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Literature DB >> 34289052

A Problematic Biomarker Trial Design.

Abstract

Efficient biomarker-driven randomized clinical trials are a key tool for implementing precision oncology. A commonly used biomarker phase III design is focused on testing the treatment effect in biomarker-positive and overall study populations. This approach may result in recommending new treatments to biomarker-negative patients when these treatments have no benefit for these patients. Published by Oxford University Press 2021. This work is written by US Government employees and is in the public domain in the US.

Entities: Chemical

Mesh：

Substances：
Biomarkers

Year: 2022 PMID： 34289052 PMCID： PMC8826527 DOI： 10.1093/jnci/djab144

Source DB: PubMed Journal: J Natl Cancer Inst ISSN： 0027-8874 Impact factor: 13.506

13 in total

1. Marker Sequential Test (MaST) design.

Authors: Boris Freidlin; Edward L Korn; Robert Gray
Journal: Clin Trials Date: 2013-10-01 Impact factor: 2.486

2. Pembrolizumab for all PD-L1-positive NSCLC.

Authors: Egbert F Smit; Adrianus J de Langen
Journal: Lancet Date: 2019-04-04 Impact factor: 79.321

3. Atezolizumab for PD-L1-Selected Patients with NSCLC.

Authors: Nobuyuki Horita; Nobuhiko Fukuda; Takeshi Kaneko
Journal: N Engl J Med Date: 2021-02-11 Impact factor: 91.245

4. PD-L1 expression in triple-negative breast cancer.

Authors: Elizabeth A Mittendorf; Anne V Philips; Funda Meric-Bernstam; Na Qiao; Yun Wu; Susan Harrington; Xiaoping Su; Ying Wang; Ana M Gonzalez-Angulo; Argun Akcakanat; Akhil Chawla; Michael Curran; Patrick Hwu; Padmanee Sharma; Jennifer K Litton; Jeffrey J Molldrem; Gheath Alatrash
Journal: Cancer Immunol Res Date: 2014-01-10 Impact factor: 11.151

5. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial.

Authors: Eric P Winer; Oleg Lipatov; Seock-Ah Im; Anthony Goncalves; Eva Muñoz-Couselo; Keun Seok Lee; Peter Schmid; Kenji Tamura; Laura Testa; Isabell Witzel; Shoichiro Ohtani; Nicholas Turner; Stefania Zambelli; Nadia Harbeck; Fabrice Andre; Rebecca Dent; Xuan Zhou; Vassiliki Karantza; Jaime Mejia; Javier Cortes
Journal: Lancet Oncol Date: 2021-03-04 Impact factor: 41.316

Review 6. Biomarker enrichment strategies: matching trial design to biomarker credentials.

Authors: Boris Freidlin; Edward L Korn
Journal: Nat Rev Clin Oncol Date: 2013-11-26 Impact factor: 66.675

7. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer.

Authors: Peter Schmid; Sylvia Adams; Hope S Rugo; Andreas Schneeweiss; Carlos H Barrios; Hiroji Iwata; Véronique Diéras; Roberto Hegg; Seock-Ah Im; Gail Shaw Wright; Volkmar Henschel; Luciana Molinero; Stephen Y Chui; Roel Funke; Amreen Husain; Eric P Winer; Sherene Loi; Leisha A Emens
Journal: N Engl J Med Date: 2018-10-20 Impact factor: 91.245

8. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC.

Authors: Roy S Herbst; Giuseppe Giaccone; Filippo de Marinis; Niels Reinmuth; Alain Vergnenegre; Carlos H Barrios; Masahiro Morise; Enriqueta Felip; Zoran Andric; Sarayut Geater; Mustafa Özgüroğlu; Wei Zou; Alan Sandler; Ida Enquist; Kimberly Komatsubara; Yu Deng; Hiroshi Kuriki; Xiaohui Wen; Mark McCleland; Simonetta Mocci; Jacek Jassem; David R Spigel
Journal: N Engl J Med Date: 2020-10-01 Impact factor: 91.245

Review 2. Cancer Immunotherapy with Immune Checkpoint Inhibitors-Biomarkers of Response and Toxicity; Current Limitations and Future Promise.

Authors: Brian Healey Bird; Ken Nally; Karine Ronan; Gerard Clarke; Sylvie Amu; Ana S Almeida; Richard Flavin; Stephen Finn
Journal: Diagnostics (Basel) Date: 2022-01-06

2 in total