Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma : results from a randomised controlled trial
Siena, Salvatore (Università degli Studi di Milano (Italy))
Tabernero, Josep (Vall d'Hebron Institut d'Oncologia)
Bodoky, Gyorgy (St László Hospital (Hongria))
Cunningham, David (Royal Marsden National Health Service Foundation Trust (United Kingdom))
Rivera, Fernando (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Ruff, Paul (University of the Witwatersrand (South Africa))
Canon, Jean Luc (Grand Hôpital de Charleroi. Service d'Oncologie-Hématologie (Belgium))
Koukakis, Reija (Amgen Ltd. Department of Biostatistics (United Kingdom))
Demonty, Gaston (Amgen GmbH. Medical Development (Suïssa))
Hechmati, Guy (Amgen GmbH. Global Health Economics (Suïssa))
Douillard, Jean-Yves (Institut de Cancérologie de l'Ouest (France))
Universitat Autònoma de Barcelona

Data:	2016
Resum:	Metastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type RAS tumours (n=505). Quality of life (prespecified end point) was assessed using the EuroQoL 5-domain health state index and overall health rating in all patients and by early tumour shrinkage status (≥30% reduction in size by week 8; exploratory end point). Differences in quality of life were assessed using analysis of covariance and a mixed-effect piecewise linear model, and were also analysed by skin toxicity severity. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Grade 3+ skin toxicity was reported by 38% of patients receiving panitumumab+FOLFOX4 and 2% receiving FOLFOX4 alone. There were no significant differences in quality of life between patients with grade 0-2 skin toxicity and those with grade 3+ skin toxicity. More patients receiving panitumumab+FOLFOX4 vs FOLFOX4 had early tumour shrinkage (p<. 001). In patients with tumour symptoms at baseline, there were statistically significant improvements in quality of life in those with early tumour shrinkage versus those without early tumour shrinkage. Addition of panitumumab to FOLFOX4 in first-line therapy for metastatic colorectal cancer prolongs survival and has no negative effect on overall quality of life compared with FOLFOX4 alone. Specific quality of life assessments for skin toxicity should be included in study designs to better define the direct effect of these adverse events. NCT00364013.
Drets:	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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Chemotherapy ; Tumour shrinkage ; Quality of life ; EGFR inhibitors ; Metastatic colorectal cancer
Publicat a:	ESMO open, Vol. 1, Issue 2 (March 2016) , art. e000041, ISSN 2059-7029

DOI: 10.1136/esmoopen-2016-000041
PMID: 27843597

7 p, 814.0 KB

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