Clinical variables are associated with treatment satisfaction in patients with breast, lung, and colorectal cancer

6608 Background: The association between clinical variables (e.g. disease stage/type, side effects, ECOG performance status (PS)) and patient-reported treatment satisfaction has received little attention, despite the potential implications for treatment adherence and decision-making. We examined the relation between clinical variables and treatment satisfaction in a U.S. sample of patients with breast (BC), lung (LC), or colorectal (CRC) cancer using the Cancer Treatment Satisfaction Questionnaire (CTSQ), a recently validated 16-item measure designed to assess expectations of therapy (ET), feelings about side effects (FSE), and satisfaction with therapy (SWT). Methods: Cancer stage, line of therapy, physician-reported ECOG PS, presence vs. absence of medication side effects, and perceived change in cancer over the last two weeks were obtained on patients. These clinical variables were examined in relation to the ET, FSE, and SWT scales of the CTSQ. Higher scale scores indicated better outcomes (e.g., better satisfaction). Group means were compared using one-way ANOVAs; trends of scale scores across clinical variables were also examined. Results: Participants were 349 patients with early and late stage BC (n=137), CRC (n=121), or LC (n=91) who had ≥ 1 cycles of chemo-, bio-, or hormonal therapy in the last 6 months. In all cancer types, FSE differed by presence of side effects (BC&lt;.03; CRC&lt;.01; LC&lt;.02). In BC patients, FSE differed by stage, and ET differed significantly depending on ECOG PS (p&lt;.006) and perceived change (p&lt;.05). For CRC patients, ET significantly differed by stage (p&lt;.05) and perceived change (p&lt;.02); and SWT by presence of side effects (p&lt;.01). SWT also differed by perceived change (p&lt;.01) for LC patients. Most trends were in the expected direction. Conclusions: These results indicate that patient-reported satisfaction with therapy is correlated with clinical variables. On average, patients who perceive less improvement in their cancer, have side effects, and poorer ECOG PS are less satisfied with their current cancer therapy. Unknown is the impact of this relation on adherence and decision-making. Recent changes in healthcare suggests that treatment satisfaction may become an increasingly important measure of clinical outcome. No significant financial relationships to disclose. </jats:p

Is there an additional health-related quality of life (HRQL) benefit with abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) beyond that mediated by clinical endpoints?

9617 Background: HRQL was evaluated as part of COU-AA-301, a randomized phase 3 trial of AA + prednisone (P) vs placebo + P in mCRPC patients (pts) post-docetaxel, where AA + P demonstrated significant benefits over P in numerous HRQL measures. Here we report post hoc analyses investigating the role of disease progression (px) in mediating the HRQL benefits of AA. Methods: Intensity of pain and fatigue and their interference with daily activities were assessed with the BPI-SF and BFI questionnaires and multiple domains of HRQL with the FACT-P questionnaire. Mediation analyses were conducted using a series of 3 models (Baron &amp; Kenny J Pers Soc Psychol 1986), to assess whether presence and timing of disease px mediated treatment effects of AA + P vs P on HRQL changes: in Model 1, HRQL (i.e. the outcome variable) is predicted by treatment, in Model 2, px (i.e. the mediator variable) is predicted by treatment, and in Model 3, HRQL is predicted by both treatment and px. Three different disease px indicators (ie, PSA px, radiographic px, and a composite px variable) were used. Results: Treatment predicted the change in FACT-P total score from baseline (Model 1; p = 0.011). Treatment (as sole predictor) was significantly (p ≤ 0.001) predictive of both PSA px and radiographic px (Model 2). Some of the treatment benefit of AA + P on the FACT-P total score was not explained as the result of the effect of treatment on PSA and radiographic px (Model 3; p = 0.030). In Model 3, pts with late (&gt; 250 d post-randomization) or no px had better FACT-P scores than those with early px for PSA px (p = 0.019, no px; p = 0.008, late px) and radiographic px (p = 0.054, no px; p = 0.017, late px). Models evaluating the mediating role of the composite px variable showed the same pattern of results. Identical sets of mediation analyses conducted for the BPI and BFI also exhibited very similar outcomes. Conclusions: In post-docetaxel mCRPC pts, the benefits of AA to HRQL appear to be related to both treatment assignment and the mediating effects of disease px. HRQL end points expand understanding of treatment benefit beyond clinical disease px end points. Clinical trial information: NCT00638690. </jats:p