Meeting
2014 ASCO Annual Meeting
Health-related quality of life (HRQL) impact of idelalisib (IDELA) in patients (pts) with relapsed chronic lymphocytic leukemia (CLL): Phase 3 results.
Authors
Paolo Ghia
Università Vita e Salute; San Raffaele Scientific Institute, Milano, Italy
Paolo Ghia , Susan Mary O'Brien , Peter Hillmen , Richard R. Furman , Steven E. Coutre , Jeff Porter Sharman , Bruce D. Cheson , John M. Pagel , Jacqueline Claudia Barrientos , Andrew David Zelenetz , Thomas J. Kipps , Ian Flinn , Herbert Aaron Eradat , Nicole Lamanna , Michael J. Hallek , Bertrand Coiffier , Andrew Pettitt , Wei Ye , Thomas Michael Jahn , Lynne I. Wagner
Organizations
Università Vita e Salute; San Raffaele Scientific Institute, Milano, Italy, The University of Texas MD Anderson Cancer Center, Houston, TX, The Leeds Teaching Hospitals, St. James Institute of Oncology, Leeds, United Kingdom, Weill Cornell Medical College, New York, NY, Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Springfield, OR, Georgetown University Medical Center, Washington, DC, Fred Hutchinson Cancer Research Center, Seattle, WA, Hofstra North Shore-LIJ School of Medicine, Hempstead, NY, Memorial Sloan Kettering Cancer Center, New York, NY, University of California, San Diego, School of Medicine, San Diego, CA, Sarah Cannon Research Institute, Nashville, TN, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, University of Cologne, Cologne, Germany, Lyon Sud University Hospital, Pierre-Bénite, France, University of Liverpool, Liverpool, United Kingdom, Gilead Sciences, Foster City, CA, Feinberg School of Medicine, Northwestern University, Chicago, IL
Research Funding
Pharmaceutical/Biotech Company
Background: Pt-reported outcomes (PROs) evaluated HRQL among CLL pts randomized to IDELA + rituximab (R) (n=110) vs double-blind placebo + R (n=110). Methods: The 44-item Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu) scale measured Physical (PWB), Functional (FWB), Social (SWB) and Emotional (EWB) Well-being and leukemia-specific concerns (LeuS). The FACT-Leu Total score is the sum of subscales; Trial Outcome Index (TOI) is the sum of PWB, FWB and LeuS. Higher scores reflect better HRQL. Repeated measures mixed-effects models assessed change from baseline within and between-arms. Results: IDELA + R was superior for OS: HR=0.28 (0.09, 0.86), p=0.018. In the mixed-effects model analysis, PWB (p=0.015), FWB (p= 0.014), LeuS (p=0.001), TOI (p=0.002), and FACT-Leu Total (p=0.006) scores were significantly higher for IDELA + R. EWB/SWB scores did not change significantly over time. Repeated measure mixed-effects model results are shown in the table. Conclusions: In this frail CLL population, IDELA + R had superior efficacy, clinically significant improvements in HRQL, and superior symptom control occurring by 8 weeks compared to R + placebo. Clinical trial information: NCT01539512.
| Week | PWB | FWB | LeuS | TOI | FACT-Leu total |
|---|---|---|---|---|---|
| 2 | -0.1 (0.65) | 0.6 (0.80) | 0.4 (1.31) | 1.3 (2.38) | 1.1 (2.96) |
| 4 | 0.8 (0.66) | 1.0 (0.81) | 2.5 (1.33) | 4.0 (2.41) | 4.0 (3.01) |
| 6 | 0.1 (0.68) | 1.0 (0.84) | 2.2 (1.37) | 2.9 (2.48) | 3.9 (3.09) |
| 8 | 0.6 (0.71) | 0.7 (0.87) | 3.5 (1.43)* | 4.6 (2.57) | 5.2 (3.2) |
| 12 | 1.1 (0.75) | 1.5 (0.92) | 4.7 (1.51 ** | 7.0 (2.72)** | 6.5 (3.39) |
| 16 | 1.9 (0.83)* | 1.3 (1.01) | 5.3 (1.66)** | 8.4 (2.99)** | 9.2 (3.72)** |
| 20 | 1.6 (0.91) | 1.4 (1.13) | 5.4 (1.85)** | 9.0 (3.33)** | 9.0 (4.14)** |
| 24 | 1.8 (1.02) | 1.9 (1.26) | 5.0 (2.06)** | 9.1 (3.69)** | 10.0 (4.58)** |
| 30 | 2.1 (1.14) | 2.6 (1.41) | 3.0 (2.32) | 7.7 (4.13) | 9.6 (5.13) |
| 36 | 1.5 (1.26) | 2.8 (1.56) | 5.1 (2.54)** | 8.2 (4.59) | 9.1 (5.69) |
| 42 | 2.1 (1.57) | 2.8 (1.93) | 3.9 (3.16) | 8.1 (5.57) | 9.1 (6.92) |
| 48 | 3.6 (1.79)** | 3.6 (2.20) | 5.5 (3.60) | 12.4 (6.32)** | 13.1 (7.85) |
* p< 0.05; ** p<0.05 and exceeded established minimally important difference (MID) change scores of 2, 4, 5 and 6 points for PWB, LeuS, TOI and FACT-Leu total, respectively, between arms.
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Abstract Details
Session Type
Poster Session
Session Title
Leukemia, Myelodysplasia, and Transplantation
Track
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Sub Track
Leukemia
Clinical Trial Registration Number
NCT01539512
Citation
J Clin Oncol 32:5s, 2014 (suppl; abstr 7099)
DOI
10.1200/jco.2014.32.15_suppl.7099
Abstract #
7099
Poster Bd #
384
Abstract Disclosures
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