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An event is serious (FDA MedWatch definition) when the patient outcome is:

  • * death

  • * life-threatening

  • * hospitalisation

  • * disability

  • * congenital anomaly

  • * requires intervention to prevent permanent impairment or damage

A 42-year-old woman developed tuberculous granulomatous lymphadenitis and a 62-year-old man developed non-tuberculous granulomatous lymphadenitis during treatment with imatinib [imatinib mesylate]. [routes not stated]

The 42-year-old woman diagnosed with a tyrosine kinase-positive high risk gastrointestinal stromal tumour (GIST) of the jejunum, underwent surgery resulting in complete removal of gross disease. Postoperatively she was started on imatinib 400 mg/day. Eight months later she underwent resection of progressive recurrent peritoneal disease, followed by dose escalation of imatinib to 800 mg/day. At 16 months from initial diagnosis, 1 suspicious positron emission tomography (PET) positive supraclavicular lymph node revealed caseating granulomatous inflammation consistent with tuberculosis. Mycobacterium tuberculosis infection was confirmed by PCR examination. She was started on anti-tuberculous therapy with isoniazid, rifabutin and pyrazinamide for 2 months, followed by isoniazid and rifabutin for an additional 4 months. Sufficient imatinib exposure was ensured by continuously monitoring imatinib levels during the anti-tuberculous treatment. For further 8 months imatinib 800 mg was continued and then because of intra-abdominal progression of disease, had to be stopped. She was switched to sunitinib, sorafenib and nilotinib because of progressive disease, during the next 15 months. There was no evidence of reactivation of tuberculosis until her death 29 months after initial diagnosis.

The 62-year-old man with intermediate risk GIST developed an abdominal recurrence 7 years later. After neoadjuvant 400 mg/day imatinib for 8 months, he underwent resection of the stomach antrum, gallbladder and atypical resection of the liver. One month later, a subcarinal lymph node with increased FDG uptake on PET-CT was noted suggesting metastatic disease. Lymph node biopsy revealed granulomatous disease with focal necrosis suggesting sarcoidosis or tuberculosis. During imatinib treatment, new lung lesions were surgically removed. Histological examination revealed near totally regressing lung metastasis from GIST without evidence of granulomatous disease. He remained in continuous complete remission on imatinib for more than 38 months. The lymph nodes showed decreasing FDG uptake on follow-up FDG-PET-CT. Periodic CT scans did not show any new lymphadenopathy.

Author comment: "In this report, we present our experience with 2 patients who developed lymphadenopathy under imatinib treatment for metastatic GIST"