J 2017

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

FUCHS, C.S., K. MURO, Jiří TOMÁŠEK, E. VAN CUTSEM, J.Y. CHO et. al.

Basic information

Original name

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

Authors

FUCHS, C.S. (840 United States of America), K. MURO (392 Japan), Jiří TOMÁŠEK (203 Czech Republic, guarantor, belonging to the institution), E. VAN CUTSEM (56 Belgium), J.Y. CHO (410 Republic of Korea), S.C. OH (410 Republic of Korea), H. SAFRAN (840 United States of America), G. BODOKY (348 Hungary), I. CHAU (826 United Kingdom of Great Britain and Northern Ireland), Y. SHIMADA (392 Japan), S.E. AL-BATRAN (276 Germany), R. PASSALACQUA (380 Italy), A. OHTSU (392 Japan), M. EMIG (276 Germany), D. FERRY (840 United States of America), K. CHANDRAWANSA (840 United States of America), Y. HSU (840 United States of America), A. SASHEGYI (840 United States of America), A.M. LIEPA (840 United States of America) and H. WILKE (276 Germany)

Edition

JOURNAL OF GASTRIC CANCER, SEOUL, KOREAN GASTRIC CANCER ASSOC, 2017, 2093-582X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

Republic of Korea

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 1.400

RIV identification code

RIV/00216224:14110/17:00099924

Organization unit

Faculty of Medicine

DOI

UT WoS

000413196500004

Keywords in English

Prognosis; Stomach neoplasms; Gastroesophageal junction; Survival

Tags

Tags

International impact, Reviewed
Změněno: 22/3/2018 17:32, Soňa Böhmová

Abstract

V originále

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.