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Prostate cancer, trio of therapies increases survival

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Prostate cancer, trio of therapies increases survival

The trio of therapies works and opens up new possible scenarios for patients with metastatic hormone-sensitive prostate cancer. Confirmation of the efficacy of darolutamide plus androgen deprivation therapy (Adt) and docetaxel comes from new data from the Phase III Arasens study presented at the Game Changer oral session at the European Association of Urology Congress 2022 (UAE22).

I study

The Arasens study is the only randomized, Phase III, multicenter, double-blind study that was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi), darolutamide, in combination with docetaxel. more androgen deprivation therapy (ADT) than docetaxel plus ADT (a guideline recommended standard of care) in hormone-sensitive metastatic prostate cancer (mHSPC). The study shows clear overall survival benefits of darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC), in pre-specified subgroups based on the extent of metastatic disease (bone metastases or visceral) and the alkaline phosphatase (ALP) value at study entry, compared to the current standard of care, i.e. ADT plus docetaxel. Specifically, the 1,306 patients were randomized 1: 1 to receive darolutamide plus ADT and docetaxel or placebo plus ADT and docetaxel. Randomisation was stratified according to the extent of metastatic disease in accordance with the most used tumor staging system.

The results

Of the 1,306 patients with hormone-sensitive metastatic prostate cancer who were randomized, 79.5% had bone metastases (M1b) and 17.5% had visceral metastases (M1c); 55.5% had ALP ≥ normal. The extent of metastatic disease and the value of ALP are known prognostic factors in patients with this type of tumor. “The latest results from the Arasens study – he said Karim FizzaziProfessor of Medicine at the Gustave Roussy Institute of Villejuif in France – reconfirm the overall survival benefits of darolutamide plus ADT and docetaxel in various patient groups with mHSPC, and provide clinicians with more details on who will benefit from this therapy , as soon as it becomes available “.

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Reduction of the risk of death

A uniform overall survival benefit (with equal safety) was observed between the subgroups with darolutamide plus ADT and docetaxel compared to ADT plus docetaxel, with a reduction in the risk of death of 33% for the subgroup with bone metastases and 21% for those with visceral metastasis. The subgroup with non-regional lymph node metastases, on the other hand, was too small for a meaningful comparison. For patients with alkaline phosphatase values ​​below normal, the reduction in the risk of death was 36% and 31% for patients who, on the other hand, had this value above the threshold considered normal. These results add to existing data from the overall population in the Arasens study, which demonstrate that darolutamide plus ADT and docetaxel significantly reduced the risk of death in patients with mHSPC by 32.5% compared to ADT plus docetaxel.

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Metastatic hormone-sensitive prostate cancer

Prostate cancer is the second largest cancer in the male population worldwide. It is estimated that 1.4 million men worldwide were diagnosed with prostate cancer in 2020 and about 375,000 men died of prostate cancer. Most men have localized cancer at the time of diagnosis, which means the cancer is confined to the prostate gland and can be treated with curative surgery or radiation therapy.

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The therapies

In case of relapse, when the disease spreads or becomes metastatic, the disease is sensitive to hormones and androgen deprivation therapy (ADT) is the mainstay of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor inhibitors plus ADT, or a combination of docetaxel and ADT chemotherapy. Despite treatment, most patients with metastatic hormone-sensitive prostate cancer progress to castration-resistant cancer (mCRPC), a disease condition characterized by high morbidity and limited survival. Darolutamide, developed by Bayer together with Orion Corporation, is an oral androgen receptor inhibitor (ARi) with a unique chemical structure that binds the androgen receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells.

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