Regorafenib in Patients With Solid Tumors With BRAF Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Autor:	Sahai V; University of Michigan Rogel Cancer Center, Ann Arbor, MI., Rothe M; American Society of Clinical Oncology, Alexandria, VA., Mangat PK; American Society of Clinical Oncology, Alexandria, VA., Garrett-Mayer E; American Society of Clinical Oncology, Alexandria, VA., Suhag V; Sutter Health Roseville Cancer Center, Roseville, CA., Dib EG; Michigan Cancer Research Consortium, Ypsilanti, MI., Mehmi I; The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA., Kadakia KC; Levine Cancer Institute, Atrium Health, Charlotte, NC., Pisick E; City of Hope Chicago, Zion, IL., Duvivier HL; City of Hope Atlanta, Newnan, GA., Le P; The University of Texas MD Anderson Cancer Center, Houston, TX., Li R; Providence Cancer Institute, Providence Portland Medical Center, Portland, OR., Michelin DP; Munson Medical Center, Cancer Research Consortium of West Michigan, Traverse City, MI., Wilcox RE; Intermountain Healthcare, St George, UT., Grantham GN; American Society of Clinical Oncology, Alexandria, VA., Hinshaw DC; American Society of Clinical Oncology, Alexandria, VA., Gregory A; American Society of Clinical Oncology, Alexandria, VA., Halabi S; Duke University Medical Center, Durham, NC., Schilsky RL; American Society of Clinical Oncology, Alexandria, VA.
Jazyk:	angličtina
Zdroj:	JCO precision oncology [JCO Precis Oncol] 2024 Apr; Vol. 8, pp. e2300527.
DOI:	10.1200/PO.23.00527
Abstrakt:	Purpose: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer with genomic alterations known to be drug targets. Results of a cohort of patients with solid tumors with BRAF alterations treated with regorafenib are reported. Methods: Eligible patients had measurable disease (RECIST v.1.1), Eastern Cooperative Oncology Group performance status 0-1, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as investigator assessment of patients with complete or partial response (PR) or stable disease of at least 16-weeks duration (SD16+). Low accruing histology-specific cohorts with BRAF alterations treated with regorafenib were collapsed into a single histology-pooled cohort for this analysis. The results were evaluated on the basis of a one-sided exact binomial test with a null DC rate of 15% versus 35% (power, 0.84; α, .10). Secondary end points were objective response (OR), progression-free survival, overall survival, duration of response, duration of stable disease, and safety. Results: Twenty-eight patients with 12 tumor types with BRAF alterations were enrolled from June 2016 to June 2021. All patients were evaluable for efficacy. Two patients with PR and four with SD16+ were observed for DC and OR rates of 21% (90% CI, 12 to 100) and 7% (95% CI, 1 to 24), respectively. The null hypothesis of 15% DC rate was not rejected ( P = .24). Eight patients had at least one grade 3 adverse event or serious adverse event at least possibly related to regorafenib. Conclusion: Regorafenib did not meet prespecified criteria to declare a signal of activity in patients with solid tumors with BRAF alterations.
Databáze:	MEDLINE
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