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Epidemiological analysis of second primary malignancies in more than 9500 patients treated with imatinib

Leukemia volume 20, page 148 (2006)Cite this article

Reply to Roy et al. Leukemia advance online publication, 14 July 2005. Unexpected occurrence of second malignancies in patients treated with interferon followed by imatinib mesylate for chronic myelogenous leukemia. In their correspondence,1 Roy et al. report that six among 189 CML patients treated with imatinib at their Institution developed a second malignancy. All of the patients had received interferon-based therapy before beginning imatinib therapy. The study reported that the appearance of second malignancies was potentially in accordance with the incidence of cancer in the French population, with the exception of prostate cancer, which was found in three patients. They reported this incidence to be higher than the expected incidence in a French population.

In November 2004 Novartis performed an epidemiological analysis of second primary malignancies among 9518 patients in our global database treated with imatinib during Novartis sponsored clinical trials as well as spontaneous adverse reports from approximately 124 000 patient years (PY) of treatment (unpublished observations, data on file Novartis). The objective was to compare the incidence rates of second cancers among patients treated with imatinib with the expected incidence based on the rates among the general population. In addition, the frequency of spontaneous reports of cancer associated with imatinib was analyzed based on cases collected in the clinical safety database. This analysis did not provide evidence for an increased overall incidence of malignancies or in the incidence of bladder, kidney or prostate tumors in patients treated with imatinib compared to that of an age adjusted general population.

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References

  1. Roy L, Guilhot J, Martineau G, Larchee R, Guilhot F . Unexpected occurrence of second malignancies in patients treated with interferon followed by imatinib mesylate for chronic myelogenous leukemia. Leukemia 2005, Jul 14; [E-pub ahead of print].

  2. Quaglia A, Parodi S, Grosclaude P, Martinez-Gracia C, Coebergh JW, Vercelli M . Differences in the epidemic rise and decrease of prostate cancer among geographical areas in Southern Europe: an analysis of differential trends in incidence and mortality in France, Italy and Spain. Eur J Cancer 2003; 39: 654–665.

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  1. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

    P R Pilot, S Owen & A Hatfield

  2. Novartis Pharma AG, Basel, Switzerland

    K Sablinska

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  1. P R Pilot
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  2. K Sablinska
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  3. S Owen
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  4. A Hatfield
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Pilot, P., Sablinska, K., Owen, S. et al. Epidemiological analysis of second primary malignancies in more than 9500 patients treated with imatinib. Leukemia 20, 148 (2006). https://doi.org/10.1038/sj.leu.2404025

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