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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
In a report, two men aged 60s and 73 years [not all exact ages stated] were described, who developed nausea, diarrhoea, cold sensitivity or neutropenia during treatment with folinic acid, fluorouracil and oxaliplatin for invasive adenocarcinoma of distal oesophagus. Additionally, both men developed transient vision loss attributed to fluorouracil [routes, dosages and durations of treatment to reactions onset not stated; not all outcomes stated].
Case 1: The man in his 60s presented with dysphagia in May 2019 at the age of 61 years. His anamnesis revealed gastroesophageal reflux disease, atrial fibrillation, cerebral vascular accident, automated implantable cardioverter defibrillator placement, coronary artery disease, ischemic cardiomyopathy, hypertension, chronic kidney disease stage III/IV, stage 1 bladder carcinoma, ejection fraction 25% and was every day smoker (one fourth packs per day). He was diagnosed with stage IIIB T3N1 HER2 neu positive moderately differentiated invasive adenocarcinoma of distal oesophagus with local nodal metastasis. He received six cycles of weekly unspecified taxols and carboplatin with good results. Follow-up imaging studies in August 2020 was suspicious for early metastatic disease. In January 2021, he presented to the emergency department and imaging revealed rib fracture and progression of lung nodules. In February 2021, he started receiving palliative FOLFOX regimen including fluorouracil [5-fluorouracil], folinic acid and oxaliplatin due to compromised ejection fraction. He tolerated the therapy, except for self-limiting nausea, grade 1 diarrhoea and grade 1 cold sensitivity. He had concurrent weight loss likely due to dysphagia. After cycle 2, he developed neutropenia attributed to therapy. The man's subsequent cycles were administered with omission of fluorouracil bolus dose. CT chest abdomen and pelvis after the fourth cycle showed overall stable disease. After the sixth cycle, he experienced two episodes of transient vision loss. Each time, he had bilateral, painless, complete vision loss for nearly two minutes before returning to the baseline. The transient vision loss was attributed to fluorouracil. Fluorouracil infusion dose for subsequent cycles was reduced to 80%. After the seventh cycle, he further experienced four episodes of transient vision loss. He did not experience any episodes after the eighth cycle on 7 June 2021.
Case 2: The 73-year-old man presented with progressive dysphagia and subsequent weight loss in March 2020 at the age of 72 years. His anamnesis revealed past tobacco use, obstructive sleep apnoea, hypertension, atrial fibrillation, hyperlipidaemia and vitamin D deficiency. In May 2020, imaging studies confirmed invasive adenocarcinoma of the distal oesophagus. He completed 5 to 6 cycles of concurrent chemoradiation from 29 July 2020 to 16 September 2020 with weekly cycles of carboplatin administration as he tested positive for COVID-19 in late August. On 11 January 2021, he underwent Ivor Lewis oesophagectomy with extensive residual disease. In February 2021, no evidence of metastatic disease was noted. Thereafter, he received six months of FOLFOX therapy including fluorouracil [5-fluorouracil], folinic acid and oxaliplatin with uneventful first cycle. However within two days of the second cycle, he developed painless, transient and complete visual loss involving both eyes that lasted upto 10 seconds. He experienced five similar episodes, which occurred sporadically after the second and third cycles described as bilateral tunnel vision and lasted less than 10 seconds. The ophthalmologists ruled out any ophthalmologic pathology as the cause of visual loss. Additionally, he also developed neutropenia attributed to therapy after the third cycle. The man's subsequent cycles were administered after omission of fluorouracil infusion. Oxaliplatin dose was reduced to 80% and the fourth cycle was delayed for two weeks. After dose reduction, he did not experience any episodes of visual loss. It was concluded that the transient vision loss was attributed to fluorouracil.