EVEROLIMUS FOR GASTRIC CANCER

NEW YORK (Reuters Health) Mar 25 - Everolimus may help control previously treated metastatic gastric cancer, according to a report in the March 15th Journal of Clinical Oncology.

"There are very limited treatment options for patients who progress despite the standard treatment for this aggressive cancer," lead author Dr. Toshihiko Doi from National Cancer Center Hospital East, Chiba, Japan, told Reuters Health in an email. "The results from this study demonstrate that everolimus has the potential to provide an effective new option for these patients."

In a single-arm phase II study, Dr. Doi and colleagues tested the safety and efficacy of everolimus monotherapy in 53 patients whose gastric cancer had progressed despite one or two prior chemotherapy regimens (with at least one containing fluorouracil or platinum derivatives, taxanes, or irinotecan).

Patients received 10 mg/day orally until progression, unacceptable toxicity, or study discontinuation for any other reason.

Twenty-eight of 50 patients (56.0%) in the per protocol analysis and 29 of 53 in the full analysis (54.7%) achieved some period of progression-free survival (median, 2.7 months). There were no complete responses.

Nearly half the patients (45%) had a decrease in tumor size, with the maximum best change reaching a 34% decrease in sum of longest diameters when compared with baseline.

The proportion of patients with stable disease (56.0%) and progressive disease (44.0%) was similar in the second-line and third-line treatment subgroups.

The median overall survival was 10.1 months.

The most common adverse events were stomatitis, anorexia, fatigue, rash, nausea, peripheral edema, diarrhea, and pruritus. Twenty patients (37.7%) had grade 3 adverse events, and 4 patients had grade 4 treatment-related adverse events.

At the time of the report, 36 (67.9%) of patients had died, 33 from gastric cancer, 2 from aspiration pneumonia unrelated to everolimus, and 1 from an unknown cause.

"We are now conducting a phase 3 trial for gastric cancer," Dr. Doi said. "GRANITE-1 (GastRic ANtItumor Trial with Everolimus-1) is a randomized, double-blind, placebo-controlled phase 3 clinical trial comparing continuous treatment with 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 regimens for advanced disease."

J Clin Oncol 2010.