IMMUNOTHERAPY causes adverse effects more often in women than in men: six months after the start of treatment, the frequency of unwanted reactions in the former is 61.4%, against 27.9% in the latter. This is demonstrated by a prospective and multicentre observational study presented at the European congress of medical oncology (Esmo 2021) and coordinated by the IRCCS National Cancer Institute of Milan (INT) Foundation.
This is an ongoing investigation (the title in Italian is “Gender differences in the side effects of immunotherapy: possible clues to optimize cancer treatment”) which is also involving Karolinska University Hospital svedeze, St Vincent’s University Hospital Dublin (Ireland) and Oslo University Hospital (Norway), and which should be completed in 2023: the data just presented are therefore preliminary results. But above all it is an innovative investigation, because it aims not only to understand if and to what extent the appearance of undesirable effects in patients treated with immunotherapy have to do with sex differences, therefore with biology and genetics, but even if and how much they have to do with gender, a concept that also takes into account the cultural context. An important step towards the optimization and personalization of care increasingly focused on individual patients.
Sex, gender and a sense of personal well-being
How did this desire to go beyond genetics, beyond chromosomes, so to speak? “When we wrote the protocol of the study, which enjoys European funding, it was not clear in the literature whether it was men or women who had more adverse events from immunotherapy”, replies Rosalba Miceli, statistical director at INT and principal investigator. of the study: “There appeared to be a higher incidence in women. Here, we wanted to understand how things really were, what kind of unwanted events were and analyze their frequency for each, in men and women. But in addition to we want to find out – since we are talking about a study that is underway – if factors related to gender can also influence the appearance of adverse reactions. Basically, if the social, behavioral, psychosocial role can influence response to treatment. In fact, we also thought of detecting the “personal sense of being” variable in the people we have enlisted, that is how the individual feels and how he lives, regardless of his genetics and biology. We would also like to detect sex changes: when you change your sex the biology remains that of birth but then you face treatments and lifestyle changes, these elements could change the results of the treatments and their unwanted effects. For now, we do not have people in transition in the already enlisted population ”.
I study
To date, researchers have enrolled 150 patients, men and women, suffering from different forms of cancer – lungs, head and neck, melanomas and others – all treated with immunotherapy or with combination therapies: classic chemo and immunotherapy. The aim is to reach 400 patients. The variables included in the study were really many: ethnic origins, marital status (i.e. if you live alone or as a couple or with your family), level of education, occupation, lifestyle, income, alcohol or smoking, physical activity, obesity, stress levels, eating habits. “Men and women – Miceli continues – are different with respect to these factors: for example, women generally do more physical activity and consume less alcohol, men have higher incomes. The fact of being different can influence the treatment and also the adverse events, we want to understand if this is the case and measure these differences “.
The first results
We know from the literature that the undesirable effects of immunotherapy – which mainly affect the digestive system, thyroid and endocrine systems, but also the skin and other areas – generally occur within six months of starting treatment, given which for now has been confirmed by the study. “While globally the proportion of adverse events of any degree is similar between men and women, when we go to see the events of grade 2 or greater, that is the more serious ones involving ad hoc treatments, we observed that in women the incidence it is significantly higher, regardless of the type of tumor and the severity of the disease: six months after the start of treatment in women we have a frequency of 61.4% while in men 27.9%: less than half.
The weight of loneliness
Another result that marks a difference between males and females concerns the marital status: those who live alone, man or woman, face adverse events more than those who have a cohabiting partner or family, but this is especially true for children. men. “These are preliminary analyzes, now we have to go into more detail – Miceli points out – and take into account other characteristics: for example, there is the issue of concomitant diseases, which can influence the incidence of adverse events, which has not yet been analyzed, but it will be. And then all the genetic aspects. The aim of everything – he concludes – is to personalize care as much as possible, placing the individual person at the center more and more “.
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