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The Ministry of Health and Social Welfare (MSPBS) recently approved the use of a new molecule called “Palbociclib”, in combination with the drugs letrozole, in primary care and with fulvestrant, in secondary care or later.
For the treatment of postmenopausal women with advanced hormone receptor positive human epidermal growth factor receptor 2 (HER2) negative breast cancer as initial endocrine therapy for their metastatic disease.
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Its approval represents a breakthrough in innovative therapies. The combination of letrozole with palbociclib (the new drug already available in our country) showed a doubling of progression-free survival in the Paloma-2 and Paloma-3 studies compared to that recorded in the patients receiving hormone therapy as a monodrug . in those studies.
Paloma-2 was also shown to increase the time to indication or initiation of chemotherapy by 40 months and an increase in overall survival was observed in field studies. According to data from the Ministry of Health’s Bulletin for the Surveillance of Non-Communicable Diseases and Risk Factors, there were 429 breast cancer deaths and 1,747 new cases in Paraguay in 2019.
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Therefore, it is estimated that between 30% and 40% of the cases where an early diagnosis is made, the disease will progress to advanced stages, i.e. those in which the tumor has expanded or migrated to other tissues or organs. the body. Breast cancer is the most common cancer and is the leading cause of cancer death in women in Paraguay and some Latin American countries.
In this sense, Dr. Cinthia Gauna, clinical oncologist with the Medical Oncology Service of the Social Security Institute (IPS), “The arrival of palbociclib in Paraguay really means we have a first-line drug for the treatment of metastatic breast cancer, especially as it is the first of this type of medication. (CDK4 / 6 inhibitors) is approved in the country ”.
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“Our therapeutic arsenal now looks complete for this subset of patients in whom chemotherapy is not the appropriate first-line treatment and hormone therapy with tamoxifen and aromatase inhibitors has shown limited benefit.”
Dr. Valeria Cáceres, clinical oncologist, head of the department of clinical oncology at the Ángel H. Roffo Institute (UBA) in Buenos Aires, Argentina, stated: “Of all breast cancers diagnosed, about 70% respond to hormone therapy (ER positive) and 85 percent are HER 2 negative ”.
“Of the group that is RE positive HER 2 negative, unfortunately, about 30% will evolve to a locally advanced or metastatic stage at some point, so the universe of patients that could benefit from the approval of this new drug is very wide “.
It is the first and only drug approved in Paraguay of a new therapeutic class, with a specific target, capable of selectively inhibiting cyclin-dependent kinases (CDKs) 4 and 6 to regain control of the cell cycle. and block proliferation of tumor cells.
And it should be noted that its availability in our country is encouraging news for the medical community and for all those patients who could benefit from the indication. The approval was based on the results of the PALOMA-2 phase III study conducted in 666 patients at 186 centers in 17 countries.
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The combination of the new drug and letrozole was generally well tolerated and the safety profile was predictable and manageable. The most common side effects with the combination were neutropenia and leucopenia (reduced number of white blood cells) and fatigue.
Palbociclib has received an accelerated review for approval from the United States Food and Drug Administration (FDA) because preliminary evidence shows that this drug could provide a substantial improvement in the treatment of this disease over what was available at the time. In addition, it was awarded the designation “innovative therapy”.