Patient-reported outcomes (PROs) in IMmotion151: Atezolizumab (atezo) + bevacizumab (bev) vs sunitinib (sun) in treatment (tx) naive metastatic renal cell carcinoma (mRCC).

Authors

null

Bernard Escudier

U1015 INSERM, Gustave Roussy Cancer Campus, Paris Saclay University, Villejuif, France

Bernard Escudier , Robert J. Motzer , Brian I. Rini , Thomas Powles , David F. McDermott , Cristina Suarez , Sergio Bracarda , Walter Michael Stadler , Frede Donskov , Howard Gurney , Stephane Oudard , Motohide Uemura , Elaine Tat Lam , Carsten Grüllich , Beiying Ding , Tarik Khaznadar , Caroleen Quach , Elisabeth Piault , Christina Schiff , Michael B. Atkins

Organizations

U1015 INSERM, Gustave Roussy Cancer Campus, Paris Saclay University, Villejuif, France, Memorial Sloan Kettering Cancer Center, New York, NY, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom, Beth Israel Deaconess Medical Center, Boston, MA, Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain, Ospedale San Donato, Arezzo, Italy, University of Chicago, Chicago, IL, Aarhus University Hospital, Aarhus, Denmark, Macquarie University, Sydney, New South Wales, Australia, Paris Descartes University, Paris, France, Osaka University Graduate School of Medicine, Osaka, Japan, University of Colorado, Aurora, CO, National Center for Tumor Diseases (NCT), Heidelberg, Germany, Genentech, Inc., South San Francisco, CA, F. Hoffmann-La Roche Ltd, Basel, Switzerland, Genentech, Inc., San Francisco, CA, Georgetown Lombardi Comprehensive Cancer Center, Medstar Georgetown University Hospital, Washington, DC

Research Funding

Pharmaceutical/Biotech Company

Background: The randomized, open-label Phase III IMmotion151 study met its coprimary endpoint in PD-L1+ patients (pts) with improvement in investigator-assessed PFS for atezo + bev vs sun (HR 0.74; median 11.2 vs 7.7 mo, P = 0.02). Encouraging efficacy was also observed in the intent-to-treat (ITT) population (HR 0.83; 11.2 vs 8.4 mo) (Motzer, ASCO-GU 2018). PROs were evaluated as secondary and exploratory endpoints to document pt perspective on overall clinical benefit for each tx. Methods: Pts received atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w (n = 454) or sun 50 mg PO QD 4 wk on/2 wk off (n = 461). Pts completed the MD Anderson Symptom Inventory (MDASI) and Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaires on days 1 and 22 of each 6 wk cycle, at end of tx, and during survival follow-up. Prespecified concepts included symptom burden (MDASI symptom severity and symptom interference with daily living) and bother from tx side effects (FKSI-19 GP5 item). Health-related quality of life (HRQoL) was also assessed (FKSI-19 total). Descriptive analyses included summary statistics for scores (effect sizes [ES] ≥ 0.3 suggest clinically meaningful differences), score changes from baseline (BL), and time to deterioration (TTD; first ≥ 2-point score increase in MDASI interference). Results: BL completion in ITT pts was > 80% and ≥ 70% until wk 57. At post-BL visits, pts receiving atezo + bev had milder and more stable symptom severity, less interference (differences in mean score ES: mean 0.3; range 0.1 - 0.5), and better HRQoL (differences in mean score ES: mean 0.4; range 0.1 - 0.6) vs pts receiving sun, who more often reported worsened interference. TTD in interference was also delayed (HR 0.56; 95% CI 0.46, 0.68): median for atezo + bev was 11.3 mo vs 4.3 mo for sun. A greater proportion of atezo + bev-treated pts reported no or little bother from tx side effects vs sun-treated pts. Conclusions: PRO data suggest atezo + bev maintained day-to-day functioning with minimal symptom interference and delayed TTD vs sun, further supporting positive benefit-risk for the combination regimen in first-line mRCC. Clinical trial information: NCT02420821

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Kidney Cancer

Clinical Trial Registration Number

NCT02420821

Citation

J Clin Oncol 36, 2018 (suppl; abstr 4511)

DOI

10.1200/JCO.2018.36.15_suppl.4511

Abstract #

4511

Abstract Disclosures