A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer
There is presently no chemotherapy regimen considered to be the global standard of care for
patients with AGC, and there is still a need for new agents and/or regimens to improve the
efficacy and safety of chemotherapy in advanced stomach cancers.
The combination of 5-fluorouracil plus cisplatin (FP) has been widely used for the
first-line treatment of advanced gastric cancer in many countries.
Randomized phase III trial investigating capecitabine plus cisplatin(XP) versus FP showed XP
is at least as good as FP with improved patients' preference.
A Phase II study of capecitabine plus oxaliplatin (XELOX) was conducted in our study group.
Among 52 patients enrolled, the RR was 63% with CR in 3 patients and median PFS was 6.5
months; median OS was not reached at the time of analysis. The grade 4 neutropenia was found
only in 1 patient and grade 3 or worse toxicities were rare. The RR achieved was comparable
to triplet combinations and tolerability was much better than cisplatin-based regimens.
The EGFR/ligand system seems to be involved in the regulation of gastric mucosa
proliferation and progression of gastric carcinomas. Elevated EGFR levels were found in
gastric carcinomas showing worse prognostic factors.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Yoon-Koo Kang, MD, PhD
Asan Medical Center
South Korea: Korea Food and Drug Administration (KFDA)