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Ramucirumab plus paclitaxel improved OS, PFS in advanced gastric cancer
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Patients with advanced gastric adenocarcinoma treated with ramucirumab plus paclitaxel demonstrated improved OS, PFS and quality of life compared with patients treated with paclitaxel alone, according to phase 3 study results presented at the 2014 Gastrointestinal Cancers Symposium.
“New and effective treatments are needed for this patient population,” researcher Hansjochen Wilke, MD, director of the department of oncology, hematology and center of palliative care at Kliniken Essen-Mitte in Essen Germany, said during a press conference. “Angiogenesis-linked growth factor receptors such as VEGF receptor 2 and its ligands likely contribute to gastric cancer pathogenesis and may represent important therapeutic targets in gastric cancer.”
The study included 665 patients with metastatic gastroesophageal junction or gastric adenocarcinoma and an ECOG performance status ≤1.
Wilke and colleagues assigned 330 patients 8 mg/kg IV ramucirumab (IMC-1121B, Eli Lilly and Company) — a human lgG1 monoclonal antibody and VEGFR-2 antagonist — every other week plus 80 mg/m2 paclitaxel on days 1, 8 and 15 of a 4-week cycle.
The remaining 335 patients received paclitaxel plus placebo.
The overall response rate was significantly higher among patients who received ramucirumab (28% vs. 16%; P=.0001).
Median OS (9.63 months vs. 7.36 months; HR=0.807; 95% CI, 0.678-0.962) and median PFS (4.4 months vs. 2.86 months; HR=0.635; 95% CI, 0.536-0.752) also were higher in the ramucirumab arm.
Median time to progression was 5.5 months in the ramucirumab arm compared with 3 months in the placebo arm (P<.0001).
More patients in the ramucirumab arm experienced grade ≥3 neutropenia (40.7% vs. 18.8%), leukopenia (17.4% vs. 6.7%), hypertension (14.1% vs. 2.4%), fatigue (7% vs. 4%), abdominal pain (5.5% vs. 3.3%) and asthenia (5.5% vs. 3.3%). However, more patients in the placebo arm experienced anemia (10.3% vs. 9.2%).
Febrile neutropenia occurred in 3.1% of the ramucirumab arm vs. 2.4% of the placebo arm.
“A 2-month survival gain for patients with gastric cancer receiving second-line therapy is a big improvement,” Wilke said in a press release. “This study shows that we can achieve more with targeted therapy and chemotherapy together than we can with chemotherapy alone. We’re also encouraged that this regimen not only improves survival but also offers patients a better quality of life.”
For more information:
Wilke H. Abstract #LBA7. Presented at: 2014 Gastrointestinal Cancers Symposium; Jan. 16-18, 2014; San Francisco.
Disclosure: The researchers report research funding and honoraria from; consultant, advisory roles or employment with; and stock ownership in Bristol-Myers Squibb, Chugai Pharma, Eli Lilly, Lilly Lab France, Merck Serono, Novartis and Taiho Pharmaceutical.