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2 oktober 2019: Bron: ESMO 2019

Mannen met kanker met solide tumoren blijken beter te reageren op alleen immuuntherapie met anti-PD medicijnen in vergelijking met immuuntherapie in combinatie met chemotherapie dan vrouwen met kanker met solide tumoren. Dat blijkt uit een meta-analyse van 16 gerandomiseerde fase III studies bij totaal 9291 patienten.

De meta-analyse gaat over 2 onderzoeken uitgevoerd bij patiënten met een melanoom, 8 bij niet-kleincellige longkanker (NSCLC), 2 bij plaveiselcelcarcinoom van hoofd en nekkanker, 2 bij maagkanker en 1 studie bij patiënten met nierkanker en 1 studie bij urineleiderkanker.

Het doel van de studie was specifiek te kijken of mannen en vrouwen gelijk of minder of beter reageeerden op immuuntherpaie met anti-PD medicijnen.

Fabio Conforti, Medical Oncology of Melanoma, Sarcoma and Rare Tumors, Istituto Europeo di Oncologia in Milaan, Italië en collega's constateerden dat anti-CTLA4- of anti-PD1-medicijnen effectiever waren bij mannen dan bij vrouwen bij de analyse van genoemde anti-PD1- en anti-PD-L1 studies als monotherapie en in combinatie met chemotherapie bij mannelijke en vrouwelijke patiënten met gevorderde solide tumoren.

Daarentegen uit een aparte meta-analyse van 5 studies uitgevoerd bij niet-kleincellige longkanker bij totaal 2969 patienten blijkt dat vrouwen juist weer beter reageerden op immuuntherapie plus chemotherapie dan mannen. (The pooled OS HR was 0.50 (95% CI, 0.41-0.60) in women compared to 0.76 (95% CI, 0.66-0.87) in men (heterogeneity p = 0.0003).

Deze studieresultaten gepresenteerd op het ESMO Congress 2019 in Barcelona, Spanje, waaruit dus blijkt dat er een verschil is in de respons op immunotherapeutische middelen die worden gebruikt om gevorderde solide tumoren te behandelen.

Conclusie:

De auteurs concludeerden dat hun analyse een grote en significante interactie tussen de patiënten en de werkzaamheid van anti-PD1- of anti-PD-L1-middelen in monotherapie of in combinatie met chemotherapie bevestigde.
Ze merkten op dat de interactie werd versterkt door de combinatie van anti-PD1 / PD-L1 en de combinatie van immunotherapie en anti-PD1 / PD-L1-middelen.

Hier een grafiek uit de perspresentatie:

The analysis comprised data from 9291 patients with advanced solid tumours that showed a larger benefit in males receiving immunotherapy as monotherapy. Of the 16 trials evaluated, 15 showed significantly greater OS benefit in men than women with anti-PD1 or anti-PD-L1 monotherapy; pooled-OS HR 0.73 (95% confidence interval , 0.69-0.78) in men compared to HR 0.86 (95% CI, 0.78-0.94) in women (heterogeneity-p = 0.0079).

Conforti Pala ESMO 2019 News

Hazard ratios of death for patients assigned to intervention treatment, as compared with those assigned to control treatment, according to gender and type of immunotherapeutic strategy (i.e. anti-PD-1/PD-L1 given alone or combined to chemotherapy).

De oroginele perspresentatie: Efficacy Differences Are Observed According to Patients’ Sex with Immunotherapy in Advanced Solid Tumours is hier te lezen.

Het originele studieabstract: Conforti F, Pala L, Bagnardi V, et al. Lancet Oncol 2018;19:737–746

Het abstract met heel veel commentaar:

2018 Jun;19(6):737-746. doi: 10.1016/S1470-2045(18)30261-4. Epub 2018 May 16.

Cancer immunotherapy efficacy and patients' sex: a systematic review and meta-analysis.

Conforti F1, Pala L2, Bagnardi V3, De Pas T2, Martinetti M3, Viale G4, Gelber RD5, Goldhirsch A2.

Author information

1: Division of Medical Oncology for Melanoma & Sarcoma, European Institute of Oncology, Milan, Italy. Electronic address: fabio.conforti@ieo.it.
2: Division of Medical Oncology for Melanoma & Sarcoma, European Institute of Oncology, Milan, Italy.
3: Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
4: Department of Pathology, European Institute of Oncology & State University of Milan, Milan, Italy.
5: Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Frontier Science & Technology Research Foundation, Boston, MA, USA.

Abstract

BACKGROUND:

Despite the acknowledged sex-related dimorphism in immune system response, little is known about the effect of patients' sex on the efficacy of immune checkpoint inhibitors as cancer treatments. We did a systematic review and meta-analysis to assess the heterogeneity of immune checkpoint inhibitor efficacy between men and women.

METHODS:

We systematically searched PubMed, MEDLINE, Embase, and Scopus, from database inception to Nov 30, 2017, for randomised controlled trials of immune checkpoint inhibitors (inhibitors of PD-1, CTLA-4, or both) that had available hazard ratios (HRs) for death according to patients' sex. We also reviewed abstracts and presentations from all major conference proceedings. We excluded non-randomised trials and considered only papers published in English. The primary endpoint was to assess the difference in efficacy of immune checkpoint inhibitors between men and women, measured in terms of the difference in overall survival log(HR) reported in male and female study participants. We calculated the pooled overall survival HR and 95% CI in men and women using a random-effects model, and assessed the heterogeneity between the two estimates using an interaction test.

FINDINGS:

Of 7133 studies identified in our search, there were 20 eligible randomised controlled trials of immune checkpoint inhibitors (ipilimumab, tremelimumab, nivolumab, or pembrolizumab) that reported overall survival according to patients' sex. Overall, 11 351 patients with advanced or metastatic cancers (7646 [67%] men and 3705 [33%] women) were included in the analysis; the most common types of cancer were melanoma (3632 [32%]) and non-small-cell lung cancer (3482 [31%]). The pooled overall survival HR was 0·72 (95% CI 0·65-0·79) in male patients treated with immune checkpoint inhibitors, compared with men treated in control groups. In women treated with immune checkpoint inhibitors, the pooled overall survival HR compared with control groups was 0·86 (95% CI 0·79-0·93). The difference in efficacy between men and women treated with immune checkpoint inhibitors was significant (p=0·0019).

INTERPRETATION:

Immune checkpoint inhibitors can improve overall survival for patients with advanced cancers such as melanoma and non-small-cell lung cancer, but the magnitude of benefit is sex-dependent. Future research should guarantee greater inclusion of women in trials and focus on improving the effectiveness of immunotherapies in women, perhaps exploring different immunotherapeutic approaches in men and women.