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

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.

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

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

Změněno: 22. 3. 2018 17:32, Soňa Böhmová

Anotace

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.

Citovat

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, 2017, roč. 17, č. 2, s. 132-144. ISSN 2093-582X. Dostupné z: https://dx.doi.org/10.5230/jgc.2017.17.e16.

@article{1407089,
   author = {Fuchs, C.S. and Muro, K. and Tomášek, Jiří and Van Cutsem, E. and Cho, J.Y. and Oh, S.C. and Safran, H. and Bodoky, G. and Chau, I. and Shimada, Y. and AlandBatran, S.E. and Passalacqua, R. and Ohtsu, A. and Emig, M. and Ferry, D. and Chandrawansa, K. and Hsu, Y. and Sashegyi, A. and Liepa, A.M. and Wilke, H.},
   article_location = {SEOUL},
   article_number = {2},
   doi = {http://dx.doi.org/10.5230/jgc.2017.17.e16},
   keywords = {Prognosis; Stomach neoplasms; Gastroesophageal junction; Survival},
   language = {eng},
   issn = {2093-582X},
   journal = {JOURNAL OF GASTRIC CANCER},
   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},
   volume = {17},
   year = {2017}
}

TY  - JOUR
ID  - 1407089
AU  - Fuchs, C.S. - Muro, K. - Tomášek, Jiří - Van Cutsem, E. - Cho, J.Y. - Oh, S.C. - Safran, H. - Bodoky, G. - Chau, I. - Shimada, Y. - Al-Batran, S.E. - Passalacqua, R. - Ohtsu, A. - Emig, M. - Ferry, D. - Chandrawansa, K. - Hsu, Y. - Sashegyi, A. - Liepa, A.M. - Wilke, H.
PY  - 2017
TI  - 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
JF  - JOURNAL OF GASTRIC CANCER
VL  - 17
IS  - 2
SP  - 132-144
EP  - 132-144
PB  - KOREAN GASTRIC CANCER ASSOC
SN  - 2093582X
KW  - Prognosis
KW  - Stomach neoplasms
KW  - Gastroesophageal junction
KW  - Survival
N2  - 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.
ER  -

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. \textit{JOURNAL OF GASTRIC CANCER}. SEOUL: KOREAN GASTRIC CANCER ASSOC, 2017, roč.~17, č.~2, s.~132-144. ISSN~2093-582X. Dostupné z: https://dx.doi.org/10.5230/jgc.2017.17.e16.

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