Abstract 1124
Background
We previously showed that therapy with anti-CTLA-4 or anti-PD-1 agents was more effective for men as compared with women. Here we investigated whether women derive larger benefit than men from different immunotherapeutic strategies.
Methods
We performed a systematic review and a meta-analysis, including all RCTs testing anti-PD-1 or anti-PD-L1 given either alone or combined with chemotherapy in patients with advanced/metastatic solid tumors, to assess different efficacy of these two immunotherapeutic strategies according to patients’ sex. The primary endpoint of the study was to assess the difference of treatments efficacy between males and females, measured in terms of difference of the overall survival log(HR) reported in males and in females for each treatment strategy For this purpose, the pooled OS HR and 95% confidence interval (CI) was calculated in males and females using random-effects model and the heterogeneity between the two estimates was evaluated using an interaction test.
Results
16 phase III RCTs testing anti-PD1 or anti-PD-L1 in monotherapy versus standard chemotherapy in 9291 patients with advanced solid tumors were included in the analysis. Two RCTs were performed in patients with melanoma, 8 in NSCLC, 2 in HNSCC, 2 in gastric cancer, and 1 each in kidney and urothelial cancer. In 15 out of 16 of such RCTs, men derived larger OS benefit than women. The pooled-OS HR was 0.73 (95% CI, 0.69-0.78) in men versus 0.86 (95% CI, 0.78-0.94) in women (heterogeneity-p=0.0079). 5 phase III RCTs testing the combination of chemotherapy plus anti-PD-1 or anti-PD-L1 versus chemotherapy in 2979 patients were included in the analysis. Four RCTs were performed in NSCLC and 1 in SCLC. All these 5 RCTs showed impressively larger OS benefit in women. The pooled-OS HR was 0.50 (95% CI, 0.41-0.60) in women versus 0.76 (95% CI, 0.66-0.87) in men (heterogeneity p = 0.0003).
Conclusions
We confirmed a large and significant interaction between patients’ sex and the efficacy of anti-PD-1/anti-PD-L1 drugs given in monotherapy or combined with chemotherapy. The direction of such interaction was the opposite for the two immunotherapeutic strategies: women derived impressively larger benefit from the addition of chemotherapy to anti-PD1/PD-L1 as compared with men.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Fabio Conforti.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5383 - A pilot trial to investigate the impact of a personalised self-management lifestyle programme using mobile technology on the health and wellbeing of cancer survivors
Presenter: Mary Grace Kelly
Session: Poster Display session 3
Resources:
Abstract
5084 - The BRIGHTLIGHT national survey of the impact of specialist teenage and young adult cancer care on caregivers’ information and support needs
Presenter: Rachel Taylor
Session: Poster Display session 3
Resources:
Abstract
4328 - Life beyond cancer: Occupational health care service support in returning work experienced by cancer survivals
Presenter: Minna Nurmi
Session: Poster Display session 3
Resources:
Abstract
3337 - Investigating the factors related to primary caregivers' burden in oncology patients in Greece
Presenter: Ourania Govina
Session: Poster Display session 3
Resources:
Abstract
3387 - Factors Influencing the Level of Emotional Support from Nurses Perceived by Patients Undergoing Haematopoietic Stem Cell Transplantation in Protective Isolation
Presenter: Michela Piredda
Session: Poster Display session 3
Resources:
Abstract
935 - Progressive Muscle Relaxation and Guided Imagery Techniques and the Way of Coping of Parents of Children with Malignancies: A randomized controlled trial
Presenter: Tsitsi Theologia
Session: Poster Display session 3
Resources:
Abstract
3457 - Pharmacist and Nurse Led Melanoma Immunotherapy Clinic
Presenter: Dharmisha Chauhan
Session: Poster Display session 3
Resources:
Abstract
5160 - Measuring the impact of the Irish Cancer Society's Cancer Information Services
Presenter: Aileen McHale
Session: Poster Display session 3
Resources:
Abstract
4297 - It's Great to Talk
Presenter: Noreen Andersen
Session: Poster Display session 3
Resources:
Abstract
4444 - Impact of Burn-Out Syndrome in Oncology personnel and its improvement through specific interventions
Presenter: Inmaculada Ortega
Session: Poster Display session 3
Resources:
Abstract