Health-related quality of life analysis from ENTER, a randomized, controlled phase III trial of whole-brain radiotherapy with and without concurrent erlotinib in NSCLC with brain metastases.

Background: Health-related quality of life (HRQoL) is critical for patients with lung cancer due to poor prognosis. We presented patient-reported outcomes in patients with non-small cell lung cancer (NSCLC) brain metastases (BM) who received whole-brain radiotherapy (WBRT) in combination with erlotinib or WBRT alone in the phase 3 ENTER study.

Methods: The patients' HRQoL was assessed by using the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ-C30). Mean changes in scores on different quality of life (QoL) scales relative to baseline were reported. The QoL response and time to deterioration of QoL were compared between different treatment arms.

Results: The absolute mean differences in global health status/QoL scores, all functional and symptom scale scores from baseline between the two arms were not significantly different at all follow-up time points. After month 5, there was an improvement in nausea/vomiting symptom scores in the WBRT arm relative to their pretreatment baseline (P=0.003), while the WBRT + erlotinib arm had improved scores in fatigue (P=0.01), nausea/vomiting (P=0.02), pain (P=0.04) and insomnia (P=0.01). Compared to the WBRT arm, a greater proportion of patients in the combination treatment arm had deteriorating diarrhea (P=0.009), along with significantly delayed time to deterioration in role function (4.4 7.0 months, P=0.03), insomnia (7.0 4.7 months, P=0.02), and constipation (12.7 9.3 months, P=0.02) symptoms.

Conclusions: The simultaneous addition of erlotinib during WBRT did not decrease the QoL in the overall or epidermal growth factor receptor (EGFR)-mutant patients with BM and resulted in improvements on more QoL scales and slower worsening of some self-reported symptoms compared to WBRT alone.

Trial Registration: ClinicalTrials.gov identifier: NCT01887795.