- •Phase III metastatic trial utilization of progression-free (PFS) or overall survival (OS).
- •PFS primary end-point (PEP) trials more likely to succeed (67%) versus OS PEP (33%).
- •PEP success associated with molecular profile restriction and single agent therapy.
- •PFS PEP trials had a subsequent OS benefit 38% of the time.
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
- What advanced cancer patients with limited treatment options know about clinical research: a qualitative study.Support Care Canc. 2017; 25: 3235-3242
- Randomized controlled trials in the era of molecular oncology: methodology, biomarkers, and end points.Ann Oncol. 2012; 23: 1646-1651
- Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?.BMC Med. 2017; 15: 134
- Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and drug administration approvals.JAMA Intern Med. 2015; 175: 1992-1994
- Progression-free survival as an end-point in solid tumours–perspectives from clinical trials and clinical practice.Eur J Canc. 2014; 50: 2303-2308
- A review of studies examining the relationship between progression-free survival and overall survival in advanced or metastatic cancer.2012 (London)
- Progression-free survival: meaningful or simply measurable?.J Clin Oncol. 2012; 30: 1030-1033
- Progression-free survival is a surrogate for survival in advanced colorectal cancer.J Clin Oncol. 2007; 25: 5218-5224
- Multitrial evaluation of progression-free survival as a surrogate end point for overall survival in first-line extensive-stage small-cell lung cancer.J Thorac Oncol. 2015; 10: 1099-1106
- Progression-free survival in advanced ovarian cancer: a Canadian review and expert panel perspective.Curr Oncol. 2011; 18: S20-S27
- Should progression-free survival be the primary measure of efficacy for advanced NSCLC therapy?.Ann Oncol. 2010; 21: 2324-2332
- Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer.J Clin Oncol. 2008; 26: 1987-1992
- Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature.Oncologist. 2009; 14: 816-827
- A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology.Eur J Canc. 2019; 106: 196-211
- The value of progression-free survival as a treatment end point Among patients with advanced cancer: a systematic review and qualitative assessment of the literature.JAMA Oncol. 2019; 5: 1779-1789
- Statistical controversies in clinical research: end points other than overall survival are vital for regulatory approval of anticancer agents.Ann Oncol. 2016; 27: 373-378
- Predicting low accrual in the National Cancer Institute's Cooperative Group clinical trials.J Natl Cancer Inst. 2016; 108
- Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US food and drug administration.J Am Med Assoc. 2017; 318: 626-636
- Double-crossed: why crossover in clinical trials may be distorting medical science.J Natl Compr Canc Netw. 2013; 11: 625-627
- The misguided ethics of crossover trials.Contemp Clin Trials. 2014; 37: 167-169
- Do surrogate endpoints better correlate with overall survival in studies that did not allow for crossover or reported balanced postprogression treatments? An application in advanced non-small cell lung cancer.Value Health. 2018; 21: 9-17
- Validity of surrogate endpoints in oncology executive summary of rapid report A10-05, Version 1.1.Institute for Quality and Efficiency in Health Care: Executive Summaries, Cologne, Germany2005
- Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?.J Clin Oncol. 2008; 26: 3791-3796
- Investigating discrepancies in assessments of PFS by study investigators and independent review.Ann Oncol. 2017; 28
- Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour.BMJ Open. 2018; 8e017240
- Exaggeration of PFS by blinded, independent, central review (BICR).Ann Oncol. 2019; 30: 332-338
- Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.BMJ. 2017; 359: j4530
- Reversals of established medical practices: evidence to abandon ship.J Am Med Assoc. 2012; 307: 37-38
- A decade of reversal: an analysis of 146 contradicted medical practices.Mayo Clin Proc. 2013; 88: 790-798
- Are 90% of deaths from cancer caused by metastases?.Cancer Med. 2019; 8: 5574-5576
- Detecting an overall survival benefit that is derived from progression-free survival.J Natl Cancer Inst. 2009; 101: 1642-1649