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RISS 인기검색어
- 검색키워드
- 저자 : Olga Valota (검색결과 2 건)
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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.
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Kudo, Masatoshi,Kang, Yoon-Koo,Park, Joong-Won,Qin, Shukui,Inaba, Yoshitaka,Assenat, Eric,Umeyama, Yoshiko,Lechuga, Maria José,Valota, Olga,Fujii, Yosuke,Martini, Jean-Francois,Williams, J. Andr S. Karger AG 2018 Liver cancer Vol.7 No.2
<P><B><I>Background:</I></B> An unmet need exists for treatment of patients with advanced hepatocellular carcinoma (HCC) who progress on or are intolerant to sorafenib. A global randomized phase II trial (ClinicalTrial.gov No. NCT01210495) of axitinib, a vascular endothelial growth factor receptor 1-3 inhibitor, in combination with best supportive care (BSC) did not prolong overall survival (OS) over placebo/BSC, but showed improved progression-free survival in some patients. Subgroup analyses were conducted to identify potential predictive/prognostic factors. <B><I>Methods:</I></B> The data from this phase II study were analyzed for the efficacy and safety of axitinib/BSC in patients from Asia versus non-Asia versus Asian subgroups (Japan, Korea, or mainland China/Hong Kong/Taiwan) and predictive/prognostic values of baseline microRNAs and serum soluble proteins, using the Cox proportional hazards model. <B><I>Results:</I></B> Of 202 patients, 78 were from non-Asia and 124 from Asia (37 Japanese, 36 Korean, and 51 Chinese). No significant differences in OS were found between axitinib/BSC and placebo/BSC in non-Asians, Asians, or Asian subgroups. However, in an exploratory analysis, axitinib/BSC showed favorable OS in Asians, especially Japanese, when patients intolerant to prior antiangiogenic therapy were excluded from the data set. Axitinib/BSC was well tolerated by non-Asians and Asians alike. The presence of 4 circulating microRNAs, including miR-5684 and miR-1224-5p, or a level lower than or equal to the median protein level of stromal cell-derived factor 1 at baseline was significantly associated with longer OS in axitinib/BSC-treated Asians or non-Asians. <B><I>Conclusions:</I></B> Axitinib/BSC did not prolong survival over placebo/BSC in non-Asians, Asians, or Asian subgroups, but favorable OS with axitinib/BSC was observed in a subset of Japanese patients. A patient population that excludes sorafenib-intolerant patients might potentially be more suitable for clinical trials of new agents in advanced HCC. Since these results are very preliminary, further investigation is warranted. The potential predictive/prognostic value of several baseline microRNAs and soluble proteins identified in this study would require validation in prospective studies on a large cohort of patients.</P>
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