FUCHS, C.S., K. MURO, Jiří TOMÁŠEK, E. VAN CUTSEM, J.Y. CHO, S.C. OH, H. SAFRAN, G. BODOKY, I. CHAU, Y. SHIMADA, S.E. AL-BATRAN, R. PASSALACQUA, A. OHTSU, M. EMIG, D. FERRY, K. CHANDRAWANSA, Y. HSU, A. SASHEGYI, A.M. LIEPA a H. WILKE. 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. JOURNAL OF GASTRIC CANCER. SEOUL: KOREAN GASTRIC CANCER ASSOC, roč. 17, č. 2, s. 132-144. ISSN 2093-582X. doi:10.5230/jgc.2017.17.e16. 2017.
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Základní údaje
Originální název 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
Autoři FUCHS, C.S. (840 Spojené státy), K. MURO (392 Japonsko), Jiří TOMÁŠEK (203 Česká republika, garant, domácí), E. VAN CUTSEM (56 Belgie), J.Y. CHO (410 Korejská republika), S.C. OH (410 Korejská republika), H. SAFRAN (840 Spojené státy), G. BODOKY (348 Maďarsko), I. CHAU (826 Velká Británie a Severní Irsko), Y. SHIMADA (392 Japonsko), S.E. AL-BATRAN (276 Německo), R. PASSALACQUA (380 Itálie), A. OHTSU (392 Japonsko), M. EMIG (276 Německo), D. FERRY (840 Spojené státy), K. CHANDRAWANSA (840 Spojené státy), Y. HSU (840 Spojené státy), A. SASHEGYI (840 Spojené státy), A.M. LIEPA (840 Spojené státy) a H. WILKE (276 Německo).
Vydání JOURNAL OF GASTRIC CANCER, SEOUL, KOREAN GASTRIC CANCER ASSOC, 2017, 2093-582X.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30204 Oncology
Stát vydavatele Korejská republika
Utajení není předmětem státního či obchodního tajemství
Impakt faktor Impact factor: 1.400
Kód RIV RIV/00216224:14110/17:00099924
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.5230/jgc.2017.17.e16
UT WoS 000413196500004
Klíčová slova anglicky Prognosis; Stomach neoplasms; Gastroesophageal junction; Survival
Štítky EL OK
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Soňa Böhmová, učo 232884. Změněno: 22. 3. 2018 17:32.
Anotace
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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