Abiraterone (Zytiga) 1/3 STAMPEDE trial results

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Jim Marshall (not a doctor) said ...

Earlier STAMPEDE results

An earlier version of the STAMPEDE trial looked at men newly diagnosed with metastatic prostate cancer. 

One group of men was given hormone therapy, then chemotherapy when that was not enough to control their cancer.

The other group started with hormone therapy plus chemotherapy.

Men survived 22 months longer if they started with hormone therapy + chemotherapy.

 

These STAMPEDE results

Mostly newly diagnosed men who needed hormone therapy had:

• standard hormone therapy OR 
• standard hormone therapy + abiraterone + prednisolone

(Abiraterone is always given with a steroid. Prednisolone is a steroid.)

The men who started abiraterone and hormone therapy at the same time took longer for their disease to progress, and survived longer.

 

Standard hormone therapy

Zoladex (Goserelin), Lupron (leuprorelin), Eligard (leuprolide), Lucrin (leuprorelin acetate),  Suprefact/Suprecor (buserelin), Synarel (nafarelin), histrelin (Supprelin), Suprelorin/Ovuplant (deslorelin), Triptorelin (diphereline)

and

Firmagon (degarelix)

... end Jim

 

N Engl J Med. 2017 Jun 3. doi: 10.1056/NEJMoa1702900. [Epub ahead of print]

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.

 

James ND1, de Bono JS1, Spears MR1, Clarke NW1, Mason MD1, Dearnaley DP1, Ritchie AWS1, Amos CL1, Gilson C1, Jones RJ1, Matheson D1, Millman R1, Attard G1, Chowdhury S1, Cross WR1, Gillessen S1, Parker CC1, Russell JM1, Berthold DR1, Brawley C1, Adab F1, Aung S1, Birtle AJ1, Bowen J1, Brock S1, Chakraborti P1, Ferguson C1, Gale J1, Gray E1, Hingorani M1, Hoskin PJ1, Lester JF1, Malik ZI1, McKinna F1, McPhail N1, Money-Kyrle J1, O'Sullivan J1, Parikh O1, Protheroe A1, Robinson A1, Srihari NN1, Thomas C1, Wagstaff J1, Wylie J1, Zarkar A1, Parmar MKB1, Sydes MR1; STAMPEDE Investigators.

Author information

Abstract

Background Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design. Methods We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer). Results A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events). Conclusions Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476 , and Current Controlled Trials number, ISRCTN78818544 .).

PMID: 28578639

This extract can be found on http://PubMed.com, and is in the public domain.

On PubMed.com there will be a link to the full paper (often USD$30+, sometimes free).

 

Any highlighting (except the title) is not by the author, but by Jim Marshall.

Jim is not a doctor.