LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Disease Free Survival (DFS) Rate at 2 Years

Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.

Time frame: Up to 2 years

Percentage of Patient Deaths (Overall Survival (OS))

Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.

Time frame: Up to 5 years

Patients With Improved Health Related Quality of Life (HRQOL)

HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.

Time frame: Up to 5 years

Time to Deterioration in Health Related Quality of Life (HRQOL)

HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.