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Quality of life (QoL) in the phase 3 METEOR trial of cabozantinib vs everolimus for advanced renal cell carcinoma (RCC)

Date

09 Oct 2016

Session

Poster display

Presenters

David Cella

Citation

Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373

Authors

D. Cella1, B. Escudier2, N. Tannir3, T. Powles4, F. Donskov5, K. Peltola6, M. Schmidinger7, D. Heng8, P. Mainwaring9, H. Hammers10, J. Lee11, B.I. Rini12, B. Roth13, J. Baer14, M. Mangeshkar15, C. Scheffold16, T. Hutson17, S. Pal18, R.J. Motzer19, T.K. Choueiri20

Author affiliations

  • 1 Department Of Medical Social Sciences, Northwestern University, 60611 - Chicago/US
  • 2 Department Of Medical Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 3 Department Of Genitourinary Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Experimental Cancer Medicine, Barts Cancer Institute-Queen Mary University of London, EC1M 6BQ - London/GB
  • 5 Department Of Oncology, Aarhus University, 8000 - Aarhus C/DK
  • 6 Comprehensive Cancer Center, HUCH Helsinki University Central Hospital, 00029 - Helsinki/FI
  • 7 Department Of Medicine I, Medical University of Vienna, 1090 - Vienna  /AT
  • 8 Medical Oncology, Tom Baker Cancer Centre, T2N 4N2 - Calgary/CA
  • 9 Medical Oncology, ICON Cancer Care, 4101 - South Brisbane/AU
  • 10 Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, 21231 - Baltimore/US
  • 11 Department Of Oncology And Internal Medicine, Asan Medical Center/Asan GU Medical Center, 05505 - Seoul/KR
  • 12 Department Of Hematology And Oncology, Cleveland Clinic Taussig Cancer Institute, 44195 - Cleveland/US
  • 13 Division Of Oncology, Section Of Medical Oncology, Washington University School of Medicine, 63110 - St Louis/US
  • 14 Translational Medicine, Exelixis, Inc., 94080 - South San Francisco/US
  • 15 Biostatistics, Exelexis, Inc., 94080 - South San Francisco/US
  • 16 Clinical Research, Exelixis, Inc., 94080 - South San Francisco/US
  • 17 Charles A Sammons Cancer Center, Baylor University Medical Center, 75254 - Dallas/US
  • 18 Department Of Medical Oncology And Therapeutic Research, City of Hope, 91010 - Duarte/US
  • 19 Medical Oncology, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 20 Department Of Genitourinary Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, 02215 - Boston/US
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Resources

Abstract 3390

Background

In a randomized Phase 3 trial in advanced RCC after prior VEGFR TKI therapy (Choueiri N Engl J Med 2015, ASCO 2016 abstract 4506) cabozantinib was superior to everolimus in the primary endpoint of PFS (median 7.4 vs 3.8 mo; HR 0.58; p 

Methods

658 patients were randomized 1:1 to receive cabozantinib 60 mg qd (n = 330), or everolimus 10 mg qd (n = 328). QoL questionnaires (Functional Assessment of Cancer Therapy-Kidney Symptom Index [FKSI-19] and EuroQol EQ-5D-5L) were administered on Day 1 (pre-dose), every 4 weeks through W25D1, then every 8 weeks through final tumor assessment. The FKSI-19 has 19 items each scored on a 5-point scale (0-4); a 9-item disease-related symptom index (FKSI-DRS) is a subset. Higher scores indicate better QoL. A priori statistical methods included a repeated-measures mixed-effects model change from baseline (BL) analysis. An important change was defined as an effect size (ES) ≥ 0.3.

Results

Completion rates were ≥ 75% of patients (# completed/expected at each timepoint) through Week 48 for both instruments. The FKSI-19 total score was similarly sustained in each arm over time: estimated mean change from BL −3.48 cabozantinib vs −2.21 everolimus (ES difference −0.13). Scores at end of treatment (mainly due to progression) were ∼7 points lower than BL in each arm. On the Treatment Side Effects subscale, diarrhea and nausea were worse for cabozantinib (ES -0.77 and -0.34, respectively), shortness of breath was worse for everolimus (ES +0.30). Diarrhea and nausea are frequent AEs for VEGFR TKIs. No treatment differences were observed for the other three FKSI subscales (DRS-Physical, DRS-Emotional, Function/Well Being) or for the EQ-5D-5L questionnaire. In a post hoc analysis, median time to deterioration (earlier of death, progression, or ≥ 4-point decrease in FKSI-DRS) was longer in the cabozantinib arm (5.5 vs 3.7 mo; p 

Conclusions

Cabozantinib improved PFS, OS, and ORR, and resulted in QoL similar to everolimus in patients with advanced RCC. The benefits of cabozantinib are further supported by a delay of time to deterioration.

Clinical trial identification

NCT01865747

Legal entity responsible for the study

Exelixis, Inc.

Funding

Exelixis, Inc.

Disclosure

D. Cella: Stock or Other Ownership: Facit.org Patents, Royalties, Other Intellectual Prop.: Facit.org B. Escudier: Honoraria: Exelixis, Novartis, Pfizer, BMS, Roche. N. Tannir: Honoraria: Novartis, BMS, GSK, Pfizer, Exelixis, Nektar Consulting Fees: Novartis, BMS, GSK, Pfizer, Exelixis, Nektar Research Funding: Novartis, BMS, Exelixis, Epizyme Travel, Accomodations, Expenses: Novartis, BMS, GSK, Pfizer, Exelixis, Nektar. T. Powles: Honoraria: Roche/Genentech, Novartis Consulting or Advisory Role: Roche/Genentech, BMS Research Funding: AZ/MedImmune, Roche/Genentech, GSK. F. Donskov: Research Funding: Novartis, GSK, Pfizer (received by institution). K. Peltola: Employee: Part-time, Orion Pharma Stock/other Ownership: Faron Pharma Honoraria: Novartis, Lilly Consulting/Advisory: Lilly, BMS, Sanofi, Baxter, Pfizer, MSD, Astellas. Travel Accomodations: Pierre Fabre, BMS, Novartis, Lilly. M. Schmidinger: Honoraria: Pfizer, Roche, BMS, Novartis Consulting/Advisory: Pfizer, Roche, BMS, Novartis, Exelixis Research Funding: Pfizer, Roche. D. Heng: Consulting/Advisory: Pfizer, Novartis, BMS, Exelixis. P. Mainwaring: Honoraria, Consulting/Advisory, Speakers' Bureau: Astellas, Janssen, Roche, Novartis Patents, Royalties, Other Intellectual Prop: Xing Technologies P/L Travel Accomodations: Astellas, Janssen, Roche. H. Hammers: Research Funding: sfj, BMS, Newlink, Pfizer, GSK, Tracon Consulting/Advisory: BMS, Exelixis, Pfizer, Cerulean. J-L. Lee: Honoraria: Pfizer, Astellas, Novartis Consulting/Advisory: AZ Research Funding: Pfizer, Bayer, Novartis, Exelixis, MSD, Roche, AZ. B.I. Rini: Research Funding: Pfizer, BMS, Peleton, Acceleron, Furmatics Consulting/Advisory: Pfizer, Roche, BMS, Acceleron, Novartis, GSK Travel Accomodations, Expenses: Pfizer. B. Roth: Research Funding: Argos, Medivation, Exelixis, Jansen. J. Baer: Employment: Exlexis Stock or other ownership: Exelixis, GSK. M. Mangeshkar: Employee and Stock Ownership: Exelixis, Inc. C. Scheffold: Employee: Exelixis Stock or other ownership: Exelixis. T. Hutson: Research Funding: Pfizer, Bayer, BMS, Novartis Honoraria: Pfizer, Novartis, Bayer, BMS Consulting/Advisory: Pfizer, Novartis, Bayer, Exelixis, Eisai, BMS Speakers' Bureau: Pfizer, Novartis, Bayer, BMS. S. Pal: honoraria: Novartis, Medivation, Astellas Pharma consulting fees: Pfizer, Novartis, Aveo, Genentech, Exelixis, BMS, Astellas, GSK. R.J. Motzer: Consulting/Advisory: Pfizer, Novartis, Eisai Research Funding: Exelixis, BMS, Novartis, Pfizer, Genentech/Roche. T.K. Choueiri: Consulting/Advisory Role: Pfizer, GSK, Novartis, Merck, Bayer, Eisai, Roche, Prometheus Labs Inc, BMS, Foundation Medicine Inc. Research Funding: Pfizer, GSK, Novartis, BMS, Merck, Exelixis, Roche, AstraZeneca, Tracon, Peloton.

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