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Current Oncology
Volume 18
Issue s2
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Curr. Oncol., Volume 18, Issue s2 (October 2011) – 4 articles

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388 KiB  
Proceeding Paper
Progression-Free Survival in Advanced Ovarian Cancer: A Canadian Review and Expert Panel Perspective
by A. M. Oza, V. Castonguay, D. Tsoref, I. Diaz–Padilla, K. Karakasis, H. Mackay, S. Welch, J. Weberpals, P, Hoskins, M. Plante, D. Provencher, K, Tonkin, A. Covens, P. Ghatage, J. Gregoire, H. Hirte, D. Miller, B. Rosen, J. Maroun, M. Buyse, C. Coens, M. F. Brady and G. C. E. Stuartadd Show full author list remove Hide full author list
Curr. Oncol. 2011, 18(s2), 20-27; https://doi.org/10.3747/co.v18i0.939 - 1 Oct 2011
Cited by 5 | Viewed by 75
Abstract
Ovarian cancer is leading cause of gynecologic cancer mortality in Canada. To date, overall survival (os) has been the most-used endpoint in oncology trials because of its relevance and objectivity. However, as a result of various factors, including the pattern of sequential salvage [...] Read more.
Ovarian cancer is leading cause of gynecologic cancer mortality in Canada. To date, overall survival (os) has been the most-used endpoint in oncology trials because of its relevance and objectivity. However, as a result of various factors, including the pattern of sequential salvage therapies, measurement of os and collection of os data are becoming particularly challenging. Phase ii and iii trials have therefore adopted progression-free survival (pfs) as a more convenient surrogate endpoint; however, the clinical significance of pfs remains unclear. This position paper presents discussion topics and findings from a pan-Canadian meeting of experts that set out to 1. evaluate the relevance of pfs as a valid endpoint in ovarian cancer; 2. reach a Canadian consensus on the relevance of pfs in ovarian cancer; and 3. try to address how pfs translates into clinical benefit in ovarian cancer. Overall, the findings and the group consensus posit that future studies should 1. ensure that trials are designed to evaluate pfs, os, and other clinically relevant endpoints such as disease-related symptoms or quality of life; 2. incorporate interim futility analyses intended to stop accrual early when the experimental regimen is not active; 3. stop trials early to declare superiority only when compelling evidence suggests that a new treatment provides benefit for a pre-specified, clinically relevant endpoint such as os or symptom relief; and 4. discourage early release of secondary endpoint results when such a release might increase the frequency of crossover to the experimental intervention. Full article
9 pages, 378 KiB  
Article
Progression-Free Survival as a Clinical Trial Endpoint in Advanced Renal Cell Carcinoma
by S.J. Hotte, 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, J.D. Ruether, D. Soulieres, P.M. Venner, E.W. Winquist, L. Wood, J.H.E. Yong and F. Saad
Curr. Oncol. 2011, 18(s2), 11-19; https://doi.org/10.3747/co.v18is2.958 - 1 Oct 2011
Cited by 25 | Viewed by 1359
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 [...] Read more.
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. Full article
6 pages, 390 KiB  
Article
Progression-Free Survival as a Primary Endpoint in Clinical Trials of Metastatic Colorectal Cancer
by S. Gill, S. Berry, J. Biagi, C. Butts, M. Buyse, E. Chen, D. Jonker, C. Mărginean, B. Samson, J. Stewart, M. Thirlwell, R. Wong and J.A. Maroun
Curr. Oncol. 2011, 18(s2), 5-10; https://doi.org/10.3747/co.v18is2.941 - 1 Oct 2011
Cited by 20 | Viewed by 1058
Abstract
In recent years, significant advances have been made in the management of metastatic colorectal cancer. Traditionally, an improvement in overall survival has been considered the “gold standard”—the most convincing measure of efficacy. However, overall survival requires larger patient numbers and longer follow-up and [...] Read more.
In recent years, significant advances have been made in the management of metastatic colorectal cancer. Traditionally, an improvement in overall survival has been considered the “gold standard”—the most convincing measure of efficacy. However, overall survival requires larger patient numbers and longer follow-up and may often be confounded by other factors, including subsequent therapies and crossover. Given the number of active therapies for potential investigation, demand for rapid evaluation and early availability of new therapies is growing. Progression-free survival is regarded as an important measure of treatment benefit and, compared with overall survival, can be evaluated earlier, with fewer patients and no confounding by subsequent lines of therapy. The present paper reviews the advantages, limitations, and relevance of progression-free survival as a primary endpoint in randomized trials of metastatic colorectal cancer. Full article
2 pages, 303 KiB  
Editorial
The Significance of Progressionfree Survival as an Endpoint in Evaluating the Therapeutic Value of Antineoplastic Agents
by J.A. Maroun
Curr. Oncol. 2011, 18(s2), 3-4; https://doi.org/10.3390/curroncol18120004 - 1 Oct 2011
Cited by 3 | Viewed by 671
Abstract
In the last decade, thanks to the development of new and effective cytotoxic and biologic agents, significant progress has been achieved in the treatment of various forms of cancer. [...] Full article
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