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| |  Dasatinib Monotherapy Effective and Feasible as First-Line Treatment of Adult Philadelphia-Chromosome Positive Acute Lymphoblastic Leukaemia: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 17, 2008 -- Dasatinib showed a 100% complete haematological response rate in patients with adult Philadelphia (Ph)-chromosome-positive acute lymphoblastic leukaemia (ALL), according to new research. Robin Foà, MD, Haematology Institute, Sezione Clinica, Turin, Italy, presented the interim study results of the GIMEMA LAL (Italian Group for Adult Haematologic Diseases, Acute Lymphoid Leukaemia) 1205 study here on June 15 at the 13th Congress of the European Hematology Association (EHA). Adult Ph-chromosome-positive patients with previously untreated ALL received oral dasatinib 70 mg BID. To enable the identification of Bcr/Abl transcripts, a steroid predose was initiated 1 week prior to dasatinib treatment and was continued for 1 month. Intrathecal methotrexate was also administered at days 22 and 43. The current analysis included 36 patients out of an expected enrolment of 48 patients. The median age was 56 years, although 9 patients were older than 60 years. One patient stopped treatment after 14 days due to intestinal toxicity and 1 patient refused treatment, for a total of 34 evaluable patients. The interim results show that all evaluable patients achieved a complete haematological response. Of the 34 evaluable patients, 32 (95%) obtained a complete haematological remission at the first determination at day 22, "highlighting the high level of activity of this agent," Dr. Foà pointed out. No fatalities occurred during treatment. A total of 23 severe adverse events were reported: 1 was life-threatening, 9 severe, 10 moderate, and 3 mild. One patient stopped treatment during the induction phase. Overall survival at 10 months was 80.7%, and no patients relapsed during treatment with dasatinib. Nine relapses have occurred to date, all after stopping treatment. Molecular analysis indicated that among 6 relapsed patients, 3 had the T315I mutation, 1 had E255K, and 2 had wild-type mutations. Multivariate analysis showed that a polymerase chain reaction (PCR) reduction of >10-3 compared with <10-3 was associated with a trend toward disease-free survival (P = .0664). In addition, patients with the p190-positive molecular subgroup of Bcr/Abl showed a trend towards greater sensitivity to treatment compared with the p210-positive subgroup. "These preliminary findings suggest that treatment of adult Philadelphia-chromosome-positive ALL is feasible in all age groups in adults," Dr. Foà said. "Overall compliance was good and there was a high rate of very early remission and a marked, and rapid, debulking of disease documented by immunophenotypic and molecular monitoring." "The degree of PCR response appears to be of prognostic relevance, and patients with rapid debulking and good clearance appeared to do better," he noted.
[Presentation title: Dasatinib Monotherapy as 1st Line Treatment of Ph Acute Lymphoblastic Leukemia (ALL) Patients: Update of the GIMEMA LAL1205 Study. Abstract 922]
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