Signal Detection in Real-world Data and Confirmation in Clinical Trials: Diabetes As a Case Study for a Conversation Worth Having

Overview

Journal Cancer

Publisher Wiley

Specialty Oncology

Date 2023 Jul 13

PMID 37439269

Authors

Elad Sharon

Megan Othus

Zoe Eloise Quandt

Affiliations

Soon will be listed here.

References

Kim E, Bruinooge S, Roberts S, Ison G, Lin N, Gore L . Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. J Clin Oncol. 2017; 35(33):3737-3744. PMC: 5692724. DOI: 10.1200/JCO.2017.73.7916. View

Kim E, Uldrick T, Schenkel C, Bruinooge S, Harvey R, Magnuson A . Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of Cancer Research Joint Research Statement. Clin Cancer Res. 2021; 27(9):2394-2399. DOI: 10.1158/1078-0432.CCR-20-3852. View

Vora K, Ricciuti B, Awad M . Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials. Sci Rep. 2021; 11(1):6637. PMC: 7988004. DOI: 10.1038/s41598-021-86081-w. View

Leshem Y, Dolev Y, Siegelmann-Danieli N, Sharman Moser S, Apter L, Chodick G . Association between diabetes mellitus and reduced efficacy of pembrolizumab in non-small cell lung cancer. Cancer. 2023; 129(18):2789-2797. DOI: 10.1002/cncr.34918. View

Liu Q, Mathur R, Xu Y, Torres A, Miksad R, Liu C . The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial Data. Clin Pharmacol Ther. 2023; 113(5):1139-1149. DOI: 10.1002/cpt.2874. View

Reuss J, Stern D, Foster J, Ramaswami R, Lurain K, Chen H . Assessment of Cancer Therapy Evaluation Program Advocacy and Inclusion Rates of People Living With HIV in Anti-PD1/PDL1 Clinical Trials. JAMA Netw Open. 2020; 3(12):e2027110. PMC: 7709086. DOI: 10.1001/jamanetworkopen.2020.27110. View

Uldrick T, Goncalves P, Abdul-Hay M, Claeys A, Emu B, Ernstoff M . Assessment of the Safety of Pembrolizumab in Patients With HIV and Advanced Cancer-A Phase 1 Study. JAMA Oncol. 2019; 5(9):1332-1339. PMC: 6547135. DOI: 10.1001/jamaoncol.2019.2244. View

Spillane S, Baxi S, Torres A, Lenis D, Freedman A, Mariotto A . Organ Dysfunction in Patients with Advanced Melanoma Treated with Immune Checkpoint Inhibitors. Oncologist. 2020; 25(11):e1753-e1762. PMC: 7648349. DOI: 10.1634/theoncologist.2020-0055. View

Boi S, Orlandella R, Gibson J, Turbitt W, Wald G, Thomas L . Obesity diminishes response to PD-1-based immunotherapies in renal cancer. J Immunother Cancer. 2021; 8(2). PMC: 7757487. DOI: 10.1136/jitc-2020-000725. View

10.

Kim D, Scherer P . Obesity, Diabetes, and Increased Cancer Progression. Diabetes Metab J. 2021; 45(6):799-812. PMC: 8640143. DOI: 10.4093/dmj.2021.0077. View

11.

Rivera D, Henk H, Garrett-Mayer E, Christian J, Belli A, Bruinooge S . The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies. Clin Pharmacol Ther. 2021; 111(1):283-292. PMC: 9298732. DOI: 10.1002/cpt.2453. View

12.

Yoo S, Chowell D, Valero C, Morris L, Chan T . Outcomes Among Patients With or Without Obesity and With Cancer Following Treatment With Immune Checkpoint Blockade. JAMA Netw Open. 2022; 5(2):e220448. PMC: 8886536. DOI: 10.1001/jamanetworkopen.2022.0448. View