M Moehler1, A Mueller2, T Trarbach3, F Lordick4, T Seufferlein5, S Kubicka6, M Geißler7, S Schwarz2, P R Galle2, S Kanzler8. 1. First Department of Internal Medicine, University of Mainz, Mainz. Electronic address: moehler@mail.uni-mainz.de. 2. First Department of Internal Medicine, University of Mainz, Mainz. 3. Department of Medicine (Cancer Research), West German Cancer Centre, University Hospital of Essen, Essen. 4. Third Department of Internal Medicine, University Hospital, Technical University of Munich, Munich. 5. First Department of Internal Medicine, University Hospital of Halle, Halle. 6. Department of Gastroenterology and Hepatology, Center of Internal Medicine, Hannover Medical School, Hannover. 7. Department of Internal Medicine, City Hospital of Esslingen, Esslingen. 8. First Department of Internal Medicine, University of Mainz, Mainz; Second Department of Medicine, Schweinfurt Hospital, Schweinfurt, Germany.
Abstract
BACKGROUND: Cetuximab plus irinotecan/folinic acid/5-fluorouracil (5-FU) (IF) was evaluated as first-line treatment of patients with advanced gastric cancer and gastroesophageal junction tumors. Preplanned analyses of the influence of tumor biomarkers on treatment outcome were carried out. PATIENTS AND METHODS: Patients received weekly cetuximab (400 mg/m(2) on day 1, subsequently 250 mg/m(2)) plus irinotecan (80 mg/m(2)) and a 24-hour continuous infusion of folinic acid (200 mg/m(2)) and 5-FU (1500 mg/m(2)) on days 1, 8, 15, 22, 29 and 36 of a 50-day cycle, until progressive disease (PD). RESULTS: The most common grade 3/4 toxic effects in 49 patients were diarrhea (15%) and skin toxic effects (14%). In 48 assessable patients, the overall response rate was 46% and disease control rate was 79%. Median progression-free survival (PFS) and overall survival (OS) was 9.0 months [95% confidence interval (CI) 7.1-15.6] and 16.5 months (95% CI 11.7-30.1), respectively. Tumor response was more common than nonresponse in epidermal growth factor receptor-expressing tumors (P = 0.041). Tumor PTEN expression was associated with longer PFS (P = 0.035) and OS (P = 0.0127) than no PTEN expression. CONCLUSION: Cetuximab plus IF was well tolerated and efficacy data were encouraging. This treatment combination and the role of selected biomarkers are under investigation in the ongoing phase III EXPAND trial.
BACKGROUND:Cetuximab plus irinotecan/folinic acid/5-fluorouracil (5-FU) (IF) was evaluated as first-line treatment of patients with advanced gastric cancer and gastroesophageal junction tumors. Preplanned analyses of the influence of tumor biomarkers on treatment outcome were carried out. PATIENTS AND METHODS: Patients received weekly cetuximab (400 mg/m(2) on day 1, subsequently 250 mg/m(2)) plus irinotecan (80 mg/m(2)) and a 24-hour continuous infusion of folinic acid (200 mg/m(2)) and 5-FU (1500 mg/m(2)) on days 1, 8, 15, 22, 29 and 36 of a 50-day cycle, until progressive disease (PD). RESULTS: The most common grade 3/4 toxic effects in 49 patients were diarrhea (15%) and skin toxic effects (14%). In 48 assessable patients, the overall response rate was 46% and disease control rate was 79%. Median progression-free survival (PFS) and overall survival (OS) was 9.0 months [95% confidence interval (CI) 7.1-15.6] and 16.5 months (95% CI 11.7-30.1), respectively. Tumor response was more common than nonresponse in epidermal growth factor receptor-expressing tumors (P = 0.041). TumorPTEN expression was associated with longer PFS (P = 0.035) and OS (P = 0.0127) than no PTEN expression. CONCLUSION:Cetuximab plus IF was well tolerated and efficacy data were encouraging. This treatment combination and the role of selected biomarkers are under investigation in the ongoing phase III EXPAND trial.
Authors: Markus Moehler; Thomas Thomaidis; Chourouk Zeifri; Tareq Barhoom; Jens Marquardt; Philippe Ploch; Joern Schattenberg; Annett Maderer; Carl Christoph Schimanski; Arndt Weinmann; Marcus Alexander Woerns; Anne L Kranich; Jens M Warnecke; Peter Robert Galle Journal: J Cancer Res Clin Oncol Date: 2014-09-19 Impact factor: 4.553
Authors: Felice Pasini; Anna Paola Fraccon; Yasmina Modena; Maria Bencivenga; Simone Giacopuzzi; Francesca La Russa; Milena Gusella; Giovanni de Manzoni Journal: Gastric Cancer Date: 2016-08-27 Impact factor: 7.370