The addition of everolimus to paclitaxel did not significantly improve overall response rate, progression-free survival, or overall survival among patients with advanced gastric or gastroesophageal adenocarcinoma who progressed after treatment with a fluoropyrimidine/platinum-containing regimen, according to a study being presented at the 2017 Gastrointestinal Cancers Symposium.1

There is a substantial need for effective treatments in the second- or subsequent-line treatment setting in advanced gastric cancer. Researchers evaluated whether adding everolimus, an mTOR inhibitor, would improve outcomes in this patient population.

For the multicenter, double-blind, phase 3 trial ( Identifier: NCT01248403), investigators enrolled 300 adult patients with gastric carcinoma or adenocarcinoma of the esophagogastric junction whose disease progressed after initial treatment with a fluoropyrimidine/platinum-containing regimen.

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Participants were randomly assigned 1:1 to receive paclitaxel on days 1, 8, and 15 plus everolimus daily or placebo for each 4-week cycle as second-, third-, or fourth-line therapy.

Eight percent (95% CI, 4.2-13.6) of patients in the everolimus arm achieved an overall response compared with 7.3% (95% CI, 3.7-12.7) of those in the placebo arm (P = .4).

There was no significant difference in median progression-free survival (hazard ratio, 0.88; P = .3) or median overall survival (hazard ratio, 0.92; P = .48) between the 2 treatment arms. Median progression-free survival was 2.2 months with everolimus and 2.07 months with placebo; median overall survival was 6.1 months vs 5.1 months, respectively.

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Although combination therapy with everolimus plus paclitaxel was tolerable, patients in the everolimus arm were more likely to experience mucositis, fever, leukopenia, neutropenia, and thrombocytopenia.

Researchers plan to conduct biomarker analyses to identify subgroups that may benefit from combination therapy.


  1. Al-Batran SE, Riera-Knorrenschild J, Pauligk C, et al. A randomized, double-blind, multicenter phase III study evaluating paclitaxel with and without RAD001 in patients with gastric cancer who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen (RADPAC). J Clin Oncol. 2017;35(suppl):4S. Abstract 4.