A pooled analysis [
[1]
] 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) [
[2]
,
[3]
] and three interventional studies (CEBIFOX, CECOG/CORE 1.2.002 and APEC) [
4
,
5
,
6
], 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 [
[7]
] and the Japanese Pharmaceuticals and Medical Devices Agency [
US Food and Drug Administration
Erbitux full prescribing information.
Erbitux full prescribing information.
April 2021
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf
Date accessed: January 27, 2022
[8]
]) versus the standard schedule of cetuximab at an initial dose of 400 mg/m2 followed by weekly doses of 250 mg/m2 (Q1W) [
[7]
]. 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.US Food and Drug Administration
Erbitux full prescribing information.
Erbitux full prescribing information.
April 2021
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf
Date accessed: January 27, 2022
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References
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Japanese Pharmaceuticals and Medical Devices Agency (2022). Package insert. Erbitux (2022)
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- 509PD - primary tumour location (PTL) as a prognostic and predictive factor in advanced colorectal cancer (aCRC): data from 2075 patients (Pts) in randomised trials.Ann Oncol. 2014; 25: iv172https://doi.org/10.1093/annonc/mdu333.12
Article info
Publication history
Published online: December 21, 2022
Accepted:
November 19,
2022
Received:
October 4,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
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- Noninferiority of cetuximab every-2-weeks versus standard once-weekly administration schedule for the first-line treatment of RAS wild-type metastatic colorectal cancerEuropean Journal of CancerVol. 144
- PreviewThis study assessed whether cetuximab 500 mg/m2 administered every 2 weeks (Q2W), when combined with chemotherapy as a first-line (1L) treatment, was noninferior to the approved dose (400 mg/m2 followed by 250 mg/m2 once weekly [Q1W]) for overall survival (OS) in adults with RAS wild-type metastatic colorectal cancer (mCRC).
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