Everolimus demonstrated disease control, tumor shrinkage in previously treated advanced gastric cancer

Everolimus monotherapy in previously treated patients with advanced gastric cancer was well-tolerated and demonstrated promising disease control, according to the findings of a phase-2 trial.

Researchers analyzed data from 53 patients assigned 10 mg per day everolimus (Afinitor, Novartis) taken orally until tumor progression, unacceptable toxicity or study discontinuation.

Fifty-six percent (95% CI, 41.3%-70%) of patients demonstrated disease control, the primary endpoint. No complete or partial response was observed; but, by central review, 45% of patients had a decrease in tumor size. The maximum best change was a 34% reduction in the sum of longest diameters.

The median PFS was 2.7 months (95% CI, 1.6-3), and at four months, 28.3% of patients were progression-free. Median PFS was 2.6 months (95% CI, 1-3) in the second-line setting and 2.8 months (95% CI, 1.6-4) in the third-line setting.

Median OS was 10.1 months (95% CI, 6.5-12.1) at a median follow-up of 9.6 months. Median OS was 9.8 months (95% CI, 6.2-12.3) in the second-line setting and 10.7 months (95% CI, 6.3-not reached) in the third-line setting.

Major adverse events were grade 1 or grade 2. Grade-3 and grade-4 events included anemia, hyponatremia, increased y-glutamyltransferase, lymphopenia, fatigue, stomatitis, anorexia, abnormal hepatic function, hyperglycemia, hypophosphatemia and ileus.

The promising rate of disease control and limited adverse events warrant further evaluation in a phase-3 trial of everolimus monotherapy in this population, according to researchers.

Doi T. J Clin Oncol. 2010;doi:10.1200/JCO.2009.26.2923.