Cancer, genomic profiling changes treatment for one in 3 patients
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It’s called Rome Trial, and it’s a one-of-a-kind study. Launched in October 2020 and promoted by Sapienza University of Rome, the Higher Institute of Health (ISS) and the Foundation for Personalized Medicine (FMP), this is a trial that involved over 40 centers and a thousand people with different types of cancer, on which extensive genomic profiling was performed. The results were discussed within the Molecular Tumor Board (MTB), a multidisciplinary group of experts whose task is to identify the most appropriate therapy for individual patients. In this case, regardless of the organ affected by the tumor. A decidedly innovative oncological approach (called the mutational model), the efficacy of which, of course, needs to be proven: and this is exactly what the Rome Trial deals with.
Tumors: every year in Italy over 8 thousand patients are candidates for liquid biopsy
by Irma D’Aria
The first results of the Rome Trial
Today, at the Tat (Targeted Anticancer Therapies) congress of the European Society of Medical Oncology (Esmo), the preliminary results of the work were presented, which seem very encouraging: the multidisciplinary discussion of genomic profiling has made it possible to modify the treatment in about a third of patients with metastatic cancer; in 10% of cases indications were given to carry out a genetic test in the other members of the family, to evaluate their risk of developing cancer. Finally, another 10% of patients had access to other clinical trials, with therapies not included in the Rome Trial.
Cancers, with extended profiling benefits for 40% of patients
by Letizia Gabaglio
“1,319 patients were involved, 721 (55%) carriers of relevant genomic alterations were selected and, in 24% of the cases, genomic mutations amenable to treatment with targeted drugs were discovered – he says Paolo Marchetti, scientific director of the IDI of Rome, full professor of oncology at Sapienza and president of the Foundation for Personalized Medicine – In some cases alterations have emerged at the germinal level, i.e. transmitted hereditarily, which has allowed us to start a path of oncogenic counseling. In other cases, the Molecular Tumor Board has suggested modifying the standard therapy originally chosen, in the presence of genomic alterations of resistance to the therapy proposed by the treating oncologist”. This model is not based on clinical studies that have already demonstrated the efficacy of a certain treatment in the presence of a specific genomic mutation, but is aimed at evaluating, in a complex study path, how much the discussion in a MTB of the data derived from the Extended profiling can help the individual patient (and not a group of patients) who harbor a certain mutation.
Against cancer, let’s play the “joker”
by Mara Magistroni
Pending establishment of Molecular Tumor Boards and list of NGS centers
Precisely in light of the importance of this approach in guaranteeing patients ever better treatment opportunities, in a “controlled” pathway, a ministerial decree is awaiting approval by the State-Regions Conference for the establishment of Molecular Tumor Boards in the area of regional oncological networks and for the identification of specialist centers where extensive profiling tests can be performed. The provision implements the technical document sent by AGENAS. “In extended profiling – he explains Andrea Botticelli, Principal Investigator of the ‘Rome Trial – we do not use small NGS panels to see the 8-10 mutations already known, but we carry out a broader search and are able to analyze over 300/500 genes significant in the evolution of the neoplasm. Extended profiling can now be carried out in various centers in our country and is carried out in metastatic cancer patients who have faced no more than two lines of treatment”.
Hitting the Braf mutation to cure many cancers
by Fabio DiTodaro
After the Rome Trial
While in the literature it is estimated that about 35% of patients have a mutation which theoretically can be the prerequisite for the use of a specific therapy with a molecular target, in the ‘Rome Trial’ this percentage was lower, equal to 28%: ” We have understood that some patients, while presenting a possible molecular target, are characterized by additional alterations that make the response to a therapy aimed at the molecular target completely improbable” – continues Marchetti, who concludes – This national project has opened up a new path for research which will be deepened by another experiment, ‘Beyond the Rome Trial’, with which we want to define innovative paths”.
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