TABLE A2.
Time to Sustained Improvement for the EORTC QLQ-C30 and BPI-SF in the EV Mono Arm
| EORTC QLQ-C30 or BPI-SF Scale/Item | EV Mono (n = 63) | Subgroup of Patients With Moderate-to-Severe Pain at Baselinea (n = 21) | ||
|---|---|---|---|---|
| No. of Events, No./n (%) | Median, Months (95% CI) | No. of Events, No./n (%) | Median, Months (95% CI) | |
| EORTC QLQ-C30b | ||||
| QOL | 24/49 (49.0) | 1.4 (0.95 to NE) | 13/20 (65.0) | 1.2 (0.5 to NE) |
| Role functioning | 19/36 (52.8) | 1.6 (0.7 to NE) | 10/15 (66.7) | 1.4 (0.5 to NE) |
| Physical functioning | 15/39 (38.5) | NE (1.6 to NE) | 7/16 (43.8) | NE (0.7 to NE) |
| Emotional functioning | 21/33 (63.6) | 1.1 (0.5 to 3.2) | 10/12 (83.3) | 0.9 (0.3 to 3.2) |
| Fatigue | 30/53 (56.6) | 2.4 (1.4 to 4.9) | 14/20 (70.0) | 1.4 (0.7 to 4.9) |
| Pain | 34/52 (65.4) | 1.0 (0.5 to 2.6) | 17/21 (81.0) | 0.9 (0.5 to 2.4) |
| BPI-SFc | ||||
| Worst pain | 21/44 (47.7) | 1.4 (0.5 to NE) | 13/21 (61.9) | 1.4 (0.5 to NE) |
| Pain interference | 14/30 (46.7) | 2.6 (0.5 to NE) | 11/18 (61.1) | 0.7 (0.3 to NE) |
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. A Kaplan-Meier estimator was used to estimate time to sustained improvement, which was defined as the number of months from the start of treatment to time of sustained improvement, where meaningful improvement was considered if a change in score increased from baseline by at least one MCT and was sustained for at least two consecutive assessments among patients who were not within one MCT of best possible score 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; MCT, meaningful change threshold; mono, monotherapy; NE, not estimable; PRO, patient-reported outcome; PRP, patient-reported outcome population; QOL, quality of life.
Moderate-to-severe pain was defined as a baseline BPI-SF worst pain score of ≥5.
A 30-item questionnaire to assess QOL in patients with cancer; scores range from 0 to 100. Higher QOL and functioning scores represent better QOL and functioning, whereas higher symptom scores represent greater symptom burden; a 10-point MCT was applied. For QOL and functional scores, an improvement was defined as an increase in score from baseline by at least one MCT, stable was defined as a change in score from baseline within one MCT, and worsening was defined as a decrease in score from baseline by at least one MCT. For symptom scores, an improvement was defined as the decrease in score from baseline by at least one MCT, stable was defined as a change in score from baseline within one MCT, and worsening was defined as an increase in score from baseline by at least one MCT.
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. Higher scores are associated with more pain; a 2-point MCT was applied. An improvement in pain was defined as a decrease in score from baseline by at least one MCT, pain reported as stable was defined as a change in score from baseline within one MCT, and a worsening in pain was defined as an increase in score from baseline by at least one MCT.