Ipilimumab/nivolumab

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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

An 83-year-old man and a 74-year-old woman developed immune-related pneumonitis during treatment with ipilimumab and nivolumab for metastatic melanoma.

Both patients, who had a history of metastatic melanoma, were treated with ipilimumab 3 mg/kg and nivolumab 1 mg/kg [routes not stated]. After the first cycle of chemotherapy, both patients developed acute respiratory symptoms with low-grade fever, dry cough, decreased oxygen saturation and dyspnoea. After the initiation of the first cycle, the man and the woman developed symptoms after 5 and 16 days, respectively. A chest CT showed non-specific bilateral ground-glass opacities and alveolar consolidations, while CT angiogram [Angio-CT] ruled out the possibility of pulmonary embolism. At hospitalisation, the reverse transcriptase-polymerase chain reaction (RT-PCR) test for new severe acute respiratory syndrome coronavirus-2 was performed for both patients.

Subsequently, both patients started receiving unspecified supportive treatment. The woman also treated with ceftriaxone, azithromycin and hydroxychloroquine. In view of COVID-19 epidemiology, treatment with steroids was withheld. Within the first 48h after the presentation, both patients had worsening of their symptoms. Two days after the admission, a repeat chest CT scan showed a more severe pattern, indicative of COVID-19 infection. Therefore, a repeat RT-PCR test was performed for both patients. Subsequently, the man was treated with methylprednisolone, which resulted in a dramatic improvement of symptoms within 24h, while the woman did not receive treatment with steroids. A repeat RT-PCR test showed negative results. The third CT scan showed worsening of her previous findings, indicative of immune-related pneumonitis. Both patients were diagnosed with immune-related pneumonitis. Hence (4 days after the admission), the woman started receiving methylprednisolone., and within a day, her symptoms improved. Three days later, a repeat chest CT scan showed improvement in consolidation and ground-glass opacities. Two to 5 days after the initiation of tapered prednisone therapy, both patients were discharged from hospital in good clinical condition with no oxygen support. A third RT-PCR test for both patients showed negative results.