IN ITALY it is the third most common form of cancer in women in Italy in women between 50 and 69 years of age, with increasing incidence rates and over 8,000 new cases per year. It is carcinoma of the endometrium, the tissue that lines the uterus internally, and which mainly affects post menopause. Today, and for about 10 years, the standard of care for patients with advanced cancer has been chemotherapy (with carboplatin and taxol). But if the disease progresses, the chances of a cure are limited: the median survival is 3 years from the diagnosis of advanced or relapsed disease, and second-line therapies available to date are ineffective. But something could change in the near future, thanks to immunotherapy. A clinical study just published in the New England Journal of Medicine, coordinated by Italian researchers, has in fact shown that disease-free and overall survival significantly increase with the combination of pembrolizumab (anti-PD-1 monoclonal antibody) with lenvatinib, an oral tyrosine kinase inhibitor.
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The study enrolled 827 women with advanced endometrial cancer who had previously been treated with platinum-based chemotherapy. The patients were randomly divided into two groups: an experimental and a control group. The former were given pembrolizumab plus lenvatinib, while the women in the control group received doxorubicin or paclitaxel, the chemotherapy drugs normally used in the second line of treatment in advanced forms of endometrial cancer.
Drugs that act synergistically
“We have seen that the two drugs, pembrolizumab and lenvatinib, are enhanced – he explains Sunday Lorusso, associate professor of Obstetrics and Gynecology and head of Clinical Research Planning at the Irccs Foundation Policlinico Universitario Gemelli and co-author of the publication in the Nejm: “For about 10 years, the standard of care against relapsing or metastatic endometrial cancer has consisted of platinum and taxol, but as the disease progresses, whatever treatment we tried in the second line worked poorly, with response rates of 10-15% and median survival of about 8 months. But now, thanks to this combined treatment, we are recording an increase in survival for the first time compared to standard chemotherapy “.
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The patients in the experimental group had an overall survival of 18.3 months, which is approximately 7 months longer than that recorded in patients treated with standard therapy. “Seven months are not a few – Lorusso continues – because they translate into a 38% reduction in the risk of death and because we are talking about a lengthening of life without worsening the quality of life: in practice, the patients who receive the combined therapy live longer. and well, although it is important that clinicians learn to handle the toxicity of this new therapeutic possibility ”. Toxicity consists mainly of arterial hypertension, thyroid disorders (hyper or hypothyroidism), nausea, vomiting and loss of appetite with weight loss. Handling care well is an important aspect, also because we are almost always talking about elderly women.
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Approval in Italy
The FDA and EMA have already approved combined treatment with immunotherapy as a second line for advanced endometrial cancer. But when will we have the opportunity to treat our patients? “We are awaiting the approval of the Italian drug agency – concludes the expert – but we are working with the pharmaceutical companies producing the two drugs to make the treatment quickly available for women with advanced stage endometrial cancer”.
Image credits: National Cancer Institute via Unsplash