Quality Of Life Implications Of Osteonecrosis Of The Jaw In Cancer Patients: A Pilot Study

17557 Background: Presenting as exposed, necrotic bone, osteonecrosis of the jaw (ONJ) is associated with intravenous (IV) bisphosphonate use in cancer patients. Because these patients usually have incurable cancers, side effects that decrease health related quality of life (HRQoL) need to be understood. The overall aim of the study is to estimate the QoL impact of ONJ in order to inform individual and societal bisphosphonate treatment decisions; the aim of this pilot study was to develop and test the feasibility of the survey instruments, assess the level of emotional discomfort caused by the survey and provide preliminary QoL estimates. Methods: A phone survey was developed in collaboration with oncology, oral medicine, oral surgery, psychiatry and QoL experts. Subjects were randomly identified from a cohort of 80 cancer patients with ONJ. A chart review determined eligibility. Oral health-specific QoL before and after ONJ was determined with the Oral Health Impact Profile (OHIP), a validated psychometric instrument. Four standardized health states for cancer in the bone and ONJ were developed and preference values (utilities) for each state were obtained using the Visual Analogue Scale (VAS), the EQ5D and time- tradeoff (TTO) questions. Emotional discomfort during and after the survey was evaluated. Results: With a response rate of 100%, the pilot study included 5 subjects. Two subjects reported “a little” emotional discomfort during the survey (2 on a 5 point Likert scale) but none were upset afterwards. The mean OHIP score was 1.6 pre-ONJ and 7.2 post-ONJ (0–28 scale). The largest change occurred for the pain domain (mean increase =1.2). The only domain not affected was overall function. Subjects reporting more ONJ symptoms had larger OHIP score changes. The utility value decreased when cancer in bone alone was compared to cancer in the bone with Stage 3 ONJ: 0.76 to 0.42 (VAS), 0.88 to 0.49 (EQ5D) and 0.86 to 0.56 (TTO). Rank order was appropriate and consistent across instruments. Conclusions: Preliminary results suggest study design was feasible and instrument results were internally consistent. Both oral-health specific and global HRQoL instruments capture QoL changes associated with ONJ. There was minimal subject distress. No significant financial relationships to disclose.