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    QoL better with bladder Ca immunotherapy vs. chemo

    Results support agent as new standard of care for previously treated urothelial carcinoma

     

    Mean EORTC QLQ-C30 score at baseline was similar in the pembrolizumab and chemotherapy groups (61.1 vs. 59.1). An analysis of change in HrQoL from baseline to week 15 showed no significant change in the EORTC QLQ-C30 score in the pembrolizumab group (n=157; least squares mean change +0.75) but a significant decrease in the patients receiving chemotherapy (least squares mean change –8.30), and the difference between treatment groups was statistically significant (p<.001).

    The data were also analyzed using Kaplan-Meier methodology to determine time to deterioration of HrQoL as defined by a ≥10-point change in the EORTC QLQ-C30. The results showed HrQoL was better sustained in the patients on pembrolizumab compared with their chemotherapy-treated counterparts. Median time to deterioration was 3.5 months in the pembrolizumab group and 2.2 months among chemotherapy-treated patients (HR 0.70; p=.002).

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    Additional analyses of HrQoL considered change from baseline to week 15 with patients categorized based on whether they had disease progression. Among patients without progression, mean EORTC QLQ-C30 score improved from baseline to week 15 in the pembrolizumab group (+5.97), whereas it declined in patients receiving chemotherapy (–4.31). The EORTC QLQ-30 scores declined in both treatment groups among patients whose disease progressed, but the deterioration was less among patients treated with pembrolizumab compared with the chemotherapy control group (–3.54 vs. –13.95).

    With few exceptions, analyses of changes from baseline to week 15 for the individual functional and symptom domain scores comprising the HrQoL instrument showed that pembrolizumab treatment was associated with higher rates of score improvements and lower rates of score deterioration.

    Dr. de Wit has received honoraria from and served as a consultant/adviser to Lilly, Merck, Roche/Genentech, and Sanofi. His institution has received funding from Sanofi. Several of his co-authors have a financial or other relationship with Merck and/or other pharmaceutical companies.

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