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/m² on day 1 followed by weekly infusions of 250 mg/m². Oxaliplatin 130 mg/m² was administered intravenously on day 1 and capecitabine 1,000 mg/m² 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.
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/m² on day 1 followed by weekly infusions of 250 mg/m². Oxaliplatin 130 mg/m² was administered intravenously on day 1 and capecitabine 1,000 mg/m² 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.
Authors: Roy S Herbst; Matthew Arquette; Dong M Shin; Karel Dicke; Everett E Vokes; Nozar Azarnia; Waun Ki Hong; Merrill S Kies Journal: J Clin Oncol Date: 2005-07-11 Impact factor: 44.544
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Authors: Felice Pasini; Anna Paola Fraccon; Yasmina Modena; Maria Bencivenga; Simone Giacopuzzi; Francesca La Russa; Milena Gusella; Giovanni de Manzoni Journal: Gastric Cancer Date: 2016-08-27 Impact factor: 7.370