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

Abstract

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: Chul Kim, Jae-Lyun Lee, Min-Hee Ryu, Heung Moon Chang, Tae Won Kim, Ho Young Lim, Hye Jin Kang, Young Suk Park, Baek-Yeol Ryoo, Yoon-Koo Kang
• Journal: Investigational new drugs (Invest New Drugs) Vol. 29 Issue 2 Pg. 366-73 (Apr 2011) ISSN: 1573-0646 [Electronic] United States
• PMID: 19997960 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• Oxaloacetates
• Deoxycytidine
• Capecitabine
• ErbB Receptors
• Cetuximab
• Fluorouracil

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Capecitabine
• Cetuximab
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• ErbB Receptors (metabolism)
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Staging
• Oxaloacetates
• Prospective Studies
• Recurrence
• Stomach Neoplasms (drug therapy, pathology)
• Treatment Outcome