S Rao1, N Starling1, D Cunningham2, K Sumpter3, D Gilligan4, T Ruhstaller5, M Valladares-Ayerbes6, H Wilke7, C Archer8, R Kurek9, C Beadman9, J Oates1. 1. Gastrointestinal Unit, Royal Marsden Hospital, London and Surrey, UK. 2. Gastrointestinal Unit, Royal Marsden Hospital, London and Surrey, UK. Electronic address: david.cunningham@rmh.nhs.uk. 3. Oncology Department, Newcastle General Hospital, Newcastle, UK. 4. Oncology Department, Addenbrooke's NHS Trust, Cambridge, UK. 5. Department of Haematology and Oncology, St Gallen, Switzerland. 6. Department of Medical Oncology, Complejo Hospitalario Juan Canalejo, A Coruña, Spain. 7. Oncology Department, Kliniken Essen-Mitte, Essen, Germany. 8. Oncology Department, St Mary's Hospital, Portsmouth, UK. 9. Gastrointestinal Oncology, Merck Serono, Darmstadt, Germany.
Abstract
BACKGROUND: Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin, cisplatin and capecitabine (ECX) chemotherapy in untreated advanced oesophago-gastric (OG) cancer. The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone. PATIENTS AND METHODS: In this multicentre, randomised open-label phase II study, 72 patients with metastatic OG cancer were randomly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle (ECX) or the same ECX regimen alone. The primary end point was objective response. Secondary end points included progression-free survival (PFS), overall survival (OS), quality of life, safety and tolerability. RESULTS: Following random assignment, 35 patients (median age 59 years) receivedECX/matuzumaband 36 patients (median age 64 years) ECX. The addition of matuzumab to ECX did not improve objective response: 31% for ECX/matuzumab [95% confidence interval (CI) 17-49] compared with 58% for the ECX arm (95% CI 41-74) P = 0.994 (one sided). There was no significant difference in median PFS: 4.8 months (95% CI 2.9-8.1) for ECX/matuzumab versus 7.1 months (95% CI 4.4-8.5) for ECX, or in median OS: 9.4 months (95% CI 7.5-16.2), compared with 12.2 months (95% CI 9.8-13.8 months). Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups, respectively. CONCLUSION:Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer. Therefore, ECX/matuzumab should not be examined further in phase III trials.
RCT Entities:
BACKGROUND: Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin, cisplatin and capecitabine (ECX) chemotherapy in untreated advanced oesophago-gastric (OG) cancer. The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone. PATIENTS AND METHODS: In this multicentre, randomised open-label phase II study, 72 patients with metastatic OG cancer were randomly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle (ECX) or the same ECX regimen alone. The primary end point was objective response. Secondary end points included progression-free survival (PFS), overall survival (OS), quality of life, safety and tolerability. RESULTS: Following random assignment, 35 patients (median age 59 years) received ECX/matuzumab and 36 patients (median age 64 years) ECX. The addition of matuzumab to ECX did not improve objective response: 31% for ECX/matuzumab [95% confidence interval (CI) 17-49] compared with 58% for the ECX arm (95% CI 41-74) P = 0.994 (one sided). There was no significant difference in median PFS: 4.8 months (95% CI 2.9-8.1) for ECX/matuzumab versus 7.1 months (95% CI 4.4-8.5) for ECX, or in median OS: 9.4 months (95% CI 7.5-16.2), compared with 12.2 months (95% CI 9.8-13.8 months). Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups, respectively. CONCLUSION:Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer. Therefore, ECX/matuzumab should not be examined further in phase III trials.
Authors: Vincent T Janmaat; Ewout W Steyerberg; Ate van der Gaast; Ron Hj Mathijssen; Marco J Bruno; Maikel P Peppelenbosch; Ernst J Kuipers; Manon Cw Spaander Journal: Cochrane Database Syst Rev Date: 2017-11-28
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
Authors: Marwa Matboli; Sarah El-Nakeep; Nourhan Hossam; Alaa Habieb; Ahmed E M Azazy; Ali E Ebrahim; Ziad Nagy; Omar Abdel-Rahman Journal: World J Gastroenterol Date: 2016-07-14 Impact factor: 5.742