Intan Purnajo

PURPOSE Locally advanced/metastatic urothelial cancer (la/mUC) affects patients' quality of life (QOL) and functioning. We describe the impact of first-line (1L) enfortumab vedotin (EV) alone or with pembrolizumab (P) on QOL/functioning/symptoms in patients with la/mUC who were cisplatin-ineligible from EV-103 Cohort K. METHODS In this phase Ib/II trial, patients were randomly assigned 1:1 to EV + P or EV monotherapy (mono). Exploratory patient-reported outcomes (PROs) were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core Questionnaire (EORTC QLQ-C30) and Brief Pain Inventory Short Form (BPI-SF) at baseline, once per week for cycles 1-3, and then in every cycle through the end of treatment. Changes in scores from baseline to week 24, reported as least squares mean (standard error), were assessed by mixed models for repeated measures. There were no formal statistical comparisons between treatment arms. RESULTS Of 149 patients treated, 65 (EV + P) and 63 (EV mono) comprised the PRO analysis set. For EV + P, EORTC QLQ-C30 QOL was maintained through week 24 with improvements in emotional functioning, pain, and insomnia. Clinically meaningful improvements were seen in EORTC QLQ-C30 pain after EV + P at weeks 12 (–14.41 [3.14]) and 24 (–14.99 [3.56]) and BPI-SF worst pain at week 24 (–2.07 [0.37]). For EV mono, EORTC QLQ-C30 QOL remained stable with clinically meaningful improvements in EORTC QLQ-C30 pain (–12.55 [4.27]), insomnia (–14.46 [4.69]), and constipation (–10.09 [4.35]) at week 24. There were small-to-moderate improvements in BPI-SF worst pain at week 24. CONCLUSION EV + P in patients with la/mUC who were cisplatin-ineligible was associated with preservation or improvement of QOL/functioning/symptoms. Improvement in pain was seen in both PRO instruments and treatment arms. These data complement clinical outcomes of 1L EV + P.

Background and objectives Many individuals with kidney disease, particularly those belonging to racial and ethnic minority groups and whose primary language is not English, lack knowledge related to kidney disease symptoms, physiologic functions of the kidney, and benefits and risks of kidney transplantation. Valid instruments to assess patients’ knowledge of CKD and kidney transplantation are needed. Design, setting, participants, & measurements Using a sample of 977 patients with stages 3–5 CKD in the Kaiser Permanente health system, we developed the Knowledge Assessment of Renal Transplantation (KART) 2.0 instrument. We conducted cognitive interviews followed by item response theory (IRT) to reduce 48 candidate items. Construct validity was tested by examining differences in scores between patients who spent <1 and ≥1 hour receiving CKD and transplant education. Results Cognitive interviews modified four items and omitted 11. IRT analyses resulted in two scales: the KART 2.0–Transplant Knowledge Scale (16 items; Cronbach’s α =0.8) and the KART 2.0–CKD Knowledge Scale (nine items; Cronbach’s α =0.79). Differential item functioning showed that the scales were unbiased to capture knowledge across self-identified race, primary language, CKD stage, and sex. Both scales distinguished patients who had spent <1 and ≥1 hour speaking with health professionals (effect size [ES]=0.33 [transplant], 0.54 [CKD]; P <0.001 for both), reading about kidney disease (ES=0.45 [transplant], 0.62 [CKD]; P <0.001), reading about kidney transplantation (ES=0.67 [transplant], 0.69 [CKD]; P <0.001), and reading about living donor kidney transplant (ES=0.76 [transplant], 0.62 [CKD]; P <0.001). Conclusions The KART 2.0 is a valid tool to assess patients’ knowledge of CKD and kidney transplantation.