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Evaluating Alternative Ramucirumab Doses as a Single Agent or with Paclitaxel in Second-Line Treatment of Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: Results from Two Randomized, Open-Label, Phase II Studies
MA. Shah, AA. Udrea, I. Bondarenko, W. Mansoor, RG. Sánchez, T. Sarosiek, S. Bozzarelli, M. Schenker, C. Gomez-Martin, C. Morgan, M. Özgüroğlu, J. Pikiel, HP. Kalofonos, E. Wojcik, T. Buchler, D. Swinson, I. Cicin, M. Joseph, I. Vynnychenko, AV....
Jazyk angličtina Země Švýcarsko
Typ dokumentu časopisecké články
Grantová podpora
N/A
Eli Lilly and Company, USA
NLK
Directory of Open Access Journals
od 2010
Free Medical Journals
od 2009
PubMed Central
od 2009
Europe PubMed Central
od 2009
ProQuest Central
od 2009-01-01
Open Access Digital Library
od 2009-01-01
Open Access Digital Library
od 2009-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2009
PubMed
35267477
DOI
10.3390/cancers14051168
Knihovny.cz E-zdroje
- Publikační typ
- časopisecké články MeSH
Studies JVDB and JVCZ examined alternative ramucirumab dosing regimens as monotherapy or combined with paclitaxel, respectively, in patients with advanced/metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma. For JVDB, randomized patients (N = 164) received ramucirumab monotherapy at four doses: 8 mg/kg every 2 weeks (Q2W) (registered dose), 12 mg/kg Q2W, 6 mg/kg weekly (QW), or 8 mg/kg on days 1 and 8 (D1D8) every 3 weeks (Q3W). The primary objectives were the safety and pharmacokinetics of ramucirumab monotherapy. For JVCZ, randomized patients (N = 245) received paclitaxel (80 mg/m2-D1D8D15) plus ramucirumab (8 mg/kg- or 12 mg/kg-Q2W). The primary objective was progression-free survival (PFS) of 12 mg/kg-Q2W arm versus placebo from RAINBOW using meta-analysis. Relative to the registered dose, exploratory dosing regimens (EDRs) led to higher ramucirumab serum concentrations in both studies. EDR safety profiles were consistent with previous studies. In JVDB, serious adverse events occurred more frequently in the 8 mg/kg-D1D8-Q3W arm versus the registered dose; 6 mg/kg-QW EDR had a higher incidence of bleeding/hemorrhage. In JVCZ, PFS was improved with the 12 mg/kg plus paclitaxel combination versus placebo in RAINBOW; however, no significant PFS improvement was observed between the 12 mg/kg and 8 mg/kg arms. The lack of a dose/exposure-response relationship in these studies supports the standard dose of ramucirumab 8 mg/kg-Q2W as monotherapy or in combination with paclitaxel as second-line treatment for advanced/metastatic gastric/GEJ adenocarcinoma.
Cancer Center Medisprof SRL 400641 Cluj Napoca Romania
Centrul de Oncologie Sf Nectarie SRL 200542 Craiova Romania
Deanesly Centre New Cross Hospital Wolverhamptom WV10 0QP UK
Department of Clinical Oncology and Oncological Surgery LUXMED Onkologia 04125 Warszawa Poland
Department of Clinical Oncology Narodny Onkologicky Ustav 83310 Bratislava Slovakia
Department of Clinical Oncology Velindre Cancer Centre Cardiff CF14 2TL UK
Department of Medical Oncology The Christie NHS Foundation Trust Manchester M20 4BX UK
Department of Medical Oncology University of Medicine and Pharmacy Craiova 200342 Craiova Romania
Department of Oncology Copernicus Podmiot Leczniczy 80 803 Gdańsk Poland
Department of Oncology Dnipropetrovsk Medical Academy 49044 Dnipropetrovsk Ukraine
Department of Oncology No 1 Leningrad Regional Clinical Hospital 194291 St Petersburg Russia
Department of Oncology University General Hospital of Patras Rion 26504 Patras Greece
Eli Lilly and Company Indianapolis IN 46225 USA
Eli Lilly and Company New York NY 10016 USA
Institute of Oncology St James's University Hospital Leeds LS9 7TF UK
Medical Oncology Dana Farber Cancer Institute Boston MA 02215 USA
Medical Oncology Department Hospital Universitario 12 de Octubre 28041 Madrid Spain
Medical Oncology Istanbul University Cerrahpaşa Fatih Istanbul 34098 Turkey
Medical Oncology Trakya University Edirne 22030 Turkey
NZOZ Centrum Medyczne HCP 62 030 Luboń Poland
Sumy Regional Oncology Center Sumy State University 40000 Sumy Ukraine
Citace poskytuje Crossref.org
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