Progress with interferon in CML--results of the MRC UK CML III study.

527 patients with CML were entered into the multicentre randomised MRC CML III study comparing IFN-alpha n1 to standard chemotherapy, either busulphan or hydroxyurea. Haematologic response to IFN as assessed by the level of control of the WCC predicted cytogenetic response to IFN. Cytogenetic response (< 80% Ph + ve) was seen in 22% of all patients randomised, 11% showing major or complete responses. Major cytogenetic response rate was 18% in Sokal low risk patients, 15% in intermediate risk patients but only 4% in high risk patients. Mantel Byar analyses allowing for time to response showed a survival advantage for cytogenetic responders compared to non-responders. In addition, cytogenetic non-responders to IFN did significantly better than chemotherapy-treated patients. Median survival for all patients was 61 months in the IFN treated groups and 41 months in the no-IFN group. For Ph + ve patients only, the median survival was 63 months compared to 43 months. Sub-group analysis comparing busulphan or hydroxyurea treatment in the IFN and no-IFN treatment arms showed a significant advantage for IFN-compared to busulphan, but no significant difference between IFN and hydroxyurea treated patients, although there was a trend favouring IFN. A proposed overview of all randomised trials comparing IFN to hydroxyurea should, by virture of larger numbers, enable a more accurate assessment of the probable benefit of IFN compared to hydroxyurea therapy.