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会議資料 (170 ページ)

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》
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要望番号;III➀-73
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 C1 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.
7.2. Group B, high risk: Induction: R-COPADM course n°1 and course
n°2
R-COPADM1 starts on D8 of COP (can delay for up to 3 days if ongoing
metabolic/other problems).
Note: Control renal function before administrating methotrexate. If GFR is
< 60 ml/min/1.73m2 delay methotrexate until GFR > 60 ml/min/1.73m2.
Rituximab 375 mg/m2 on D-2 (= D6 COP) and on D1, before starting
chemotherapy.
Premedicate with paracetamol and chlorpheniramine as per BNFC dosing
and administer as per local practice.

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