Infective complications in cancer patients treated with subcutaneous versus intravenous trastuzumab and rituximab: An individual patient data meta-analysis

Alexander, M; Jachno, K; Phillips, KA; Seymour, JF; Slavin, MA; Cheung, A; Shen, V; Maarouf, D; Wolfe, R; Lingaratnam, S

Author(s): Alexander, M; Jachno, K; Phillips, KA; Seymour, JF; Slavin, MA; Cheung, A; Shen, V; Maarouf, D; Wolfe, R; Lingaratnam, S;
Details: Publication Year 2024-06,Volume 30,Issue #4,Page 642-660
Journal Title: Journal of Oncology Pharmacy Practice
Publication Type: Research article
Abstract: BACKGROUND: Investigation of infection risk with subcutaneous versus intravenous trastuzumab and rituximab administration in an individual patient data (IPD) and published data meta-analysis of randomised controlled trials (RCTs). METHODS: Databases were searched to September 2021. Primary outcomes were serious and high-grade infection. Relative-risk (RR) and 95% confidence intervals (95%CI) were calculated using random-effects models. RESULTS: IPD meta-analysis (6 RCTs, 2971 participants, 2320 infections) demonstrated higher infection incidence with subcutaneous versus intravenous administration, without reaching statistical significance (serious: 12.2% versus 9.3%, RR 1.28, 95%CI 0.93to1.77, P = 0.13; high-grade: 12.2% versus 9.9%, RR 1.32, 95%CI 0.98to1.77, P = 0.07). With exclusion of an outlying study in post-hoc analysis, increased risks were statistically significant (serious: 13.1% versus 8.4%, RR 1.53, 95%CI 1.14to2.06, P = 0.01; high-grade: 13.2% versus 9.3%, RR 1.56, 95%CI 1.16to2.11, P < 0.01). Published data meta-analysis (8 RCTs, 3745 participants, 648 infections) demonstrated higher incidence of serious (HR 1.31, 95%CI 1.02to1.68, P = 0.04) and high-grade (HR 1.52, 95%CI 1.17to1.98, P < 0.01) infection with subcutaneous versus intravenous administration. CONCLUSIONS: Results suggest increased infection risk with subcutaneous versus intravenous administration, although IPD findings are sensitive to exclusion of one trial with inconsistent results and identified risk-of-bias. Ongoing trials may confirm findings. Clinical surveillance should be considered when switching to subcutaneous administration. PROSPERO registration CRD42020221866/CRD42020125376.
Publisher: Sage
Keywords: Humans; *Rituximab/administration & dosage/adverse effects; *Trastuzumab/administration & dosage/adverse effects; Injections, Subcutaneous; *Administration, Intravenous; Antineoplastic Agents, Immunological/administration & dosage/adverse effects; Infections/epidemiology; Randomized Controlled Trials as Topic; Neoplasms/drug therapy; Incidence; Monoclonal antibody; infection; rituximab; subcutaneous; trastuzuamb
Department(s): Pharmacy; Medical Oncology; Clinical Haematology; Infectious Diseases
Publisher's Version: https://doi.org/10.1177/10781552231180875
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-06-25 08:02:22

Last Modified: 2024-06-25 08:02:45