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논문 기본 정보

자료유형
학술저널
저자정보
Charles S. Fuchs (Dana-Farber Cancer Institute) Kei Muro (Aichi Cancer Center Hospital) Jiri Tomasek (Masaryk University) Eric Van Cutsem (University Hospital Gasthuisberg Leuven and KU Leuven) 조재용 (강남세브란스병원) 오상철 (고려대학교) Howard Safran (Brown University) György Bodoky (Szent László Hospital) Ian Chau (Royal Marsden Hospital) Yasuhiro Shimada (National Cancer Center Hospital) Salah-Eddin Al-Batran (Universitären Centrum für Tumorerkrankungen-University Cancer Center) Rodolfo Passalacqua (Istituti Ospitalieri di Cremona) Atsushi Ohtsu (National Cancer Center) Michael Emig (Lilly Deutschland GmbH) David Ferry (Eli Lilly and Company) Kumari Chandrawansa (Eli Lilly and Company) Yanzhi Hsu (Eli Lilly and Company) Andreas Sashegyi (Eli Lilly and Company) Astra M Liepa (Eli Lilly and Company) Hansjochen Wilke (Kliniken Essen-Mitte)
저널정보
대한위암학회 Journal of Gastric Cancer Journal of Gastric Cancer 제17권 제2호
발행연도
2017.6
수록면
132 - 144 (13page)

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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.

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