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Investigational New Drugs

, Volume 29, Issue 2, pp 366–373 | Cite as

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

  • 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
PHASE II STUDIES

Summary

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.

Keywords

Cetuximab Targeted therapy Capecitabine Oxaliplatin Gastric cancer 

Notes

Acknowledgements

Potential conflict of interest: Dr. Yoon-Koo Kang received honoraria for lecture from Merck, Roche, and Sanofi-Aventis.

Study drugs (cetuximab, capecitabine, and oxaliplatin) were supported by Merck, Roche, and Sanofi-Aventis

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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  • Chul Kim
    • 1
  • Jae-Lyun Lee
    • 1
  • Min-Hee Ryu
    • 1
  • Heung Moon Chang
    • 1
  • Tae Won Kim
    • 1
  • Ho Young Lim
    • 2
  • Hye Jin Kang
    • 3
  • Young Suk Park
    • 2
  • Baek-Yeol Ryoo
    • 1
  • Yoon-Koo Kang
    • 1
  1. 1.Department of OncologyAsan Medical Center, University of Ulsan College of MedicineSeoulSouth Korea
  2. 2.Division of Hematology-Oncology, Department of Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulKorea
  3. 3.Division of Hematology and Oncology, Department of Internal MedicineKorea Institute of Radiological and Medical SciencesSeoulSouth Korea

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