A new systematic review and meta-analysis published in Scientific Reports on January 30, 2024 has investigated sex differences in adverse events among cancer patients receiving immune checkpoint inhibitors (ICIs). The study, known as MOUSEION-07, aimed to assess the association between sex and treatment-related adverse events in cancer patients treated with immunotherapy.
The research was conducted by an international team of scientists and included data from 16 studies encompassing a total of 4,658 patients. The meta-analysis focused on immune-related adverse events (irAEs) reported in patients receiving ICI therapy for various types of cancer, including non-small cell lung cancer, melanoma, and renal cell carcinoma.
The study design followed the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. The researchers conducted a comprehensive literature search and included randomized clinical trials and quasi-experimental studies that reported sex-specific irAEs for males and females separately. The protocol for this systematic review was registered with PROSPERO (registration number CRD42024549518).
In total, 2,133 adverse effects were identified across the included studies. The primary analysis revealed no statistically significant difference in terms of irAEs between males and females (Odds Ratio 1.19; CI 0.88–1.63). However, the researchers noted the presence of publication bias in their analysis.
The study's inclusion criteria encompassed adult patients (over 18 years of age) receiving ICI therapy for cancer. Exclusion criteria included pediatric patients, healthy participants, and non-English language publications. The demographic data varied across the included studies but generally represented a mix of male and female patients with advanced cancers.
While the meta-analysis did not find a significant overall difference in irAE rates between sexes, several individual studies included in the review reported varying results. Some studies suggested that females might experience a higher incidence of certain types of irAEs, such as thyroid dysfunction, while others found no significant sex-based differences.
The authors acknowledged several limitations of their study. The use of published study-level data rather than individual patient data limited the ability to control for potential confounding factors such as age, comorbidities, and concomitant medications. Additionally, the heterogeneity of the included studies and the presence of publication bias may have impacted the overall results.
Despite these limitations, the researchers concluded that sex differences in immunotherapy-related adverse events remain an important consideration in cancer treatment. They emphasized the need for a personalized approach to patient care and called for further research to fully understand the mechanisms driving potential sex-based differences in irAE occurrence.
The potential clinical impacts of this study are significant. While the meta-analysis did not demonstrate a clear overall difference in irAE rates between sexes, it highlights the complexity of the issue and the need for individualized monitoring and management strategies. The findings suggest that clinicians should remain vigilant for potential sex-based differences in irAE presentation and consider tailoring their approach to patient care accordingly.
Furthermore, the study underscores the importance of considering sex as a variable in future clinical trials and research on ICI therapy. The authors suggest that more targeted investigations into specific types of irAEs and their relation to sex could yield valuable insights for improving patient outcomes.
In conclusion, while the MOUSEION-07 study did not find a statistically significant overall difference in irAE rates between males and females receiving ICI therapy, it has opened the door for more nuanced investigations into this important aspect of cancer immunotherapy. As the use of ICIs continues to expand in oncology, understanding and addressing potential sex-based differences in treatment responses and adverse events will be crucial for optimizing patient care and improving clinical outcomes.
References
Vitale E, Rizzo A, Maistrello L, et al. Sex differences in adverse events among cancer patients receiving immune checkpoint inhibitors: the MOUSEION-07 systematic review and meta-analysis. Sci Rep. 2024;14(1):28309. Published 2024 Nov 16. doi:10.1038/s41598-024-71746-z
