Ibrahim, Ezzeldin MZeeneldin, Ahmed AAl-Gahmi, Aboelkhair MSallam, Yasser AFawzi, Ehab EBahadur, Yasser A2009-05-282009-05-282007-04-17Ibrahim EM, Zeeneldin AA, Al-Gahmi AM, Sallam YA, Fawzi EE, Bahadur YA. Safety and efficacy of cetuximab-chemotherapy combination in Saudi patients with metastatic colorectal cancer. Indian Journal of Cancer. 2007 Apr-Jun; 44(2): 56-61http://imsear.searo.who.int/handle/123456789/50168BACKGROUND: 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.engAdenocarcinoma --drug therapyAdultAgedAngiogenesis Inhibitors --administration & dosageAntibodies, Monoclonal --administration & dosageAntineoplastic Combined Chemotherapy Protocols --administration & dosageCamptothecin --administration & dosageColorectal Neoplasms --drug therapyDisease-Free SurvivalExanthema --chemically inducedFemaleFluorouracil --administration & dosageFollow-Up StudiesHumansInfusions, IntravenousLeucovorin --administration & dosageMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisOrganoplatinum Compounds --administration & dosageProspective StudiesReceptor, erbB-2 --antagonists & inhibitorsSaudi ArabiaSurvival RateClinical Trial, Phase II