P1.01-115 Long-Term Effects of Concurrent Chemoradiotherapy on Quality of Life in Locally Advanced Non-Small Cell Lung Cancer Patients

Concurrent chemoradiotherapy imposes beneficial effects on overall survival (OS) in patients with locally advanced non-small cell lung cancer (NSCLC). Currently, it is unknown what the effects on long-term health-related quality of life (HRQOL) are. Therefore, we investigated long-term HRQOL in locally advanced NSCLC patients treated with concurrent chemoradiotherapy, using an accelerated fractionation scheme of 24 x 2.75 Gy +/- Cetuximab. A 2-armed phase II, multi-center study (NTR2230) was performed with the initial aim to assess the effect of additional Cetuximab to concurrent chemoradiotherapy in locally advanced NSCLC patients. Arm A received high dose accelerated radiotherapy (24 x 2.75 Gy) and concurrent daily low-dose cisplatin (6 mg/m2). Arm B additionally received weekly Cetuximab (400 mg/m2 one-week pre-treatment followed by weekly 250 mg/m2). HRQOL was assessed using the EORTC QLQ-C30 at baseline, 3 months post treatment and after 1 year. The primary endpoints included dyspnea, pain, physical functioning, cognitive functioning and the QLQ-C30 summary score. Following the EORTC guidelines, the scores of the endpoints were linearly transformed to 0–100 scales. Higher scores correspond to improved functioning for the functioning scales and for the summary score while for symptom scales (pain and dyspnea), higher scores indicate more symptoms. Linear mixed-modeling was used to assess differences over time. Standardized effect sizes based on the t-test statistic were calculated: (2*t)/(√degrees of freedom). Effect sizes of 0.2 were considered small, 0.5 moderate and clinically relevant, and 0.8 large. Between February 2009 and May 2011, 102 patients were randomly allocated in two arms; 51 patients (50%) in arm A and 51 patients (50%) in arm B. Of those, 79 (77%) patients had at least one evaluable questionnaire. Figure 1 shows the development of the HRQOL endpoints over time. Over time, physical functioning (ES 0.48, P-value 0.003), cognitive functioning (ES 0.37, P-value 0.020), dyspnea complaints (ES 0.67, P-value <0.001) and the summary score (ES 0.44, P-value 0.006) significantly worsened. Only pain showed a reversing pattern in which pain was less present at 1 year (ES 0.37, P-value 0.021). No differences between the two arms were found. In this randomized study of locally advanced NSCLC patients treated with concurrent chemoradiotherapy with or without Cetuximab, a clinically meaningful and long-term decline for all HRQOL endpoints except pain was observed. This analysis suggests that although concurrent chemoradiotherapy improves OS in NSCLC patients, efforts should also be taken to improve long-term HRQOL.