Everolimus Shows Potential In Tough-to-Treat Gastric Cancer

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Main Category: GastroIntestinal / Gastroenterology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 28 Jan 2010 - 8:00 PDT

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ORLANDO - Everolimus monotherapy shows promising activity and is generally well tolerated in patients with metastatic gastric cancer who have undergone prior anticancer therapy, according to phase 2 results reported by Japanese researchers at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancers Symposium (ASCO GI).

Hiroya Takiuchi, MD, with Osaka Medical College, presented results in 53 patients with metastatic gastric cancer who received a daily 10 mg dose oral everolimus. All patients had failed up to two prior chemotherapy regimens.

Everolimus is an oral inhibitor of mammalian target of rapamycin (mTOR) that has demonstrated anticancer activity in preclinical cellular and animal models and also in patients with advanced gastric cancer.

"Because of poor long-term outcomes with surgery and standard chemotherapy management of advanced gastric cancer, it is important to study new targeted agents in this population," Dr. Takiuchi said.

Oral everolimus was administered in continuous 28-day cycles until the patient developed progressive disease or unacceptable toxicity or elected to withdraw from the study for any other reason, with a dose reduction permitted for tolerability.

The primary study endpoint was disease control rate (DCR), defined as the proportion of patients with complete response, partial response or stable disease as the best overall response.

Results showed a DCR of 56%.

While no complete or partial responses were observed, 45% of patients had a decrease in tumor size from baseline by central review.

The median overall survival was 10.1 months with a median follow-up time of 9.6 months.

The drug's safety profile was consistent with the known safety profile of everolimus. Dr. Takiuchi said. Grade 3 events occurred in 20 patients and grade 4 adverse events that were thought to be possibly related to the study drug occurred in only four patients.

Based on these results, a phase 3 trial known as Gastric Antitumor Trial with Everolimus (GRANITE-1) has been launched. The trial is comparing everolimus plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer whose disease has progressed after prior systemic chemotherapy.

Gastric cancer is the fourth most common cancer worldwide and the second most common cause of cancer mortality, Dr. Takiuchi said.

Novartis funded the study.

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
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