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Literature DB >> 22478698

Translating cancer trial endpoints into the language of managed care.

Abstract

Oncology endpoints are an essential component of cancer trials, but often they are confusing, making it difficult to evaluate cancer therapies based on trial data. As more oncology agents hit the market and as indications expand for existing products, familiarity with these endpoints is critical for payers when making coverage decisions.

Entities: Disease

Year: 2008 PMID： 22478698 PMCID： PMC2651701

Source DB: PubMed Journal: Biotechnol Healthc ISSN： 1554-169X

18 in total

1. The validation of surrogate endpoints in meta-analyses of randomized experiments.

Authors: M Buyse; G Molenberghs; T Burzykowski; D Renard; H Geys
Journal: Biostatistics Date: 2000-03 Impact factor: 5.899

2. Trastuzumab plus chemotherapy: convincing survival benefit or not?

Authors: Charles L Vogel; Elizabeth Tan-Chiu
Journal: J Clin Oncol Date: 2005-05-23 Impact factor: 44.544

3. End points for adjuvant therapy trials: has the time come to accept disease-free survival as a surrogate end point for overall survival?

Authors: Sharlene Gill; Daniel Sargent
Journal: Oncologist Date: 2006-06

4. Efficacy of cetuximab after treatment with oral epidermal growth factor receptor tyrosine kinase inhibitor-based chemotherapy in metastatic colorectal cancer.

Authors: Jeffrey A Meyerhardt; Denise Heseltine; Shuji Ogino; Jeffrey W Clark; Peter C Enzinger; David P Ryan; Craig C Earle; Andrew X Zhu; Charles S Fuchs
Journal: Clin Colorectal Cancer Date: 2006-05 Impact factor: 4.481

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Authors: L A Ries; P A Wingo; D S Miller; H L Howe; H K Weir; H M Rosenberg; S W Vernon; K Cronin; B K Edwards
Journal: Cancer Date: 2000-05-15 Impact factor: 6.860

Review 6. Surrogate end points in clinical trials: are we being misled?

Authors: T R Fleming; D L DeMets
Journal: Ann Intern Med Date: 1996-10-01 Impact factor: 25.391

7. Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials.

Authors: Daniel J Sargent; Harry S Wieand; Daniel G Haller; Richard Gray; Jacqueline K Benedetti; Marc Buyse; Roberto Labianca; Jean Francois Seitz; Christopher J O'Callaghan; Guido Francini; Axel Grothey; Michael O'Connell; Paul J Catalano; Charles D Blanke; David Kerr; Erin Green; Norman Wolmark; Thierry Andre; Richard M Goldberg; Aimery De Gramont
Journal: J Clin Oncol Date: 2005-10-31 Impact factor: 44.544

8. An economic evaluation of Herceptin in adjuvant setting: the Breast Cancer International Research Group 006 trial.

Authors: M Neyt; J Albrecht; V Cocquyt
Journal: Ann Oncol Date: 2005-11-30 Impact factor: 32.976

9. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.

Authors: Martine J Piccart-Gebhart; Marion Procter; Brian Leyland-Jones; Aron Goldhirsch; Michael Untch; Ian Smith; Luca Gianni; Jose Baselga; Richard Bell; Christian Jackisch; David Cameron; Mitch Dowsett; Carlos H Barrios; Günther Steger; Chiun-Shen Huang; Michael Andersson; Moshe Inbar; Mikhail Lichinitser; István Láng; Ulrike Nitz; Hiroji Iwata; Christoph Thomssen; Caroline Lohrisch; Thomas M Suter; Josef Rüschoff; Tamás Suto; Victoria Greatorex; Carol Ward; Carolyn Straehle; Eleanor McFadden; M Stella Dolci; Richard D Gelber
Journal: N Engl J Med Date: 2005-10-20 Impact factor: 91.245

10. American Joint Committee on Cancer tumor-node-metastasis stage after neoadjuvant chemotherapy and breast cancer outcome.

Authors: Lisa A Carey; Richard Metzger; E Claire Dees; Frances Collichio; Carolyn I Sartor; David W Ollila; Nancy Klauber-DeMore; Jan Halle; Lynda Sawyer; Dominic T Moore; Mark L Graham
Journal: J Natl Cancer Inst Date: 2005-08-03 Impact factor: 13.506

4 in total

1. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB).

Authors: Ingrid A Mayer; Aleix Prat; Daniel Egle; Sibel Blau; J Alejandro Pérez Fidalgo; Michael Gnant; Peter A Fasching; Marco Colleoni; Antonio C Wolff; Eric P Winer; Christian F Singer; Sara Hurvitz; Laura García Estévez; Peter A van Dam; Sherko Kümmel; Christoph Mundhenke; Frankie Holmes; Naveen Babbar; Laure Charbonnier; Ivan Diaz-Padilla; Florian D Vogl; Dalila Sellami; Carlos L Arteaga
Journal: Clin Cancer Res Date: 2019-02-05 Impact factor: 12.531

Review 2. Confirmatory Trials in the Evaluation of Anticancer Medicinal Products in Man--PFS2: A Measure of Therapeutic Action-At-A-Distance.

Authors: Bryan Oronsky; Corey A Carter; Tony R Reid; Jan Scicinski; Arnold Oronsky; Michelle Lybeck; Scott Caroen; Meaghan Stirn; Neil Oronsky; Peter Langecker
Journal: Neoplasia Date: 2015-09 Impact factor: 5.715

3. The impact of pharmacokinetic gene profiles across human cancers.

Authors: Michael T Zimmermann; Terry M Therneau; Jean-Pierre A Kocher
Journal: BMC Cancer Date: 2018-05-21 Impact factor: 4.430

4. Aggregative Perivascular Tumor Cell Growth Pattern of Primary Central Nervous System Lymphomas Is Associated with Hypoxia-Related Endoplasmic Reticulum Stress.

Authors: Miaoxia He; Weiwei Zhang; Jianjun Wang; Lei Gao; Lijuan Jiao; Laixing Wang; Jianmin Zheng; Zailong Cai; Jianmin Yang
Journal: J Cancer Date: 2021-05-05 Impact factor: 4.207

4 in total