Extended care in Cancer of the Metastatic HR+/HER2 Non -resortable or Metastatic

These are the most frequent female cancer: 61,214 cases of breast cancer estimated in 2023.SbytovaMN / iStock / Getty Images Plus / via Getty Images

En oncology, the specialty TRODELVY 200 mg powder for solution to be diluted for infusion (Sacituzumab Govitecan) is now approved by communities [1] and support in addition to hospital services [2] In the treatment of adults with breast cancer with positive (HR+) and HER2 negative (HER2-) hormonal (HER2-) receptors (HER2-) that has already received hormone therapy, and at least two additional systemic treatments at the advanced stage of the disease.

Before this care in ordinary law. Nevertheless, Trodelvy had, since February 23, 2023, benefited from care under the early access system in extended care cancer metastatic hr+/her2 this indication.

As a reminder. Consequently, since the end of August 2024, Trodelvy (Sacituzumab Govitecan) has been approved by communities and taken care of in addition to GHS for the treatment of triple negative breast cancer, after at least two systemic treatments including at least one for an advanced form of the disease (cf. our article of October 17, 2024 and Framed).

This specialty is one of the Antibody-Drug Conjugates [(ADC) ou anticorps drogue-conjugués]new drug class which makes it possible to deliver chemotherapy in a more targeted. Consequently, less toxic way thanks to the association between an antibody targeting a marker of cancer cells and a cytotoxic agent.

In the case of Trodelvy. the monoclonal antibody is the Sacituzumab Govitecan, the tumor marker is too 2 (present in more than 90 % of breast cancers) and the cytotoxic molecule, SN-38, Topoisomerase I inhibitor.

An important SMR and extended care cancer metastatic hr+/her2 a minor ASMR

Regarding the treatment of adults with breast cancer with positive hormonal receptors (HR+) and HER2 negative (HER2-), the transparency commission (CT) of the High Authority for Health (HAS) took into account the results of the Open Tropics-02 randomized study, which has demonstrated the superiority of Trodelvy compared to chemotherapy. She thus attributed to Trodelvy [3] :

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• An important medical service rendered;
• an improvement in the MEDICAL MEDICAL SERVICE (ASMR) Minor (IV);
• a place in 3^e line and more (after at least two systemic treatments) in the treatment of breast cancer with HR+ and HER2- non-resisable or metastatic.

A study in more than 500 patients

In this work was included 543 adults with HR breast cancer+ / her2- locally advanced or metastatic, having progressed after treatment by CDK 4/6 inhibitor, hormone therapy, taxana, and having received from 2 to 4 chemotherapy. Patients extended care cancer metastatic hr+/her2 have received chemotherapy to choose from the investigator from: eRibulin, Capécitabine, Gemcitabine or Vinorelbine.

An extension of progression -free survival and overall survival

In the Sacituzumab Govitecan group (versus The monochimotherapy group), the results show significant extension:

• of the Survival without progression (HR = 0,661 ; IC95% [0,529 ; 0,826] ; p = 0,0003) : + 1.5 months (punctual difference in the middle);
• of the global survival (HR = 0,789 ; IC95% [0,646 ; 0,964] ; p = 0,0223) : + 3.2 months ;
• of the deterioration period of:
  • Health/Quality of Life (HR = 0.751; CI95% [0,612 ; 0,922] ; p = 0,0059),
  • fatigue (hr = 0.732; IC95% [0,598 ; 0,894] ; p = 0,0021).

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Note, an additional toxicity in the Sacituzumab Govitecan group compared to the monochimotherapy group: 28 % of serious adverse events (including the majority of grade 3) versus 19 % in the monochimotherapy group and no significant difference in the period of deterioration extended care cancer metastatic hr+/her2 of pain.

The risk management plan retains as significant risks identified the serious infections secondary to neutropenia and severe diarrhea in particular.