http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
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>