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The Tokyo Children's Cancer Study Group (TCCSG) has performed prospective randomized controlled studies since 1984 for childhood acute lymphoblastic leukemia (ALL). Four hundred and ninety-eight newly diagnosed patients were treated with 5 different regimens designated as S1, S2 for a standard risk group (SRG), H1 and H2 for a high risk group (HRG) and HEX for an extremely high risk group of patients. We added intermediate-dose methotrexate as early intensification therapy in the S2 and H2 groups to reduce extramedullary and medullary relapses. Event-free survival of all patients at 4 years 6 months from the start of this regimen (median follow-up period 32 months) was 67.5%. The CNS relapse rate was significantly decreased to 2.2% compared to previously reported studies and our own experience. There were some unexpected complications of the CNS such as myelopathy and/or leukoencephalopathy. For the SRG early ID-MTX seemed to be useful to improve the prognosis, but triple intrathecal injections (TIT) should be limited in number. The 24Gy cranial irradiation (CRX) was effective but possibly excessive for the HRG. As evidenced by the success of the HEX group regimen, more intensive multi-drug consolidation in the early post-remission phase might be necessary to improve further the prognosis and to make it possible to shorten the treatment periods.

Hepatitis infection in haemophiliacs has been a major problem in their replacement therapy, and factor VIII concentrates manufactured from pooled plasma were realized to be the cause of transmission of AIDS virus. However, several investigators have shown that some of these viruses are inactivated by chemical or physical treatment on factor VIII concentrates. After infusion of a heat-treated factor VIII concentrate (heat-treated at 65°C for 96 hours), a follow up study was carried out in 11 patients who had no infusion of blood nor blood preparations beforehand. During the observation period, there was detected no sign of hepatitis in all patients, and no positive seroconversion to AIDS virus was proved. These results were in a good agreement with the experimental data previously reported from in vitro as well as in vivo experiments where chimpanzees were employed for virus infection test. For the evaluation of the safety for viral infection of clotting factor concentrates in clinical use, these survey results in untreated patients are of a great importance.