会議資料 (172 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000198856_00046.html |
| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議(第68回 5/25)《厚生労働省》 |
ページ画像
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
**CNS pos: IT before each CYVE and HDMTX between 1st and 2nd CVYE
8.1. Group C1 Pre-phase: COP
Rituximab 375 mg/m2 on D6 (= D-2 R-COPADM1).
Premedicate with paracetamol and chlorpheniramine as per BNFC dosing
and administer as per local practice.
ALL PATIENTS RECEIVE RITUXIMAB AND SHOULD RECEIVE
IT AT D-2 OF COURSE N°1, ie, AT D6 OF COP, one day before the D7
COP evaluation. There may be situations where it does not seem possible
to proceed with R-COPADM1 at D8, then a second course of COP should
be considered:
• the patient is too unstable to receive R-COPADM1, i.e. patients with
renal failure, creatinine clearance < 60 ml/min/1.73m2, septicaemia or
other sepsis or grade 3/4 organ toxicity, then a second course of COP
should be considered.
• In the case of significant effusion at diagnosis (with a risk of MTX
accumulation):
- If the effusion is small at D7 assessment, ignore and continue
R-COPADM1.
- If significant effusions but adequate overall response then give next
course with MTX at day 5 instead of day 1 or consider to give a
second course COP.
- If significant effusions and no response (< 20% reduction), then move
to Group C3 and give next course with MTX at day 5 instead of day 1
(as long as effusions small).
• elevation of transaminases, sometimes with an increase in liver size, can
be seen after COP and is probably due to a combination of
corticosteroids and poor nutrition status (where this was present at
outset). In the case of transaminases > 10 × ULN it is preferable to wait
48 hours and proceed to R-COPADM1 if transaminases decrease. If not,
give a second course of COP.
In any case when R-COPADM1 has to be postponed, Rituximab will
not be given with R-COPADM1, but at the planned time, ie at D6 and
D8 of 1st COP, if the clinical situation is controlled.
8.2. Group C1- INDUCTION: R-COPADM course n°1 and course n°2
R-COPADM1 starts on COP D8 (can delay for up to 3 days if ongoing
metabolic/other problems).
36
172/370