Abiraterone; pour cancer metastasique avancé

Bonjour, Voici une médicament qui a fait la une du journal télévisé de Skynews en angletterre le 22 juillet 2007.

Voici ci dessous un coupé collé d’un article de
http://www.cancernet.co.uk/abiraterone.htm
malheureusement en anglais mais l’important pour nous en cet instant est de savoir que la recherche progresse et ce medicament s’il est prouvé efficace pourrait etre disponible dans environ 3 ans (celon skynews)
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Abiraterone & Prostate cancer
Home Treatments Lifestyle Symptoms Cancers

The results of a trial of new drug called abiraterone have been published related to men with metastatic advanced prostate cancer. This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer. It was published in the Journal of Clinical Oncology and involved men with prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel

How does it work? It blocks the formation of the male hormone testosterone by inhibiting (CYP450c17), an enzyme also known as 17α-hydroxylase/17,20 lyase. This enzyme is involved in the formation of DHEA, which may ultimately be metabolized into testosterone.

Condition Intervention Phase
Metastatic Castration-Resistant Prostate Cancer
Drug: placebo plus prednisone/prednisolone
Drug: abiraterone acetate plus prednisone/prednisolone
Phase III

The Primary Outcome Measure was overall Survival and secondary outcome measures: Proportion of patients achieving a PSA decline ≥ 50% according to Prostate Specific Antigen Working Group (PSAWG) criteria. Men in both published studies were given 1000mg of abiraterone daily
The results showed that in this category of disease abiraterone lowered PSA, it shrank the size of tumours and doubled their rate of survival. (in effect about by about 3 months).

These are promising results but further tests are necessary

Cougar Biotechnology Inc. of Los Angeles, the company which owns abiraterone, expects the drug to reach the market in 2011. In the mean time it is only available in a trial setting. (About clinical trails)

Information on the latest UK Abiraterone trial (starting august 2008).

This is a Double blind placebo controlled (2:1 in favour of abiraterone) trial of placebo plus prednisone versus abiraterone acetate plus prednisone.

Eligibility

Histologically/cytologocally proven adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.

At least 1 but not more than 2 chemotherapy regimes for metastatic castration-resistant prostate cancer. 1 regime must have contained docetaxel. (Docetaxel plus docetaxel retreatment is considered as a single chemotherapy regime).

PSA progression and/or progressive soft tissue metastases and/or 2 or more new lesions on a bone scan.

On-going androgen deprivation.

ECOG 0, 1, 2.

Hb>=9.0, Plt >= 100, Alb>=30g/L, creatinine<1.5xULN, K+>=3.5mmol/L

Able to swallow tablet whole.

Main exclusion

Serious comorbidity

Elevated LFT’s: bilirubin>=1.5xULN, ALT/AST>=2.5xULN

Uncontrolled HT.

Brain mets.

Prior treatment with abiraterone.

Prior treatment with ketoconazole.

Radiotherapy, chemotherapy or immunotherapy within 30 days of prospective first dose abiraterone. Single fraction RT within 14 days first dose.

4 tablets daily throughout 28 day cycles. See day 1 and 15 first cycle and then day 1 each subsequent cycle. Rescan every 12 weeks. Treatment is ongoing until study end-point is reached.

Other comments – if you have been randomised to placebo, it is not possible to then crossover to abiraterone.