De GruttolaVG, ClaxP, DeMetsDL, et al.
Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop. Control Clin Trials.
ElstonJ, TaylorRS. Use of surrogate outcomes in cost-effectiveness models: A review of United Kingdom health technology assessment reports. Int J Technol Assess Health Care.
YudkinJS, LipskaKJ, MontoriVM. The idolatry of the surrogate. BMJ.
MesserliFH, BangaloreS. ALTITUDE Trial and Dual RAS Blockade: The alluring but soft science of the surrogate end point. Am J Med.
FlemingTR, DeMetsDL. Surrogate end points in clinical trials: Are we being misled? Ann Intern Med.
CianiO, BuyseM, GarsideR, et al.
Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: Meta-epidemiological study. BMJ.
LassereMN. The Biomarker-Surrogacy Evaluation Schema: A review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints. Stat Methods Med Res.
WeirCJ, WalleyRJ. Statistical evaluation of biomarkers as surrogate endpoints: A literature review. Stat Med.
BuyseM, MolenberghsG, BurzykowskiT, RenardD, GeysH. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics.
BuyseM, SargentDJ, GrotheyA, MathesonA, de GramontA. Biomarkers and surrogate end points–the challenge of statistical validation. Nat Rev Clin Oncol.
Velasco GarridoM, MangiapaneS. Surrogate outcomes in health technology assessment: An international comparison. Int J Technol Assess Health Care.
EllenbergS, HamiltonJM. Surrogate endpoints in clinical trials: Cancer. Stat Med.
DunnBK, AkpaE. Biomarkers as surrogate endpoints in cancer trials. Semin Oncol Nurs.
BerghmansT, PasleauF, PaesmansM, et al.
Surrogate markers predicting overall survival for lung cancer: ELCWP recommendations. Eur Respir J.
ShiQ, SargentDJ. Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials. Int J Clin Oncol.
SaadED, KatzA, BuyseM. Overall survival and post-progression survival in advanced breast cancer: A review of recent randomized clinical trials. J Clin Oncol.
JaffeCC. Measures of response: RECIST, WHO, and new alternatives. J Clin Oncol.
EisenhauerEA, TherasseP, BogaertsJ, et al.
New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer.
DanceyJE, DoddLE, FordR, et al.
Recommendations for the assessment of progression in randomised cancer treatment trials. Eur J Cancer.
TappendenP, ChilcottJ, WardS, EggingtonS, HindD, HummelS. Methodological issues in the economic analysis of cancer treatments. Eur J Cancer.
SridharaR, JohnsonJR, JusticeR, et al.
Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst.
HartleyR, KeenEM, LargeJ, TeddLA. Online searching: Principles and practice. Epping, UK: BowkerSaur; 1990.
BowaterRJ, BridgeLJ, LilfordRJ. The relationship between progression-free and post-progression survival in treating four types of metastatic cancer. Cancer Lett.
BurzykowskiT, BuyseM. Surrogate threshold effect: An alternative measure for meta-analytic surrogate endpoint validation. Pharm Stat.
ChirilaC, OdomD, DevercelliG, et al.
Meta-analysis of the association between progression-free survival and overall survival in metastatic colorectal cancer. Int J Colorectal Dis.
GreenE, YothersG, SargentDJ. Surrogate endpoint validation: Statistical elegance versus clinical relevance. Stat Methods Med Res.
JohnsonKR, RinglandC, StokesBJ, et al.
Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: A meta-analysis. Lancet Oncol.
SherrillB, AmonkarM, WuY, et al.
Relationship between effects on time-to-disease progression and overall survival in studies of metastatic breast cancer. Br J Cancer.
BuyseM. Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials. Cancer J.
SherrillB, KayeJA, SandinR, CappelleriJC, ChenC. Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology. Onco Targets Ther.
LeeL, WangL, CrumpM. Identification of potential surrogate end points in randomized clinical trials of aggressive and indolent non-Hodgkin's lymphoma: Correlation of complete response, time-to-event and overall survival end points. Ann Oncol.
TibaldiF, BarbosaFT, MolenberghsG. Modelling associations between time-to-event responses in pilot cancer clinical trials using a Plackett-Dale model. Stat Med.
BucherHC, GuyattGH, CookDJ, HolbrookA, McAlisterFA. Users’ guides to the medical literature: XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points. Evidence-Based Medicine Working Group. JAMA.
LassereMN, JohnsonKR, SchiffM, ReesD. Is blood pressure reduction a valid surrogate endpoint for stroke prevention? An analysis incorporating a systematic review of randomised controlled trials, a by-trial weighted errors-in-variables regression, the surrogate threshold effect (STE) and the Biomarker-Surrogacy (BioSurrogate) Evaluation Schema (BSES). BMC Med Res Methodol. 2012;12:27.
LassereMN, JohnsonKR, BoersM, et al.
Definitions and validation criteria for biomarkers and surrogate endpoints: Development and testing of a quantitative hierarchical levels of evidence schema. J Rheumatol.
BowaterRJ, LilfordPE, LilfordRJ. Estimating changes in overall survival using progression-free survival in metastatic breast and colorectal cancer. Int J Technol Assess Health Care.
BurzykowskiT, MolenberghsG, BuyseM, GeysH, RenardD. Validation of surrogate end points in multiple randomized clinical trials with failure time end points. J R Stat Soc Ser C Appl Stat. 2001;50:405–422.
AmirE, SerugaB, KwongR, TannockIF, OcanaA. Poor correlation between progression-free and overall survival in modern clinical trials: Are composite endpoints the answer?
Eur J Cancer.
WilkersonJ, FojoT. Progression-free survival is simply a measure of a drug's effect while administered and is not a surrogate for overall survival. Cancer J.
PolleyMY, LambornKR, ChangSM, et al.
Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide. Neuro Oncol.
BallmanKV, BucknerJC, BrownPD, et al.
The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro Oncol.
LouvetC, de GramontA, TournigandC, ArtruP, Maindrault-GoebelF, KrulikM. Correlation between progression free survival and response rate in patients with metastatic colorectal carcinoma. Cancer.
TangPA, BentzenSM, ChenEX, SiuLL. Surrogate end points for median overall survival in metastatic colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol.
BuyseM, BurzykowskiT, CarrollK, et al.
Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol.
HottaK, FujiwaraY, MatsuoK, et al.
Time to progression as a surrogate marker for overall survival in patients with advanced non-small cell lung cancer. J Thorac Oncol.
LiX, LiuS, GuH, WangD. Surrogate end points for survival in the target treatment of advanced non-small-cell lung cancer with gefitinib or erlotinib. J Cancer Res Clin Oncol.
MandrekarSJ, QiY, HillmanSL, et al.
Endpoints in phase II trials for advanced non-small cell lung cancer. J Thorac Oncol.
HayashiH, OkamotoI, TaguriM, MoritaS, NakagawaK. Postprogression survival in patients with advanced non-small-cell lung cancer who receive second-line or third-line chemotherapy. Clin Lung Cancer.
HottaK, KiuraK, FujiwaraY, et al.
Role of survival post-progression in phase III trials of systemic chemotherapy in advanced non-small-cell lung cancer: A systematic review. PloS One.
BurzykowskiT, BuyseM, Piccart-GebhartMJ, et al.
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.
HackshawA, KnightA, Barrett-LeeP, LeonardR. Surrogate markers and survival in women receiving first-line combination anthracycline chemotherapy for advanced breast cancer. Br J Cancer.
MiksadRA, ZietemannV, GotheR, et al.
Progression-free survival as a surrogate endpoint in advanced breast cancer. Int J Technol Assess Health Care.
RosePG, TianC, BookmanMA. Assessment of tumor response as a surrogate endpoint of survival in recurrent/platinum-resistant ovarian carcinoma: A Gynecologic Oncology Group study. Gynecol Oncol.
SundarS, WuJ, HillabyK, YapJ, LilfordR. A systematic review evaluating the relationship between progression free survival and post progression survival in advanced ovarian cancer. Gynecol Oncol.
ShitaraK, IkedaJ, YokotaT, et al.
Progression-free survival and time to progression as surrogate markers of overall survival in patients with advanced gastric cancer: Analysis of 36 randomized trials. Invest New Drugs.
FosterNR, QiY, ShiQ, et al.
Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: Findings on the basis of North Central Cancer Treatment Group trials. Cancer.
HalabiS, VogelzangNJ, OuSS, OwzarK, ArcherL, SmallEJ. Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer. J Clin Oncol.
HengDY, XieW, BjarnasonGA, et al.
Progression-free survival as a predictor of overall survival in metastatic renal cell carcinoma treated with contemporary targeted therapy. Cancer.
DeleaTE, KhuuA, HengDYC, HaasT, SoulieresD. Association between treatment effects on disease progression end points and overall survival in clinical studies of patients with metastatic renal cell carcinoma. Br J Cancer.
ParmarMK, TorriV, StewartL. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Statist Med.
BuyseM, SargentDJ, SaadED. Survival is not a good outcome for randomized trials with effective subsequent therapies. J Clin Oncol.
2011;29:4719–4720; author reply 4720–4721.
SaadED, KatzA, HoffPM, BuyseM. Progression-free survival as surrogate and as true end point: Insights from the breast and colorectal cancer literature. Ann Oncol.
CianiO, TaylorRS. A more evidence based approach to the use of surrogate end points in policy making. BMJ.