Safety and efficacy of cetuximab-chemotherapy combination in Saudi patients with metastatic colorectal cancer.

Abstract

BACKGROUND:

Cetuximab-based combination chemotherapy (CBCC) proved safe and effective as second-line strategy for metastatic colorectal cancer (mCRC). This prospective phase-II study was designed to assess the efficacy and safety of CBCC as first-, second- or third-line among Saudi patients with mCRC.

MATERIALS AND METHODS:

Patients with mCRC were offered CBCC to assess time-to-disease progression (TTP), response rate and duration, overall survival (OS) and safety.

RESULTS:

Nineteen patients were eligible and their median age was 51 years. Seven patients received CBCC as first-line and 12 as second- or third-line. Responses: 11 (58%) partial responses, 5 (26%) stable disease and 3 (16%) disease progressions. The median response duration was 4.3 months [95% confidence interval (CI): 3.4-5.2 months]. The median TTP was 6.8 months (95% CI: 2-13.9 months) for all 19 patients compared to 9.3 months (95% CI: 3.9-14.6 months) for the seven patients who received CBCC as first-line. The median OS for the entire population was 12.3 months (95% CI could not be determined). On the other hand, while the median OS for those who received CBCC as first-line have not been reached, the median OS for those who received CBCC after failure of other salvage therapies was 12.3 months (95% CI: 3.2-21.4 months). CBCC was generally tolerable. One patient had a severe hypersensitivity reaction and another fatal cardiac arrest.

CONCLUSION:

CBCC is active with an acceptable safety profile. Until results from phase-III clinical trials are available, using CBCC as first-line is probably justified.

• Authors: Ezzeldin M Ibrahim, Ahmed A Zeeneldin, Aboelkhair M Al-Gahmi, Yasser A Sallam, Ehab E Fawzi, Yasser A Bahadur
• Journal: Indian journal of cancer (Indian J Cancer) 2007 Apr-Jun Vol. 44 Issue 2 Pg. 56-61 ISSN: 0019-509X [Print] India
• PMID: 17938482 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Organoplatinum Compounds
• Receptor, ErbB-2
• Cetuximab
• Leucovorin
• Fluorouracil
• Camptothecin

Topics

• Adenocarcinoma (drug therapy, metabolism, pathology)
• Adult
• Aged
• Angiogenesis Inhibitors (administration & dosage, adverse effects)
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Cetuximab
• Colorectal Neoplasms (drug therapy, metabolism, pathology)
• Disease-Free Survival
• Exanthema (chemically induced)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Follow-Up Studies
• Humans
• Infusions, Intravenous
• Leucovorin (administration & dosage, adverse effects)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Prospective Studies
• Receptor, ErbB-2 (antagonists & inhibitors, metabolism)
• Saudi Arabia
• Survival Rate