returning of cardiac functions to baseline he was re-challenged with second dose of nivolumab. Patient again developed decomensated CHF with ejection fraction of 30-40%. Subsequent therapy was aborted. Patient continues to have stable disease off therapy for the past 8 months. Our second patient developed moderate to severe pericardial effusion after fifth dose of nivolumab. Pericardial fluid cytology was negative for malignancy and CT scans showed stable visceral metastatic disease. He is currently off therapy and will get a prolonged 8 week steroid taper. Our literature review revealed only nineteen documented cases of immune checkpoint mediated cardiotoxicity. Seventeen of the 19 patients had metastatic melanoma; the remaining two had non-small cell lung cancer (one adenocarcinoma and one squamous cell). Six of the 19 patients developed cardiotoxicity within five weeks of treatment initiation. One of the patients developed biopsy confirmed immune mediated cardiotoxicity 31 weeks after initiation of treatment. Seven patients were treated with ipilimumab alone, four with nivolumab, one with pembrolizumab and the remaining seven patients received a combination of PD1/PDL-1 and CTLA-4 antibody either sequentially or concurrently. Six out of 19 patients died from toxicity of the respective drugs. Conclusion: Immune checkpoint associated cardiotoxicity is rare but well defined in literature. Patients can present with decompensated heart failure, arrhythmia or pericardial effusions. Early recognition, prolonged steroid taper and optimization of cardiac function with diuretics, ACE inhibitors and beta blockade are critical steps for the successful management.
To evaluate the cost-effectiveness of intravitreal aflibercept 2 mg every 8 weeks after 3 initial monthly doses (IVT-AFL 3+Q8) versus Ranibizumab 0.5 mg monthly (RAN Q4) and pro re nata after 3 initial monthly doses (RAN 3+PRN) in the treatment of patients with Neovascular Age-related Macular Degeneration (nAMD) from a Chinese payer's perspective, so as to provide evidence to support rational drug use in clinical practice in China. Methods: A Markov model was developed to simulate the progression of the disease in terms of visual acuity. The model included health status of "no visual impairment", "mild visual impairment", "moderate visual impairment", "severe vision loss", "blindness", and "death". Transition probabilities and utility scores were derived from published literature. Cost data were collected from medical institutions and physician surveys. Costs and QALYs were discounted at 5.0% per year. One-way sensitivity analyses were conducted. Results: For the lifetime horizon, the costs of IVT-AFL 3+Q8, RAN Q4 and RAN 3+PRN were 129,676.18 CNY, 164,903.36 CNY and 135,912.20 CNY respectively. The corresponding qualityadjusted life years (QALYs) were 6.162 QALYs, 6.162 QALYs and 6.156 QALYs. IVT-AFL 3+Q8 was dominant vs. RAN Q4 vs. RAN 3+PRN groups since it was cost saving (same outcome 6.162 QALYs with less costs). Sensitivity analyses showed that this result was robust. Conclusions: IVT-AFL 3+Q8 was similarly or more effective in terms of QALYs and less costly compared with RAN Q4 and RAN 3+PRN for nAMD patients in China.
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