Multicenter Phase II Study of Everolimus in Patients With Previously Treated Metastatic Gastric Cancer

• DOI: 10.1200/jco.2009.26.2923
• Publication Date: 2010-03-16T04:10:44Z
• Authors: Toshihiko Doi; Kei Muro; Narikazu Boku; Yasuhide Yamada; Tomohiro Nishina; Hiroya Takiuchi; Yoshito Komatsu; Yasuo Hamamoto; Nobutsugu Ohno; Yoshie Fujita; Matthew Robson; Atsushi Ohtsu
• Keywords: Everolimus; Discontinuation; Clinical endpoint; Pneumonitis; Mucositis

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