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Second-Line Ramucirumab Plus Paclitaxel Improves Overall Survival in Patients With Advanced Gastric Cancer

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Key Points

  • Patients who received ramucirumab plus paclitaxel had a median survival of 9.6 months vs 7.4 months for patients who received placebo plus paclitaxel.
  • Treatment with ramucirumab plus paclitaxel significantly reduced the risk of disease progression or death by 37%.
  • There was a statistically significant increase in objective response rate, from 16% to 28%, with the addition of ramucirumab.

The addition of the monoclonal antibody VEGFR-2 antagonist ramucirumab (Cyramza) to paclitaxel led to a statistically significant improvement in median overall survival in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma in a phase III trial, reported Wilke et al in The Lancet Oncology. The trial also met its secondary endpoints of progression-free survival and objective response rate.

In the global, randomized, double-blind, phase III RAINBOW study, ramucirumab and paclitaxel were compared to placebo and paclitaxel in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma that was refractory to or progressive after initial platinum- and fluoropyrimidine-containing chemotherapy. A total of 665 patients were randomly assigned to ramucirumab plus paclitaxel (n = 330) or placebo plus paclitaxel (n = 335) between December 2010 and September 2012. The primary endpoint was overall survival

RAINBOW Study Findings

Patients who received ramucirumab plus paclitaxel had a median overall survival rate of 9.6 months, compared to 7.4 months for patients who received placebo plus paclitaxel (stratified hazard ratio [HR] = 0.807, 95% confidence interval [CI] = 0.678–0.962, P = .017). Treatment with ramucirumab plus paclitaxel significantly reduced the risk of disease progression or death by 37%, with a 52% increase in median progression-free survival compared with placebo plus paclitaxel (4.4 months vs 2.9 months; stratified HR = 0.635, 95% CI = 0.536–0.752, P < .0001). There was a statistically significant increase in objective response rate, from 16% to 28%, with the addition of ramucirumab (P = .0001).

Grade ≥ 3 adverse events occurring at a higher rate and for more than 10% of patients on the ramucirumab-plus-paclitaxel arm included neutropenia (41% vs 19%), leukopenia (17% vs 7%), hypertension (15% vs 3%), and fatigue/asthenia (12% vs 5%). The incidence of febrile neutropenia was low in both trial arms (3% vs 2%, respectively).

“I am very pleased that this trial demonstrated a significant and clinically meaningful benefit for patients with advanced stomach cancer,” said Hansjochen Wilke, MD, of the Department of Medical Oncology, Hematology with the Center for Palliative Care at Kliniken Essen-Mitte in Germany, and principal investigator of the RAINBOW trial. “Currently, there is a significant need for effective therapies to help combat this deadly disease, and ramucirumab in this combination could provide a valuable second-line treatment option.”

Dr. Wilke is the corresponding author for The Lancet Oncology article.

The study was funded by Eli Lilly and Company. For full disclosures of the study authors, visit www.thelancet.com.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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