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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case-series five patients (3 men and 2 women) aged 31−71 years were described, who developed immune checkpoint inhibitor related sarcoid-like granulomatous inflammation, indicated for cancers [not all routes and outcomes stated].
Case 1 : The 32-year-old woman 1had malignant melanoma of the left upper shoulder status post wide local excision and sentinel lymph node excision with focal involvement of the left axillary sentinel lymph node with metastatic melanoma, T4b, N1a, Mx, Stage IIIC. She received adjuvant therapy with two doses of IV nivolumab 480mg. She was then advised to follow-up with medical oncology every 4−6 months for 5 years, followed by annual follow-up thereafter. She eventually underwent melanoma excision. Two months after the excision, she received...
- Rodriguez EF, et al. Immune checkpoint blocker-related sarcoid-like granulomatous inflammation: a rare adverse event detected in lymph node aspiration cytology of patients treated for advanced malignant melanoma. Human Pathology 91: 69-76, Sep 2019. Available from: URL: http://doi.org/10.1016/j.humpath.2019.07.001 - USA