Stomach Cancer Didn't Respond to Rx

Stomach cancer overall survival not extended by everolimus

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Stomach cancer is relatively rare in the US but common in other parts of the world, particularly in Asia. A recent study evaluated the effectiveness of an existing medication in treating this cancer.

A new trial has revealed that everolimus (Afinitor) did not significantly extend the lives of patients with advanced stomach (gastric) cancer.

The study involved stomach cancer patients who had previously been treated with one or two lines of chemotherapy. Patients given everolimus were compared with those provided best supportive care designed to relieve symptoms.

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Atsushi Ohtsu, MD, PhD, a physician scientist with the National Cancer Center Hospital East in Kashiwa, Japan, led this international phase lll trial.

Everolimus targets a protein known as mammalian target of rapamycin (mTOR) that’s present in about 60 percent of stomach cancers.

An earlier, small phase ll study found that everolimus controlled advanced stomach cancer.

This new study — the GRANITE-1 (First Gastric Antitumor Trial With Everolimus) — looked at the efficacy and safety of everolimus in advanced stomach cancer patients whose disease had progressed despite one or two lines of chemotherapy.

A total of 656 previously treated patients from 137 centers in 23 countries were enrolled in the GRANITE study between July 2009 and November 2010. The average age was 62 and most (73.6 percent) of the study members were men.

The participants were randomly assigned to receive everolimus plus best supportive care (BSC) or a placebo (fake medication) plus BSC.

Best supportive care is designed to offer symptom relief instead of curative treatment.

The median progression free survival (period of time during which the disease does not get worse) was 1.7 months for the treated group and 1.4 months for the BSC group.

Median overall survival was 5.4 months for patients who received everolimus and 4.3 months for patients who were given a placebo.

Nearly all participants experienced serious side effects, including fatigue, nausea, decreased appetite and mouth sores.

"Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy," the authors concluded.

“It’s disappointing to learn that everolimus doesn’t impact overall survival among patients with advanced gastric cancer," Richard  Berri, MD, director of Surgical Oncology at St. John Hospital and Medical Center's Van Elslander Cancer Center, told dailyRx News. "Research will continue to look for therapies for this population.”

Everolimus is currently approved by the US Food and Drug Administration (FDA) to treat pancreatic cancer, as well as advanced breast cancer and kidney cancers.

Stomach cancer will be diagnosed in an estimated 21,500 Americans this year. In 2008, almost a million (989,600) people were diagnosed with the disease around the world.

Results from this study were published September 16 in the Journal of Clinical Oncology.

A number of the study authors reported financial ties with various pharmaceutical companies, including Novartis, the manufacturer of everolimus.

Review Date: 
September 16, 2013
Last Updated:
January 2, 2014