Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)

BackgroundRegorafenib and trifluridine/tipiracil (FTD/TPI) ± bevacizumab are both indicated for patients diagnosed with metastatic colorectal cancer (mCRC) in the third line or later. However, in the absence of recommendations regarding preferred treatment order, our study aimed to improve the under...

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Main Authors: Tanios Bekaii-Saab, Ila Sruti, Junxin Shi, Wei Dai, Gregory Patton, Sreevalsa Appukkuttan, Brian Hocum, Arvind Katta, Svetlana Babajanyan, David Cosgrove
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Oncology
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Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2025.1591245/full
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author Tanios Bekaii-Saab
Ila Sruti
Junxin Shi
Wei Dai
Gregory Patton
Sreevalsa Appukkuttan
Brian Hocum
Arvind Katta
Svetlana Babajanyan
David Cosgrove
author_facet Tanios Bekaii-Saab
Ila Sruti
Junxin Shi
Wei Dai
Gregory Patton
Sreevalsa Appukkuttan
Brian Hocum
Arvind Katta
Svetlana Babajanyan
David Cosgrove
author_sort Tanios Bekaii-Saab
collection DOAJ
description BackgroundRegorafenib and trifluridine/tipiracil (FTD/TPI) ± bevacizumab are both indicated for patients diagnosed with metastatic colorectal cancer (mCRC) in the third line or later. However, in the absence of recommendations regarding preferred treatment order, our study aimed to improve the understanding of real-world optimal treatment sequences.MethodsThis retrospective study assessed real-world outcomes and treatment patterns among mCRC patients who initiated sequential regorafenib and FTD/TPI ± bevacizumab between the first line and sixth line from September 2015 to November 2022 in The US Oncology Network. Patient and treatment characteristics were assessed descriptively overall and stratified by treatment order. The Kaplan–Meier methods were used for time-to-event endpoints, including real-world overall survival (rwOS), real-world progression-free survival (rwPFS), and real-world time to next treatment (rwTTNT) following sequence. Endpoints were also evaluated using Cox proportional hazards models.ResultsThis study examined 308 patients initiating sequential regorafenib and FTD/TPI, 156 patients initiating regorafenib first (R-T), and 152 patients initiating FTD/TPI first (T-R). Demographic and clinical characteristics were similar across cohorts. The population was predominantly male and had a mean age of 63 years and colon primary at diagnosis. The median rwOS was numerically longer among the R-T cohort compared to the T-R cohort (12.8 [11.2, 14.1] vs. 10.2 [8.8, 11.9] months). The median rwPFS was similar (3.4 [3.0, 3.6] vs. 3.4 [3.0, 3.7 months) for both the R-T and T-R cohorts. The median rwTTNT following sequence was numerically longer among the R-T cohort compared to the T-R cohort (9.3 [8.4, 10.3] vs. 8.6 [7.8, 9.4] months). Index treatment was not significantly associated with rwOS (Hazard Ratio (HR) = 1.2, p = 0.2), rwPFS (Hazard Ratio (HR) = 0.9, p = 0.4), or rwTTNT (Hazard Ratio (HR) = 1.1, p = 0.6).ConclusionTreatment sequence numerically favored R-T and provided an additional survival benefit of 2.6 months in this cohort, although this was not statistically significant. Providing access to regorafenib and FTD/TPI ± bevacizumab is critical to maximizing patient benefit and optimizing patient care in advanced stages of mCRC.
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spelling doaj-art-62dc58b9525d459092e53a1ecd234d552025-08-20T02:33:00ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-06-011510.3389/fonc.2025.15912451591245Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)Tanios Bekaii-Saab0Ila Sruti1Junxin Shi2Wei Dai3Gregory Patton4Sreevalsa Appukkuttan5Brian Hocum6Arvind Katta7Svetlana Babajanyan8David Cosgrove9Medical Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, United StatesReal World Research, Ontada, Boston, MA, United StatesReal World Research, Ontada, Boston, MA, United StatesReal World Research, Ontada, Boston, MA, United StatesReal World Research, Ontada, Boston, MA, United StatesUS Medical Affairs, Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United StatesUS Medical Affairs, Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United StatesUS Medical Affairs, Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United StatesUS Medical Affairs, Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United StatesCompass Oncology, The US Oncology Network, Vancouver, WA, United StatesBackgroundRegorafenib and trifluridine/tipiracil (FTD/TPI) ± bevacizumab are both indicated for patients diagnosed with metastatic colorectal cancer (mCRC) in the third line or later. However, in the absence of recommendations regarding preferred treatment order, our study aimed to improve the understanding of real-world optimal treatment sequences.MethodsThis retrospective study assessed real-world outcomes and treatment patterns among mCRC patients who initiated sequential regorafenib and FTD/TPI ± bevacizumab between the first line and sixth line from September 2015 to November 2022 in The US Oncology Network. Patient and treatment characteristics were assessed descriptively overall and stratified by treatment order. The Kaplan–Meier methods were used for time-to-event endpoints, including real-world overall survival (rwOS), real-world progression-free survival (rwPFS), and real-world time to next treatment (rwTTNT) following sequence. Endpoints were also evaluated using Cox proportional hazards models.ResultsThis study examined 308 patients initiating sequential regorafenib and FTD/TPI, 156 patients initiating regorafenib first (R-T), and 152 patients initiating FTD/TPI first (T-R). Demographic and clinical characteristics were similar across cohorts. The population was predominantly male and had a mean age of 63 years and colon primary at diagnosis. The median rwOS was numerically longer among the R-T cohort compared to the T-R cohort (12.8 [11.2, 14.1] vs. 10.2 [8.8, 11.9] months). The median rwPFS was similar (3.4 [3.0, 3.6] vs. 3.4 [3.0, 3.7 months) for both the R-T and T-R cohorts. The median rwTTNT following sequence was numerically longer among the R-T cohort compared to the T-R cohort (9.3 [8.4, 10.3] vs. 8.6 [7.8, 9.4] months). Index treatment was not significantly associated with rwOS (Hazard Ratio (HR) = 1.2, p = 0.2), rwPFS (Hazard Ratio (HR) = 0.9, p = 0.4), or rwTTNT (Hazard Ratio (HR) = 1.1, p = 0.6).ConclusionTreatment sequence numerically favored R-T and provided an additional survival benefit of 2.6 months in this cohort, although this was not statistically significant. Providing access to regorafenib and FTD/TPI ± bevacizumab is critical to maximizing patient benefit and optimizing patient care in advanced stages of mCRC.https://www.frontiersin.org/articles/10.3389/fonc.2025.1591245/fullmetastatic colorectal cancerregorafenibreal world researchclinical outcomestreatment patternssequencing
spellingShingle Tanios Bekaii-Saab
Ila Sruti
Junxin Shi
Wei Dai
Gregory Patton
Sreevalsa Appukkuttan
Brian Hocum
Arvind Katta
Svetlana Babajanyan
David Cosgrove
Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)
Frontiers in Oncology
metastatic colorectal cancer
regorafenib
real world research
clinical outcomes
treatment patterns
sequencing
title Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)
title_full Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)
title_fullStr Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)
title_full_unstemmed Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)
title_short Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2)
title_sort real world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine tipiracil bevacizumab in patients with metastatic colorectal cancer in a us community setting seqrt2
topic metastatic colorectal cancer
regorafenib
real world research
clinical outcomes
treatment patterns
sequencing
url https://www.frontiersin.org/articles/10.3389/fonc.2025.1591245/full
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