Quality of life outcomes for cabozantinib versus everolimus in patients with metastatic renal cell carcinoma

METEOR phase III randomized trial

David Cella, Bernard Escudier, Nizar M. Tannir, Thomas Powles, Frede Donskov, Katriina Peltola, Manuela Schmidinger, Daniel Y.C. Heng, Paul N. Mainwaring, Hans J. Hammers, Jae Lyun Lee, Bruce J. Roth, Florence Marteau, Paul Williams, John Baer, Milan Mangeshkar, Christian Scheffold, Thomas E. Hutson, Sumanta Pal, Robert J. Motzer & 1 others Toni K. Choueiri

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose: In the phase III METEOR trial (ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantinib or everolimus. The cabozantinib arm had improved progression-free survival, overall survival, and objective response rate compared with everolimus. Changes in quality of life (QoL), an exploratory end point, are reported here. Patients and Methods: Patients completed the 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the five-level EuroQol (EQ-5D-5L) questionnaires at baseline and throughout the study. The nine-item FKSI-Disease-Related Symptoms (FKSI-DRS), a subset of FKSI-19, was also investigated. Data were summarized descriptively and by repeated-measures analysis (for which a clinically relevant difference was an effect size ≥ 0.3). Time to deterioration (TTD) was defined as the earlier of date of death, radiographic progressive disease, or ≥ 4-point decrease from baseline in FKSI-DRS. Results: The QoL questionnaire completion rates remained ≥ 75% through week 48 in each arm. There was no difference over time for FKSI-19 Total, FKSI-DRS, or EQ-5D data between the cabozantinib and everolimus arms. Among the individual FKSI-19 items, cabozantinib was associated with worse diarrhea and nausea; everolimus was associated with worse shortness of breath. These differences are consistent with the adverse event profile of each drug. Cabozantinib improved TTD overall, with a marked improvement in patients with bone metastases at baseline. Conclusion: In patients with advanced renal cell carcinoma, relative to everolimus, cabozantinib generally maintained QoL to a similar extent. Compared with everolimus, cabozantinib extended TTD overall and markedly improved TTD in patients with bone metastases.

Original languageEnglish (US)
Pages (from-to)757-764
Number of pages8
JournalJournal of Clinical Oncology
Volume36
Issue number8
DOIs
StatePublished - Mar 10 2018

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Renal Cell Carcinoma
Quality of Life
Neoplasm Metastasis
Bone and Bones
Kidney Neoplasms
Everolimus
cabozantinib
Dyspnea
Nausea
Disease-Free Survival
Diarrhea
Survival
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Quality of life outcomes for cabozantinib versus everolimus in patients with metastatic renal cell carcinoma : METEOR phase III randomized trial. / Cella, David; Escudier, Bernard; Tannir, Nizar M.; Powles, Thomas; Donskov, Frede; Peltola, Katriina; Schmidinger, Manuela; Heng, Daniel Y.C.; Mainwaring, Paul N.; Hammers, Hans J.; Lee, Jae Lyun; Roth, Bruce J.; Marteau, Florence; Williams, Paul; Baer, John; Mangeshkar, Milan; Scheffold, Christian; Hutson, Thomas E.; Pal, Sumanta; Motzer, Robert J.; Choueiri, Toni K.

In: Journal of Clinical Oncology, Vol. 36, No. 8, 10.03.2018, p. 757-764.

Research output: Contribution to journalArticle

Cella, D, Escudier, B, Tannir, NM, Powles, T, Donskov, F, Peltola, K, Schmidinger, M, Heng, DYC, Mainwaring, PN, Hammers, HJ, Lee, JL, Roth, BJ, Marteau, F, Williams, P, Baer, J, Mangeshkar, M, Scheffold, C, Hutson, TE, Pal, S, Motzer, RJ & Choueiri, TK 2018, 'Quality of life outcomes for cabozantinib versus everolimus in patients with metastatic renal cell carcinoma: METEOR phase III randomized trial', Journal of Clinical Oncology, vol. 36, no. 8, pp. 757-764. https://doi.org/10.1200/JCO.2017.75.2170
Cella, David ; Escudier, Bernard ; Tannir, Nizar M. ; Powles, Thomas ; Donskov, Frede ; Peltola, Katriina ; Schmidinger, Manuela ; Heng, Daniel Y.C. ; Mainwaring, Paul N. ; Hammers, Hans J. ; Lee, Jae Lyun ; Roth, Bruce J. ; Marteau, Florence ; Williams, Paul ; Baer, John ; Mangeshkar, Milan ; Scheffold, Christian ; Hutson, Thomas E. ; Pal, Sumanta ; Motzer, Robert J. ; Choueiri, Toni K. / Quality of life outcomes for cabozantinib versus everolimus in patients with metastatic renal cell carcinoma : METEOR phase III randomized trial. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 8. pp. 757-764.
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abstract = "Purpose: In the phase III METEOR trial (ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantinib or everolimus. The cabozantinib arm had improved progression-free survival, overall survival, and objective response rate compared with everolimus. Changes in quality of life (QoL), an exploratory end point, are reported here. Patients and Methods: Patients completed the 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the five-level EuroQol (EQ-5D-5L) questionnaires at baseline and throughout the study. The nine-item FKSI-Disease-Related Symptoms (FKSI-DRS), a subset of FKSI-19, was also investigated. Data were summarized descriptively and by repeated-measures analysis (for which a clinically relevant difference was an effect size ≥ 0.3). Time to deterioration (TTD) was defined as the earlier of date of death, radiographic progressive disease, or ≥ 4-point decrease from baseline in FKSI-DRS. Results: The QoL questionnaire completion rates remained ≥ 75{\%} through week 48 in each arm. There was no difference over time for FKSI-19 Total, FKSI-DRS, or EQ-5D data between the cabozantinib and everolimus arms. Among the individual FKSI-19 items, cabozantinib was associated with worse diarrhea and nausea; everolimus was associated with worse shortness of breath. These differences are consistent with the adverse event profile of each drug. Cabozantinib improved TTD overall, with a marked improvement in patients with bone metastases at baseline. Conclusion: In patients with advanced renal cell carcinoma, relative to everolimus, cabozantinib generally maintained QoL to a similar extent. Compared with everolimus, cabozantinib extended TTD overall and markedly improved TTD in patients with bone metastases.",
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T1 - Quality of life outcomes for cabozantinib versus everolimus in patients with metastatic renal cell carcinoma

T2 - METEOR phase III randomized trial

AU - Cella, David

AU - Escudier, Bernard

AU - Tannir, Nizar M.

AU - Powles, Thomas

AU - Donskov, Frede

AU - Peltola, Katriina

AU - Schmidinger, Manuela

AU - Heng, Daniel Y.C.

AU - Mainwaring, Paul N.

AU - Hammers, Hans J.

AU - Lee, Jae Lyun

AU - Roth, Bruce J.

AU - Marteau, Florence

AU - Williams, Paul

AU - Baer, John

AU - Mangeshkar, Milan

AU - Scheffold, Christian

AU - Hutson, Thomas E.

AU - Pal, Sumanta

AU - Motzer, Robert J.

AU - Choueiri, Toni K.

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N2 - Purpose: In the phase III METEOR trial (ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantinib or everolimus. The cabozantinib arm had improved progression-free survival, overall survival, and objective response rate compared with everolimus. Changes in quality of life (QoL), an exploratory end point, are reported here. Patients and Methods: Patients completed the 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the five-level EuroQol (EQ-5D-5L) questionnaires at baseline and throughout the study. The nine-item FKSI-Disease-Related Symptoms (FKSI-DRS), a subset of FKSI-19, was also investigated. Data were summarized descriptively and by repeated-measures analysis (for which a clinically relevant difference was an effect size ≥ 0.3). Time to deterioration (TTD) was defined as the earlier of date of death, radiographic progressive disease, or ≥ 4-point decrease from baseline in FKSI-DRS. Results: The QoL questionnaire completion rates remained ≥ 75% through week 48 in each arm. There was no difference over time for FKSI-19 Total, FKSI-DRS, or EQ-5D data between the cabozantinib and everolimus arms. Among the individual FKSI-19 items, cabozantinib was associated with worse diarrhea and nausea; everolimus was associated with worse shortness of breath. These differences are consistent with the adverse event profile of each drug. Cabozantinib improved TTD overall, with a marked improvement in patients with bone metastases at baseline. Conclusion: In patients with advanced renal cell carcinoma, relative to everolimus, cabozantinib generally maintained QoL to a similar extent. Compared with everolimus, cabozantinib extended TTD overall and markedly improved TTD in patients with bone metastases.

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