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An event is serious (based on the ICH definition) when the patient outcome is:

  • * death

  • * life-threatening

  • * hospitalisation

  • * disability

  • * congenital anomaly

  • * other medically important event

A 78-year-old man received off label treatment of trastuzumab emtansine for metastatic mucoepidermoid carcinoma and developed grade IV liver toxicity while receiving trastuzumab emtansine [route and dosage not stated].

The man, who was diagnosed with mucoepidermoid carcinoma (MEC) underwent surgery for MEC of the right parotid gland in 2012. Ipsilateral neck lymph node dissection showed spread to multiple lymph nodes and extranodal extension. postoperatively, he received external radiation therapy over 7 weeks. After 16 months of surgery and radiation therapy, MEC metastasis to multiple bones including the axial and appendicular skeleton was noted. Further, genetic screening of tumor cells revealed overexpressed HER-2 Neu oncogene. He was initiated on a clinical trial of trastuzumab and later pertuzumab was added to his regimen. He achieved an objective response with significant pain relief for approximately three and half years. However, in June 2018, he complained of a new-onset left anterior chest pain. And, chest CT showed evidence of a soft tissue lesion near the left fourth rib with pleural involvement. Rib lesion biopsy confirmed MEC. He then received external radiation therapy to the bone to relieve pain and initiated on trastuzumab emtansine on a compassionate basis. A complete resolution of rib pain with pleural effusion resolution was noted. He achieved objective response with trastuzumab emtansine treatment. However, after eleven doses in July 2019, trastuzumab emtansine was discontinued due to the grade IV liver toxicity with jaundice as an adverse effect of trastuzumab emtansine.

The man was continuously monitored and did well until 6 months after treatment discontinuation. however, he developed new symptoms including confusion, headaches and unstable gait. A brain MRI demonstrated multiple enhancing lesions of brain metastasis. he was then transferred to home hospice. Unfortunately, the age of 86 years, he died in April 2020.