Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data
DC Field | Value | Language |
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dc.contributor.author | Fuchs, Charles S. | - |
dc.contributor.author | Muro, Kei | - |
dc.contributor.author | Tomasek, Jiri | - |
dc.contributor.author | Van Cutsem, Eric | - |
dc.contributor.author | Cho, Jae Yong | - |
dc.contributor.author | Oh, Sang-Cheul | - |
dc.contributor.author | Safran, Howard | - |
dc.contributor.author | Bodoky, Gyorgy | - |
dc.contributor.author | Chau, Ian | - |
dc.contributor.author | Shimada, Yasuhiro | - |
dc.contributor.author | Al-Batran, Salah-Eddin | - |
dc.contributor.author | Passalacqua, Rodolfo | - |
dc.contributor.author | Ohtsu, Atsushi | - |
dc.contributor.author | Emig, Michael | - |
dc.contributor.author | Ferry, David | - |
dc.contributor.author | Chandrawansa, Kumari | - |
dc.contributor.author | Hsu, Yanzhi | - |
dc.contributor.author | Sashegyi, Andreas | - |
dc.contributor.author | Liepa, Astra M. | - |
dc.contributor.author | Wilke, Hansjochen | - |
dc.date.accessioned | 2021-09-03T05:45:24Z | - |
dc.date.available | 2021-09-03T05:45:24Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-06 | - |
dc.identifier.issn | 2093-582X | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/83354 | - |
dc.description.abstract | 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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | KOREAN GASTRIC CANCER ASSOC | - |
dc.subject | QUALITY-OF-LIFE | - |
dc.subject | 5-FLUOROURACIL | - |
dc.subject | CHEMOTHERAPY | - |
dc.subject | VALIDATION | - |
dc.subject | TRIALS | - |
dc.subject | MODEL | - |
dc.subject | INDEX | - |
dc.title | Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Oh, Sang-Cheul | - |
dc.identifier.doi | 10.5230/jgc.2017.17.e16 | - |
dc.identifier.scopusid | 2-s2.0-85022006266 | - |
dc.identifier.wosid | 000413196500004 | - |
dc.identifier.bibliographicCitation | JOURNAL OF GASTRIC CANCER, v.17, no.2, pp.132 - 144 | - |
dc.relation.isPartOf | JOURNAL OF GASTRIC CANCER | - |
dc.citation.title | JOURNAL OF GASTRIC CANCER | - |
dc.citation.volume | 17 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 132 | - |
dc.citation.endPage | 144 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002241588 | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | 5-FLUOROURACIL | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | VALIDATION | - |
dc.subject.keywordPlus | TRIALS | - |
dc.subject.keywordPlus | MODEL | - |
dc.subject.keywordPlus | INDEX | - |
dc.subject.keywordAuthor | Prognosis | - |
dc.subject.keywordAuthor | Stomach neoplasms | - |
dc.subject.keywordAuthor | Gastroesophageal junction | - |
dc.subject.keywordAuthor | Survival | - |
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