Imatinib: In Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia

Author： Cross Sarah A. Lyseng-Williamson Katherine A.

ISSN： 0012-6667

Source： Drugs, Vol.67, Iss.17, 2007-01, pp. : 2645-2654

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Abstract

▴ Imatinib inhibits the breakpoint cluster region-Abelson (BCR-ABL) tyrosine kinase, which is produced by the chromosomal abnormality known as the Philadelphia (Ph) chromosome in patients with Ph chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL).▴ The clinical efficacy and safety of oral imatinib in patients with relapsed or refractory Ph+ ALL has been demonstrated in a noncomparative, open-label phase II trial (n = 48) and an expanded-access study (n = 353). The majority of patients received imatinib 600mg once daily. ▴ In the phase II trial, imatinib induced complete haematological responses in 19% of patients, marrow complete responses in 10% of patients and partial marrow responses in 31% of patients. These were sustained for at least 4 weeks in 27% of patients.▴ The estimated median times to progression were 2-3.1 months in the phase II trial, the expanded-access study and a population of 68 patients pooled from these studies, with estimated median overall survival rates of 4.9-9 months. ▴ In 22 patients receiving imatinib prior to undergoing allogeneic stem cell tranplantation (SCT) in the phase II trial and expanded-access study, estimated disease-free survival and overall survival rates 12 months after SCT were 25.5% and 44.8%. ▴ Although adverse events were frequent among relapsed or refractory Ph+ ALL patients treated with imatinib, the majority of non-haematological adverse events were mild or moderate in severity.