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Current Status of the Korean Venous Thromboembolism Registry
오도연 연세대학교의과대학 2011 Yonsei medical journal Vol.52 No.4
The Korean venous thromboembolism (VTE) registry, which was initiated by the Working Parties of Korean Society on Thrombosis and Hemostasis, and the Korean Society of Hematology, is a web-based multicenter registry (http://kdvt.chamc.co.kr) for recruiting consecutive VTE patients. The aim of the registry is to prospectively collect data on the epidemiology and clinical outcomes of VTE from a large, unselected cohort of patients, and to provide data on the true incidence and management of VTE in the real-world. By the end of 2007, the starting year of the registry, 840 patients were registered. By the end of 2008, 1,121 were registered, with 1,289 by the end of 2009, and 1,463 by April 2010 from 11 hospitals. The first report on the epidemiologic characteristics of 596 consecutive VTE patients was released in October 2007.
Phase I Study of OPB-31121, an Oral STAT3 Inhibitor, in Patients with Advanced Solid Tumors
오도연,이세훈,한세원,김미정,김태민,김태유,허대석,Miyuki Yuasa,Yasuo Yanagihara,방영주 대한암학회 2015 Cancer Research and Treatment Vol.47 No.4
Purpose OPB-31121 is an oral STAT3 inhibitor with a good preclinical antitumor activity. This phaseI dose-escalation study of OPB-31121 was conducted to determine maximum-tolerateddose (MTD), safety, pharmacokinetics, and preliminary antitumor efficacy in patients withadvanced solid tumors. Materials and MethodsPatients received OPB-31121 once daily for 28 days of each cycle followed by 2 weeks rest. A standard 3+3 design was used for dose-escalation. Safety and response were evaluatedby the National Cancer Institute–Common Terminology Criteria for Adverse Events (NCICTCAE)ver. 3.0 and Response Evaluation Criteria in Solid Tumor (RECIST) ver. 1.0, respectively. ResultsTwenty-five patients were treated with OPB-31121 at five dose levels: 100 mg (n=4), 200mg (n=3), 400 mg (n=3), 600 mg (n=7), and 800 mg (n=8). Seven patients discontinuedtreatment during cycle 1 for various reasons other than study drug-related adverse events. Among 18 patients who were evaluable for dose-limiting toxicity (DLT), three DLTs wereobserved: one DLT (grade 3 vomiting) at 600 mg and two DLTs (grade 3 vomiting, grade 3diarrhea) at 800 mg. The MTD was determined as 800 mg/day. Common adverse eventswere gastrointestinal adverse event including nausea (84%), vomiting (80%), and diarrhea(72%). Pharmacokinetics did not demonstrate dose-proportionality of OPB-31121. Eightpatients had stable disease and 10 patients had disease progression. Two patients (1 coloncancer, 1 rectal cancer) showed tumor shrinkage. One gastric cancer patient continuedtreatment up to cycle 13 before disease progression. ConclusionThis study demonstrates feasibility of STAT3 inhibition in patients with advanced solid tumor. OPB-31121, at the MTD of 800 mg/day, was safe and relatively well tolerated, and has apreliminary antitumor activity.
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.