Indian Journal of Cancer
Medknow Publications on behalf of Indian Cancer Society
Vol. 44, No. 2, 2007, pp. 56-61
Bioline Code: cn07010
Full paper language: English
Document type: Research Article
Document available free of charge
Indian Journal of Cancer, Vol. 44, No. 2, 2007, pp. 56-61
© Copyright 2007 Indian Journal of Cancer.
Safety and efficacy of cetuximab-chemotherapy combination in Saudi patients with metastatic colorectal cancer|
Ibrahim, Ezzeldin M.; Zeeneldin, Ahmed A.; Al-Gahmi, Aboelkhair M.; Sallam, Yasser A.; Fawzi, Ehab E. & Bahadur, Yasser A.
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.
Cetuximab, chemotherapy, metastatic colorectal carcinoma, Saudi Arabia
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