レボホリナート・フルオロウラシル療法  [in Japanese] Levofolinate and fluorouracil combination therapy  [in Japanese]

Abstract

レボホリナート(アイソボリン<SUP>®</SUP>)·フルオロウラシル療法(l-LV·5FU療法)は, biochemical modulationの理論に基づく治療法であり欧米においてはロイコボリン·5FU療法(dl-LV·5FU療法)として結腸·直腸癌を中心にその臨床応用が活発に行われ, 現在では標準治療の一つと位置付けられている. 国内においてはd-LVが生理活性の無いことから生理活性を有するl-LVを用いて臨床試験を実施し, 欧米の成績に匹敵する効果が得られ1999年8月にレボホリナート·フルオロウラシル療法として胃癌(手術不能または再発), 結腸·直腸癌の効能で承認された. 用法·用量はRoswell Park Memorial Institute (RPMI)のPetrelli, N.らが開発したweekly法が国内で承認されている. 近年, LV·5FU療法とイリノテカン(CPT-11)あるいはオキサリプラチンを併用する療法の有用性が確認されつつあるが, 日本人を対象としたこれらの臨床試験成績はまだ無く, 日常診療において実施できる状況ではない. l-LV·5FU療法の臨床試験における有害事象は白血球減少と下痢が主なものであり, grade3以上の重篤なものも認められている. そのため, 本療法実施にあたっては適切な症例を選択し副作用症状や臨床検査値を投与毎にモニターし, 異常が認められた場合には休薬または減量をするなどの対処が重要である.

Levofolinate and fluorouracil regimen (l-leucovorin and 5 fluorouracil regimen) is a biochemical modulation of 5 fluorouracil (5FU) by leucovorin (LV). In the USA and Europe d,l-LV and 5FU regimen is frequently administered for colorectal cancer treatment and recognized as the standard regimen. In Japan, multi-institutional clinical trials of l-leucovorin (l-LV), a bioactive diastereomer of leucovorin, and 5FU combination were conducted for the treatment of advanced gastrointestinal cancer with comparable results to the US/Europe data. This l-LV and 5FU regimen was approved in August 1999 for the indications of advanced gastric cancer and colorectal cancer. The dosage and administration is referred to the weekly method developed at RPMI. Recently, the irinotecan (CPT-11) or oxariplatin plus LV and 5FU combination showed higher antitumor activities than the LV and 5FU combination with increased progression-free survival. These regimens, however, are not yet properly established because clinical trial results with Japanese patients are not completed for agreement of the dosage and administration schedule. For the l-LV and 5FU regimen diarrhea and leukocytopenia, including grade 3 and higher, were reported as the major adverse events. Administration for eligible patients with periodical monitoring of diagnostic data is necessary.

Journal

Folia Pharmacologica Japonica  

Folia Pharmacologica Japonica 118(3), 211-218, 2001-09-01 

The Japanese Pharmacological Society

References:  22

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Codes

  • NII Article ID (NAID) :
    10007943485
  • NII NACSIS-CAT ID (NCID) :
    AN00198335
  • Text Lang :
    JPN
  • Article Type :
    REV
  • ISSN :
    00155691
  • NDL Article ID :
    5890685
  • NDL Source Classification :
    ZS51(科学技術--薬学)
  • NDL Call No. :
    Z19-247
  • Databases :
    CJP  NDL  J-STAGE 

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