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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>
Multimodal Treatment Strategies in Esophagogastric Junction Cancer: a Western Perspective
Goetze, Thorsten Oliver,Al-Batran, Salah-Eddin,Berlth, Felix,Hoelscher, Arnulf Heinrich The Korean Gastric Cancer Association 2019 Journal of gastric cancer Vol.19 No.2
Esophagogastric junction (EGJ) cancer is a solid tumor entity with rapidly increasing incidence in the Western countries. Given the high proportion of advanced cancers in the West, treatment strategies routinely employed include surgery and chemotherapy perioperatively, and chemoradiation in neoadjuvant settings. Neoadjuvant chemoradiation and perioperative chemotherapy are mostly performed in esophageal cancer that extends to the EGJ and gastric as well as EGJ cancers, respectively. Recent trials have tried to combine both strategies in a perioperative context, which might have beneficial outcomes, especially in patients with EGJ cancer. However, it is difficult to recruit patients for trials, exclusively for EGJ cancers; therefore, the results have to be carefully reviewed before establishing a standard protocol. Trastuzumab was the first drug for targeted therapy that was positively evaluated for this tumor entity, and there are several ongoing trials investigating more targeted drugs in order to customize effective therapies based on tissue characteristics. The current study reviews the multimodal treatment concept for EGJ cancers in the West and summarizes the latest reports.
Multimodal Treatment Strategies in Esophagogastric Junction Cancer: a Western Perspective
Thorsten Oliver Goetze,Salah-Eddin Al-Batran,Felix Berlth,Arnulf Heinrich Hoelscher 대한위암학회 2019 Journal of gastric cancer Vol.19 No.2
Esophagogastric junction (EGJ) cancer is a solid tumor entity with rapidly increasing incidence in the Western countries. Given the high proportion of advanced cancers in the West, treatment strategies routinely employed include surgery and chemotherapy perioperatively, and chemoradiation in neoadjuvant settings. Neoadjuvant chemoradiation and perioperative chemotherapy are mostly performed in esophageal cancer that extends to the EGJ and gastric as well as EGJ cancers, respectively. Recent trials have tried to combine both strategies in a perioperative context, which might have beneficial outcomes, especially in patients with EGJ cancer. However, it is difficult to recruit patients for trials, exclusively for EGJ cancers; therefore, the results have to be carefully reviewed before establishing a standard protocol. Trastuzumab was the first drug for targeted therapy that was positively evaluated for this tumor entity, and there are several ongoing trials investigating more targeted drugs in order to customize effective therapies based on tissue characteristics. The current study reviews the multimodal treatment concept for EGJ cancers in the West and summarizes the latest reports.
Kim, T. Y.,Yen, C. J.,Al-Batran, S. E.,Ferry, D.,Gao, L.,Hsu, Y.,Cheng, R.,Orlando, M.,Ohtsu, A. Springer Science + Business Media 2018 Gastric cancer Vol.21 No.2
<P>Conclusions This exploratory analysis suggests a positive relationship between efficacy and ramucirumab exposure with manageable toxicities in East Asian patients from RAINBOW, consistent with the overall exposure-response analysis from this trial. A regimen with a higher dosage of ramucirumab warrants further consideration for East Asian patients with gastric/GEJ cancer.</P>
Charles S. Fuchs,Kei Muro,Jiri Tomasek,Eric Van Cutsem,조재용,오상철,Howard Safran,György Bodoky,Ian Chau,Yasuhiro Shimada,Salah-Eddin Al-Batran,Rodolfo Passalacqua,Atsushi Ohtsu,Michael Emig,David Ferry,Ku 대한위암학회 2017 Journal of gastric cancer Vol.17 No.2
The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.
Fuchs, Charles S.,Muro, Kei,Tomasek, Jiri,Van Cutsem, Eric,Cho, Jae Yong,Oh, Sang-Cheul,Safran, Howard,Bodoky, Gyorgy,Chau, Ian,Shimada, Yasuhiro,Al-Batran, Salah-Eddin,Passalacqua, Rodolfo,Ohtsu, Ats The Korean Gastric Cancer Association 2017 Journal of gastric cancer Vol.17 No.2
Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.