Antineoplastics

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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 56-year-old man developed myelosuppression and SARS-CoV-2 infection during treatment with rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine or bendamustine for mantle cell lymphoma therapy [dosages, routes and durations of treatment to reactions onsets and outcomes not stated].

The man was admitted with SARS-CoV-2 infection. He was diagnosed with mantle cell lymphoma in September 2019. He received 4 cycles of R-hyper CVAD/MA chemotherapy consisting of rituximab, cyclophosphamide, vincristine [vincristine sulfate], doxorubicin [doxorubicin hydrochloride], dexamethasone, methotrexate and cytarabine from October 2019 to February 2020. However, he subsequently developed chemotherapy induced myelosuppression.

Therefore the man's chemotherapy was discontinued and he started treatment with bendamustine and rituximab therapy on 10 March 2020 (day -20). A routine pharyngeal PCR test was performed due to a COVID-19 outbreak (day -4). The following day, he developed a fever of 38.0°C. On 31 March 2020 (day 1), he tested positive for the SARS-CoV-2 infection. Therefore, he was admitted in another hospital. At admission, his temperature was 36.5°C , heart rate 66 /minute and oxygen saturation of 99%. Laboratory findings were as follows: white blood cell count 2,200 /μL, lymphocyte count 610 /μL, hemoglobin 11.2 g/dL, platelet count 33,000 /μL, aspartate aminotransferase 60 U/L, alanine aminotransferase 80 U/L, lactate dehydrogenase level 237 U/L and C-reactive protein concentration 0.75 mg/dL. His chest CT revealed mild bilateral ground-glass opacities in lower lobes. Therefore, it was determined that he had mild COVID-19 symptoms. He started receiving off label favipiravir (1,800mg twice a day on day 1 and 800mg twice a day on days 2–14). He also received cefepime, vancomycin, meropenem, piperacillin/tazobactam, teicoplanin and micafungin for probable bacterial co-infection. From day 2 of admission he continued to have a fever of greater than 38°C. He was repeatedly tested positive for SARS-CoV-2 on PCR testing. Blood and sputum were cultures did not grow significant bacteria. Due to prolonged fever, a CT performed on day 11 revealed slight improvement with exacerbation of pneumonia. COVID-19 was considered as the cause of fever. Therefore he received off label hydroxychloroquine (400mg twice a day on day 1 and 200mg twice a day on days 2–10), inhaled ciclesonide 400μg twice a day on days 1–14 and IV immune-globulin [polyglobin] 5g for 3 days. Consequently his WBC increased gradually from day 10. However, pneumonia worsened progressively from day 26 and he required supplementary oxygen. Blood and sputum cultures were repeatedly negative for bacterial infection. Therefore, it was concluded that the pneumonia was due to SARS-CoV-2 infection. On day 35 the interleukin-6 levels were significantly increased to 187 pg/mL and a COVID-19 induced cytokine storm was confirmed. Subsequently, his oxygen requirement increased and a chest X-ray revealed worsening pneumonia. He denied tracheal intubation. On day 39, he died [cause of death not stated].