Efficacity and safety of panitumumab in mCRC patients: A post-AMM OMIT study.

Abstract

608 Background: Metastatic colorectal cancer (mCRC) management has been improved by targeted therapies. The evaluation of the use of panitumumab (PANI), after approval, in the real life is strategic to assess health politics. OMIT Bretagne - Pays de Loire is a network of private and public cancer centers. Methods: Data from patients treated with PANI in mCRC were collected. Previously published data are recited. Sex, age, primary tumor, Kras status, line of treatment, toxicity, reason of discontinuation, response, progression free survival (PFS) and overall survival (OS) have been studied. Results: Data of 322 patients treated between second half of 2008 and end of 2010 have been collected. PANI was used alone (85.5%) or with chemotherapy (14.5%) : mainly FOLFIRI, IRINOTECAN or FOLFOX). KRAS status was wild-type (WT 96.5%), mutated (0.5%), undetermined (2.5%) or not searched (0.5%). Only KRAS WT patients treated with monotherapy of PANI at 6 mg/kg every 2 weeks were analysed (n=263). Sexe : 177 men and 86 women. Median age : 67 years [36-90] (Van Custem JCO 2007: 62 years [27-83]). Primary tumor of patients was : colon (75%), rectum (22%) and others (3%). They received PANI mostly at line 2 (25%), 3 (46%) or 4 (19%). Discontinuation of treatment was mostly due to disease progression : 64%, death: 15% and toxicities : 7% (skin toxicities 3.7%). Clinical response was evaluated for the first 84 patients: partial response (PR): 30%, stable disease (SD): 14% and progression (P): 56%. In KRAS WT patients treated by PANI, Amado described 17% of PR, 34% of SD and 49% of P (Amado JCO 2008). Median duration of treatment was 69 days [0;360] (n=249). Median duration between end of treatment and death when death is the cause of end of treatment was 13 days [0;54] (n=35). Median of OS was 137 days [0;816] (n=143) which is lower than previously described (Van Cutsem JCO 2007 : 192 days regardless of KRAS status ; Amado JCO 2008 : 243 days in KRAS WT). Conclusions: The OMIT analysis of patients treated by PANI in Bretagne/Pays de Loire for a mCRC allows to assess the good use, according to its label, in the real life. Complete results about clinical response, PFS (cut-off 01/12/2011), OS and safety as well as previously published data will be shown at the meeting.

Optimisation du bon usage et maîtrise des coûts des médicaments anticancéreux : expérience de l’Observatoire dédié au Cancer Bretagne – Pays-de-la-Loire

“…La communauté a rapidement adhéré aux études de cohorte nécessaires afin d'évaluer ces nouveaux protocoles, d'anticiper les risques redoutés ou bien de répondre à des questions de santé publique [1]. Ces études concernent aussi bien le rapport bénéfice/risque des médicaments (bévacizumab [2], cétuximab [3], panitumumab [4] ou encore la succession de thérapies ciblées [5,6]) que des thèmes tels que la pharmacovigilance (alopécies persistantes post-chimiothérapie [7,8], toxicité cardiaque du trastuzumab [9], recueil d'évènements indésirables sous docétaxel ou bévacizumab [10]), le consensus anatomopathologique (récepteur HER2 dans le cancer de l'estomac), la pertinence des thérapeutiques palliatives [11] ou la prise en charge des personnes âgées [2]. Le référentiel inter régional a laissé place aux référentiels nationaux depuis 2007.…”