Efficacy and tolerability of cetuximab 750 mg/m2 every three

weeks in metastatic colorectal cancer

Mohamed Aseafan1, Kanan Alshammari2, Bader Alshamsan3, Nasser Alagel1, Hosam M. Elhariry1,4, Shouki
Bazarbashi5.
1
Section of Medical Oncology, Department of Internal Medicine, Security Forces Hospital, Riyadh, Saudi
Arabia. 2Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia. 3Department of Medicine,
College of Medicine, Qassim University, Qassim, Saudi Arabia. 4National Cancer Institute, Cairo
University, Cairo, Egypt. 5Section of Medical Oncology, Oncology Center, King Faisal Specialist Hospital
and Research Center, Riyadh, Saudi Arabia.

Background: Earlier studies that established weekly dosing of cetuximab did not reach a
maximum-tolerated dose. Subsequent pharmacokinetic studies showed equal efficacy and
toxicity for the dose of 500 mg/m2 every-2-weeks in combination with chemotherapy. This study
aims to report the tolerability and efficacy of cetuximab at a dose of 750 mg/m 2 every-3-week
(q3w) in combination with chemotherapy in metastatic colo-rectal cancer (mCRC).

Methods: This is a retrospective review. Data of patients with RAS wild-type (wt) mCRC
treated with chemotherapy in combination with cetuximab at a dose of 750 mg/m2 q3w at two
tertiary cancer centers were abstracted and analysed for efficacy and tolerability. Response
assessment followed Response Evaluation Criteria in Solid Tumors (RECIST). Adverse effects
reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Survival analysis was estimated by using the Kaplan-Meier estimator.

Results: Eleven patients were identified. The disease characteristic presented in table 1.
Cetuximab was given as first line in six patients, second line to three, and beyond second-line in
two patients. The chemotherapy backbone was XELOX in ten patients, and irinotecan in one.
The median relative dose intensity, and observed toxicity are illustrated in Figure 1, and Figure
2.
The median duration of follow-up was eight months (range 2-75). Response evaluation presented
in Figure 3. The median progression-free survival was 8 months (95% CI, 2.56-13.43).

Conclusion: Cetuximab at a dose of 750 mg/m2 q3w in combination with chemotherapy had
manageable toxicity and encouraging efficacy in patients with RAS-wt mCRC. The small sample
size is a limitation of the above conclusion. A prospective evaluation of the above regimen is
warranted.