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Ramucirumab for the treatment of gastroesophageal cancers
Y Shimodaira1, E Elimova1, R Wadhwa1
1Department of Gastrointestinal Medical Oncology, University of Texas M. D. Anderson Cancer Center 1515 Holcombe Blvd, (FC10.3022), Houston, TX 77030, USA.
Introduction:
In 2014, the U.S. Food and Drug Administration (FDA) approved ramucirumab for use in the second line setting of advanced or metastatic, gastric or gastroesophageal adenocarcinoma (GEAC) based on the result of Phase III clinical trials; REGARD and RAINBOW.
Areas Covered:
We briefly review the mechanisms of angiogenesis, anti-angiogenic therapy, and current status of advanced GEAC treatment then highlight the challenges and future prospects of novel molecular targeted agents.
Expert Opinion:
Although both the REGARD and RAINBOW trials met their primary endpoints of significantly prolonged overall survival (OS) and progression-free survival (PFS), the magnitude of the difference is still relatively modest. Given that ramucirumab alone has a marginal effect, a combination of paclitaxel and ramucirumab is strongly preferred as a second line therapy. To maximize the impact of ramucirumab in patients with GEAC, we can leverage the recent pharmacokinetics (PK) data of ramucirumab from the REGARD and RAINBOW trials. In addition, the quest for identifying biomarkers to select patients who are likely to benefit the most should continue. It is our firm belief that taxanes should no longer be added to the frontline regimens in most cases, given the success of the taxane/ramucirumab in the second line setting.
Insights
Ramucirumab, approved for advanced gastric cancer, shows modest survival benefits alone. Combination therapy with paclitaxel is preferred for improved outcomes in second-line treatment.
Area of Science:
- Oncology
- Pharmacology
- Gastroenterology
Background:
- Ramucirumab gained FDA approval in 2014 for advanced gastric or gastroesophageal adenocarcinoma (GEAC).
- Approval was based on Phase III REGARD and RAINBOW trials for second-line treatment.
Purpose of the Study:
- Review mechanisms of angiogenesis and anti-angiogenic therapy.
- Discuss current advanced GEAC treatment and novel targeted agents.
- Highlight challenges and future prospects in GEAC therapy.
Main Methods:
- Review of existing clinical trial data (REGARD, RAINBOW).
- Analysis of pharmacokinetic (PK) data for ramucirumab.
- Discussion of treatment strategies and biomarker identification.
Main Results:
- Both REGARD and RAINBOW trials demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS).
- Ramucirumab alone showed a modest effect, with combination therapy showing greater benefit.
Conclusions:
- Combination therapy of paclitaxel and ramucirumab is strongly preferred for second-line GEAC treatment.
- Further research into biomarkers for patient selection is crucial.
- Taxanes may not be necessary in frontline regimens due to second-line combination success.
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