Many people engagingin medical scienceasked me,"You’ve beenworking on the exploration of Holistic Integrated Medicine（HIM）for quite awhile.What is the progressyou have made in your research?Have you got your article published?May I beyour first reader?"
Supplementary Methods Supplementary Figure 1-5 Supplementary Table 1-2
Background: Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months' follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression.Methods: EMPOWER-Lung 1 was a multicentre, open-label, randomised, phase 3 trial. We enrolled patients (aged >= 18 years) with histologically confirmed squamous or non-squamous advanced non-small-cell lung cancer with PD-L1 tumour expression of 50% or more. We randomly assigned (1:1) patients to intravenous cemiplimab 350 mg every 3 weeks for up to 108 weeks, or until disease progression, or investigator's choice of chemotherapy. Central randomisation scheme generated by an interactive web response system governed the randomisation process that was stratified by histology and geographical region. Primary endpoints were overall survival and progression free survival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumours version 1.1. Patients with disease progression on cemiplimab could continue cemiplimab with the addition of up to four cycles of chemotherapy. We assessed response in these patients by BICR against a new baseline, defined as the last scan before chemotherapy initiation. The primary endpoints were assessed in all randomly assigned participants (ie, intention-to-treat population) and in those with a PD-L1 expression of at least 50%. We assessed adverse events in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03088540.Findings: Between May 29, 2017, and March 4, 2020, we recruited 712 patients (607 [85%] were male and 105 [15%] were female). We randomly assigned 357 (50%) to cemiplimab and 355 (50%) to chemotherapy. 284 (50%) patients assigned to cemiplimab and 281 (50%) assigned to chemotherapy had verified PD-L1 expression of at least 50%. At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 261 months (95% CI 221-318; 149 [52%] of 284 died) versus 133 months (105-162; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 057, 95% CI 046-071; p<00001), median progression-free survival was 81 months (95% CI 62-88; 214 events occurred) in the cemiplimab group versus 53 months (43-61; 236 events occurred) in the chemotherapy group (HR 051, 95% CI 042-062; p<00001). Continued cemiplimab plus chemotherapy as second-line therapy (n=64) resulted in a median progression-free survival of 66 months (61-93) and overall survival of 151 months (113-187). The most common grade 3-4 treatment-emergent adverse events were anaemia (15 [4%] of 356 patients in the cemiplimab group vs 60 [17%] of 343 in the control group), neutropenia (three [1%] vs 35 [10%]), and pneumonia (18 [5%] vs 13 [4%]). Treatment-related deaths occurred in ten (3%) of 356 patients treated with cemiplimab (due to autoimmune myocarditis, cardiac failure, cardio-respiratory arrest, cardiopulmonary failure, septic shock, tumour hyperprogression, nephritis, respiratory failure, [n=1 each] and general disorders or unknown [n=2]) and in seven (2%) of 343 patients treated with chemotherapy (due to pneumonia and pulmonary embolism [n=2 each], and cardiac arrest, lung abscess, and myocardial infarction [n=1 each]). The safety profile of cemiplimab at 35 months, and of continued cemiplimab plus chemotherapy, was generally consistent with that previously observed for these treatments, with no new safety signalsINTERPRETATION: At 35 months' follow-up, the survival benefit of cemiplimab for patients with advanced non-small-cell lung cancer was at least as pronounced as at 1 year, affirming its use as first-line monotherapy for this population. Adding chemotherapy to cemiplimab at progression might provide a new second-line treatment for patients with advanced non-small-cell lung cancer.Copyright (c) 2023 Elsevier Ltd. All rights reserved.
Objective To investigate the problems existing in pain treatment of cancer patients from outpatient depart-ment and to explore the value of clinical pharmacists in pain treatment of cancer patients.Methods Patients with cancer pain who visited the pain relief clinic of Cancer Hospital of Chinese Academy of Medical Sciences between June 2019 and September 2020 were included in this study.Clinical pharmacists conducted medication education and pain perception sur-vey on their first day of treatment,followed up the problems existing in the pain treatment after 2 weeks and provide phar-maceutical service.Results 63 patients with cancer pain participated in the follow-up,and 51 patients were finally select-ed.Most of them were patients with chest tumors,gastrointestinal tumors and gynecological tumors.The most common prob-lems in patients'analgesic treatment included"poor analgesic effect","intolerable adverse drug reactions"and"worrying about drug addiction".73%of patients said they would endure pain,65%would use the minimum dose of painkillers,and 49%were worried about the addiction of painkillers.Clinical pharmacists provided pharmaceutical services for 71%of pa-tients,including suggestions for dosage adjustment(15%),introduction to drug literacy(17%),education on drug use(20%),suggestions on adverse reaction management(22%),and suggestions for follow-up visits(26%).Conclusion There were still many deficiencies in the management of cancer pain patients in the outpatient department,such as unsatisfactory analgesic effect,insufficient drug knowledge,and cognitive deviation of pain relief.Clinical pharmacists should participate in the whole process management of cancer pain patients in the outpatient department,and continue to strengthen medica-tion education for patients.
Objective To investigate the characteristics,management and immunotherapy rechallenges of immune checkpoint inhibitor-induced diabetes mellitus(ICI-DM).Methods We reported four cases of patients with new-onset DM during ICI treatment,and provide a systematic review of all published cases(PubMed/Web of Science/CNKI/VIP/Wanfang databases)of autoimmune diabetes mellitus related to ICI therapy.The four cases in our hospital were pooled with cases previously reported in the literature.Results A total of 187 cases were included,of which 71.7%were treated with pro-grammed death-1(PD-1)inhibitors,and the ICI-DM occurred with a median time of 14 weeks after the medication.The presence of pancreatic autoantibodies was associated with a shorter time to the onset of DM[(4.10±33.7)vs.(22.86±19.16)weeks,P=0.032)].Diabetic ketoacidosis(DKA)was the first symptom in 75.4%of the ICI-DM patients.65.8%of the ICI-DM patients were diagnosed due to emergency admission,and 34.3%were accompanied with other immune-related endo-crine adverse reactions.Glycemic index was controllable in 66.8%patients after insulin replacement therapy,and 36.9%of the patients restarted immunotherapy.Conclusion ICI-DM has the characteristics of insidious onset and high probability of ketoacidosis.Regular monitoring of blood glucose and timely endocrine examination in case of hyperglycemia is recom-mended.
