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Current Oncology
Volume 18
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Article

Progression-Free Survival as a Clinical Trial Endpoint in Advanced Renal Cell Carcinoma

by
S.J. Hotte
1,*,
G.A. Bjarnason
2,
D.Y.C. Heng
3,
M.A.S. Jewett
4,
A. Kapoor
5,
C. Kollmannsberger
6,
J. Maroun
7,
L.A. Mayhew
8,
S. North
9,
M.N. Reaume
10,
J.D. Ruether
11,
D. Soulieres
12,
P.M. Venner
9,
E.W. Winquist
13,
L. Wood
14,
J.H.E. Yong
15 and
F. Saad
12
1
Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, ON, Canada
2
Department of Medical Oncology, Sunnybrook Health Services, Toronto, ON, Canada
3
Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, AB, Canada
4
Department of Surgery (Urology) and Surgical Oncology, Princess Margaret Hospital, University Health Network and University of Toronto, Toronto, ON, Canada
5
Department of Urology, Juravinski Cancer Centre, Hamilton, ON, Canada
6
Department of Medical Oncology, BC Cancer Agency, Vancouver, BC, Canada
7
Ottawa Region Cancer Centre, University of Ottawa, Ottawa, ON, Canada
8
Department of Radiation Medicine, University Health Network, Toronto, ON, Canada
9
Department of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada
10
Division of Medical Oncology, Ottawa Hospital, Ottawa, ON, Canada
11
Tom Baker Cancer Centre, Calgary, AB, Canada
12
Department of Hematology/Oncology (Soulieres) and Division of Urology (Saad), Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada
13
Division of Medical Oncology, Department of Oncology, University of Western Ontario, London, ON, Canada
14
Division of Medical Oncology, QEII Health Sciences Centre, Halifax, NS, Canada
15
Pharmacoeconomics Research Unit, Canadian Centre for Applied Research in Cancer Control (ARCC), St. Michael’s Hospital, Toronto, ON, Canada
 
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*
Author to whom correspondence should be addressed.
Curr. Oncol. 2011, 18(s2), 11-19; https://doi.org/10.3747/co.v18is2.958
Submission received: 8 September 2011 / Revised: 8 September 2011 / Accepted: 13 September 2011 / Published: 1 October 2011

Abstract

Traditionally, overall survival (os) has been considered the “gold standard” for evaluating new systemic oncologic therapies, because death is easy to define, is easily compared across disease sites, and is not subject to investigator bias. However, as the available options for continuing therapy increase, the use of os as a clinical trial endpoint has become problematic because of the increasing crossover and contamination of trials. As a result, the approval of promising new therapies may be delayed. Many clinicians believe that progression-free survival (pfs) is a more viable option for evaluating new therapies in metastatic and advanced renal cell carcinoma. As with all endpoints, pfs has inherent biases, and those biases must be addressed to ensure that trial results are not compromised and that they will be accepted by regulatory authorities. In this paper, we examine the issues surrounding the use of pfs as a clinical trial endpoint, and we suggest solutions to ensure that data integrity is maintained.
Keywords: kidney cancer; progression-free survival; overall survival; regulatory approval; clinical trial endpoints kidney cancer; progression-free survival; overall survival; regulatory approval; clinical trial endpoints

Share and Cite

MDPI and ACS Style

Hotte, S.J.; Bjarnason, G.A.; Heng, D.Y.C.; Jewett, M.A.S.; Kapoor, A.; Kollmannsberger, C.; Maroun, J.; Mayhew, L.A.; North, S.; Reaume, M.N.; et al. Progression-Free Survival as a Clinical Trial Endpoint in Advanced Renal Cell Carcinoma. Curr. Oncol. 2011, 18, 11-19. https://doi.org/10.3747/co.v18is2.958

AMA Style

Hotte SJ, Bjarnason GA, Heng DYC, Jewett MAS, Kapoor A, Kollmannsberger C, Maroun J, Mayhew LA, North S, Reaume MN, et al. Progression-Free Survival as a Clinical Trial Endpoint in Advanced Renal Cell Carcinoma. Current Oncology. 2011; 18(s2):11-19. https://doi.org/10.3747/co.v18is2.958

Chicago/Turabian Style

Hotte, S.J., G.A. Bjarnason, D.Y.C. Heng, M.A.S. Jewett, A. Kapoor, C. Kollmannsberger, J. Maroun, L.A. Mayhew, S. North, M.N. Reaume, and et al. 2011. "Progression-Free Survival as a Clinical Trial Endpoint in Advanced Renal Cell Carcinoma" Current Oncology 18, no. s2: 11-19. https://doi.org/10.3747/co.v18is2.958

APA Style

Hotte, S. J., Bjarnason, G. A., Heng, D. Y. C., Jewett, M. A. S., Kapoor, A., Kollmannsberger, C., Maroun, J., Mayhew, L. A., North, S., Reaume, M. N., Ruether, J. D., Soulieres, D., Venner, P. M., Winquist, E. W., Wood, L., 14, Yong, J. H. E., & Saad, F. (2011). Progression-Free Survival as a Clinical Trial Endpoint in Advanced Renal Cell Carcinoma. Current Oncology, 18(s2), 11-19. https://doi.org/10.3747/co.v18is2.958

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