On the World Day dedicated to gynecological cancers, from the European Congress of Medical Oncology (ESMO) comes an important news for patients affected by the most severe form of cervical cancer, the persistent, recurrent or metastatic one. The news concerns the combination of an immunotherapy – pembrolizumab – with standard chemotherapy: in the first line of treatment, this combination has been shown to improve overall survival, taking it to over two years. The data comes from the Keynote-826 clinical trial and was published concurrently in the New England Journal of Medicine.
“Immunotherapy has already proven to be effective in the treatment of second-line cervical cancer where it increases survival compared to chemotherapy”, explains Domenica Lorusso, associate professor of Obstetrics and Gynecology, Head of UOS Clinical Research Programming at the Gemelli Polyclinic in Rome, national coordinator of the Keynote-826 study in the center that enrolled the largest number of patients in Italy: “The results of the Keynote-826 study are capable of changing daily clinical practice in frontline therapy. The combination of pembrolizumab with chemotherapy improves overall survival by as much as 8 months compared to chemotherapy alone and there is a two-month advantage in progression-free survival in the face of an absolutely manageable toxicity “.
Immunotherapy plus chemo as the first treatment
The study evaluated the efficacy of pembrolizumab (anti-PD-1 immunotherapy) in combination with chemotherapy (paclitaxel and cisplatin or carboplatin, with or without bevacizumab), compared to chemotherapy alone (with or without bevacizumab) in over 600 patients with a average age of 51 years. Median overall survival in the pembrolizumab arm was 24.4 months, compared with 16.5 months in the other arm, resulting in a 33% reduction in relative risk of death. Median progression-free survival was 10.4 months and 8.2 months, respectively, while the objective response rate was 65.9% versus 50.8%. The mean duration of response was 18 months (with a range from 1.3 to 24.2) in the first case, versus 10.4 months (range from 1.5 to 22) in the second. The benefit was observed regardless of adding bevacizumab to the chemotherapy regimen.
The second leading cause of cancer death in young women
In Italy, cervical cancer represents the fifth cancer by frequency in women under 50 (4% of cases) and in 2020 2,400 new diagnoses were estimated. “This neoplasm continues to be the second leading cause of cancer death in young women between the ages of 15 and 44 and historically has a poor prognosis if diagnosed at an advanced stage”, underlines Nicoletta Colombo, associate professor at the Milano-Bicocca University and Director of the Oncological Gynecology of the European Institute of Oncology (IEO) in Milan: “These important survival results support pembrolizumab in combination with chemotherapy with or without bevacizumab as a potential new first-line treatment option for patients with persistent, recurrent or metastatic cervical cancer. “.
The increase in advanced and aggressive cases
The World Health Organization has launched the ambitious challenge of defeating cervical cancer by 2050, but we are still far from the goal. “The real goal – continues Lorusso – must be to completely eradicate cervical cancer thanks to the vaccine and secondary prevention programs already available. We continue to observe, especially in the last period, young patients with aggressive cervical tumors. Migration flows bring women to Western countries who come from areas where primary and secondary prevention programs are not available ”. This is also why more targeted drugs are needed. “Pembrolizumab in combination with chemotherapy with or without bevacizumab is the first anti-PD-1 / PD-L1-based regimen to demonstrate statistically significant improvement in overall survival in first-line treatment of patients with persistent, recurrent cervical cancer. or metastatic “, adds Roy Baynes, Senior Vice President and head of global clinical development, Chief Medical Officer, Merck Research Laboratories:” These results – he concludes – highlight the fundamental role of pembrolizumab in improving the outcome of women with persistent cervical cancer , recurrent or metastatic. We continue to prioritize the search for therapies that can prolong the life of patients who have to deal with fatal cancers, such as that of the cervix, through innovative combined approaches ”.
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