Palbociclib

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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 49-year-old woman developed COVID-19 infection during treatment with palbociclib for invasive ductal breast carcinoma.

The woman was diagnosed with de-novo, estrogen receptors/progesterone receptors-positive, human epidermal growth factor receptor-2 negative, grade 2 invasive ductal breast carcinoma with liver metastases in 2019. She started receiving treatment with palbociclib 125mg daily [route not stated] concomitantly with goserelin and letrozole on days 1−21 every 28 days. After the initiation of palbociclib therapy, her average neutrophil and lymphocyte counts were found to be reduced. Her medical history was significant for multiple drug allergies to various antibiotics, positive family history for lupus, and she had undergone laparoscopic sleeve gastrectomy 4 years prior to the current presentation. During late March 2020, she presented to the emergency department with 4 days of fever, nausea and weakness. On presentation, she was found to be stable. Blood count revealed mild leucopenia and moderate neutropenia of 1.1. Additionally, a real-time reverse transcription polymerase-chain-reaction (RT-PCR) from a nasopharyngeal swab showed positive results for COVID-19 infection.

The woman was hospitalised. On admission day 1, her therapy with palbociclib was stopped. During her hospital stay, she suffered from fevers of up to 39.4°C, which persisted for 9 days along with worsening dyspnoea, which developed on admission day 5. Follow-up blood tests revealed normalisation of the neutrophilia and leucopenia. However, lymphopenia occurred along with elevated CRP. Due to the prolonged course of disease in a presumed immunosuppressed state, chest X-ray performed on admission day 8 revealed new bilateral basal infiltrates. On admission day 11, non-contrast whole-body CT scan showed bilateral pulmonary multifocal peripheral ground glass opacities and consolidations. Based on these findings, COVID-19 infection secondary to the palbociclib therapy was considered. On admission days 12−14, short term desaturation of as low as 88% on room air was noted, which was resolved by oxygen delivery via a nasal cannula. After a gradual improvement of symptoms during 15 days hospital stay followed by two negative nasopharyngeal RT-PCR tests, she was discharged home in good general condition for further ambulatory medical care.