CELSG CML 11 “ISTAHIT” Phase III Study – Planned Interim Analysis: High Doses of Imatinib Mesylate (800mg/day) Significantly Improve Rates of Major and Complete Cytogenetic Remissions (MCR, CCR) in Pretreated Ph + /BCR-ABL + CML Patients in Chronic Phase.
2008
We have recently reported results from the first planned interim analysis of a multicenter, randomised, 2-arm - phase III study comparing imatinib standard dose (400 mg/day; arm A) with imatinib high dose (HD) induction (800 mg/day; HD arm B) followed by imatinib standard dose maintenance (400 mg/day) in pretreated Ph + /BCRABL + CML patients in chronic phase (CP; Blood,110,1048a). The first planned interim analysis was performed after 50% of the patients had been treated for 12 months (mo) since randomisation. A total of 227 patients were randomized. Pretreatments included hydroxyurea (96%), interferon (72%), busulfan (17%) and “others” (26%; mainly AraC +/− combinations). Although rates of complete haematological responses did not differ significantly between the 2 arms at 3, 6 and 12 mo, significantly more patients achieved a major (MCR) and a complete cytogenetic response (CCR) at 3 mo (MCR: 21% arm A, 37% arm B, p=0.01; CCR: 6% arm A, 25% arm B, p Conclusions: These updated phase III data not only support the concept of more rapid and higher rates of cytogenetic remissions (MCR, CCR) when higher doses of imatinib are applied, they also suggested that patients that are capable to tolerate continous high dose imatinib may have a better outcome.
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