The Molecular Analysis for Therapy Choice (NCI-MATCH) Trial: Lessons for Genomic Trial Design
| Autor: | Flaherty, Keith T, Gray, Robert, Chen, Alice, Li, Shuli, Patton, David, Hamilton, Stanley R, Williams, Paul M, Mitchell, Edith P, Iafrate, A John, Sklar, Jeffrey, Harris, Lyndsay N, McShane, Lisa M, Rubinstein, Larry V, Sims, David J, Routbort, Mark, Coffey, Brent, Fu, Tony, Zwiebel, James A, Little, Richard F, Marinucci, Donna, Catalano, Robert, Magnan, Rick, Kibbe, Warren, Weil, Carol, Tricoli, James V, Alexander, Brian, Kumar, Shaji, Schwartz, Gary K, Meric-Bernstam, Funda, Lih, Chih-Jian, McCaskill-Stevens, Worta, Caimi, Paolo, Takebe, Naoko, Datta, Vivekananda, Arteaga, Carlos L, Abrams, Jeffrey S, Comis, Robert, O’Dwyer, Peter J, Conley, Barbara A |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Biopsy MEDLINE Antineoplastic Agents Young Adult 03 medical and health sciences Clinical Trial Protocols as Topic Clinical Trials Phase II as Topic 0302 clinical medicine Text mining Neoplasms Internal medicine medicine Humans Molecular Targeted Therapy Precision Medicine Young adult Aged 030304 developmental biology Aged 80 and over 0303 health sciences medicine.diagnostic_test business.industry High-Throughput Nucleotide Sequencing Articles Middle Aged Precision medicine Interim analysis Clinical trial Sample size determination 030220 oncology & carcinogenesis Female business |
| Zdroj: | JNCI Journal of the National Cancer Institute |
| ISSN: | 1460-2105 0027-8874 |
| Popis: | Background The proportion of tumors of various histologies that may respond to drugs targeted to molecular alterations is unknown. NCI-MATCH, a collaboration between ECOG-ACRIN Cancer Research Group and the National Cancer Institute, was initiated to find efficacy signals by matching patients with refractory malignancies to treatment targeted to potential tumor molecular drivers regardless of cancer histology. Methods Trial development required assumptions about molecular target prevalence, accrual rates, treatment eligibility, and enrollment rates as well as consideration of logistical requirements. Central tumor profiling was performed with an investigational next-generation DNA–targeted sequencing assay of alterations in 143 genes, and protein expression of protein expression of phosphatase and tensin homolog, mutL homolog 1, mutS homolog 2, and RB transcriptional corepressor 1. Treatments were allocated with a validated computational platform (MATCHBOX). A preplanned interim analysis evaluated assumptions and feasibility in this novel trial. Results At interim analysis, accrual was robust, tumor biopsies were safe ( Conclusions The experiences in the design and implementation of the NCI-MATCH trial suggest that profiling from fresh tumor biopsies and assigning treatment can be performed efficiently in a large national network trial. The success of such trials necessitates a broad screening approach and many treatment options easily accessible to patients. |
| Databáze: | OpenAIRE |
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