Preliminary results of phase II study of irinotecan and capecitabine combination as first line chemotherapy for advanced and metastatic gastric cancer

Abstract

14030 Background: Chemotherapy has a proven palliative role in advanced gastric cancer. The most widely investigated single-agent chemotherapy is 5-fluorouracil with partial response rates up to 20%. Single-agent irinotecan achieved response rates of 18%-23%. We investigated the combination Irinotecan plus Capecitabine for previously untreated locally advanced or metastatic gastric cancer. Methods: We conducted a phase II study with the combination of Irinotecan 80 mg/m2 on day 1, 8, and 15, and capecitabine 625 mg/m2 twice daily on days 1 to 14 repeated every 4 weeks. Patients were evaluated every second cycle. Previous chemotherapy for metastatic disease was not allowed. Patients must have measurable disease, ECOG PS < 2, life expectancy > 2 months, adequate hematological, liver and renal functions. Response was evaluated according to RECIST and toxicities according to NCI common toxicity criteria 3.0. Results: Between February 2002 and December 2005 31 patients were enrolled (20 male and 11 female). The median age was 57 years [range 37–74 years]. 142 cycles were administered with a median of 4.6 cycles per patient [range 1–10 cycles]. 29 patients were evaluable for response, and two are on ongoing treatment. Partial response rate was 38.5% . 9 patients (29%) had stable disease. Overall tumor control rate was 67.5%. Median time to progression and overall survival were 5.8 months [range- 1–16] and 10.58 months [range- 1–21] respectively. There was no grade III-IV reported toxicity including no hand and foot syndrome. Conclusions: Irinotecan and capecitabine in combination show an interesting tumor control rate (67.5%) with extremely well tolerated toxicity in patients with extensive gastric cancer. No significant financial relationships to disclose.