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RISS 인기검색어
- 검색키워드
- 저자 : Chandrawansa, Kumari (검색결과 2 건)
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Tabernero, Josep,Ohtsu, Atsushi,Muro, Kei,Van Cutsem, Eric,Oh, Sang Cheul,Bodoky, Gyorgy,Shimada, Yasuhiro,Hironaka, Shuichi,Ajani, Jaffer A.,Tomasek, Jiri,Safran, Howard,Chandrawansa, Kumari,Hsu, Yan American Association for Cancer Research 2017 Molecular cancer therapeutics Vol.16 No.10
<P>Ramucirumab is an IgG1 monoclonal antibody specific for the vascular endothelial growth factor receptor-2. Ramucirumab, 8 mg/kg every 2 weeks, administered as monotherapy (REGARD) or in combination with paclitaxel (RAINBOW), was safe and effective in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer. We evaluated exposure-efficacy and exposure-safety relationships of ramucirumab from two randomized, placebo-controlled phase III trials. Sparse pharmacokinetic samples were collected, and a population pharmacokinetic analysis was conducted to predict ramucirumab minimumtrough concentration at steady state (C-min,C-ss). Kaplan-Meier methods and Cox proportional hazards models were used to evaluate the ramucirumab exposure (C-min,C-ss)-efficacy relationship to overall survival (OS) and progression-free survival (PFS). Logistic regression analyses were used to evaluate exposure-safety relationships. Analyses included 321 ramucirumab + paclitaxel and 335 placebo + paclitaxel patients from RAINBOW and 72 ramucirumab and 35 placebo patients from REGARD. Exposure-efficacy analysis showed ramucirumab C-min,C-ss was a significant predictor of OS and PFS in both trials. Higher ramucirumab exposure was associated with longer OS and PFS. In RAINBOW, grade >= 3 hypertension, leukopenia, and neutropenia, but not febrile neutropenia, significantly correlated with Cmin, ss, with increased exposure leading to increased incidence. Exploratory exposure-response analyses suggest a positive relationship between efficacy and ramucirumab exposure with manageable toxicities at exposures generated from a dose of 8 mg/kg ramucirumab given every 2 weeks for patients with advanced gastric/GEJ cancer. These findings suggest an opportunity to further optimize benefit versus risk profiles of ramucirumab treatment in patients with gastric/GEJ cancer. (C) 2017 AACR.</P>
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Al-Batran, S.-E.,Van Cutsem, E.,Oh, S. C.,Bodoky, G.,Shimada, Y.,Hironaka, S.,Sugimoto, N.,Lipatov, O. N.,Kim, T.-Y.,Cunningham, D.,Rougier, P.,Muro, K.,Liepa, A. M.,Chandrawansa, K.,Emig, M.,Ohtsu, A Oxford University Press 2016 Annals of Oncology Vol.27 No.4
<P><B>Background</B></P><P>The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine–platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses.</P><P><B>Patients and methods</B></P><P>Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m<SUP>2</SUP>) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models.</P><P><B>Results</B></P><P>Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, <I>P</I> = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, <I>P</I> = 0.0508), deterioration by ≥1 PS level (HR = 0.802, <I>P</I> = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, <I>P</I> = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation.</P><P><B>Conclusion</B></P><P>In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration.</P><P><B>ClinicalTrials.gov</B></P><P>NCT01170663.</P>
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