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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 68-year-old man developed leucopenia and skin rash during treatment with gemcitabine and paclitaxel for pancreatic acinar cell carcinoma (PACC). Additionally, he developed pruritus during treatment with gimeracil/oteracil/tegafur, oxaliplatin and toripalimab for PACC [routes, exact duration of treatments to reactions onsets and outcomes not stated].
The man, who presented with a one year history of epigastric pain and a one week history of severe abdominal pain, nausea and vomiting was diagnosed with PACC with lung metastases. In April 2019, he received the first line treatment with two cycles of gemcitabine 1000 mg/m2 plus paclitaxel [nab-paclitaxel] 125 mg/m2 on day 1, day 8; every 3 weeks.
However, he discontinued the treatment after two courses due to grade III leucopenia and grade II–III skin rashes side effects and poor efficacy. Then, in June 2019, SOX regimen including oxaliplatin 150mg on day 1, gimeracil/oteracil/tegafur [S-1] 50mg twice daily on days 1–14; every 3 weeks was started as the second-line treatment. Although he tolerated this regimen, CT scan revealed that the retroperitoneal lymph node metastases were markedly enlarged after two courses in August 2019, indicating progression of disease. Next-generation sequencing results showed PD-L1 positive, high tumor mutation burden and FANCA-deletion. In August 2019, toripalimab 240 mg on day 1, every 3 weeks was added to the SOX regimen. However, he developed grade 2 pruritus as the major side effect of toripalimab and SOX regimen. Response to the triple therapy was quickly observed through CT scan, which showed reduced tumour size in the pancreatic head, both lungs, celiac and retroperitoneal lymph nodes following two courses in October 2019. After four courses in December 2019, the imaging results showed that he exhibited continuous partial response. He completed six cycles of treatment in January 2020, but the disease assessment and treatment had to be stopped for two months due to the COVID-19 pandemic. Based on CT scan in March 2020, the tumour in the pancreatic head, both lungs and celiac and retroperitoneal lymph nodes were markedly enlarged, indicating disease progression. The number of metastatic pulmonary nodules was also increased. The time to second progression took up to at least 8 months. Due to a lack of proven effective treatment strategy and budget constraints, his treatment was stopped and he chose palliative care and died in June 2020 [cause of death not stated].