(beraking latest news) – “I am enthusiastic. Participating in the Ruby study”, which investigated the addition of immunotherapy to chemotherapy, “I found a fair number of patients” with advanced or recurrent primary endometrial cancer “who had a superior” clinical response, “out of the norm, compared to the traditional taxol carboplatin chemotherapy” alone. “Now we ask ourselves the question of whether chemo is needed for everyone, when only immunotherapy is needed, what to do in patients who progress, in those who do not respond to therapies. There are other studies underway on this.” This was stated in a meeting with journalists by Giorgio Valabrega, associate professor of medical oncology at the University of Turin, Fpo-Irccs Candiolo, coordinator for Italy of the Ruby clinical study, whose phase 3 results were presented in these hours at the Annual Meeting of Women’s Cancer, organized by the American Society of Gynecologic Oncology in Tampa, Florida.
The Phase 3 Ruby clinical study demonstrated that, in the treatment of advanced or recurrent primary endometrial cancer, dostarlimab-based immunotherapy plus chemotherapy, compared with chemotherapy alone, resulted in a 72% and 36% reduction in risk of disease progression or death in the population with a genetic condition known as microsatellite instability (dMMR/MSI-H) and in the overall patient population, respectively.
“There is a gradient to consider – explains Valabrega – When we have a clear target”, such as microsatellite instability, “the extent of the benefit is greater, with an Hr (Hazard ratio, i.e. a risk of recurrence) of 0 ,28, but in the general population, an Hr between 0.6-0.7 is still wonderful”. It must also be considered that “this benefit, with immunotherapy, continues even when we suspend it. With chemotherapy we continue until there is no progression. Now we see that the benefits of immune system modifications are more durable than chemotherapy,” adds the expert.
“We started from chemo for all and hormone therapy where it was useful – observes Valabrega – and now we have a situation in which we molecularly characterize the tumors and give effective therapy that lasts for a very long time. The curves in the Ruby study tell us that we are “potentially” healing these women. Immunotherapy takes a little while to work, but when it becomes fully operational it works”. Indeed, “when immunotherapy is done alone versus placebo the curves remain separate. One may think that some groups might benefit from immunotherapy alone without chemo. Studies are currently underway in which, in the first line, chemo is not used ”.
There is a huge work in progress and “the results will arrive in about a year and a half from the translational study – adds Valabrega -. Tissues were collected at various stages of the disease to correlate particularly positive responses or resistance to treatments with molecular data. Studies are being done on the amount of mutations affecting these tumors, molecular subtypes, what happens in the mutated P53. These are apparently less important data but, in perspective, they could be of fundamental importance for the selection of patients who have the greatest possibility of responses to particular therapies ”, she concludes.
Endometrial cancer that affects the body of the uterus – he recalled in the meeting – is extremely frequent: 9-10 thousand cases a year. It tends to be typical of post menopause, the diagnosis is around the age of 60. It is a disease for which there are metabolic risk factors (diabetes, obesity), others of a genetic type, such as microsatellite instability, which is connected to Lynch Syndrome, with which there is genetic transmission. Drugs such as tamoxifen used for breast cancer, which increase the risk of endometrial cancer. It is a disease that has been somewhat neglected, even if it is diagnosed locally, generally in the first phase, but for which there is no screening such as the pap test for the neck of the uterus. The diagnosis is quite simple because it is linked to an early symptom which is abnormal bleeding in pre and postmenopause, for this reason it must always be investigated with transvaginal ultrasound, hysteroscopy and CT to define if the tumor lesion is limited to the uterus and, if so, it is operated on laparoscopically.