Abiraterone (Zytiga) 2/3 LATITUDE trial results

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Jim Marshall (not a doctor) said ...

Earlier results

When standard hormone therapy is no longer holding the cancer in check, adding abiraterone (always plus a steroid) delays progression of the cancer and extends life.

 

These LATITUDE results

Newly diagnosed metastatic men had:

• standard hormone therapy OR 
• standard hormone therapy + abiraterone + 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 4. doi: 10.1056/NEJMoa1704174. [Epub ahead of print]

Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.

 

Fizazi K1, Tran N1, Fein L1, Matsubara N1, Rodriguez-Antolin A1, Alekseev BY1, Özgüroğlu M1, Ye D1, Feyerabend S1, Protheroe A1, De Porre P1, Kheoh T1, Park YC1, Todd MB1, Chi KN1; LATITUDE Investigators.

Author information

Abstract

Background Abiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer. Methods In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 1199 patients to receive either androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) (the abiraterone group) or androgen-deprivation therapy plus dual placebos (the placebo group). The two primary end points were overall survival and radiographic progression-free survival. Results After a median follow-up of 30.4 months at a planned interim analysis (after 406 patients had died), the median overall survival was significantly longer in the abiraterone group than in the placebo group (not reached vs. 34.7 months) (hazard ratio for death, 0.62; 95% confidence interval [CI], 0.51 to 0.76; P<0.001). The median length of radiographic progression-free survival was 33.0 months in the abiraterone group and 14.8 months in the placebo group (hazard ratio for disease progression or death, 0.47; 95% CI, 0.39 to 0.55; P<0.001). Significantly better outcomes in all secondary end points were observed in the abiraterone group, including the time until pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, and prostate-specific antigen progression (P<0.001 for all comparisons), along with next symptomatic skeletal events (P=0.009). These findings led to the unanimous recommendation by the independent data and safety monitoring committee that the trial be unblinded and crossover be allowed for patients in the placebo group to receive abiraterone. Rates of grade 3 hypertension and hypokalemia were higher in the abiraterone group. Conclusions The addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly increased overall survival and radiographic progression-free survival in men with newly diagnosed, metastatic, castration-sensitive prostate cancer. (Funded by Janssen Research and Development; LATITUDE ClinicalTrials.gov number, NCT01715285 .).

PMID: 28578607

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.