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Cho, Byoung Chul,Dy, Grace K.,Govindan, Ramaswamy,Kim, Dong-Wan,Pennell, Nathan A.,Zalcman, Gerard,Besse, Benjamin,Kim, Joo-Hang,Koca, Goekben,Rajagopalan, Prabhu,Langer, Simon,Ocker, Matthias,Nogai, Elsevier 2018 Lung cancer Vol.123 No.-
<P><B>Abstract</B></P> <P><B>Objectives</B></P> <P>This phase Ib/II study evaluated safety, pharmacokinetics, maximum tolerated dose (MTD), and efficacy of the pan-cyclin-dependent kinase inhibitor roniciclib with cisplatin-etoposide (CIS-ETOP) or carboplatin-etoposide (CARBO-ETOP) in patients with extensive-disease small-cell lung cancer (ED-SCLC).</P> <P><B>Patients and methods</B></P> <P>In this open-label, non-randomized study, patients with previously untreated ED-SCLC received roniciclib twice daily (BID) in a 3 days on/4 days off schedule. Cisplatin 75 mg/m<SUP>2</SUP> or carboplatin (AUC5) dose was administered on day 1, and etoposide 100 mg/m<SUP>2</SUP> on days 1–3, of 21-day cycles. Phase Ib used a dose-escalation design to define the MTD for phase II. Pharmacokinetics were assessed.</P> <P><B>Results</B></P> <P>Forty-three patients received treatment (roniciclib 2.5 mg BID [+ CARBO-ETOP, n = 4; + CIS-ETOP, n = 3] and roniciclib 5 mg BID [+ CARBO-ETOP, n = 24; + CIS-ETOP, n = 12]). The MTD of roniciclib was 5 mg BID with CARBO-ETOP or CIS-ETOP. Common adverse events were nausea (90.7%) and vomiting (69.8%). Roniciclib was readily absorbed following oral administration at the MTD (median t<SUB>max</SUB> 0.5–1 h), with a 30–40% reduction in exposure when co-administered with CARBO-ETOP or CIS-ETOP; administration of roniciclib had no effect on etoposide or platinum pharmacokinetics. The response rate was 81.4% (35/43) overall and 86.1% (31/36) in the pooled roniciclib 5 mg BID population (all partial responses).</P> <P><B>Conclusion</B></P> <P>Roniciclib co-administered with chemotherapy in patients with ED-SCLC demonstrated tolerability, acceptable pharmacokinetics, and promising efficacy. An observed safety signal in a related phase II study resulted in discontinuation of the present study and termination of further roniciclib development.</P> <P><B>Highlights</B></P> <P> <UL> <LI> Phase Ib/II study of ED-SCLC patients treated with roniciclib plus chemotherapy. </LI> <LI> Combination was well tolerated and readily absorbed across all dose combinations. </LI> <LI> No clinically relevant PK interactions were observed upon concomitant treatment. </LI> <LI> Promising efficacy of roniciclib plus chemotherapy, despite low patient numbers. </LI> <LI> Unfavorable benefit/risk balance from another study led to study termination. </LI> </UL> </P>
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