OBJECTIVE: This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer. RESEARCH DESIGN AND METHODS: Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000 mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120 mg/m2 on Day 1 of each 3-week cycle). RESULTS: Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%CI: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% CI: 15.1--not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%). CONCLUSIONS: The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naïve metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.
OBJECTIVE: This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer. RESEARCH DESIGN AND METHODS: Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000 mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120 mg/m2 on Day 1 of each 3-week cycle). RESULTS: Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%CI: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% CI: 15.1--not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%). CONCLUSIONS: The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naïve metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.
Authors: Wells A Messersmith; Antonio Jimeno; Heather Jacene; Ming Zhao; Piotr Kulesza; Daniel A Laheru; Yasmin Kahn; Alexander Spira; Janet Dancey; Christine Iacobuzio-Donahue; Ross C Donehower; Michael Carducci; Michelle A Rudek; Manuel Hidalgo Journal: Clin Colorectal Cancer Date: 2010-12 Impact factor: 4.481
Authors: Nise H Yamaguchi; Ingrid A Mayer; Artur Malzyner; Carlos Jc de Andrade; Andre M Murad; Auro Del Giglio; Venancio Alves Journal: J Gastrointest Oncol Date: 2014-02
Authors: Hafiz A Makeen; Syam Mohan; Mohamed Ahmed Al-Kasim; Ibraheem M Attafi; Rayan A Ahmed; Nabeel Kashan Syed; Muhammad Hadi Sultan; Mohammed Al-Bratty; Hassan A Alhazmi; Mohammed M Safhi; Raisuddin Ali; M Intakhab Alam Journal: Drug Deliv Date: 2020-12 Impact factor: 6.419