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がん化学療法における副作用管理とリスク因子の探索に関する研究

近藤 勝弘 Kondo Masahiro 名古屋市立大学

2021.03.24

概要

がんによる死亡は全世界で増加の一途にあり、日本においても死因の第 1 位である（厚生労働省「令和元年 人口統計月報年計」）。平成 18 年には「がん対策基本法」が施行されるなど、がん治療の発展・充実は我が国の社会的課題であると言える。がん治療には手術療法、放射線療法、化学療法があり、全身治療である化学療法は造血器腫瘍および固形がんのいずれにも適応される。化学療法に用いられる抗悪性腫瘍剤には、従来の殺細胞性抗がん剤に加え、昨今では分子標的治療剤や免疫チェックポイント阻害剤など様々な作用機序を有する薬剤が登場している。多くの臨床試験によって、これらの単剤治療もしくは多剤併用療法が、従来治療と比べ腫瘍縮小効果や生存期間の点で改善をもたらすことが証明されており、化学療法は近年目覚ましい進歩を遂げている。

一方、抗悪性腫瘍剤による化学療法は、副作用が必発で不可避であることが臨床上問題となる。化学療法の効果を最大限に発揮させるためには、副作用による抗悪性腫瘍剤の減量や中止を可能な限り回避し、治療強度と治療継続性を維持することが必要である。したがって、副作用の発現率、発現時期、ならびに発現に関連するリスク因子の把握は、副作用を制御するための支持療法の最適化に繋がり治療成績を向上させるうえで重要となる。通常、副作用に関する情報は治験を含む臨床試験の結果から得られる。しかし、後期高齢者や高度腎機能低下患者など、臨床試験の対象外となる「スペシャル・ポピュレーション」と呼ばれる集団が存在するとおり、臨床試験が実臨床で対象となる全ての患者層をカバーできているわけではない。また、臨床試験は主に有効性に主眼を置いて実施されるため、副作用に関連したリスク因子に関する検討は乏しい。

本研究は、化学療法の治療成績向上に繋がる効果的な副作用管理をテーマに、副作用の発現に係るリスク因子、および「スペシャル・ポピュレーション」における副作用情報に着目し、病院薬剤師としての臨床経験から生まれたクリニカル・クエスチョンに基づく 3つの検討を行った。第一章では、化学療法による副作用「悪心・嘔吐」に対する予防制吐剤ホスアプレピタントを静脈内投与した際の「投与部位反応」に関する研究を行った。第二章では、片側腎摘出術後の単腎患者を対象にシスプラチン投与時の治療忍容性に関する研究を行った。単腎患者は臨床試験において除外基準に含まれる「スペシャル・ポピュレーション」に該当する集団である。第三章では、多発性骨髄腫患者を対象に、化学療法によって腫瘍細胞が崩壊することで発症する副作用「腫瘍崩壊症候群」に関する研究を行った。

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