en
Scientific article
English

Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK

Published inAnnals of oncology, vol. 19, no. 7, p. 1288-1292
Publication date2008
Abstract

BACKGROUND: To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC). PATIENTS AND METHODS: In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles. RESULTS: Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B. CONCLUSION: Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.

Keywords
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal/administration & dosage/adverse effects
  • Antineoplastic Agents/administration & dosage/adverse effects
  • Antineoplastic Combined Chemotherapy Protocols/therapeutic use
  • Colorectal Neoplasms/drug therapy/pathology/radiography
  • Drug Administration Schedule
  • Exanthema/chemically induced
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis/drug therapy/pathology/radiography
  • Organoplatinum Compounds/administration & dosage/adverse effects
  • Switzerland
  • Time Factors
  • Treatment Outcome
Citation (ISO format)
BORNER, M. et al. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. In: Annals of oncology, 2008, vol. 19, n° 7, p. 1288–1292. doi: 10.1093/annonc/mdn058
Main files (1)
Article (Accepted version)
accessLevelRestricted
Identifiers
ISSN of the journal0923-7534
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