Apalutamide (Erleada) w leczeniu mHSPC

[zosia bluszcz]

BREAKING NEWS: FDA Approves Apalutamide (Erleada) for the treatment of metastatic hormone-sensitive prostate cancer | Prostate Cancer Foundation

September 18, 2019 –
Last night the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for the treatment of metastatic hormone-sensitive (aka, “castration-sensitive”) prostate cancer (mHSPC).
Apalutamide has previously received FDA-approval for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

PCF funded the initial synthesis of apalutamide at UCLA by chemist Michael Jung, PhD, in collaboration with prostate cancer physician-scientist Charles Sawyers, MD (now at Memorial Sloan Kettering Cancer Center).

mHSPC refers to men whose prostate cancer has spread to areas of the body outside of the prostate itself, and who are responsive to testosterone-lowering agents. This may refer to men who have had prior surgery or radiation and recurred, or men who were initially diagnosed with disease that was already metastatic (outside the prostate). Patients who are “hormone-sensitive” may have previously received androgen deprivation therapy (ADT) for a certain amount of time, but their cancer has not yet developed resistance to ADT.

This approval is based on results from the randomized phase 3 TITAN clinical trial, which was presented at the 2019 American Society of Clinical Oncology (ACSO) Annual Meeting, held in June, and published in the prestigious medical journal, The New England Journal of Medicine.

The TITAN trial, led by PCF-funded investigator Dr. Kim Chi, MD, of the Vancouver Prostate Centre, tested the addition of apalutamide versus placebo, to ADT in 1,052 men with mHSPC.
Patients on this trial could have previously received ADT for no more than 6 months for mHSPC or no more than 3 years if used as adjuvant therapy for localized prostate cancer, and were not on ADT at the time of disease progression and trial enrollment.
Patients could also have previously received docetaxel chemotherapy for no more than 6 cycles, and could not have progressed on that treatment.

Compared with a placebo, the addition of apalutamide to ADT significantly reduced the risk of death by 33%, and reduced the risk of radiographic disease progression (tumors growing on scans) or death (whichever came first) by 52%.
Apalutamide also significantly delayed the average time to PSA progression, use of chemotherapy, and pain progression.
Apalutamide was shown to prolong survival of patients with both low and high volume metastatic disease.
The treatment combination of apalutamide and ADT was considered tolerable, and quality of life in patients receiving apalutamide was similar to those receiving placebo in addition to ADT.
Adverse effects that were higher in patients receiving apalutamide vs placebo included rash (27% vs. 8.5% of patients), hypothyroidism (6.5% vs. 1.1% of patients), and fractures (6.3% vs. 4.6% of patients).

https://www.pcf.org/news/breaking-news- ... 0190918fda




FDA approves apalutamide for metastatic castration-sensitive prostate cancer |
https://www.fda.gov/drugs/resources-inf ... ate-cancer

[kemoturf]

Tylko w FDA jest w USA.
Nam to raczej nie grozi


Praktycznie zawsze nowy lek/nowe zastosowanie leku najpierw zatwierdza FDA, potem EMA a potem poszczegolne kraje decydują czy je stac na wprowadzenie leku na listę lekow refundowanych.
Polska, niestety, pozostaje na ogół w ogonie...
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[wiatger]

Zostały opublikowane końcowe rezultaty badania klinicznego TITAN, z których wynika, że apalutamid stosowany w połączeniu z ADT wiąże się z poprawą odległych wyników leczenia u pacjentów z wrażliwym na kastrację przerzutowym rakiem prostaty (mCSPC).

Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer


TAKE-HOME MESSAGE

• The authors report the final efficacy and safety results of the TITAN study of patients with metastatic castration-sensitive
prostate cancer treated with androgen deprivation therapy (ADT) randomized to receive apalutamide or placebo after a median
follow-up of 44 months. The use of apalutamide compared with placebo was associated with a 35% reduction in the risk of death, which increased to a 48% reduction after adjustment for crossover (P < .0001).
In addition, the addition of apalutamide was associated with delayed second progression-free survival and castration resistance.
There were no new safety signals, and health-related quality of life was similar in the two treatment groups.

• The use of apalutamide with ADT was associated with improved long-term outcomes in patients with metastatic castration-sensitive
prostate cancer.

http://www.practiceupdate.com


Bezpośredni link do publikacji:
https://www.practiceupdate.com/content/ ... cer/117492
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