Title:Gender Matters. Sex-related Differences in Immunotherapy Outcome in Patients with Non-small Cell Lung Cancer
Volume: 25
Issue: 1
Author(s): Enrico Caliman, Maria Cristina Petrella, Virginia Rossi, Francesca Mazzoni, Anna Maria Grosso, Sara Fancelli, Luca Paglialunga, Camilla Eva Comin, Giandomenico Roviello, Serena Pillozzi and Lorenzo Antonuzzo*
Affiliation:
- Medical Oncology Unit, Careggi University Hospital, Florence, Italy
- Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
Keywords:
Non-small cell lung cancer, gender, immunotherapy, gender-medicine, sex differences, immune-checkpoint inhibitors.
Abstract:
Background: Emerging evidence identified sex as a variable regulating immune system
functions and modulating response to immunotherapy in cancer patients.
Objective: This retrospective study analysed sex-related differences in immunotherapy outcomes in a
real-world population of non-small cell lung cancer (NSCLC) patients treated with immune checkpoint
inhibitors (ICIs).
Methods: We retrospectively investigated clinical data of 99 patients with advanced NSCLC and
treated with single-agent nivolumab and pembrolizumab at Medical Oncology Unit, Careggi University
Hospital, Florence (Italy), between April 2014 to August 2019. Main clinical characteristics and
clinical outcomes were analysed.
Results: Our study showed that the efficacy of ICI treatment differed according to gender. A trend for
better median progression-free survival (mPFS) was reported in males (mPFS 5.0 months, 95% Confidence
Interval [CI] 4.0-11.0) than females (mPFS 4.5 months, 95% CI 2.0-9.0) (p=0.133), while no
significant difference for overall survival (OS) between the two sex groups was observed (p=0.622).
In the nivolumab cohort, we showed a statistically significant difference for a longer PFS in men
compared to women (log-rank p=0.054), HR for PFS in females versus males was 1.81 (95% CI 0.97-
3.37, p=0.062). Disease control rate (DCR) was achieved in 55.7% and 45.7% of men and women,
respectively, while disease progression was registered in 44.3% of males and 54.3% of females
(p=0.386).
Conclusion: Gender is a variable that should be taken into account in the choice of immunotherapy.
Future prospective randomized trials testing tailored sex-based immunotherapy strategies are required
to validate our findings before integrating into clinical practice.
