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Thématique :
- Cancer colorectal (CCR)
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Originalité :
Intermédiaire
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| Doit faire évoluer notre pratique : |
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Dans certains cas
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Nom du veilleur :
Professeur David TOUGERON
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Annals of oncology
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2016/06
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2016 May;27(5):843-9
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10.1093/annonc/mdw052
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FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials.
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C. Cremolini, F. Loupakis, G. Masi, S. Lonardi, C. Granetto, M.L. Mancini, S. Chiara, R. Moretto, D. Rossini, S. Vitello, G. Allegrini, G. Tonini, F. Bergamo, G. Tomasello, M. Ronzoni, A. Buonadonna, S. Bustreo, C. Barbara, L. Boni, A. Falcone
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http://www.ncbi.nlm.nih.gov/pubmed/?term=C.+Cremolini%2C+F.+Loupakis%2C+G.+Masi%2C+S.+Lonardi%2C+C.+Granetto%2C+M.L.+Mancini%2C+S.+Chiara%2C+R.+Moretto%2C+D.+Rossini%2C+S.+Vitello%2C+G.+Allegrini%2C+G.+Tonini%2C+F.+Bergamo%2C+G.+Tomasello%2C+M.+Ronzoni%2C
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BACKGROUND:
FOLFOXIRI plus bevacizumab is a valid option as upfront treatment for metastatic colorectal cancer (mCRC) patients. While several trials investigated the effect of combining bevacizumab with different chemotherapy regimens, including fluoropyrimidines monotherapy and oxaliplatin- or irinotecan-containing doublets, no randomized comparison assessing the impact of the addition of bevacizumab to FOLFOXIRI is available.
PATIENTS AND METHODS:
A total of 122 mCRC patients received first-line FOLFOXIRI in the phase III trial by the GONO (FOLFOXIRI group) and 252 patients received first-line FOLFOXIRI plus bevacizumab in the TRIBE trial (FOLFOXIRI plus bevacizumab group). A propensity score-adjusted method was adopted to provide an estimation of the benefit from the addition of bevacizumab to FOLFOXIRI in terms of survival and activity parameters.
RESULTS:
Patients in the FOLFOXIRI group had more frequently Eastern Cooperative Oncology Group performance status of one or two, high Köhne score, metachronous and liver-limited disease, had previously received adjuvant treatments and had their primary tumors resected. The median progression-free survival (PFS) was 12.3 months in the FOLFOXIRI plus bevacizumab group compared with 10.0 months in the FOLFOXIRI group {propensity score-adjusted hazard ratio (HR) 0.74 [95% confidence interval (CI) 0.59-0.94], P = 0.013}. This association was significant also in the multivariable model (P = 0.024). The median OS was 29.8 months in the FOLFOXIRI plus bevacizumab group compared with 23.6 months in the FOLFOXIRI group [propensity score-adjusted HR: 0.72 (95% CI 0.56-0.93), P = 0.014]. At the multivariable model, the addition of bevacizumab was still associated with significantly longer OS (P = 0.030). No significant differences in RECIST response rate (RR) [65.1% versus 55.7%; propensity score-adjusted odds ratio (OR): 1.29 (95% CI 0.81-2.05), P = 0.280], early RR [62.7% versus 57.8%; OR: 1.14 (95% CI 0.68-1.93), P = 0.619] and median depth of response (42.2% versus 53.8%, P = 0.259) were reported.
CONCLUSIONS:
Though in the absence of a randomized comparison, the addition of bevacizumab to FOLFOXIRI provides significant benefit in PFS and OS, thus supporting the use of FOLFOXIRI plus bevacizumab as upfront treatment for mCRC patients.
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Dans les cancers colorectaux métastatiques le FOLFOXIRI plus bévacizumab est supérieur au FOLFIRI plus bévacizumab en survie globale (essai TRIBE). Aucune étude n’a comparé le FOLFOXIRI seul au FOLFOXIRI plus bévacizumab.
Dans cette étude les auteurs ont repris les données de plusieurs essais (GONO et TRIBE) et comparer le FOLFOXIRI seul au FOLFOXIRI plus bévacizumab.
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L’ajout du bévacizumab au FOLFOXIRI permet d’augmenter la survie sans progression (12,3 mois versus 10,0 mois) et la survie globale (29,8 mois versus 23,6 mois).
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Cette étude suggère un gain en survie du bévacizumab combiné au FOLFOXIRI. Néanmoins, il ne s’agit pas d’un essai randomisé qui permettrait de conclure définitivement sur le gain en survie du FOLFOXIRI plus bévacizumab par rapport au FOLFOXIRI seul.
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