Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies : exploratory analyses of the RAISE trial and validation in an electronic medical record data set
Grothey, Axel (Mayo Clinic)
Yoshino, Takayuki (National Cancer Center Hospital East)
Bodoky, Gyorgy (St László Hospital (Hongria))
Ciuleanu, Tudor Eliade (The Oncology Institute Prof Dr Ion Chiricută and Iuliu Hațieganu University of Medicine and Pharmacy)
García-Carbonero, Rocío (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
García-Alfonso, Pilar (Hospital General Universitario Gregorio Marañón)
Van Cutsem, Eric (University Hospitals Leuven (Bèlgica))
Muro, Kei (Aichi Cancer Center Hospital)
Mytelka, Daniel S. (Formerly of Eli Lilly and Company)
Li, Li (Eli Lilly and Company)
Lipkovich, Olga (Eli Lilly and Company)
Hsu, Yanzhi (Eli Lilly and Company)
Sashegyi, Andreas (Eli Lilly and Company)
Ferry, David (Eli Lilly and Company)
Nasroulah, Federico (Eli Lilly Argentina)
Tabernero, Josep (Vall d'Hebron Institut d'Oncologia)
Universitat Autònoma de Barcelona

Date:	2018
Abstract:	In the RAISE trial, ramucirumab+leucovorin/fluorouracil/irinotecan (FOLFIRI) improved the median overall survival (mOS) of patients with previously treated metastatic colorectal cancer versus patients treated with placebo+FOLFIRI but had a higher incidence of neutropaenia, leading to more chemotherapy dose modifications and discontinuations. Thus, we conducted an exploratory post-hoc analysis of RAISE and a retrospective, observational analysis of electronic medical record (EMR) data to determine and verify the association of neutropaenia, baseline absolute neutrophil count (ANC) and survival. The RAISE analysis used the study safety population (n=1057). IMS Health Oncology Database (IMS EMR) was the source for the real-world data set (n=617). RAISE patients with treatment-emergent neutropaenia had improved mOS compared with those without (ramucirumab arm: 16. 1 vs 10. 7 months, HR=0. 57, p<0. 0001; placebo arm: 12. 7 vs 10. 7 months, HR=0. 76, p=0. 0065). RAISE patients with low ANC versus high baseline ANC also had longer mOS (ramucirumab arm: 15. 2 vs 8. 9 months, HR=0. 49, p<0. 0001; placebo arm: 13. 2 vs 7. 3 months, HR=0. 50, p<0. 0001). The results were similar for IMS EMR low versus high baseline ANC (bevacizumab+FOLFIRI patients: 14. 9 vs 7. 7 months, HR=0. 59, p<0. 0001; FOLFIRI alone: 14. 6 vs 5. 4 months, HR=0. 37, p<0. 0001). Patients in the RAISE trial with low baseline ANC were more likely to develop neutropaenia (OR: ramucirumab arm=2. 62, p<0. 0001; placebo arm=2. 16, p=0. 0003). Neutropaenia during treatment, and subsequent dose modifications or discontinuations, do not compromise treatment efficacy. Baseline ANC is a strong prognostic factor for survival and is associated with treatment-emergent neutropaenia in the analysed population. , Results.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Neutropenia ; Ramucirumab ; Bevacizumab ; Electronic medical records ; Prognostic
Published in:	ESMO open, Vol. 3 (april 2018) , ISSN 2059-7029

DOI: 10.1136/esmoopen-2018-000347
PMID: 29713498

9 p, 1.3 MB

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