Baseline carcinoembryonic antigen as a predictive factor of ramucirumab efficacy in RAISE, a second-line metastatic colorectal carcinoma phase III trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F17%3A00077892" target="_blank" >RIV/00209805:_____/17:00077892 - isvavai.cz</a>
Result on the web
<a href="https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804917308250.pdf?locale=en_US" target="_blank" >https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804917308250.pdf?locale=en_US</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ejca.2017.03.007" target="_blank" >10.1016/j.ejca.2017.03.007</a>
Alternative languages
Result language
angličtina
Original language name
Baseline carcinoembryonic antigen as a predictive factor of ramucirumab efficacy in RAISE, a second-line metastatic colorectal carcinoma phase III trial
Original language description
Background: The RAISE phase III clinical trial demonstrated that ramucirumab + (folinic acid plus 5-fluorouracil plus irinotecan) FOLFIRI significantly improved overall survival (OS) versus placebo + FOLFIRI for second-line metastatic colorectal carcinoma (mCRC) patients failing bevacizumab-and oxaliplatin-based chemotherapy (hazard ratio [HR] = 0.84, 95% CI = 0.73-0.98, P = 0.022). Post hoc analyses of RAISE patient data examined the association of carcinoembryonic antigen (CEA) subgroups with efficacy parameters. Methods: CEA subgroups (<= 10 versus >10 ng/ml) were based on 2X upper limit of normal (ULN) (5 ng/ml). The Kaplan-Meier method estimated the median OS and the progression-free survival (PFS). Log-rank test compared the survival distributions within the subgroups. Hazard ratio (HR) (95% confidence interval [CI]) and treatment-by-subgroup interaction p-values were calculated by Cox proportional hazards model. Results: Ramucirumab treatment prolonged survival for the CEA <= 10 subgroup (HR = 0.68; 95% CI = 0.50-0.92; P = 0.013) and CEA > 10 subgroup (HR = 0.90; 95% CI = 0.76-1.07; P = 0.233). However, the ramucirumab OS benefit over placebo was greater for the CEA <= 10 subgroup than for the CEA > 10 subgroup (median OS: 3.6 versus 0.8 months greater, respectively). The interaction P-value between CEA level and treatment effect on OS was 0.088. This trend was observed across randomisation strata and to a lesser extent for PFS (P = 0.594). Conclusions: Although patients in both high-and low-CEA subgroups derive OS and PFS benefits from ramucirumab treatment, the low baseline CEA level may identify a subgroup of patients with mCRC who obtain greater benefit from ramucirumab.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European journal of cancer
ISSN
0959-8049
e-ISSN
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Volume of the periodical
78
Issue of the periodical within the volume
červen 2017
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
61-69
UT code for WoS article
000401930300009
EID of the result in the Scopus database
2-s2.0-85017388731