よむ、つかう、まなぶ。
会議資料 (175 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》 |
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要望番号；III➀-73
•
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.
9.2. Group C3 - INDUCTION: R-COPADM1 course n°1
The difference between R-COPADM1 and R-COPADM2 is the
duration of infusion of methotrexate and dose of cyclophosphamide
which is doubled in R-COPADM2.
R-COPADM1 starts on D8 after COP (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.
HDMTX 8g/m2 is given over 24 hours infusion except in the first course
where it is given over 4 hours.
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.
9.3. Group C3 - INDUCTION: R-COPADM2 course n°2
COPADM2 should start as soon as peripheral counts have recovered (ANC
~ 1.0 × 109/l and platelets ~ 100 × 109/l), (but not less than D16), generally
around D18-21 and should be no more than 21 days after D1 of the first
course. Rituximab of D-2 should be given as soon as peripheral is starting
to recover (ANC ~ 0.5 x 109/l) and fever has resolved, so that R-COPADM2
can start as soon as peripheral count has recovered.
If G-CSF is given after the first R-COPADM course it should have been
discontinued for at least 48 hours prior to start of the course R-COPADM2.
R-COPADM2 (course n°2) is identical to R-COPADM1, EXCEPT
infusion time of MTX is 24 hours (rescue at hour 36) and
cyclophosphamide: 500 mg/m2 /dose, every 12 hours on D 2-4.
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175/370
•
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.
9.2. Group C3 - INDUCTION: R-COPADM1 course n°1
The difference between R-COPADM1 and R-COPADM2 is the
duration of infusion of methotrexate and dose of cyclophosphamide
which is doubled in R-COPADM2.
R-COPADM1 starts on D8 after COP (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.
HDMTX 8g/m2 is given over 24 hours infusion except in the first course
where it is given over 4 hours.
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.
9.3. Group C3 - INDUCTION: R-COPADM2 course n°2
COPADM2 should start as soon as peripheral counts have recovered (ANC
~ 1.0 × 109/l and platelets ~ 100 × 109/l), (but not less than D16), generally
around D18-21 and should be no more than 21 days after D1 of the first
course. Rituximab of D-2 should be given as soon as peripheral is starting
to recover (ANC ~ 0.5 x 109/l) and fever has resolved, so that R-COPADM2
can start as soon as peripheral count has recovered.
If G-CSF is given after the first R-COPADM course it should have been
discontinued for at least 48 hours prior to start of the course R-COPADM2.
R-COPADM2 (course n°2) is identical to R-COPADM1, EXCEPT
infusion time of MTX is 24 hours (rescue at hour 36) and
cyclophosphamide: 500 mg/m2 /dose, every 12 hours on D 2-4.
39
175/370