The impact of infection on health-related quality of life (HRQoL) in patients with Philadelphia negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (Ph- R/R BCP ALL) in a randomized, open-label, phase 3 study (TOWER).

Authors

null

Andre C. Schuh

Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada

Andre C. Schuh , Yan Li , Max S. Topp , Xinke Zhang , Paul Cannell , Herve Dombret , Johan Maertens , Anthony Selwyn Stein , Janet Franklin

Organizations

Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, University of Florida, Department of Pharmaceutical Outcomes & Policy, Gainesville, FL, Medizinische Klinik und Poliklinik II, Würzburg, Bayern, Germany, Amgen Inc., Thousand Oaks, CA, Department of Health, Western Australia, Perth, Australia, Université Diderot, Paris, France, UZ Leuven, Leuven, Belgium, Department of Hematology and Hematopietic Cell Transplantation, City of Hope, Duarte, CA

Research Funding

Pharmaceutical/Biotech Company

Background: In the phase 3 TOWER study (NCT02013167), blinatumomab (BLIN) significantly improved overall survival in adults with Ph- R/R BCP ALL, and these patients (pts) also reported better HRQoL (EORTC QLQ-C30 measures) compared with standard of care (SOC) chemotherapy. This analysis assessed the impact of grade 3+ infection, which was reported in 34.1% of BLIN pts vs 52.3% of SOC pts, on HRQoL in TOWER. Methods: Pts were stratified into two groups: those with infection vs those without infection, between baseline and Day 8, Day 15, and Day 29. A difference-in-difference (DID) model investigated the impact of infection on HRQoL. A 5-point change is considered the minimum clinically important difference in the EORTC QLQ-C30 for between group comparisons (King et al. 1996). Results: In total, 342 pts (n = 247 BLIN; n = 95 SOC) had a non-missing baseline and ≥1 post-baseline HRQoL score for any scale. Grade 3+ infection was reported in 15 (4.5%) pts before Day 8, 49 (14.5%) pts before Day 15, and 76 (22.6%) pts before Day 29. Pts with grade 3+ infection reported clinical meaningful deterioration in global health status (GHS) score and in almost all functional subscales across timepoints assessed (Table). At Day 29, grade 3+ infection was associated with statistically significant and clinically meaningful deterioration in GHS and most functional scales (Table). Similar but smaller effects were also observed for symptom scales/items (data not shown). Conclusions: Grade 3+ infection in pts with Ph- R/R BCP ALL was associated with clinically meaningful deterioration in HRQoL. The lower incidence of infection in pts treated with BLIN vs SOC may have contributed to the improved HRQoL for pts treated with BLIN. Clinical trial information: NCT02013167

Impact of Grade 3+ Infection on GHS & functional scales.

DID estimate95% CIs
Day 8GHS-12-294
Physical-12-305
Role-15-4110
Cognitive-17-32-1
Emotional-6-2411
Social-10-3414
Day 15GHS-7-174
Physical-10-211
Role-0.3-1615
Cognitive-4-157
Emotional-5-167
Social-9-246
Day 29GHS-10-20-1
Physical-14-25-4
Role-2-1611
Cognitive-12-23-2
Emotional-14-25-4
Social-14-27-1

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant: Publication Only

Track

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Sub Track

Acute Leukemia

Clinical Trial Registration Number

NCT02013167

Citation

J Clin Oncol 37, 2019 (suppl; abstr e18511)

DOI

10.1200/JCO.2019.37.15_suppl.e18511

Abstract #

e18511

Abstract Disclosures