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Overall survival with cetuximab every-2-weeks versus standard once-weekly administration schedule for first-line treatment of RAS wild-type metastatic colorectal cancer in patients with left- and right-sided primary tumour location

Published:December 21, 2022DOI:https://doi.org/10.1016/j.ejca.2022.11.021
      A pooled analysis [
      • Kasper S.
      • Foch C.
      • Messinger D.
      • Esser R.
      • Lamy F.X.
      • Rothe V.
      • et al.
      Noninferiority of cetuximab every-2-weeks versus standard once-weekly administration schedule for the first-line treatment of RAS wild-type metastatic colorectal cancer.
      ] of patient-level data from patients with rat sarcoma proto-oncogene (RAS) wild-type (wt) metastatic colorectal cancer (mCRC) receiving first-line treatment with cetuximab in combination with chemotherapy in two non-interventional cohort studies (EREBUS and ERBITAG) [
      • Rouyer M.
      • Francois E.
      • Cunha A.S.
      • Monnereau A.
      • Bignon E.
      • Jové J.
      • et al.
      Effectiveness of cetuximab as first-line therapy for patients with wild-type KRAS and unresectable metastatic colorectal cancer in real-life practice: results of the EREBUS cohort.
      ,
      • Sahm S.
      • Goehler T.
      • Hering-Schubert C.
      • Janssen J.
      • Neumann U.P.
      • Schwittay M.
      • et al.
      Outcome of patients with KRAS exon 2 wildtype (KRAS-wt) metastatic colorectal carcinoma (mCRC) with cetuximab-based first-line treatment in the noninterventional study ERBITAG and impact of comorbidity and age.
      ] and three interventional studies (CEBIFOX, CECOG/CORE 1.2.002 and APEC) [
      • Kasper S.
      • Meiler J.
      • Knipp H.
      • Höhler T.
      • Reimer P.
      • Steinmetz T.
      • et al.
      Biweekly cetuximab plus FOLFOX6 as first-line therapy in patients with RAS wild-type metastatic colorectal cancer: the CEBIFOX trial.
      ,
      • Brodowicz T.
      • Ciuleanu T.E.
      • Radosavljevic D.
      • Shacham-Shmueli E.
      • Vrbanec D.
      • Plate S.
      • et al.
      FOLFOX4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer: a randomized phase II CECOG study.
      ,
      • Cheng A.L.
      • Cornelio G.
      • Shen L.
      • Price T.
      • Yang T.S.
      • Chung I.J.
      • et al.
      Efficacy, tolerability, and biomarker analyses of once-every-2-weeks cetuximab plus first-line FOLFOX or FOLFIRI in patients with KRAS or all RAS wild-type metastatic colorectal cancer: the phase 2 APEC study.
      ], demonstrated the noninferiority of the cetuximab 500 mg/m2 once every-2-weeks (Q2W) dosing schedule (currently only approved by the US Food and Drug Administration [
      US Food and Drug Administration
      Erbitux full prescribing information.
      ] and the Japanese Pharmaceuticals and Medical Devices Agency [

      Japanese Pharmaceuticals and Medical Devices Agency (2022). Package insert. Erbitux (2022)

      ]) versus the standard schedule of cetuximab at an initial dose of 400 mg/m2 followed by weekly doses of 250 mg/m2 (Q1W) [
      US Food and Drug Administration
      Erbitux full prescribing information.
      ]. At the time of data extraction for the main analysis (early 2019), information on tumour sidedness was not available; it was thus not considered. Since the finalisation of the manuscript, data on tumour sidedness have been collected for all the above-mentioned studies, with the exception of CECOG/CORE 1.2.002. This Letter presents the results in patients with left-sided and right-sided primary tumours.
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