Correlation Between Surrogate End Points and Overall Survival in a Multi-institutional Clinicogenomic Cohort of Patients With Non-Small Cell Lung or Colorectal Cancer.

Autor:	Kehl KL; Department of Medical Oncology, Division of Population Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts., Riely GJ; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Lepisto EM; Department of Medical Oncology, Division of Population Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts., Lavery JA; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Warner JL; Department of Medicine, Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.; Department of Biomedical Informatics, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee., LeNoue-Newton ML; Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee., Sweeney SM; American Association for Cancer Research, Philadelphia, Pennsylvania., Rudolph JE; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Brown S; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Yu C; Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre/University Health Network, Toronto, Ontario, Canada., Bedard PL; Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre/University Health Network, Toronto, Ontario, Canada.; Department of Medicine, University of Toronto, Toronto, Ontario, Canada., Schrag D; Department of Medical Oncology, Division of Population Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.; Associate Editor, JAMA., Panageas KS; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2021 Jul 01; Vol. 4 (7), pp. e2117547. Date of Electronic Publication: 2021 Jul 01.
DOI:	10.1001/jamanetworkopen.2021.17547
Abstrakt:	Importance: Contemporary observational cancer research requires associating genomic biomarkers with reproducible end points; overall survival (OS) is a key end point, but interpretation can be challenging when multiple lines of therapy and prolonged survival are common. Progression-free survival (PFS), time to treatment discontinuation (TTD), and time to next treatment (TTNT) are alternative end points, but their utility as surrogates for OS in real-world clinicogenomic data sets has not been well characterized. Objective: To measure correlations between candidate surrogate end points and OS in a multi-institutional clinicogenomic data set. Design, Setting, and Participants: A retrospective cohort study was conducted of patients with non-small cell lung cancer (NSCLC) or colorectal cancer (CRC) whose tumors were genotyped at 4 academic centers from January 1, 2014, to December 31, 2017, and who initiated systemic therapy for advanced disease. Patients were followed up through August 31, 2020 (NSCLC), and October 31, 2020 (CRC). Statistical analyses were conducted on January 5, 2021. Exposures: Candidate surrogate end points included TTD; TTNT; PFS based on imaging reports only; PFS based on medical oncologist ascertainment only; PFS based on either imaging or medical oncologist ascertainment, whichever came first; and PFS defined by a requirement that both imaging and medical oncologist ascertainment have indicated progression. Main Outcomes and Measures: The primary outcome was the correlation between candidate surrogate end points and OS. Results: There were 1161 patients with NSCLC (648 women [55.8%]; mean [SD] age, 63 [11] years) and 1150 with CRC (647 men [56.3%]; mean [SD] age, 54 [12] years) identified for analysis. Progression-free survival based on both imaging and medical oncologist documentation was most correlated with OS (NSCLC: ρ = 0.76; 95% CI, 0.73-0.79; CRC: ρ = 0.73; 95% CI, 0.69-0.75). Time to treatment discontinuation was least associated with OS (NSCLC: ρ = 0.45; 95% CI, 0.40-0.50; CRC: ρ = 0.13; 95% CI, 0.06-0.19). Time to next treatment was modestly associated with OS (NSCLC: ρ = 0.60; 0.55-0.64; CRC: ρ = 0.39; 95% CI, 0.32-0.46). Conclusions and Relevance: This cohort study suggests that PFS based on both a radiologist and a treating oncologist determining that a progression event has occurred was the surrogate end point most highly correlated with OS for analysis of observational clinicogenomic data.
Databáze:	MEDLINE
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