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会議資料 (171 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
2nd course of R-COPADM: is identical to course n°1. It should start as
soon as peripheral blood 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 at D-2 should be given as soon as peripheral blood count is
starting to recover (ANC ~ 0.5 × 109/l) and fever has resolved, so that
course R-COPADM2 can start as soon as peripheral count has recovered
(ANC ~ 1.0 × 109/l and platelets ~ 100 × 109/l). It is very important not to
delay the start of course n°2, as delay between the 2 courses has been
shown to be of adverse prognostic significance. Note: G-CSF is not
recommended after these courses. If G-CSF is given after the first
COPADM course, it should have been discontinued for at least 48 hours
prior to start the second course of COPADM.
7.3. Group B, high risk: CONSOLIDATION: 2 × R-CYM = Course n°3
and course n°4
First R-CYM (= course n°3) should start when the peripheral counts have
recovered following 2nd course of R-COPADM, with ANC ~ 1.0 × 109/l and
platelets ~ 100 × 109/l (but not less than D16).
Rituximab 375 mg/m2 on D1, before starting chemotherapy.
Premedicate with paracetamol and chlorpheniramine as per BNFC dosing
and administer as per local practice.
Following recovery from 1st R-CYM a full assessment of response
should be carried out (see section 11.5). If complete remission is not
obtained with histological confirmation, the patient (“slow responder”)
should be switched to C1 regimen starting at R-CYVE. They will receive
rituximab only with the first R-CYVE in order to receive a total of 6
courses.
Second R-CYM is identical to course n°3. It should start as soon as
peripheral counts have recovered (ANC ~ 1.0 × 109/l and platelets ~ 100 ×
109/l).
8. Group C1 – Burkitt acute leukaemia and CNS positive (CSF
negative)
COP* → R-COPADM1 → R-COPADM2 → R-CYVE** → R-CYVE → M1 →
M2
HDMTX 8 g/m2 infused over 4h
* Non responder at D7: assigned to group C3
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2nd course of R-COPADM: is identical to course n°1. It should start as
soon as peripheral blood 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 at D-2 should be given as soon as peripheral blood count is
starting to recover (ANC ~ 0.5 × 109/l) and fever has resolved, so that
course R-COPADM2 can start as soon as peripheral count has recovered
(ANC ~ 1.0 × 109/l and platelets ~ 100 × 109/l). It is very important not to
delay the start of course n°2, as delay between the 2 courses has been
shown to be of adverse prognostic significance. Note: G-CSF is not
recommended after these courses. If G-CSF is given after the first
COPADM course, it should have been discontinued for at least 48 hours
prior to start the second course of COPADM.
7.3. Group B, high risk: CONSOLIDATION: 2 × R-CYM = Course n°3
and course n°4
First R-CYM (= course n°3) should start when the peripheral counts have
recovered following 2nd course of R-COPADM, with ANC ~ 1.0 × 109/l and
platelets ~ 100 × 109/l (but not less than D16).
Rituximab 375 mg/m2 on D1, before starting chemotherapy.
Premedicate with paracetamol and chlorpheniramine as per BNFC dosing
and administer as per local practice.
Following recovery from 1st R-CYM a full assessment of response
should be carried out (see section 11.5). If complete remission is not
obtained with histological confirmation, the patient (“slow responder”)
should be switched to C1 regimen starting at R-CYVE. They will receive
rituximab only with the first R-CYVE in order to receive a total of 6
courses.
Second R-CYM is identical to course n°3. It should start as soon as
peripheral counts have recovered (ANC ~ 1.0 × 109/l and platelets ~ 100 ×
109/l).
8. Group C1 – Burkitt acute leukaemia and CNS positive (CSF
negative)
COP* → R-COPADM1 → R-COPADM2 → R-CYVE** → R-CYVE → M1 →
M2
HDMTX 8 g/m2 infused over 4h
* Non responder at D7: assigned to group C3
35
171/370