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A phase I, open-label study evaluating the safety and pharmacokinetics of trifluridine/tipiracil in patients with advanced solid tumors and varying degrees of renal impairment
MW. Saif, CR. Becerra, MG. Fakih, W. Sun, L. Popovic, S. Krishnamurthi, TJ. George, MA. Rudek, DR. Shepard, J. Skopek, V. Sramek, B. Zaric, I. Yamamiya, KA. Benhadji, K. Hamada, Y. He, L. Rosen
Jazyk angličtina Země Německo
Typ dokumentu klinické zkoušky, fáze I, časopisecké články, práce podpořená grantem
NLK
ProQuest Central
od 1997-02-01 do Před 1 rokem
Medline Complete (EBSCOhost)
od 2000-01-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 1997-02-01 do Před 1 rokem
Public Health Database (ProQuest)
od 1997-02-01 do Před 1 rokem
- MeSH
- anemie chemicky indukované epidemiologie MeSH
- dospělí MeSH
- fixní kombinace léků MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory farmakoterapie MeSH
- nemoci ledvin patofyziologie MeSH
- neutropenie chemicky indukované epidemiologie MeSH
- plocha pod křivkou MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky farmakokinetika MeSH
- pyrrolidiny aplikace a dávkování škodlivé účinky farmakokinetika MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- thymin aplikace a dávkování škodlivé účinky farmakokinetika MeSH
- trifluridin aplikace a dávkování škodlivé účinky farmakokinetika MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze I MeSH
- práce podpořená grantem MeSH
PURPOSE: Trifluridine/tipiracil (FTD/TPI) is approved for advanced colorectal and gastric/gastroesophageal cancer; however, data in patients with renal impairment (RI) are limited. This phase I study evaluated FTD/TPI in patients with advanced solid tumors and varying degrees of RI to develop dosing guidance. METHODS: Patients were enrolled into normal renal function (CrCl ≥ 90 mL/min), mild RI (CrCl 60-89 mL/min), or moderate RI (CrCl 30-59 mL/min) cohorts and administered the recommended FTD/TPI dose (35 mg/m2 twice daily, days 1-5 and 8-12; 28-day cycle). Based on interim pharmacokinetics/safety data, patients with severe RI (CrCl 15-29 mL/min) were enrolled and received FTD/TPI 20 mg/m2 twice daily. RESULTS: Forty-three patients (normal renal function [n = 12]; mild RI [n = 12]; moderate RI [n = 11]; severe RI [n = 8]) were enrolled and treated. At steady state, compared to values in patients with normal renal function, FTD area under the curve (AUC) was not significantly different in patients with RI, but TPI AUC was significantly higher and increased with RI severity. FTD/TPI safety profile was consistent with prior experience, but grade ≥ 3 adverse events (AEs) were more frequent in the RI cohorts (83.3% [mild], 90.9% [moderate], 75.0% [severe], and normal [50.0%]). Hematologic AEs (anemia and neutropenia) were more frequent with RI. Overall, seven patients discontinued because of unrelated, nonhematologic AEs. CONCLUSION: FTD/TPI is safe and tolerable at the recommended 35 mg/m2 dose in patients with mild/moderate RI and at the reduced 20 mg/m2 dose in patients with severe RI. TRIAL REGISTRATION: NCT02301117, registration date: November 21, 2014.
City of Hope Comprehensive Cancer Center Duarte CA USA
Cleveland Clinic Cleveland OH USA
Division of Hematology Oncology University of California Los Angeles CA USA
Division of Oncology University of Kansas Medical Center Kansas City KS USA
Fakultni Nemocnice u Sv Anny v Brně Anesteziologicko Resustitační Klinika Brno Czech Republic
Institute for Pulmonary Diseases of Vojvodina University of Novi Sad Novi Sad Serbia
Oncology Institute of Vojvodina University of Novi Sad Novi Sad Serbia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore MD USA
Taiho Oncology Inc Princeton NJ USA
Texas Oncology Baylor University Medical Center Dallas TX USA
University of Florida Health Cancer Center Gainesville FL USA
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- $a Saif, Muhammad Wasif $u Medical Oncology, Northwell Health Cancer Institute, 1111 Marcus Avenue, Suite 216, Lake Success, NY, 11042, USA. wsaif@northwell.edu
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- $a A phase I, open-label study evaluating the safety and pharmacokinetics of trifluridine/tipiracil in patients with advanced solid tumors and varying degrees of renal impairment / $c MW. Saif, CR. Becerra, MG. Fakih, W. Sun, L. Popovic, S. Krishnamurthi, TJ. George, MA. Rudek, DR. Shepard, J. Skopek, V. Sramek, B. Zaric, I. Yamamiya, KA. Benhadji, K. Hamada, Y. He, L. Rosen
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- $a PURPOSE: Trifluridine/tipiracil (FTD/TPI) is approved for advanced colorectal and gastric/gastroesophageal cancer; however, data in patients with renal impairment (RI) are limited. This phase I study evaluated FTD/TPI in patients with advanced solid tumors and varying degrees of RI to develop dosing guidance. METHODS: Patients were enrolled into normal renal function (CrCl ≥ 90 mL/min), mild RI (CrCl 60-89 mL/min), or moderate RI (CrCl 30-59 mL/min) cohorts and administered the recommended FTD/TPI dose (35 mg/m2 twice daily, days 1-5 and 8-12; 28-day cycle). Based on interim pharmacokinetics/safety data, patients with severe RI (CrCl 15-29 mL/min) were enrolled and received FTD/TPI 20 mg/m2 twice daily. RESULTS: Forty-three patients (normal renal function [n = 12]; mild RI [n = 12]; moderate RI [n = 11]; severe RI [n = 8]) were enrolled and treated. At steady state, compared to values in patients with normal renal function, FTD area under the curve (AUC) was not significantly different in patients with RI, but TPI AUC was significantly higher and increased with RI severity. FTD/TPI safety profile was consistent with prior experience, but grade ≥ 3 adverse events (AEs) were more frequent in the RI cohorts (83.3% [mild], 90.9% [moderate], 75.0% [severe], and normal [50.0%]). Hematologic AEs (anemia and neutropenia) were more frequent with RI. Overall, seven patients discontinued because of unrelated, nonhematologic AEs. CONCLUSION: FTD/TPI is safe and tolerable at the recommended 35 mg/m2 dose in patients with mild/moderate RI and at the reduced 20 mg/m2 dose in patients with severe RI. TRIAL REGISTRATION: NCT02301117, registration date: November 21, 2014.
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- $a protokoly antitumorózní kombinované chemoterapie $x aplikace a dávkování $x škodlivé účinky $x farmakokinetika $7 D000971
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- $a Becerra, Carlos R $u Texas Oncology, Baylor University Medical Center, Dallas, TX, USA
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- $a Fakih, Marwan G $u City of Hope Comprehensive Cancer Center, Duarte, CA, USA
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- $a Sun, Weijing $u Division of Oncology, University of Kansas Medical Center, Kansas City, KS, USA
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- $a Popovic, Lazar $u Oncology Institute of Vojvodina, University of Novi Sad, Novi Sad, Serbia
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- $a Krishnamurthi, Smitha $u Cleveland Clinic, Cleveland, OH, USA
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- $a George, Thomas J $u University of Florida Health Cancer Center, Gainesville, FL, USA
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- $a Rudek, Michelle A $u Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
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- $a Shepard, Dale R $u Cleveland Clinic, Cleveland, OH, USA
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- $a Skopek, Jiri $u Thomayer Hospital Prague and Department of Biophysics and Informatics, First Medical Faculty, Prague, Czech Republic
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- $a Sramek, Vladimir $u Fakultni Nemocnice u Sv. Anny v Brně, Anesteziologicko Resustitační Klinika, Brno, Czech Republic
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- $a Zaric, Bojan $u Institute for Pulmonary Diseases of Vojvodina, University of Novi Sad, Novi Sad, Serbia
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- $a Yamamiya, Ikuo $u Taiho Oncology, Inc., Princeton, NJ, USA
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- $a Benhadji, Karim A $u Taiho Oncology, Inc., Princeton, NJ, USA
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- $a Hamada, Kensuke $u Taiho Oncology, Inc., Princeton, NJ, USA
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- $a He, Yaohua $u Taiho Oncology, Inc., Princeton, NJ, USA
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