Axitinib/pembrolizumab

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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 37-year-old woman developed tumour lysis syndrome following treatment with pembrolizumab and axitinib for renal cell carcinoma.

The woman, who had a history of hypertension and clear cell renal carcinoma (metastasis to lung and liver), started receiving pembrolizumab and axitinib 200/5mg [route and frequency not stated]. After 8 days of initiation of therapy, she presented with fatigue and palpitations. At the presentation, she underwent physical examination which showed tachycardia with mild abdominal tenderness. Subsequent laboratory findings showed uric acid of 11.2 mg/dL, potassium of 6.5 mg/dL, serum creatinine of 1.5 mg/dL and serum calcium of 8.8 mg/dL. Thereafter, she underwent EKG which showed sinus tachycardia with peaked T waves. Her laboratory test results and other clinical findings were suspicious of tumour lysis syndrome. Therefore, she was admitted to the intensive care unit.

Subsequently, the woman treated with unspecified IV fluid, allopurinol, calcium gluconate and insulin drip for hyperkalemia. On the day 2 of hospitalisation, she developed shortness of breath and hypoxia. Her respiratory rate was 26 bpm and oxygen saturation level reduced to 86% on room air. Thereafter, at follow-up, her chest X-ray showed a diffuse infiltrate in the lungs concerning for acute respiratory distress syndrome (ARDS). Subsequently, she was intubated and stabilized on mechanical ventilatory support. On the day 3 of hospitalisation, her laboratory findings were noted to be normal. However, she continued to require high ventilator support. Subsequently, she developed a sudden cardiac arrest. Thereafter, she died due to ARDS.