内容紹介
Clinical Evaluation of Lapatinib Therapy in Metastatic Breast Cancer Using the Bayes Meta-Analysis
Summary
The efficacy of treatments involving lapatinib for patients with metastatic breast cancers was evaluated in a Bayesian meta-analysis of published data from randomized controlled clinical trials. Four randomized controlled trials including 2,708 patients met the inclusion criteria. Among these patients, 568 were positive for the human epidermal growth factor receptor 2(HER2). The clinical benefit rate(CBR)for HER2-positive patients was the primary outcome of the analysis, and the overall survival(OS)and the number needed to treat(NNT)were the secondary outcomes of the reported meta-analysis. The Bayesian meta-analysis was conducted according to the Markov-chain Monte-Carlo technique in WinBUGS. The CBR for HER2-positive patients was significantly improved(odds ratio[OR]: 2.281, 95% confidence interval[CI]: 1.490-3.628), whereas no statistically significant improvement was seen in the overall patient CBR(OR: 1.559, 95% CI: 0.768-3.238). The OS hazard ratio(HR)and NNT for the CBR were also estimated for HER2-positive patients. The difference in the OS HR was not statistically significant(HR: 0.789, 95% CI: 0.556-1.086)for HER2-positive patients. The improvement in the NNT for the CBR was statistically significant(NNT 5.164, 95% CI: 3.803-8.723)for HER2-positive patients.
要旨
転移性乳がん患者におけるラパチニブ治療群と非ラパチニブ治療群の臨床評価をデータ統合型研究であるベイズ・メタ解析手法を用いて解析を試みた。ランダム化比較試験を中心に文献検索を実施し,4報の関連論文を入手した。臨床指標として主要評価はclinical benefit rate(CBR)を,副次的評価はoverall survival(OS),number needed to treat(NNT)とした。解析手法としては,ベイズ・メタ解析によるマルコフ連鎖モンテカルロ法(Markov-chain Monte-Carlo methods: MCMC法)を用いた。ベイズ・メタ解析を試みたところ,全患者2,708例のCBRのオッズ比(OR)では1.559[95%CI: 0.768-3.238]であったが,HER2陽性患者568例ではOR: 2.281[95%CI: 1.490-3.628]と統計学的な有意差が認められた。副次的評価であるOSのハザード比(HR)は,HER2陽性患者でHR: 0.789(95%CI: 0.556-1.086)と統計的有意差は認められなかったが,HER2陽性患者に対するCBRのNNTでは5.164(95%CI: 3.803-8.723)と有意な結果が得られた。
目次
Summary
The efficacy of treatments involving lapatinib for patients with metastatic breast cancers was evaluated in a Bayesian meta-analysis of published data from randomized controlled clinical trials. Four randomized controlled trials including 2,708 patients met the inclusion criteria. Among these patients, 568 were positive for the human epidermal growth factor receptor 2(HER2). The clinical benefit rate(CBR)for HER2-positive patients was the primary outcome of the analysis, and the overall survival(OS)and the number needed to treat(NNT)were the secondary outcomes of the reported meta-analysis. The Bayesian meta-analysis was conducted according to the Markov-chain Monte-Carlo technique in WinBUGS. The CBR for HER2-positive patients was significantly improved(odds ratio[OR]: 2.281, 95% confidence interval[CI]: 1.490-3.628), whereas no statistically significant improvement was seen in the overall patient CBR(OR: 1.559, 95% CI: 0.768-3.238). The OS hazard ratio(HR)and NNT for the CBR were also estimated for HER2-positive patients. The difference in the OS HR was not statistically significant(HR: 0.789, 95% CI: 0.556-1.086)for HER2-positive patients. The improvement in the NNT for the CBR was statistically significant(NNT 5.164, 95% CI: 3.803-8.723)for HER2-positive patients.
要旨
転移性乳がん患者におけるラパチニブ治療群と非ラパチニブ治療群の臨床評価をデータ統合型研究であるベイズ・メタ解析手法を用いて解析を試みた。ランダム化比較試験を中心に文献検索を実施し,4報の関連論文を入手した。臨床指標として主要評価はclinical benefit rate(CBR)を,副次的評価はoverall survival(OS),number needed to treat(NNT)とした。解析手法としては,ベイズ・メタ解析によるマルコフ連鎖モンテカルロ法(Markov-chain Monte-Carlo methods: MCMC法)を用いた。ベイズ・メタ解析を試みたところ,全患者2,708例のCBRのオッズ比(OR)では1.559[95%CI: 0.768-3.238]であったが,HER2陽性患者568例ではOR: 2.281[95%CI: 1.490-3.628]と統計学的な有意差が認められた。副次的評価であるOSのハザード比(HR)は,HER2陽性患者でHR: 0.789(95%CI: 0.556-1.086)と統計的有意差は認められなかったが,HER2陽性患者に対するCBRのNNTでは5.164(95%CI: 3.803-8.723)と有意な結果が得られた。