ASSESSING THE IMPACT OF INCLUSION OF PATIENTS WITH MISSING EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS IN REAL-WORLD OUTCOMES OF THIRD-LINE OR LATER (3L+) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)
Author(s)
Michael Wallington, BA1, Yong Chen, PhD2, Fei Jie, PhD3, Monica Patterson, PharmD4, Karen Repetny, PhD4, Michelle Fanale, MD3, Simon Purcell, MPharm5, Jacob Ambrose, MS6, Christina M. Zettler, MPH6, Andrew J. Belli, MPH6, Laura L. Fernandes, PhD6, Ching-Kun Wang, MD6;
1Pfizer Ltd., Surrey, United Kingdom, 2Pfizer, Inc., Collegeville, PA, USA, 3Pfizer, Inc., Bothell, WA, USA, 4Pfizer, Inc., Cambridge, MA, USA, 5Pfizer, Ltd., Surrey, United Kingdom, 6COTA, Inc., New York, NY, USA
1Pfizer Ltd., Surrey, United Kingdom, 2Pfizer, Inc., Collegeville, PA, USA, 3Pfizer, Inc., Bothell, WA, USA, 4Pfizer, Inc., Cambridge, MA, USA, 5Pfizer, Ltd., Surrey, United Kingdom, 6COTA, Inc., New York, NY, USA
OBJECTIVES: An Eastern Cooperative Oncology Group (ECOG) score of 0-2 is often required for clinical trial enrollment. In real-world data, ECOG status can be missing/unknown (M/U) due to lack of assessment, documentation, or abstraction. This analysis assessed differences in outcomes among patients with ECOG 0-2 versus M/U in a real-world population similar to the ECHELON-3 trial (NCT04404283).
METHODS: Using the COTA database, eligible adult patients received at least 2 prior lines of therapy (LOTs). Qualifying index-LOTs (multiple per patient) were identified by initiation of third line or later (3L+) between OCT/18/2017 and DEC/31/2023, no documentation of an ECOG score of ≥3 at baseline, no exclusionary treatment or diagnosis history, and sufficiently precise key dates. Baseline was defined as the earlier of 30 days prior to index or the end of prior LOT not exceeding 90 days until 7 days post-index. Real-world overall survival (rwOS) was evaluated using the Kaplan-Meier (KM) method.
RESULTS: Among 476 unique qualifying patients (716 qualifying index-LOTs), ECOG score was known for 57% of qualifying index-LOTs and was M/U for 43%. Although missingness across variables was slightly greater among ECOG M/U, key characteristics were similar between groups except index LOT initiation year (initiation 2021-2023: M/U: 59.1%, ECOG 0-2: 35.0%). Median rwOS among ECOG 0-2 and M/U was 6.9 (95% CI: 5.8, 9.1) and 10.6 months (95% CI: 7.9, 13.8) over a median follow-up time (reverse KM) of 36.1 (95% CI: 28.0, 41.5) and 17.0 months (95% CI: 15.0, 24.2), respectively.
CONCLUSIONS: In this analysis, M/U ECOG score was not associated with poor outcomes, although limitations include differences in follow-up time between groups. We hypothesize that patients who are fit enough to initiate 3L+ therapy are more likely to have ECOG score 0-2 than ≥3 at baseline, and additional research should assess inclusion of similar cohorts in future clinical trial comparisons.
METHODS: Using the COTA database, eligible adult patients received at least 2 prior lines of therapy (LOTs). Qualifying index-LOTs (multiple per patient) were identified by initiation of third line or later (3L+) between OCT/18/2017 and DEC/31/2023, no documentation of an ECOG score of ≥3 at baseline, no exclusionary treatment or diagnosis history, and sufficiently precise key dates. Baseline was defined as the earlier of 30 days prior to index or the end of prior LOT not exceeding 90 days until 7 days post-index. Real-world overall survival (rwOS) was evaluated using the Kaplan-Meier (KM) method.
RESULTS: Among 476 unique qualifying patients (716 qualifying index-LOTs), ECOG score was known for 57% of qualifying index-LOTs and was M/U for 43%. Although missingness across variables was slightly greater among ECOG M/U, key characteristics were similar between groups except index LOT initiation year (initiation 2021-2023: M/U: 59.1%, ECOG 0-2: 35.0%). Median rwOS among ECOG 0-2 and M/U was 6.9 (95% CI: 5.8, 9.1) and 10.6 months (95% CI: 7.9, 13.8) over a median follow-up time (reverse KM) of 36.1 (95% CI: 28.0, 41.5) and 17.0 months (95% CI: 15.0, 24.2), respectively.
CONCLUSIONS: In this analysis, M/U ECOG score was not associated with poor outcomes, although limitations include differences in follow-up time between groups. We hypothesize that patients who are fit enough to initiate 3L+ therapy are more likely to have ECOG score 0-2 than ≥3 at baseline, and additional research should assess inclusion of similar cohorts in future clinical trial comparisons.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
MSR118
Topic
Methodological & Statistical Research
Topic Subcategory
Missing Data
Disease
SDC: Oncology