Less time spent administering therapy, higher quality of life. Patients with HER2-positive breast cancer can now also have a new therapeutic option in Italy that allows for a significant reduction in treatment times thanks to a new subcutaneous formulation. The Italian Medicines Agency has in fact approved the reimbursement of the fixed-dose combination of pertuzumab and trastuzumab with recombinant human hyaluronidase, which can be administered by subcutaneous injection in the treatment of early and metastatic HER2-positive breast cancer.
The novelty promises to have an important impact on the quality of life of patients with HER2-positive breast cancer: with the new formulation, the time needed for patients to receive therapy is reduced to a few minutes, with a speed of over 90%. Administration by subcutaneous injection lasts about eight minutes in the first session and about five minutes for the following maintenance session; the traditional one, on the other hand, lasts about 150 minutes for the first session and about 60-150 minutes for the following ones.
The approval is based on the results of the phase III trial FeDeriCa, which demonstrated that treatment with the combination of pertuzumab and trastuzumab by subcutaneous injection achieves blood levels no lower than intravenous administration, with comparable efficacy, and that the profile of safety is similar to that of the standard intravenous solution of pertuzumab and trastuzumab and chemotherapy.
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“The approval of the subcutaneous formulation that combines, thanks to the action of recombinant human hyaluronidase, the two monoclonal antibodies pertuzumab and trastuzumab in a single injection is good news for Italian patients affected by the HER2-positive breast cancer subtype. In fact, the combined subcutaneous administration of the two antibodies, which in traditional standard therapy are administered with separate intravenous infusions, clearly improves the therapeutic experience for patients, significantly reducing administration times and eliminating the discomfort of periodic intravenous administration – comments Michelino De Laurentiis, Director of Breast Oncology of the Pascale Foundation in Naples. – The pivotal trial FeDeriCa demonstrated that the combination of the two drugs in a single subcutaneous injection produces results comparable to intravenous infusion in terms of clinical efficacy, safety and tolerability. Furthermore, this mode of administration reduces the invasiveness of the treatment and eliminates potential dosing errors, since it uses a fixed dose of drug for all patients, unlike the intravenous formulation in which the dose must be calculated from time to time based on to body weight “.
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Even at the level of organization of the healthcare facility, the subcutaneous modality determines evident advantages, allowing to contain the times and costs of administering and preparing the therapy, as well as freeing up resources and personnel to be able to treat more patients with the same pathology.
A positive impact that has a significant impact on the daily lives of patients who have to undergo therapy. Patient preference data show that most patients prefer to receive therapy subcutaneously, being able to spend less time in the hospital for treatment, which in this case can also be administered away from the infusion chairs, making them feel more comfortable. patients and streamlining healthcare procedures.
“For women undergoing treatment for HER2 + breast cancer, often affected by the disease in the middle of their working and social life, the time factor plays a crucial role: for this reason it is important that therapeutic innovation also goes in this direction, generating an improvement also in terms of care experience and quality of life. It means regaining time and space to devote to social, work and, more importantly, family relationships. This therapeutic experience allows the patient that the needs of the “person” organically enter into the management of the disease ”- declares Rosanna D’Antona, President of Europa Donna Italia.