内容紹介
Summary
The postmarketing assessment of biosimilars is important because posttranslational modification by glycosylation is altered by the manufacturing process. A retrospective study of 15 patients with gastric cancer receiving a combination anticancer therapy with trastuzumab was performed. The most common concurrent regimen was the S—1 and oxaliplatin combination;efficacy and adverse events were assessed in this group. There was no statistically significant difference in progression—free survival between patients receiving the reference formulation and patients receiving its biosimilar. The adverse events detected were similar in both groups. In the 6 patients who switched from the reference trastuzumab to its biosimilar, adverse events did not differ before and after the switch. This small—scale retrospective study found no differences in efficacy or adverse events between the reference trastuzumab and its biosimilar.
要旨
バイオ後続品は製造工程の違いにより糖鎖付加の翻訳後修飾が異なるため,市販後の評価が重要である。本研究では,トラスツズマブ併用がん薬物療法を投与した胃癌患者15例を後方視的に調査した。併用がん薬物療法はS—1+oxaliplatinが最も多く,有効性と有害事象の評価レジメンとした。先行バイオ医薬品投与群とバイオ後続品投与群において無増悪生存期間の統計学的有意差は認められなかった。有害事象は,先行バイオ医薬品投与群,バイオ後続品投与群ともに同様であった。トラスツズマブ先行バイオ医薬品からバイオ後続品に切り替えた6例では,切り替え前後の有害事象に変化は認められなかった。本報告は少数例での後方視的調査であるが,有効性と有害事象において先行バイオ医薬品とバイオ後続品に違いは認められなかった。
目次
The postmarketing assessment of biosimilars is important because posttranslational modification by glycosylation is altered by the manufacturing process. A retrospective study of 15 patients with gastric cancer receiving a combination anticancer therapy with trastuzumab was performed. The most common concurrent regimen was the S—1 and oxaliplatin combination;efficacy and adverse events were assessed in this group. There was no statistically significant difference in progression—free survival between patients receiving the reference formulation and patients receiving its biosimilar. The adverse events detected were similar in both groups. In the 6 patients who switched from the reference trastuzumab to its biosimilar, adverse events did not differ before and after the switch. This small—scale retrospective study found no differences in efficacy or adverse events between the reference trastuzumab and its biosimilar.
要旨
バイオ後続品は製造工程の違いにより糖鎖付加の翻訳後修飾が異なるため,市販後の評価が重要である。本研究では,トラスツズマブ併用がん薬物療法を投与した胃癌患者15例を後方視的に調査した。併用がん薬物療法はS—1+oxaliplatinが最も多く,有効性と有害事象の評価レジメンとした。先行バイオ医薬品投与群とバイオ後続品投与群において無増悪生存期間の統計学的有意差は認められなかった。有害事象は,先行バイオ医薬品投与群,バイオ後続品投与群ともに同様であった。トラスツズマブ先行バイオ医薬品からバイオ後続品に切り替えた6例では,切り替え前後の有害事象に変化は認められなかった。本報告は少数例での後方視的調査であるが,有効性と有害事象において先行バイオ医薬品とバイオ後続品に違いは認められなかった。