Two studies highlight important progress in the first-line therapy of urothelial carcinoma discovered when it has already passed the early stages. For the first time there are more effective strategies than chemotherapy alone
For over three decades bladder cancer it is treated more or less the same way: surgery if possible, sometimes radiotherapy and different types of chemotherapy in the presence of an advanced stage neoplasm. In recent years, then, they have arrived
new immunotherapy medicines
and molecularly targeted which aim to stop or delay the evolution of the neoplasm in patients in an advanced or metastatic stage. From the congress of the European Society for Medical Oncology (Esmo), recently concluded in Madrid, further progress arrives which is destined to change the current standard treatments.
Watch out for blood in your urine
There are approximately 29,200 new cases of bladder cancer diagnosed every year in Italy, the fourth most frequent form of cancer in our country after the age of 50: although it mainly affects men, the numbers are growing in females especially due to the increase in smokers (cigarettes are responsible for 43% of male urothelial neoplastic diseases and 25% of female ones). In 75% of patients the disease is identified at the initial stage and confined to the superficial parts of the bladder wall; when possible, surgical intervention is possible with good healing opportunities.
Urothelial carcinoma, more commonly called bladder cancer, a malignant neoplasm that originates fromurothelium
the mucosa that internally lines the bladder and the upper urinary tract that conveys urine from the kidney into the bladder, which is the organ most affected by this tumor – explains Sergio Bracarda, director of the Department of Oncology and Medical and Translational Oncology of the Santa Maria Hospital in Terni -. The main alarm bell is the presence of blood in the urine: a clear symptom that should be reported to your doctor and urologist specialist as soon as possible to perform more specific tests with diagnostic intent. Precious time: arriving at an early diagnosis means not only that the chances of recovery are greater, because the disease is still localized and has not metastasized, but also being able to be treated with less invasive therapies, with fewer side effects and a better quality of life .
In 75% of patients the disease is identified at the initial stage and confined to the superficial parts of the bladder wall; when possible, surgical intervention is possible with good healing opportunities, so much so that Five years after diagnosis, an average of eight out of 10 patients are alive in the early stages. More difficult to manage are metastatic cases which in Italy amount to around 7,300 per year: despite the various successes obtained with the recent arrival of immunotherapy drugs, in fact, new solutions capable of extending the lives of patients are being sought.
Two studies presented at the last Esmo conference in the presidential session, reserved for the most important research, go in this direction. Both trials were of phase three (the last before the final approval and entry onto the market of a medicine), conducted on patients with locally advanced or metastatic, inoperable and previously untreated urothelial carcinoma.
The outcomes were judged for both studies destined to change current clinical practice – underlines Bracarda, who is also president of SIUrO (Italian Society of Uro-Oncology) -. The evolution of treatments in urothelial carcinoma continues in a tumultuous way: in the space of a few years we have gone from simple chemotherapy to chemo followed by maintenance immunotherapy (avelumab) already approved and available in our country, with a clear survival advantage compared to two studies in which immunotherapy had been associated, unsuccessfully, simultaneously with chemotherapy.
The two studies
The CheckMate 901 trial you involved over 600 patients and the first to demonstrate a benefit in using standard chemo (based on gemcitabine and cisplatin) with immunotherapy (nivolumab): The combination, administered in the front line, i.e. in those who had not received other treatments previously found to be effective both in improve overall survival of the participants, and disease progression-free survival (i.e. the time that elapses before a relapse) – clarifies the expert -. At a median follow-up of approximately 33 months, treatment with nivolumab plus chemo reduced the risk of death by 22%, demonstrating a median survival of 21.7 months compared to 18.9 months with chemotherapy alone. Furthermore, this treatment has “worked” in a greater number of patients than chemo alone.
Also the EV-302/KEYNOTE-A39 study tested a new solution in the front line, involving 886 patients: participants received chemotherapy (gemcitabine associated with cisplatin or carboplatin) or the new combination of enfortumab vedotin (an immunoconjugated antibody targeting Nectin 4) and pembrolizumab. The results – adds Bracarda – show how the new mix reduces the risk of death by over 50%. compared to chemotherapy alone and has determined a significant survival advantage of 31.5 months versus 16.
For the first time in the history of advanced stage urothelial carcinoma has been demonstrated a treatment that does not include standard chemotherapy is effective, but which is based on the combination of immunotherapy and an immunoconjugated antibody – concludes Andrea Necchi, director of Genitourinary Oncology at the IRCCS San Raffaele Hospital in Milan -. With this new approach, on average, the lifespan of patients almost doubles, exceeding two and a half years. And the risk of death is halved. We are facing a historic turning point, moreover in a category of patients who urgently need new strategies.
October 31, 2023 (modified October 31, 2023 | 07:29)
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