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会議資料 (174 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
R-CYVE2 (course n°4) is identical to course n°3, (but without HDMTX &
IT of D18-19 for CNS positive patients) and should start as soon as
peripheral counts have recovered (ANC ~ 1.0 × 109/l and platelets ~ 100 ×
109/l) (usually by days 25 to 28).
Following recovery from course n°4 (R-CYVE2), a full assessment of
response should be carried out. The patient should be in CR to
continue on protocol. Only progressive disease or incomplete remission
with histological confirmation of presence of viable cells in the residue
will be considered as treatment failure. A decision should not be taken
on the basis of a positive PET/CT alone.
9. Group C3 - CSF positive
COP→R-COPADM1→R-COPADM2→R-IT-CYVE-MTX→R-IT-CYVE
→M1→M2
HDMTX 8 g/m2 infused over 24h, except in 1st COPADM

9.1. Group C3 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 R-COPADM1, 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, 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, then move to next course
with MTX at day 5 instead of day 1 (as long as effusions small).
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