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This study aimed to analyze the safety and applicability of a 90-min duration of infusion (SDI) of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma (NHL) in a tertiary hospital in China. This exploratory clinical trial was performed at Jiangsu Province Hospital. All patients were treated with the standard infusion regimen for the first infusion. If no grade ≥3 infusion-related reactions (IRRs) occurred, the subsequent infusions were given as SDI. The primary endpoint was the incidence of IRR during the standard infusion (3-4 h) and 90-min SDI regimens. This study enrolled 208 patients and all completed cycle 1. Forty-one patients (19.71%) had IRRs: five (2.40%) with grade 1, twenty-eight (13.46%) with grade 2, and eight (3.85%) with grade 3. The 41 patients had 71 IRRs, mainly fever (40.85%), chest pain/tightness (12.68%), and dyspnea (9.86%). The occurrence of IRRs in the first infusion was significantly lower in patients who received oral acetaminophen prophylaxis than those who did not (10.72% vs 30.21%, P<0.001). For the subsequent cycles with 90-min SDI, only two (0.25%) IRRs occurred among 814 infusions (one grade 1 hand numbness and one grade 2 chill/fever). The 90-min obinutuzumab SDI might be safe and feasible in patients with B-cell NHL in China.
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As a new type of anthracyclines, pegylated liposomal doxorubicin (PLD) is widely used in the treatment of a variety of malignant tumors, including soft tissue sarcoma, ovarian cancer, breast cancer, multiple myeloma, and so on. Compared with traditional anthracyclines, PLD can significantly decrease the incidences of adverse events such as cardiac toxicity and alopecia. However, the use of PLD will be accompanied with toxic side effects such as hand-foot syndrome, oral mucositis, and infusion reaction. This consensus will mainly focus on the mechanism, prevention and treatment of adverse events of PLD, in order to improve the therapeutic efficacy of PLD and life quality of patients.
Subject(s)
Female , Humans , Antibiotics, Antineoplastic , Therapeutic Uses , Consensus , Doxorubicin , Therapeutic Uses , Drug-Related Side Effects and Adverse Reactions , Hand-Foot Syndrome , Neoplasms , Drug Therapy , Polyethylene Glycols , Therapeutic Uses , Practice Guidelines as Topic , StomatitisABSTRACT
Immunological checkpoint inhibitors have been approved for a short period of time in China, and real-world clinical data are still in the collection stage. Reports of domestic programmed death-1 (PD-1) treatment-related adverse reactions are rare. The author reported a case of hypotension in the process of Pembrolizumab infusion and successful infusion after blood pressure recovery, hoping to provide reference for the application of immunological checkpoint inhibitors, to provide patients with the greatest clinical benefit.
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Introduction @#Monoclonal antibodies have revolutionized the treatment of immune-mediated infl ammatory diseases (eg, rheumatoid arthritis [RA], Crohn’s disease [CD], and psoriasis) as well as malignant diseases. Currently, there are about 100 monoclonal antibodies and even more are expected in the coming years. Knowledge of not only their mechanism of action but also their adverse event profi le is tantamount. One of the distinctive side effects of these drugs is the potential for non-allergic and allergic infusion reactions caused by cytokine release. These adverse reactions should be monitored and managed immediately for patient welfare and safety.@*General Objective @#To determine the prevalence of infusion reaction among patients given monoclonal antibodies at outpatient infusion units of a University Hospital, from July 2015 to July 2017.@*Methodology @#This is a two-year retrospective study at the University of Santo Tomas Hospital (USTH), a tertiary teaching hospital. A chart review of patients seen at the USTH Benavides Cancer Institute (BCI) and Joint and Bone Center (JBC) were gathered. Patients who received monoclonal antibodies namely rituximab, infl iximab, bevacizumab, tocilizumab, belimumab, brentuximab, pembrolizumab, trastuzumab, pertuzumab, nimotuzumab and eculizumab from July 2015 to July 2017 were included in the study.@*Results @#Majority of patients were in the 61 to 70 years age group (25.7%); the median age of the population was 53 years and the majority were females (64.9%). The most common indication for monoclonal antibody infusion is rheumatoid arthritis (28.4%). More than one-fourth of the patients did not receive premedications (28.4%) but a good number (25.7%) received at least two drugs: paracetamol plus diphenhydramine plus corticosteroids followed by 17.6% who received paracetamol plus diphenhydramine. The authors found a signifi cant difference in the occurrence of infusion reaction between those that were given premedications compared to those who were not given premedications (p=0.032). The most common monoclonal antibodies administered were rituximab (28.4%); tocilizumab (23%); and infl iximab (14.9%). However, only rituximab (9.5%), infl iximab (2.7%) and bevacizumab (1.4%) had infusion reactions. The overall incidence rate of infusion reaction to monoclonal antibodies was 14%. The onset was within 2 hours with most infusion reactions occurring in the fi rst cycle. Ninety percent were classifi ed as grade 2 infusion reactions. Management of these reactions included rescue medications and brief interruption of infusion. No hospitalization nor recurrence of infusion reaction on the resumption of infusion occurred.@*Conclusions@#The prevalence rate of infusion reaction to monoclonal antibodies was 14% in this present single-center two-year retrospective study. All adverse events were graded mild to moderate (grade 2) in severity, and were all accordingly managed successfully in the outpatient setting.
Subject(s)
Antibodies, Monoclonal , PrevalenceABSTRACT
Objective To assess the safety of infliximab (IFX) treatment in patients with Crohn's disease(CD).Methods From January 2009 to May 2018,at inflammatory bowel disease (IBD) center of Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University,486 CD patients received the treatment of IFX were enrolled and their clinical data were collected.Univariate and multivariate regression of binary logistic were performed for statistical analysis.Results The median follow-up duration was 31.1 months (12.0 months to 40.0 months).The median duration of IFX therapy was 13.0 months (7.0 months to 21.0 months).Among 486 patients,98 (20.16％) patients reported adverse effects,and 12 (2.47％) patients discontinued the therapy because of adverse effects.Acute infusion reaction was the most common adverse effect in CD patients who received IFX treatment accounting for 41.84％ (41/98) of all the adverse effects,and the incidence was 8.44％.Thirty-nine patients had mild and moderate infusion reaction,and all improved after symptomatic treatment (eight patients discontinued IFX therapy because of recurrent infusion reaction).Two patients developed severe infusion reaction as allergic shock,and both relieved after emergency rescue.Four patients developed late-phase allergic reactions.Among 486 patients,39 (8.02％) patients had infections,including infections of Clostridium difficile,cytomegalovirus,herpeszoster virus,Mycobacterium tuberculosis,and other opportunistic pathogens.There was no cases of infection related death.Thirty-six patients continued with IFX treatment after infection controlled.Among 486 patients,14 (2.88％) patients had severe infection,and all the cases improved after anti-infection treatment.Twenty-seven CD patients with hepatitis B virus (HBV) infection received anti-viral treatments,no active HBV infection was observed.Colon adenocarcinoma was found in one patient under colonoscopy at 22 months after discontinuation of IFX therapy.There were six patients with the history of benign tumors,and no evidence of recurrence,progress or malignancy during treatment.In terms of other rare adverse effects in 486 patients,there were eight (1.64％) patients with liver function injury,two (0.41％) patients with anemia,one (0.21％) patient with peripheral neuropathy,and four (0.82％) patients with skin lesion.Prolonged duration of IFX therapy,without combination of immune-suppressors and with increased baseline body mass index (BMI) were the risk factors of acute infusion reactions.Prolonged duration of IFX therapy and with low baseline albumin level were the risk factors of infections.Conclusions IFX is generally safe as the treatment for CD patients,and its adverse effects can be clinically controlled.Screening before therapy and monitoring during therapy may reduce the risks of adverse effects.
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Objective: To describe the clinical consequences of acute infusion reactions associated with cetuximab treatment and analyze corresponding managing experience to explore the prevention and treatment approaches. Methods: Clinic staff identified 24 patients with advanced gastric cancer and colorectal cancer who had received chemotherapy combined with cetuximab treatment and experienced an acute infusion reaction. Their clinical manifestation and infusion reaction management procedures were retrospectively analyzed. Results: Acute infusion reactions at grade I - II were observed in 4 of 24 cases (16.7%), occurring during the first 5-10 min after the first administration of cetuximab. Patients complained chills, chest tightness, and low fever (37-38.5°C) after 0.5 h infusion. The symptoms were self relieved after 1-2 h. When cetuximab was recharged at reduced infusion rate and with close monitoring, no acute infusion reactions were observed in the 4 patients. Conclusion: Discontinuation of cetuximab therapy is not necessary for the patients who experienced grade I - II infusion reaction mild-to-moderate reactions can be managed by reduction of the infusion rate and close observation of the symptoms. Patients who experienced grade III or IV infusion reactions may require permanent discontinuation of cetuximab therapy.
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OBJECTIVE To improve the quality of venous infusion and reduce the incidence of hospital infection.METHODS We analyzed the factors of hospital infection resulted from venous infusion.RESULTS The main factors were pollution or degeneration of the liquid,over standard of the bacterial number in prepared or infused environment,disobeying the operating instruction of venous infusion and unsuitable operating method.CONCLUSIONS The measures to prevent hospital infection are holding the key step of venous infusion,constructing and executing the management system of sterilization and isolation,reducing the chance of bacterium pollution,paying attention to the sterile operation through venous infusion,fostering the well working style and improving the links of infusing operation.We reduced the infusion reaction and the incidence of hospital infection effectively.
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OBJECTIVE:To identify the high frequency period of infusion reaction and to provide clinic instructions for avoidance of its harm effects on patients. METHODS: Reports of 87 infusion reaction cases at the year of 2006～2008 in our hospital were collected. The cases were grouped according to sex, age, drug categories, season, and usage (combined use or isolated use) for the analysis on the periods of infusion reaction occurrence. RESULTS: The frequency of infusion reaction at