A prospective phase II study of cetuximab in combination with XELOX (capecitabine and oxaliplatin) in patients with metastatic and/or recurrent advanced gastric cancer

Background We evaluated the efficacy and safety of cetuximab in combination with XELOX [XELoda ^® (capecitabine) and OXaliplatin] in advanced gastric cancer (AGC) patients. The objectives were to evaluate overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety of cetuximab plus XELOX. Methods Previously untreated AGC patients received intravenous infusion of cetuximab 400 mg/m ² on day 1 followed by weekly infusions of 250 mg/m ². Oxaliplatin 130 mg/m ² was administered intravenously on day 1 and capecitabine 1,000 mg/m ² bid was administered orally for 14 days of a 3-week cycle. Chemotherapy was given until disease progression or intolerable toxicities. On completing maximum 8 cycles of chemotherapy, patients were allowed weekly cetuximab until progression. Response evaluations were done every two cycles and toxicities were assessed at each visit. Results Forty-four patients (29 male) were enrolled; median age was 57.5 years (range 36-70). In total, 253 cycles of XELOX chemotherapy (range 1-8, median 6.5 cycles) and 917 cetuximab infusions (range 1-58, median 19.0) were delivered. Overall RR was 52.3%. Median PFS and OS were 6.5 months (95% CI, 4.9-8.4) and 11.8 months (95% CI, 6.7-16.8), respectively. The most common toxicities of all grades were anemia (81.8% of patients), asthenia (81.8%), anorexia (79.6%), hand-foot syndrome (79.6%), acneiform skin eruption (77.2%), and sensory neuropathy (75.0%), and they were mostly grade 1 or 2. Grade 3-4 hematologic toxicities were uncommon (anemia, 6.8%; thrombocytopenia, 2.3%). Conclusions Cetuximab in combination with XELOX chemotherapy was active and safe as first-line treatment of metastatic and/or recurrent AGC patients.