小児急性白血病の治療研究　　Ｓｔａｎｄａｒｄ　Ｒｉｓｋ　Ｇｒｏｕｐに対するＰｒｏｔｏｃｏｌ　８１１（ＰｈａｓｅＩＩＩ　Ｓｔｕｄｙ）

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書誌事項

タイトル別名
  • Treatment of Acute Childhood Leukemia
  • 小児急性白血病の治療研究Standard risk groupに対するProtocol 811(Phase 3 Study)
  • ショウニ キュウセイ ハッケツビョウ ノ チリョウ ケンキュウ Standar
  • Standard Risk Groupに対するProtocol 811 (Phase III Study)

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抄録

A new protocol 811 for a “standard risk group” of acute lymphocytic leukemia stratified by prognostic factors based on age and white blood cell count at diagnosis was presented in this study. After inducing remission with vincristine (VCR) and prednisolone (Pred), cranial irradiation (1,800 rads) and 1 T methotrexate (MTX) were given as a menigeal leukemia prophylaxis. Thereafter, patients were randomized to receive maintenance therapy of regimen A or B. Regimen A consisted of MTX 225 mg/m2 iv push alternating at 2 week-intervals VCR 2.0 mg/m2×1, Pred 120 mg/m2/day×5. Patients in regimen B received 6 MP 50 mg/m2 daily and MTX 20 mg/m2 p.o. weekly, concomitantly with periodic reinforcement of VCR 2.0 mg/m2×1 and Pred 120 mg/m2/day×5 every four weeks. Also, even numbered patients at randomization received vindesine (VDS) 3.0 mg/m2 instead of VCR. A late intensification therapy high-dose MTX (2,000 mg/m2) was given to all the patients who have been in continuous initial complete remission at 2-years.<br>Sixty seven patients were registered in this study between January 1981 and October 1982. Sixty four patients (95.5%) achieved complete remission, and then were randomized to regimen A (n=32) and regimen B (n=32). There was no difference on remission rate among patients receiving VCR or VDS. As of March 1983, continuous complete remission rates of regimen A and B were 77.9%±10.5% (mean±1 S.D.) and 84.4%±7.5%, respectively. There was no significant differences in continuous remission rates, toxicities and side effects between these two regimens. Twelve patients have been receiving high dose MTX with citrovorum factor rescue for late intensification, but a longer period of observation is needed to evaluate the efficacy of the late intensification therapy.<br>However, these preliminary results showed that the new protocol 811 seemed to be effective to a good prognostic group of acute lymphocytic leukemia in children.

収録刊行物

  • 臨床血液

    臨床血液 24 (12), 1633-1640, 1983

    一般社団法人 日本血液学会

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