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- 저자 : Tassone, P (검색결과 2 건)
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De Cassai Alessandro,Tassone Martina,Geraldini Federico,Sergi Massimo,Sella Nicolò,Boscolo Annalisa,Munari Marina 대한마취통증의학회 2021 Korean Journal of Anesthesiology Vol.74 No.5
Background: Trial sequential analysis (TSA) is a recent cumulative meta-analysis method used to weigh type I and II errors and to estimate when the effect is large enough to be unaffected by further studies. The aim of this study was to illustrate possible TSA scenarios and their significance using meta-analyses published in the Korean Journal of Anesthesiology (KJA) as working material. Methods: We performed a systematic medical literature search for meta-analyses published in the KJA. TSA was performed on each main outcome, estimating the required sample size on the calculated effect size for the intervention, considering a type I error of 5% and a power of 90% or 99%. Results: Six meta-analyses with a total of ten main outcomes were included in the analysis. Seven TSAs confirmed the results of the meta-analyses. However, only three of them reached the required sample size. In the two TSAs, the cumulative z-lines were not statistically significant. One TSA boundary for effect was reached with the 90% analysis, but not with the 99% analysis. Conclusions: In TSA, a meta-analysis pooled effect may be established to assess if the cumulative sample size is large enough. TSA can be used to add strength to the conclusions of meta-analyses; however, pre-registration of the TSA protocol is of paramount importance. This study could be useful to better understand the use of TSA as an additional statistical tool to improve meta-analysis quality.
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Kang, Y-K,Rha, S Y,Tassone, P,Barriuso, J,Yu, R,Szado, T,Garg, A,Bang, Y-J Nature Publishing Group 2014 The British journal of cancer Vol.111 No.4
<P><B>Background:</B></P><P>Pertuzumab plus trastuzumab provides a more comprehensive blockade of HER2 signalling than trastuzumab alone. Therefore, we conducted a phase IIa study of the pharmacokinetics and safety of pertuzumab plus trastuzumab and chemotherapy in advanced gastric cancer (aGC).</P><P><B>Methods:</B></P><P>Patients received pertuzumab 840 mg for cycle 1 and 420 mg q3w for cycles 2–6 (Arm A) or pertuzumab 840 mg q3w for six cycles (Arm B). Trastuzumab, cisplatin and capecitabine were also given for six cycles, then trastuzumab q3w until disease progression or unmanageable toxicity. The co-primary endpoints were day 43 pertuzumab serum trough concentration (<I>C</I><SUB>min</SUB>) and safety.</P><P><B>Results:</B></P><P>Thirty patients were randomised. Mean pertuzumab <I>C</I><SUB>min</SUB> at day 43 was 40.0 <I>μ</I>g ml<SUP>−1</SUP> (s.d.: 17.3) in Arm A and 62.7 <I>μ</I>g ml<SUP>−1</SUP> (29.1) in Arm B. Mean day 43 <I>C</I><SUB>min</SUB> in Arm A was ∼37% lower than that seen in metastatic breast cancer. The safety profiles were similar between arms and treatment was well tolerated. Partial responses were achieved by 86% and 55% of patients in Arms A and B, respectively.</P><P><B>Conclusions:</B></P><P>On the basis of the pharmacokinetic and safety data, the 840 mg q3w pertuzumab dose has been selected for a phase III study of pertuzumab, trastuzumab and chemotherapy in HER2-positive aGC.</P>
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