内容紹介
Safety Evaluation of Paclitaxel Injection NK in Tri-Weekly Administration of Paclitaxel plus Carboplatin(TC Therapy)for Gynecological Cancers
Summary
Paclitaxel is a key drug used for the treatment of gynecological cancers, breast cancer, and gastric cancer. While there is a great deal of safety information on the weekly administration of generic paclitaxel NK(paclitaxel injection NK)and proprietary paclitaxel(TaxolⓇ injection), little is known about their safety when administered tri-weekly, partly due to a small sample size. Therefore, to gain more information and to validate the safety of using generic paclitaxel NK in a tri-weekly regimen, we investigated the incidences of adverse events in response to it in a larger number of patients. The incidence of constipation was found to be higher in response to all grades of generic paclitaxel NK, with significant differences between the various grades. The profiles of other adverse events, however, were not significantly different. Thus, generic paclitaxel NK is as safe as the proprietary paclitaxel for tri-weekly administration.
要旨
パクリタキセルは婦人科がん,乳がん,胃がんなどにおいてキードラッグである。後発医薬品であるパクリタキセル注「NK」と先発医薬品タキソールⓇ注の安全性の比較はweekly投与の報告がほとんどであり,tri-weekly投与の報告はサンプル数の少ない報告しかない。今回,サンプル数を増やしパクリタキセル注「NK」のtri-weekly投与における安全性を評価した。先発医薬品と後発医薬品の両群においてall gradeの便秘のみ有意差が認められた(p=0.037)。その他の有害事象において有意差は認められず,パクリタキセル注「NK」はtri-weekly投与においても先発医薬品と同様に安全性が保たれていることが示唆された。
目次
Summary
Paclitaxel is a key drug used for the treatment of gynecological cancers, breast cancer, and gastric cancer. While there is a great deal of safety information on the weekly administration of generic paclitaxel NK(paclitaxel injection NK)and proprietary paclitaxel(TaxolⓇ injection), little is known about their safety when administered tri-weekly, partly due to a small sample size. Therefore, to gain more information and to validate the safety of using generic paclitaxel NK in a tri-weekly regimen, we investigated the incidences of adverse events in response to it in a larger number of patients. The incidence of constipation was found to be higher in response to all grades of generic paclitaxel NK, with significant differences between the various grades. The profiles of other adverse events, however, were not significantly different. Thus, generic paclitaxel NK is as safe as the proprietary paclitaxel for tri-weekly administration.
要旨
パクリタキセルは婦人科がん,乳がん,胃がんなどにおいてキードラッグである。後発医薬品であるパクリタキセル注「NK」と先発医薬品タキソールⓇ注の安全性の比較はweekly投与の報告がほとんどであり,tri-weekly投与の報告はサンプル数の少ない報告しかない。今回,サンプル数を増やしパクリタキセル注「NK」のtri-weekly投与における安全性を評価した。先発医薬品と後発医薬品の両群においてall gradeの便秘のみ有意差が認められた(p=0.037)。その他の有害事象において有意差は認められず,パクリタキセル注「NK」はtri-weekly投与においても先発医薬品と同様に安全性が保たれていることが示唆された。