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The Pharmaceutical Journal
Vol 270 No 7241 p393
22 March 2003

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Imatinib hailed as first-line treatment

Introduction of imatinib has had an impact on numbers of transplants being performed

Imatinib (Glivec) "now seems to be the initial treatment of choice" for patients with chronic myeloid leukaemia (CML) who are not candidates for transplantation, according to Dr Karl Peggs and Dr Stephen Mackinnon, of the Royal Free and University College London medical school, London. Furthermore, initial treatment with imatinib might be useful for all CML patients while the suitability of stem-cell transplantation, the only curative treatment for CML, is considered, they say.

Their comments are made in an editorial published in The New England Journal of Medicine alongside a study showing that patients with CML assigned to imatinib were over five times more likely to respond to treatment than those assigned to interferon alfa plus low-dose cytarabine (2003; 348:1048 and 994).

The study investigators randomised 1,106 patients to receive imatinib (400mg daily) or interferon alfa (maximum tolerated dose) plus low-dose cytarabine (up to 40mg daily for 10 days every month). Patients were allowed to change groups if they had no response, had a loss of response, or could not tolerate treatment.

After 18 months, 76.2 per cent of newly diagnosed patients treated with imatinib had achieved a complete cytogenetic response (no cells containing the Philadelphia chromosome, the genetic abnormality that characterises most cases of CML, were detected) compared with 14.5 per cent of those treated with interferon plus cytarabine (P<0.001).

The investigators point out that the introduction of imatinib has already had an impact on the numbers of allograft transplants being performed. "The choice between drug therapy and transplantation for newly diagnosed CML is becoming increasingly difficult," they say.

The study will continue for at least five years, allowing the investigators to determine the long-term outcome of imatinib therapy. "However, taking into account the high rate of complete cytogenetic response and the early evidence of a delay in the progression to accelerated-phase or blast-crisis CML, we believe that imatinib therapy may significantly improve long-term survival," the investigators conclude.

Data from the study were presented in December 2002 at the American Society of Hematology in Philadelphia, Pennsylvania (PJ, 21/28 December 2002, p879).

The National Institute for Clinical Excellence is expected to publish guidance on the use of imatinib in patients newly diagnosed with CML in September. Currently, NICE recommends that only patients with Philadelphia-positive CML in the chronic phase, who are intolerant to interferon alfa therapy, or those in blast crisis or the accelerated phase, should have access to imatinib.

Prostate cancer Imatinib in combination with paclitaxel (Taxol) may be an effective treatment for bone metastases from prostate cancer, according to the authors of a new study. They injected human prostate cancer cells into the leg bones of mice treated with imatinib alone, paclitaxel alone, imatinib plus paclitaxel or water. Treatment with imatinib plus paclitaxel resulted in more tumour cell death, inhibited the growth of bone tumours and preserved bone structure (Journal of the National Cancer Institute 2003;95:458).