “very much,” or “yes.” Items associated with high symptom burden (≥30% of responses “quite a bit,” “very much,” or “yes”) at baseline were analyzed over time. Results: Of 756 pts with PRO data, highly endorsed items (≥50% experiencing the symptom) on the QLQ-C30 at baseline were pain, trouble sleeping, needing rest, tiredness, and worry; highly endorsed (≥50%) items from the H&N35 were pain in mouth, painful throat, problems swallowing solid food, coughing, hoarseness, and use of pain killers. Pts with an event, compared to pts who were event-free at the time of data cut-off, experienced greater symptom burden at baseline; for example, pain in mouth (56% vs 50%), pain in jaw (47% vs 37%), use of pain killers (71% vs 58%), weight loss (53% vs 30%), trouble eating (63% vs 46%), and problems swallowing solid food (69% vs 56%). Symptoms at baseline also differed by primary tumor location, demonstrating the heterogeneity of symptom burden across this population. Based on the threshold of ≥30% reporting worse responses at baseline, 20 items on the H&N35 were analyzed over time. Of pts who experienced an event (n = 345, 46%), 6 items met this threshold: pain in mouth (32%), problems swallowing solid food (41%), trouble eating (32%), use of pain killers (71%), use of nutritional supplements (34%), and weight loss (53%). For these items, a similar or greater percentage of pts with symptoms were observed over time in those who had events compared to those with no events. Conclusions: Observations of pts enrolled in KEYNOTE-412 study who had events, appearing to have greater symptom burden at baseline, suggests there may be a relationship between baseline item scores and clinical outcomes. Heterogeneity of populations may lead to variability of baseline PRO scores and should be considered in PRO analysis. Further research is needed to explore the relationship between baseline PROs and event outcomes as well as additional subgroup analysis. Clinical trial information: NCT03040999 .

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