Extending the survival of cancer patients is always the first goal, but with the new drugs we have available, the bar can be raised and today oncologists aim to guarantee metastatic patients a good quality of life by controlling symptoms as much as possible and pain. The new results of the Phase III ARASENS study on darolutamide for the assessment of quality of life and some relevant endpoints in patients with metastatic hormone-sensitive prostate cancer (mHSPC) presented at the Congress of the European Society of Medical Oncology (ESMO) go in this direction. , underway in Paris.
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The decline in mortality
In six years (2015-2021), in Italy, prostate cancer mortality decreased by 14.6%. An important result, obtained thanks to the prevention and progress of research in the most frequent cancer in men (about 36 thousand new diagnoses estimated in 2020 in our country). “In Italy there are 564 thousand men diagnosed with this neoplasm, characterized by a high clinical heterogeneity, oscillating between low-aggressive forms and others that are clinically important”, he says Saverio Cinieri, president of AIOM (Italian Association of Medical Oncology). “We have many weapons at our disposal to defeat or control the disease ranging from surgery, to chemotherapy, to radiotherapy, to brachytherapy, to hormone therapy. In recent years we have achieved excellent results in terms of reducing mortality ”.
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Active surveillance
When the tumor is small in size and low in aggression, patients can be subjected to active surveillance which includes monitoring through specific examinations and periodic checks. “Unfortunately, symptoms such as the frequent need to urinate, painful urination and the presence of blood in the urine are often underestimated by patients, leading to the discovery of the disease in an advanced stage,” continues Cinieri. “The impact of metastatic prostate cancer on the everyday life of patients who develop disease-related symptoms can be important. In some cases, these people are unable to sleep or walk due to pain, particularly in the bones. Hence the strong clinical need for therapies capable of guaranteeing a good quality of life even in men with metastatic disease “.
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Metastatic tumors at diagnosis
In metastatic disease, the goal of therapy must be not only to ensure an improvement in survival but also a good quality of life. A result that can be achieved thanks to the combination of darolutamide, a potent androgen receptor inhibitor, with androgen deprivation therapy (ADT) and docetaxel chemotherapy. In February 2021, the Italian Medicines Agency (AIFA) approved the reimbursement of darolutamide in the treatment of non-metastatic castration-resistant prostate cancer at high risk of developing metastatic disease. In addition to prolonging overall survival, darolutamide has a favorable tolerability profile and the ability to maintain patients’ quality of life, with the control of physical symptoms and pain related to the disease.
When the effectiveness is also tolerable
Among the cases of advanced prostate cancer, those metastatic at diagnosis, and in particular in less elderly patients, are to be considered as more aggressive and therefore to be treated more fully. “For these patients – he explains Enrico Cortesi, Professor of Oncology at La Sapienza University, Policlinico Umberto I in Rome – it is essential to identify a treatment that is not only effective, but allows you to carry out daily activities safely. The new results from the ARASENS study further confirm the potential of darolutamide, in combination with hormone therapy and chemotherapy, for patients with metastatic hormone-sensitive prostate cancer at a critical stage in their life. This drug combines in itself therapeutic efficacy and tolerability. Thanks to its peculiar chemical structure, it inhibits the growth of prostate cancer cells, limiting the side effects that impact on daily life “.
The results of the Arasens study
Treatment with darolutamide plus ADT and docetaxel showed a tendency to delay the time to worsening of disease-related physical symptoms and pain in patients with moderate or severe pain at baseline and an improvement in patient-relevant endpoints, compared to ADT plus docetaxel, to support the increase of early treatment with the addition of darolutamide. Results from the Phase III ARASENS study, Study Results, published in New England Journal of Medicine, demonstrated a 32.5% reduction in the risk of death and improvement in all secondary endpoints particularly relevant to patients, with the intensification of early treatment compared to ADT plus docetaxel. The goal achieved, the best preservation of the quality of life, is of particular importance in a disease such as prostatic neoplasia, for which a prognosis and a duration of treatments of up to many years must be foreseen.
The quality of life
Numerous patients in the phase III ARASENS study had high quality of life scores with no pain or mild pain (81%). The study data shows that darolutamide in combination with ADT and docetaxel maintained quality of life with times to worsening of therapy-related physical symptoms and pain similar to ADT and docetaxel. Treatment with darolutamide in combination with ADT and docetaxel also resulted in fewer deaths from any cause (35.1% versus 46.8%) and deaths from prostate cancer (26.1% versus 36.0%). compared to ADT and docetaxel. The overall incidence of adverse events was similar in the two arms, despite the longer exposure to treatment for patients on darolutamide therapy (median 41.0 versus 16.7 months).
Metastatic hormone-sensitive prostate cancer
Prostate cancer is the second most diagnosed cancer in the male population worldwide. Worldwide, an estimated 1.4 million men were diagnosed with prostate cancer and about 375,000 men died of prostate cancer in 2020. Most men have localized cancer at the time of diagnosis, which means that the cancer is confined to the prostate gland and can be treated with curative surgery or radiation therapy. In case of recurrence, when the disease spreads or becomes metastatic, the tumor 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 these treatments, most patients with metastatic hormone-sensitive prostate cancer progress to castration-resistant cancer (mCRPC), a disease condition characterized by high morbidity and limited survival.