SOLTI launches AI-based tool to avoid toxicities in the treatment of hormonal breast cancer patients

Barcelona, 15 May 2024.- SOLTI, a leading group in clinical cancer research in Spain, launches today the renewed version of Cyclibtool (www.cyclibtool.org), a free access digital tool for professionals based on artificial intelligence (AI) technology to avoid, for patients with hormonal breast cancer (HR+), serious or unnecessary toxicities resulting from the combination of drugs during cancer treatment. Thanks to the incorporation of AI, beyond evaluating the drug interactions of the most common treatments in combination with each of the different approved CDK 4/6 inhibitors -specific treatment for hormonal breast cancer- Cyclibtool offers positive lists, that is to say alternative drugs that the oncologist can administer safely, avoiding a toxic combination for the patient.

Hormonal breast cancer affects approximately 70% of breast cancer patients. Recently, the approval of CDK 4/6 inhibitors (ribociclib, palbociblib and abemaciclib) has revolutionized the approach to this cancer pathology, both in the early and metastatic setting. However, this treatment, based on oral drugs, often lasts for more than two years, a period during which patients may need parallel drugs in case of the appearance of other pathologies in addition to the oncological pathology.

According to Dr. Meritxell Bellet (Vall d’Hebron Hospital and VHIO), member of SOLTI’s Executive Board and promoter of Cyclibtool: “After the revolution brought about by the approval of CDK 4/6 inhibitors in the approach to hormonal breast cancer, we have found ourselves in a new situation in which two factors converge. On the one hand, patients, during the time that this oncological treatment lasts, are receiving other medications due to the appearance of new comorbid processes. On the other hand, and along these lines, other medical specialties outside oncology prescribe their drugs without considering that the interaction between their prescription and the CDK 4/6 inhibitors that the patient is already taking may be toxic, as they do not consider this oncological treatment as aggressive as chemotherapy. This puts us in a very challenging scenario for the oncologist to ensure that, with the mediation they are administering, they are not putting the patient at risk”.

Dr. Bellet concludes: “Until Cyclibtool came out, there were tools that simply told us whether or not there were drug interactions, that is whether the toxicity from the combination of certain drugs could be dangerous for patients, but they did not specify how much, for what reason and what safe alternative we could give them. Thus, the oncologist was faced with the additional work of looking for alternative”.

Dr. Mafalda Oliveira, SOLTI’s chair and medical oncologist at Vall d’Hebron and VHIO, adds: “For us it is essential to create instruments and tools that, through the integration of new technologies such as artificial intelligence, expand the knowledge base that professionals can receive in less time and in a more appropriate way to optimize clinical practice. This update of Cyclibtool stems from this ongoing effort to promote not only research but also care in routine clinical practice in accordance with one of SOLTI’s strategic lines: medical education and training for professionals involved in cancer management”.

Following the excellent reception of Cyclibtool in its 4 years of life by oncologists, pharmacists and other healthcare professionals in many countries around the world, with an average of 1600 monthly queries, SOLTI has devised a new version that has quadrupled the number of active ingredients included, is dynamic, multilingual and incorporates AI for the first time and for prescriptive purposes. The first version of the platform that SOLTI presented in 2020 was based on the SOLTI manuscript “Palbociclib and ribociclib in breast cancer: consensus workshop on the management of concomitant medication” published in May 2019. SOLTI has now created a working group led by Dr. Meritxell Bellet and composed of 5 pharmacists with extensive experience in the management of these drugs to re-evaluate and add the active ingredients to the tool’s database. This update has been possible thanks to the balanced sponsorship by the 3 pharmaceutical companies that own the 3 cyclin inhibitors: Novartis, Pfizer and Lilly.

Presentation of SOLTI results at ESMOBREAST 2024: IPATHER study

Within the framework of the ESMOBreast congress, SOLTI is also presenting the results of its IPATHER study. About 20% of all breast cancers are HER2-positive and, of these, 1 in 3 have a PI3K mutation: an alteration that worsens the prognosis of these patients.

The study results demonstrate that adding ipatasertib – a drug targeting the PI3K mutation in HER2 positive breast tumors- to anti-HER2 therapy could be an effective strategy for this patient population that currently responds less well to conventional treatment. The combination with ipatasertib achieves a response rate of 31%, a clinical benefit of almost 70% and a median progression-free survival for these patients of 15 months.

According to Dr. Mafalda Oliveira, principal investigator of this study and president of SOLTI: “the IPATHER study has shown two things: that it is safe to combine ipatasertib with standard anti-HER2 treatment (trastuzumab and pertuzumab) and that it is effective, i.e. that this triple combination could reverse the prognosis of these patients whose tumours have the PI3K mutation. We know that dual blockade with trastuzumab and pertuzumab has been a turning point in the treatment of HER2+ metastatic breast cancer, but we have also known for some time that patients whose tumours have mutations in PI3K do worse when they receive the usual combination: trastuzumab combined with pertuzumab and chemotherapy. That is why SOLTI designed this study with ipatasertib, a drug that inhibits the PI3K-AKT intracellular signaling pathway and has shown significant efficacy signals that could make it a useful strategy to improve the prognosis of these patients”.

Promoted by SOLTI, the IPATHER study is a phase Ib trial involving 17 patients with HER2+ breast cancer who additionally have a PI3K mutation, in collaboration with Roche.

SOLTI’s activity is focused on 3 fundamental pillars: expanding knowledge of the molecular biology of cancer through academic, clinical and translational research; guaranteeing the continuous training of professionals involved in cancer management; and educating patients through its own outreach programs.