OBJECTIVES: Oral chemotherapy was developed to reduce in-patient stays while providing the same level of efficacy and safety. This study assessed the health-related quality of life (HRQoL) of patients treated with oral vinorelbine for metastatic NSCLC and their caregivers. METHODS: This longitudinal survey assesses 2 visits documenting the second and third chemotherapy cycles. Patients had metastatic NSCLC and received oral vinorelbine (day 1 and 8 of 3-week cycles) and carboplatin (day 1). Baseline measures included demographics, anamnesis, co-morbidities and current treatment. SF-12 was reported at the end of each cycle, on the patients and interestingly on the caregivers. RESULTS: Three Danish centers included 45 patients: median age: 66.9 y.o., 53.3% were male. Performance status (ECOG) was 0: 33.3%; 1: 51.1%; 2+: 15.6%. Main reason for choosing oral vinorelbine was convenience. Caregivers, mainly spouses (76.7%), were 57.8 y.o. No major change on SF-12 scores was reported between cycle 2 and 3. Physical summary scores (PCS) of patients (37.0-38.6, respectively cycle 2 and 3) were lower than those of caregivers (52.9-53.4) and general population (44). Mental summary scores (MCS) of patients (47.7-44.2) and caregivers (46.2-44.6) were much lower than those one of a population of same age (patient: 52; caregiver: 51). The most affected patient scores were physical functioning (40.4), role physical (40.1), vitality (37.2). Social functioning (SF) was similarly high in patients and caregivers (76.9 vs. 78.9, patient vs. caregiver) while mental health of both patients and caregivers were lower (66.7 vs. 65.5) than SF. CONCLUSIONS: Metastatic NSCLC deeply affects patients’ HRQoL as measured by a generic instrument, both on MCS and PCS. Caregivers’ HRQoL is also affected, mainly on MCS. Patients receiving oral vinorelbine plus carboplatin and their caregivers maintain a good level of social functioning.