TABLE 2.
EORTC QLQ-C30 and BPI-SF Scores at Baseline
| EORTC QLQ-C30 or BPI-SF Scale/Item | EV + P (n = 65) | EV Mono (n = 61) |
|---|---|---|
| EORTC QLQ-C30,a mean (SD) | ||
| Global health status/QOL | 64.5 (23.9) | 63.1 (26.5) |
| Functioning scalesb | ||
| Physical functioning | 74.1 (23.2) | 78.4 (22.2) |
| Role functioning | 70.0 (30.9) | 74.6 (30.1) |
| Emotional functioning | 77.2 (19.7) | 79.5 (22.6) |
| Cognitive functioning | 86.4 (15.6) | 87.7 (17.5) |
| Social functioning | 79.0 (23.1) | 78.4 (28.4) |
| Cancer-related symptom scales and itemsb | ||
| Fatigue | 34.5 (28.5) | 33.3 (26.5) |
| Nausea/vomiting | 10.0 (22.6) | 3.6 (14.0) |
| Pain | 32.8 (32.4) | 35.3 (28.1) |
| Dyspnea | 14.4 (20.4) | 16.9 (27.6) |
| Sleep disturbances | 33.8 (32.5) | 33.9 (33.0) |
| Appetite loss | 27.2 (35.5) | 22.4 (29.0) |
| Constipation | 19.5 (24.2) | 22.4 (30.9) |
| Diarrhea | 8.7 (21.5) | 5.5 (12.4) |
| BPI-SF worst pain,c No. (%) | n = 62 | n = 58 |
| No/mild pain (score range, 0-4) | 34 (54.8) | 37 (63.8) |
| Moderate pain (score range, 5-6) | 11 (17.7) | 11 (19.0) |
| Severe pain (score range, 7-10) | 17 (27.4) | 10 (17.2) |
NOTE. All analyses were conducted in the PRP unless otherwise specified; the PRP included patients who completed at least one question of the PRO questionnaires at baseline.
Abbreviations: BPI-SF, Brief Pain Inventory Short Form; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core Questionnaire; EV, enfortumab vedotin; mono, monotherapy; P, pembrolizumab; PRO, patient-reported outcome; PRP, patient-reported outcome population; QOL, quality of life; SD, standard deviation.
A 30-item questionnaire to assess QOL in patients with cancer; scores range from 0 to 100.
Higher symptom domain score indicates a greater symptom burden and a less favorable outcome; higher functional score indicates greater functioning and a more favorable outcome.
An eight-item questionnaire assessing the severity of pain and its impact on functioning in terms of worst, least, and average pain in the past 24 hours; scores range from 0 to 10.