Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2023 Jul;149(8):4215-4224.
doi: 10.1007/s00432-022-04270-0. Epub 2022 Sep 3.

Do female and male patients derive similar benefits from approved systemic oncology therapies? A systematic review and meta-analysis

Vanessa Arciero #  1 , Erica McDonald #  1 , Vivian Nguyen  1 , Ronak Saluja  1 , Michael Raphael  1 , Ambica Parmar  1 , Kelvin K W Chan  2   3   4
Affiliations
Meta-Analysis

Do female and male patients derive similar benefits from approved systemic oncology therapies? A systematic review and meta-analysis

Vanessa Arciero et al. J Cancer Res Clin Oncol. 2023 Jul.

Abstract

Purpose: The National Institutes of Health's policy for the inclusion of females in clinical research was a pivotal step towards the consideration of sex as a biological variable, which is of particular importance in oncology, given differential incidence and outcomes of cancer between the sexes, and known pharmacodynamic, pharmacokinetic, and immunological differences. Therefore, we aim to investigate if such biological sex-based differences translate to clinically meaningful outcome differences from recently approved systemic oncology therapies.

Methods: A systematic review of randomized control trials (RCTs) cited in Food and Drug Administration, European Medicines Agency, and Health Canada approvals was conducted. Chemotherapy, targeted agents, and immunotherapy RCTs reporting sex-based sub-group analyses for overall/progression-free survival (OS/PFS) were considered. Hazard ratios (HRs) and 95% confidence intervals (CIs) were utilized. Sensitivity analyses for survival endpoints, drug type, and cancer site were conducted.

Results: Ninety-nine RCTs were included, representing 62,384 patients (23,574 (38%) female). Pooled OS HRs [95% CIs] were 0.77 [0.72-0.81] and 0.76 [0.72-0.79] for females and males, respectively (P = 0.73), and 0.51 [0.47-0.56] and 0.57 [0.53-0.61] (P = 0.08) for PFS. Sensitivity analyses yielded similar results. No RCTs reported sex-based toxicity or quality-of-life (QOL) data.

Conclusion: Female and male patients appear to derive comparable benefits from recently approved systemic oncology therapies. Future RCTs are encouraged to report sex-based toxicity and QOL data.

Keywords: Biological-sex; Immunotherapy; Oncology; Quality-of-life; Systematic review; Targeted agents.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram; FDA food and drug administration, EMA European medicines agency, HC: health Canada, OS overall survival, PFS progression-free survival
Fig. 2
Fig. 2
Summary forest plot for all sub-group analyses completed (N number of female and male paired comparisons), A Overall Survival, B Progression-Free Survival; OS overall survival, PFS progression-free survival, TKIs tyrosine kinase inhibitors, RCC renal cell carcinoma
Fig. 2
Fig. 2
Summary forest plot for all sub-group analyses completed (N number of female and male paired comparisons), A Overall Survival, B Progression-Free Survival; OS overall survival, PFS progression-free survival, TKIs tyrosine kinase inhibitors, RCC renal cell carcinoma
See this image and copyright information in PMC

References

    1. Botticelli A, Onesti CE, Zizzari I, Cerbelli B, Sciattella P, Occhipinti M, Roberto M, Di Pietro F, Bonifacino A, Ghidini M, Vici P (2017) The sexist behaviour of immune checkpoint inhibitors in cancer therapy? Oncotarget 8(59):99336 - DOI - PMC - PubMed
    1. Conforti F, Pala L, Bagnardi V, De Pas T, Martinetti M, Viale G, Gelber RD, Goldhirsch A (2018) Cancer immunotherapy efficacy and patients’ sex: a systematic review and meta-analysis. Lancet Oncol 19(6):737–746 - DOI - PubMed
    1. Cook MB, Dawsey SM, Freedman ND, Inskip PD, Wichner SM, Quraishi SM, Devesa SS, McGlynn KA (2009) Sex disparities in cancer incidence by period and age. Cancer Epidemiol Prev Biomarker 18(4):1174–1182 - DOI - PMC - PubMed
    1. Cook MB, McGlynn KA, Devesa SS, Freedman ND, Anderson WF (2011) Sex disparities in cancer mortality and survival. Cancer Epidemiol Prev Biomarker 20(8):1629–1637 - DOI - PMC - PubMed
    1. Davidson M, Wagner AD, Kouvelakis K, Nanji H, Starling N, Chau I, Watkins D, Rao S, Peckitt C, Cunningham D (2019) Influence of sex on chemotherapy efficacy and toxicity in oesophagogastric cancer: a pooled analysis of four randomised trials. Eur J Cancer 1(121):40–47 - DOI - PubMed

Substances

LinkOut - more resources