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오도연,Toshihiko Doi,Kuniaki Shirao,이근욱,박숙련,Ying Chen,Liqiang Yang,Olga Valota,방영주 대한암학회 2015 Cancer Research and Treatment Vol.47 No.4
Purpose This phase I trial evaluated the question of whether the standard starting dose of axitinibcould be administered in combination with therapeutic doses of cisplatin/capecitabine inpatients with previously untreated advanced gastric cancer, and assessed overall safety,pharmacokinetics, and preliminary antitumor activity of this combination. Materials and MethodsPatients in dose level (DL) 1 received axitinib 5 mg twice a day (days 1 to 21) with cisplatin80 mg/m2 (day 1) and capecitabine 1,000 mg/m2 twice a day (days 1 to 14) in 21-daycycles. Maximum tolerated dose (MTD) was the highest dose at which ! 30% of the first 12patients experienced a dose-limiting toxicity (DLT) during cycle 1. Ten additional patientswere enrolled and treated at the MTD in order to obtain additional safety and pharmacokineticdata. ResultsThree DLTs occurred during cycle 1 in three (25%) of the first 12 patients: ruptured abdominalaortic aneurysm, acute renal failure, and > 5 consecutive days of missed axitinib dueto thrombocytopenia. DL1 was established as the MTD, since higher DL cohorts were notplanned. Common grade 3/4 non-hematologic adverse events in 22 patients treated atDL1 included hypertension (36.4%) and decreased appetite and stomatitis (18.2% each). Cisplatin/capecitabine slightly increased axitinib exposure; axitinib decreased capecitabineand 5-fluorouracil exposure. Eight patients (36.4%) each had partial response or stable disease. Median response duration was 9.1 months; median progression-free survival was3.8 months. ConclusionIn patients with advanced gastric cancer, standard doses of axitinib plus therapeutic dosesof cisplatin and capecitabine could be administered in combination. Adverse events weremanageable.