NEWS & VIEWS GASTROINTESTINAL CANCER
Targeted therapies in gastric cancer—the dawn of a new era Manish A. Shah
The international phase III REGARD study demonstrated improved overall survival with ramucirumab as second-line therapy for patients with advanced-stage gastric and gastroesophageal junction adenocarcinoma. As a novel biological treatment, is ramucirumab also the harbinger of a new era of targeted therapies in this prevalent and highly morbid disease? Shah, M. A. Nat. Rev. Clin. Oncol. 11, 10–11 (2014); published online 3 December 2013; doi:10.1038/nrclinonc.2013.231
The recently reported REGARD study was a well carried out international phase III double-blind, placebo-controlled trial assessing the efficacy of ramucirumab, a fully humanized IgG1 monoclonal antibody inhibitor of VEGF receptor‑2 (VEGFR‑2), in patients with advanced-stage gastric cancer whose tumours had progressed on firstline chemotherapy. 1 The study enrolled 355 patients, with 238 patients assigned to receive ramucirumab and 117 assigned to placebo. Patients were required to have disease progression within 4 months of their last dose of chemotherapy (platinum-based, fluoropyrimidine-based or both) if treated for metastatic or incurable disease, or within 6 months of completion of adjuvant therapy. Patients were also required to have an ECOG performance status 0 or 1, a notably highly functioning patient population for secondline treatment in advanced-stage gastric and gastroesophageal junction carcinoma. The study primary end point was overall survival from the time of randomization. Although originally designed with 90% power to identify a hazard ratio (HR) of 0.71 (615 patients planned), the study was redesigned after 1 year owing to poor accrual (36 patients enrolled between October 2009 and November 2010, all of whom remained blinded at the time of the study amendment) to have 80% power to identify a HR of 0.69, yielding a final study population of 348 patients. Patients were appropriately stratified for weight loss (≥10% versus
Targeted therapies in gastric cancer—the dawn of a new era Manish A. Shah
The international phase III REGARD study demonstrated improved overall survival with ramucirumab as second-line therapy for patients with advanced-stage gastric and gastroesophageal junction adenocarcinoma. As a novel biological treatment, is ramucirumab also the harbinger of a new era of targeted therapies in this prevalent and highly morbid disease? Shah, M. A. Nat. Rev. Clin. Oncol. 11, 10–11 (2014); published online 3 December 2013; doi:10.1038/nrclinonc.2013.231
The recently reported REGARD study was a well carried out international phase III double-blind, placebo-controlled trial assessing the efficacy of ramucirumab, a fully humanized IgG1 monoclonal antibody inhibitor of VEGF receptor‑2 (VEGFR‑2), in patients with advanced-stage gastric cancer whose tumours had progressed on firstline chemotherapy. 1 The study enrolled 355 patients, with 238 patients assigned to receive ramucirumab and 117 assigned to placebo. Patients were required to have disease progression within 4 months of their last dose of chemotherapy (platinum-based, fluoropyrimidine-based or both) if treated for metastatic or incurable disease, or within 6 months of completion of adjuvant therapy. Patients were also required to have an ECOG performance status 0 or 1, a notably highly functioning patient population for secondline treatment in advanced-stage gastric and gastroesophageal junction carcinoma. The study primary end point was overall survival from the time of randomization. Although originally designed with 90% power to identify a hazard ratio (HR) of 0.71 (615 patients planned), the study was redesigned after 1 year owing to poor accrual (36 patients enrolled between October 2009 and November 2010, all of whom remained blinded at the time of the study amendment) to have 80% power to identify a HR of 0.69, yielding a final study population of 348 patients. Patients were appropriately stratified for weight loss (≥10% versus
