Background: Bone is the most common lesion in metastatic breast cancer (MBC) patients. Pain due to bone disease is a very limiting and frequent symptom. We evaluated prospectively the BOMET-QoL questionnaire in the context of normal clinical practice, irrespectively of the treatment received, in order to assess the impact of bone metastasis on the Health-Related Quality of Life (HRQoL) of patients with MBC.
Material and Methods: This is an observational, prospective, multicenter study conducted in Spain. Patients diagnosed of MBC with bone disease and a life expectancy ≥ 8 months were eligible. Patients completed the bone metastasis Quality of life questionnaire (BOMET-QoL), a Visual Analogue Scale (VAS) for pain and a self-perception of health status item at baseline and 4, 8, 12, 16, 20 and 24 months thereafter. Socio-demographic, clinical and therapeutic data were also collected. Assuming a level of significance of 0.05 and a 20% drop-out rate, 174 patients were to be included in the study in order to estimate the QoL with a precision of ±3.75.
Results: From October-2007 to May-2010 172 evaluable patients were included in 15 Spanish institutions. Median age was 58 years (29.6-88.6). Bone disease was most frequently localized in the backbone (76.2% of patients), pelvis (53.5%) and ribs (45.3%). Seventy patients (40.5%) had visceral disease. Most patients (147, 88.5%) had ECOG 0-1. At study entry, 65 patients were receiving analgesic therapy (44 with NSAIDs and 21 with opioids) and 136 were receiving bisphosphonates. The values obtained on the BOMET-QoL and pain VAS scores at the different visits showed a moderate positive correlation (0.2-0.5; p<0.05 at all visits). The correlation between BOMET-QoL and ECOG scores was inversely proportional, the more the symptoms, the lower the mean global BOMET-QoL score (p<0.05). Patients with ECOG 0-1 had the highest average BOMET-QoL score (the group with the best perceived HRQoL) (p<0.05 at all visits except visit 3). In addition, there was a moderate inverse correlation between the BOMET-QoL and the self-perception of health status reported by the patient (0.3-0.7). BOMET-QoL was completed in less than 10 minutes by more than 80% of patients, with a low number of missing answers (0-1.16%).
Conclusions: The BOMET-QoL questionnaire is a consistent instrument to evaluate the HRQoL of patients with bone metastasis from breast cancer in regular clinical practice conditions, with regards to cross-sectional and longitudinal validity, feasibility and sensitivity to change. BOMET-QoL is easy to understand and can be completed in a short time by the majority of patients.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-10-02.