Abstract
In a randomized phase III study, patients with advanced gastric cancer who received a combination of ramucirumab and paclitaxel lived about 2 months longer than patients who received paclitaxel alone, a statistically significant improvement.
In a large, randomized phase III study, patients with advanced gastric cancer who received a combination of ramucirumab (Lilly) and paclitaxel lived about 2 months longer than patients who received paclitaxel alone, a statistically significant improvement. Patients who received the drug combination also experienced longer progression-free survival (PFS) and improved quality of life compared with those who received paclitaxel alone.
The results were presented at the 2014 Gastrointestinal Cancers Symposium, held in San Francisco, CA, in January.
“A 2-month survival gain for patients with gastric cancer receiving second-line therapy is a big improvement,” said lead study author Hansjochen Wilke, MD, director of the Department of Oncology/Hematology and Center of Palliative Care at Kliniken Essen-Mitte in Essen, Germany.
Patients with advanced gastric cancer whose disease progresses after first-line therapy have a poor prognosis. Second-line chemotherapy with drugs such as docetaxel, paclitaxel, and irinotecan leads to overall survival (OS) of about 4 to 5 months, said Wilke, underscoring the need for new and more-effective treatments.
Dubbed RAINBOW, the trial randomly assigned 665 patients with gastric cancer who experienced disease progression within 4 months of standard first-line chemotherapy to receive ramucirumab plus paclitaxel or paclitaxel alone. Ramucirumab is a human IgG1 monoclonal antibody that blocks vascular endothelial growth factor receptor 2 (VEGFR-2). Targeting VEGFR-2 inhibits angiogenesis.
Overall, 28% of patients responded to treatment with ramucirumab and paclitaxel compared with 16% of patients treated with paclitaxel alone. The median OS was 9.6 months in the group receiving combination therapy, versus 7.4 months in the paclitaxel group; median PFS was 4.4 months and 2.9 months, respectively.
The most common side effects of treatment with ramucirumab included neutropenia, leukopenia, hypertension, anemia, fatigue, abdominal pain, and weakness. However, these side effects were manageable and caused few patients to discontinue treatment, Wilke said. In addition, he noted that patients who received ramucirumab reported decreased pain and improved quality of life.
In the earlier phase III REGARD trial, which assessed ramucirumab as a single agent, patients with advanced gastric cancer who received the drug demonstrated significant improvements in survival compared with those who received a placebo.
Drug maker Lilly has submitted ramucirumab to the U.S. Food and Drug Administration for marketing approval as a second-line treatment for patients with advanced gastric cancer. The application was granted priority review in October, and a decision is expected within the next several weeks.
