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The Ministry of Public Health and Social Welfare (MSPBS) recently approved the use of a new molecule called “Palbociclib”, in combination with the drugs letrozole, first line, and with fulvestrant, second line or posterior.

For the treatment of posmenopausal women with advanced breast cancer, with positive hormonal receptors, receptor 2 of the human epidermal disease (HER2) negative factor, as well as initial endocrine therapy for metastatic disease.

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His approach represents a great advance in respecting innovative therapies. The combination of letrozole with palbociclib (the new drug available in our country) will be demonstrated in the Paloma-2 and Paloma-3 studios, duplicating the free progression screen compared to patients receiving hormone therapy as monodrous.

También in the Paloma-2 demonstration prolongs in 40 months the time until the indication or the indication of chemotherapy and in studies of the real world is observed observed in the global sobrevida. According to data from the Bulletin of Vigilance of No Transmissions and Factors of Risk of the Ministry of Health, in 2019 429 cases of breast cancer were registered in Paraguay and 1,747 new cases.

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Therefore, it is estimated that between 30% and 40% of cases in which a diagnostic is performed while the patient is progressing to advanced stages, these are the ones in which the tumor expands or migrates to other organs. of the body. Mom’s cancer is the most common type of cancer and represents the first cause of death for cancer in women in Paraguay and some Latin American countries.

In this sense, the Dra. Cinthia Gauna, Clinical Oncologist, from the Oncology Medical Service of the Institute of Social Prevention (IPS), said the palbociclib legacy in Paraguay was significantly compared to a first-line drug in the metastatic mother’s cancer. of this type of medication (CDK4 / 6 inhibitors) approved in the country ”.

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“Our therapeutic arsenal is now complete for this subgroup of patients in that chemotherapy is not the correct therapy of first choice and hormone therapy with tamoxifeno and inhibitors of demonstrated aromatherapy have limited benefits”.

For its part, the Dra. Valeria Cáceres, Medical Oncology Clinic, Head of the Department of Clinical Oncology at the Ángel H. Roffo Institute (UBA) of Buenos Aires, Argentina, indicates: “Of all cases of breast cancer that are diagnosed, around 70% are responds to a hormonal therapy (RE positive) y el 85 por ciento son HER 2 negative ”.

“While the group that its RE positive HER 2 negative, lamentably around a 30% evolution at some point to the locally advanced or metastatic stage, because the universe of patients that could benefit from the approval of this new drug is very large ”.

It is the first and only drug approved in Paraguay of a new therapeutic class, of specific whiteness, ability to inhibit selective mode the cyclin dependent women (CDKs) 4 and 6 to regain control of the cellular cycle and block proliferation.

And it should be noted that its availability in our country is a warning notice to the medical community and to all those patients who may benefit from its indication. Its approval is based on the results of the PALOMA-2 study in phase III, which covers 666 patients in 186 centers of 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 adverse events are the combination of neutropenia and leukopenia (reduction of white blood cells) and fatigue.

Palbociclib has received accelerated revision to be approved by the Food and Drug Administration (FDA) of the United States, debating whether the evidence precludes that this drug should represent a major improvement in its treatment at this time. This is the design of the “Innovative Therapy” design.