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dc.contributor.authorShah, M
dc.contributor.authorUdrea, A
dc.contributor.authorBondarenko, I
dc.contributor.authorMansoor, Was
dc.contributor.authorSanchez, R G
dc.contributor.authorSarosiek, T
dc.contributor.authorBozzarelli, S
dc.contributor.authorSchenker, M
dc.contributor.authorGomez-Martin, C
dc.contributor.authorMorgan, C
dc.contributor.authorOezgueroglu, M
dc.contributor.authorPikiel, J
dc.contributor.authorKalofonos, H
dc.contributor.authorWojcik, E
dc.contributor.authorBuchler, T
dc.contributor.authorSwinson, D
dc.contributor.authorCicin, I.
dc.contributor.authorJoseph, M
dc.contributor.authorVynnychenko, I
dc.contributor.authorLuft, A
dc.contributor.authorEnzinger, P. C.
dc.contributor.authorSalek, T
dc.contributor.authorPapandreou, C
dc.contributor.authorTournigand, C
dc.contributor.authorMaiello, E.
dc.contributor.authorWei, R
dc.contributor.authorFerry, D
dc.contributor.authorGao, L
dc.contributor.authorOliveira, J
dc.contributor.authorAjani, J. A.
dc.date.accessioned2022-05-25T10:54:06Z
dc.date.available2022-05-25T10:54:06Z
dc.date.issued2022
dc.identifier.citationShah, M, Udrea, A A, Bondarenko, I, Mansoor, Was, Sanchez, R G, Sarosiek, T, Bozzarelli, S, Schenker, M, Gomez-Martin, C, Morgan, C, Oezgueroglu, M, Pikiel, J, Kalofonos, H et al. 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 .Cancers. 2022 14(5): 16en_US
dc.identifier.pmid35267477
dc.identifier.doi10.3390/cancers14051168
dc.identifier.urihttp://hdl.handle.net/10541/625199
dc.description.abstractStudies 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.en_US
dc.language.isoenen_US
dc.relation.urlhttps://dx.doi.org/10.3390/cancers14051168en_US
dc.titleEvaluating 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 Studiesen_US
dc.typeArticleen_US
dc.contributor.departmentDepartment of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medical College, New Yorken_US
dc.identifier.journalCancersen_US


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