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An Early Phase II Study of Etoposide (VP-16) in Advanced Gastric Cancer
Authors:Yamao, Takekazu   Shimada, Yasuhiro   Ohtsu, Atsushi   Hosokawa, Koichi   Shirao, Kuniaki   Kondo, Hitoshi   Fukuda, Haruhiko   Saito, Daizo   Yoshida, Shigeaki
Affiliation:1 Department of Medical Oncology, National Cancer Center Hospital Tokyo
2 Department of Medical Oncology, National Cancer Center Hospital East Kashiwa, Chiba
Abstract:An early phase II study was conducted to evaluate the anti-tumoreffects and toxicity of etoposide in patients with unresectableor relapsed advanced gastric cancer. From April 1991 to December1992, 13 patients were enrolled into this study; one was subsequentlyconsidered ineligible. Before enrollment, all the patients hadbeen treated with chemotherapy which did not include etoposide.Etoposide (100 mg/m2/day) was administered as an intravenousinfusion over 120 min for five consecutive days and was repeatedevery four weeks. Seven patients received one course of thistherapy and the remaining five received two. No patient showeda complete or a partial response. No change and progressivedisease were observed in three and nine patients, respectively.The clinical toxicities (grade 3–4; WHO) of leukocytopenia,anemia and alopecia occurred in 50, 42, and 42% of the patients,respectively. We conclude that this dose of etoposide administeredaccording to the present schedule is ineffective in previouslytreated patients with advanced gastric cancer.
Keywords:Etoposide (VP-16)    Early phase II study    Gastric cancer    Chemotherapy    Pharmacokinetics
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