よむ、つかう、まなぶ。
会議資料 (165 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
(2) Group C
“PRINCIPLES OF SYSTEMIC THERAPY (BL and DLBCL)”にて、
Group C に 対 す る 寛 解 導 入 療 法 の 推 奨 レ ジ メ ン と し て ”COG
ANHL1131 (based on FAB/LMB96 with omission of M3 and M4 cycles)
Regimen C1”及び”COG ANHL1131 Regimen C3”が示されており、以下
の記載がある。
Preferred Regimens for Induction Therapy (Group C)
COG ANHL1131 (based on FAB/LMB96 with omission of M3 and M4
cycles) Regimen C1
▶ Regimen C1/Induction 1 & 2 R-COPADM
◊ Induction I starts on day 8 of the COP pre-phase. Note: The first dose of
rituximab is given on day 6 of the pre-phase.
– In the event the patient is too ill to proceed to R-COPADM1, a second
COP phase may be administered.
– In the event of significant effusions or renal dysfunction on day 1,
high-dose methotrexate may be delayed to day 5 or omitted in the
context of persistent or large fluid collections.
◊ Induction II starts 16-21 days after the start of Induction I, as soon as
counts are recovering toward ANC 750 and platelets 75,000, resolving
mucositis and clinically stable. Delays are to be avoided. Give day minus
2 rituximab as counts start recovering.
[Dose and schedule]
Rituximab: 375 mg/m² on day minus 2 (day 6 of COP pre-phase for
R-COPADM1 [can be administered prior to response
assessment]) and day 1
▶ Regimen C1/Consolidation 1 & 2 R-CYVE
◊ Consolidation cycles start 16-21 days after the start of the previous cycle,
as soon as counts are recovering toward ANC 750 and platelets 75,000,
resolving mucositis and clinically stable. If not in remission after
R-CYVE 2 cycle, proceed to treatment for refractory disease.
[Dose and schedule]
Rituximab: 375 mg/m² on day 1
COG ANHL1131 Regimen C3
▶ This regimen is identical to Regimen C1 with the following exception:
◊ The high-dose methotrexate (8 gm/m²) during R-COPADM2, at day 18 of
29
165/370
(2) Group C
“PRINCIPLES OF SYSTEMIC THERAPY (BL and DLBCL)”にて、
Group C に 対 す る 寛 解 導 入 療 法 の 推 奨 レ ジ メ ン と し て ”COG
ANHL1131 (based on FAB/LMB96 with omission of M3 and M4 cycles)
Regimen C1”及び”COG ANHL1131 Regimen C3”が示されており、以下
の記載がある。
Preferred Regimens for Induction Therapy (Group C)
COG ANHL1131 (based on FAB/LMB96 with omission of M3 and M4
cycles) Regimen C1
▶ Regimen C1/Induction 1 & 2 R-COPADM
◊ Induction I starts on day 8 of the COP pre-phase. Note: The first dose of
rituximab is given on day 6 of the pre-phase.
– In the event the patient is too ill to proceed to R-COPADM1, a second
COP phase may be administered.
– In the event of significant effusions or renal dysfunction on day 1,
high-dose methotrexate may be delayed to day 5 or omitted in the
context of persistent or large fluid collections.
◊ Induction II starts 16-21 days after the start of Induction I, as soon as
counts are recovering toward ANC 750 and platelets 75,000, resolving
mucositis and clinically stable. Delays are to be avoided. Give day minus
2 rituximab as counts start recovering.
[Dose and schedule]
Rituximab: 375 mg/m² on day minus 2 (day 6 of COP pre-phase for
R-COPADM1 [can be administered prior to response
assessment]) and day 1
▶ Regimen C1/Consolidation 1 & 2 R-CYVE
◊ Consolidation cycles start 16-21 days after the start of the previous cycle,
as soon as counts are recovering toward ANC 750 and platelets 75,000,
resolving mucositis and clinically stable. If not in remission after
R-CYVE 2 cycle, proceed to treatment for refractory disease.
[Dose and schedule]
Rituximab: 375 mg/m² on day 1
COG ANHL1131 Regimen C3
▶ This regimen is identical to Regimen C1 with the following exception:
◊ The high-dose methotrexate (8 gm/m²) during R-COPADM2, at day 18 of
29
165/370