Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer

Toshihiko Doi, Kei Muro, Narikazu Boku, Yasuhide Yamada, Tomohiro Nishina, Hiroya Takiuchi, Yoshito Komatsu, Yasuo Hamamoto, Nobutsugu Ohno, Yoshie Fujita, Matthew Robson, Atsushi Ohtsu

Research output: Contribution to journalArticlepeer-review

202 Citations (Scopus)


Purpose: Everolimus, an oral inhibitor of the mammalian target of rapamycin, has shown antitumor activity in gastric cancer in preclinical and phase I studies. This phase II study evaluated the efficacy and safety of everolimus in pretreated patients with advanced gastric cancer. Patients and Methods: Patients with advanced gastric cancer who experienced progression despite prior chemotherapy received everolimus 10 mg orally daily until disease progression or study discontinuation. The primary end point was disease control rate (DCR; ie, complete response, partial response, or stable disease). Secondary end points included progression-free survival (PFS), overall survival (OS), and safety. Results: Fifty-three patients were assessable (median age, 63 years; 51% and 49% received one or two prior chemotherapy regimens, respectively). Although no complete or partial response was obtained, a decrease in tumor size from baseline was observed in 45% of patients by central review. The DCR was 56.0% (95% CI, 41.3% to 70.0%); median PFS was 2.7 months (95% CI, 1.6 to 3.0 months). At a median follow-up time of 9.6 months, median OS was 10.1 months (95% CI, 6.5 to 12.1 months). Common grade 3 or 4 adverse events included anemia, hyponatremia, increased γ-glutamyltransferase, and lymphopenia. Grade 1 or 2 pneumonitis was reported in eight patients (15.1%). Conclusion: Everolimus monotherapy resulted in a promising DCR in patients with previously treated advanced gastric cancer. Adverse events are consistent with the reported safety profile of everolimus. These results warrant further evaluation in patients with advanced gastric cancer.

Original languageEnglish
Pages (from-to)1904-1910
Number of pages7
JournalJournal of Clinical Oncology
Issue number11
Publication statusPublished - 2010 Apr 10
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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