How Long Does Zytiga Work

past Dr. C.H. Weaver M.D. updated 7/2021

The U.S. Food and Drug Administration (FDA) has expanded the canonical utilize of Zytiga® (abiraterone) to treat men with metastatic, hormone-refractory prostate cancer prior to receiving chemotherapy and the results of the LATITUDE clinical trial suggest Zytiga should be a new standard of intendance for men with newly diagnosed androgen sensitive prostate cancer.

Prostate cancer is a hormonally sensitive disease that can frequently exist controlled for long periods with androgen-deprivation therapy (ADT). When prostate cancer stops responding to this treatment, information technology is referred to as hormone-refractory prostate cancer. Metastatic hormone-refractory prostate cancer is a challenging form of the disease to treat because the cancer has spread to afar sites in the body and does non respond to treatment with standard hormonal therapy.

About Zytiga

Zytiga is an oral targeted amanuensis that blocks the production of androgens (male hormones such as testosterone) not only by the testes, simply likewise by the adrenal glands and the tumor itself. It was initially approved in Apr 2011 for utilize in patients whose prostate cancer progressed afterwards chemotherapy.

The expanded blessing was based on data from a report that involved ane,088 men with metastatic, hormone-refractory prostate cancer who had non previously received chemotherapy. Participants were randomized to receive Zytiga or placebo in combination with prednisone. Patients who received Zytiga had a median overall survival of 35.three months compared with 30.ane months for those receiving the placebo.

The well-nigh common side effects of Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention, muscle discomfort, hot flashes, diarrhea, urinary tract infection, coughing, high blood pressure level, heartbeat disorders, urinary frequency, increased dark urination, upset stomach or indigestion, and upper respiratory tract infection.

Adding Zytiga plus prednisone to standard hormonal therapy for men with newly diagnosed, metastatic prostate cancer lowers the chance of death by 38%, and more doubled the median time until the cancer worsened, from 14.8 months to 33 months according to the results of the "Latitude" trial.^three

About the LATITUDE Written report

The Breadth clinical study evaluated 1199 men with newly diagnosed, high-risk metastatic prostate cancer who had non previously received ADT. All patients had at least two of three risk factors: Gleason score (a measure of tumor grade) of 8 or more than, three or more bone metastases, or three or more than visceral metastases (spread to other organs in certain areas of the body, such as the liver). Individuals were treated with ADT plus Zytiga and prednisone, or ADT lonely and directly compared.

Later on a median follow-up of 51.8 months and a final assay the overall survival has been confirmed to be significantly longer for patients receiving Zytiga/ADT/prednisone. Zytiga treated patients survived on average 53 months compared to 36.5 months for ADT lonely.

The combination of Zytig plus prednisone with can at present be considered standard of care in patients with high-run a risk CSPC.

Metastatic prostate cancer has been treated the same fashion for over 50 years until Taxotere (docetaxel) chemotherapy was shown to improve survival in 2015. Zytiga may be the next accelerate in treatment with the potential to further improve outcomes by combining it with Taxotere.

Adding Zytiga to ADT and Taxotere delayed cancer progression when compared with ADT and Taxotere alone in patients with metastatic castration-sensitive prostate cancer (mCSPC), according to results of the phase three PEACE-1 trial presented at the 2021 American Lodge of Clinical Oncology (ASCO) Annual Meeting.

The stage three trial included 1173 patients with mCSPC who were randomly assigned to treatment with ADT solitary (Nov. 2013-2015), then ADT with docetaxel permitted (2015-2017), followed past ADT with mandatory docetaxel (2017-Dec. 2018). ADT plus docetaxel chemotherapy treatment was compared to individuals receiving Zytiga + ADT + Taxotere. The median follow-up was 36 months.

The improver of Zytiga improved the median survival elapsing without cancer progression to four.5 years compared with ii.2 years for individuals CSPC treated with ADT + Taxotere without Zytiga.

Zytiga also improved castration-resistant prostate cancer (CRPC)–free survival. In the overall population, the median CRPC–free survival was 3.8 years with Zytiga compared to one.5 years with ADT and Taxotere alone.⁹

Co-ordinate to the study author "regardless of survival results, these data question whether doctors should deny patients approximately two.5 years without radiographic progression or death, or whether combining ADT plus docetaxel and abiraterone-prednisone should simply become the new standard of care for men with de novo metastatic prostate cancer."

Neoadjuvant Zytiga Plus Hormonal Therapy Can Eliminate Tumor in Some Men with High-Run a risk Prostate Cancer

Half-dozen months of neoadjuvant treatment with the targeted agent Zytiga® plus hormonal therapy eliminated or near eliminated tumors in one-third of men with localized high-run a risk prostate cancer, according to the results of a study presented at the annual meeting of the American Order of Clinical Oncology (ASCO). The current study marks the first time that the drug has been investigated in earlier stages of prostate cancer and in the neoadjuvant (pre-surgical) setting.

Men with localized prostate cancer can often be cured with surgery or radiations lone; nonetheless, men with certain risk factors—such as a high Gleason score, very high PSA level, spread of cancer outside the prostate, and lymph node involvement—tend to have a high recurrence rate regardless of whether all detectable cancer is surgically removed and/or radiated. These men have what is referred to equally localized loftier-risk prostate cancer (LHRPC). Men with LHRPC tend to have a poor prognosis—it is infrequently cured with radical prostatectomy (RP) and neoadjuvant hormonal therapy (androgen deprivation therapy, or ADT) has non been shown to improve outcomes.

The randomized phase II report included 56 men with LHRPC who were randomized to one of two groups. Group A included 27 men who received leuprolide hormonal therapy for 12 weeks followed by leuprolide plus Zytiga for another 12 weeks. Group B included 29 men who received Zytiga and leuprolide for the entire 24-week menstruum. All men underwent prostate surgery after 24 weeks of therapy and the tissue was so examined for bear witness of cancer.

Zytiga therapy was well tolerated by both groups. Among the men in group B (who received 24 weeks of Zytiga therapy), 34 pct experienced consummate elimination of nearly complete elimination of their cancer prior to surgery. In grouping A, where the men received Zytiga therapy for half of the treatment catamenia, 15 percent of men experienced complete or nigh complete elimination of their cancer.

These are pregnant results in a population of patients with a typically poor prognosis. The researchers concluded that the combination therapy could accept the potential to amend outcomes for men with LHRPC. Further research is warranted to confirm these benefits.

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Zytiga Approved for Prostate Cancer in 2011

The US FDA originally approved Zytiga™ for the treatment of avant-garde prostate cancer in 2011 based on a report that enrolled i,195 men from 13 countries. The study participants had metastatic, hormone-refractory prostate cancer that has progressed after chemotherapy. Patients were treated with either Zytiga plus prednisone or prednisone alone. Zytiga improved overall survival past four months (overall survival was 15 months in the group that received Zytiga and 11 months in the group that did non receive Zytiga).

Zytiga Reduces Fatigue in Advanced Prostate Cancer

Zytiga® has been reported to reduce fatigue in addition to improving overall survival.

To assess how Zytiga affects fatigue—a common and potentially debilitating trouble amidst men with advanced prostate cancer—researchers evaluated information from one of the Zytiga clinical trials. Data was bachelor about 797 men who had been treated with Zytiga plus prednisone and 398 men who had been treated with prednisone alone. The two groups of men had similar fatigue scores at the offset of the study.

Fatigue was more than probable to improve, and improved more quickly, amid men treated with Zytiga.

Fatigue is a mutual problem among patients with avant-garde cancer and can have a profound effect on quality of life. The results of this analysis suggest that in addition to improving overall survival, Zytiga may also help to reduce fatigue among men with advanced prostate cancer.

Zytiga Prolongs Time to Hurting Progression

The add-on of Zytiga® to prednisone also significantly delays patient-reported pain progression and wellness-related quality-of-life deterioration compared with prednisone solitary in chemotherapy-naive men with metastatic castration-resistant prostate cancer, co-ordinate to the results of a study published in The Lancet Oncology.

In an international, double-blind trial, 1,088 patients with progressive, metastatic castration-resistant prostate cancer were randomly assigned to receive Zytiga plus prednisone or prednisone plus placebo in continuous iv-week cycles. Researchers measured patients' pain (with the Cursory Pain Inventory Short Form [BPI-SF] questionnaire) and health-related quality of life (HRQoL) (with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire). The researchers then analyzed the data to evaluate clinically meaningful pain progression and deterioration in HRQoL.

At a median follow-up of 22.ii months, the median time to progression of mean pain intensity was significantly longer in patients receiving Zytiga/prednisone (26.7 months) than in those receiving prednisone/placebo (18.4 months). The median fourth dimension to progression of pain interference with daily activities was besides significantly longer in the Zytiga group—10.3 months compared to 7.4 months. What'south more, the median time to progression of worst pain intensity was likewise longer in the Zytiga/prednisone group (26.vii months) compared to the prednisone/placebo group (xix.4 months), just the difference was considered not-significant.

The median fourth dimension to HRQoL deterioration was longer in patients receiving Zytiga/prednisone (12.7 months) than in those receiving prednisone/placebo (eight.3 months).

References:

Taplin ME, Montgomery RB, Logothetis C, et al. Effect of neoadjuvant abiraterone acetate (AA) plus leuprolide acetate (LHRHa) on PSA, pathological complete response (pCR), and most pCR in localized loftier-risk prostate cancer (LHRPC): Results of a randomized stage II report. Presented at the 2012 annual meeting of the American Society of Clinical Oncology, June 1-5, 2012, Chicago, IL. Abstruse 4521.
Ryan C, Smith M, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-bullheaded, placebo-controlled stage 3 study. The Lancet Oncology. Volume 16, No. ii, p152–160, February 2015. updated Lancet Oncol. 2019 April 12. Epub ahead of impress.
Basch Eastward, Autio K, Ryan CJ, et al: Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomized phase iii trial. The Lancet Oncology. 2013; fourteen(12):1193-1199.
de Bono JS, Logothetis CJ, Molina A et al. Abiraterone and increased survival in metastatic prostate cancer. New England Journal of Medicine. 2011;364:1995-2005.
Sternberg CN, Scher Howdy, Molina A et al. Fatigue improvement/reduction with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel – results from the COU-AA-301 phase three study. Presented at the 2011 European Multidisciplinary Cancer Conference. Stockholm, Sweden. September 23-27, 2011. Abstract 7015.
FDA news release. FDA approves Zytiga for tardily-phase prostate cancer. April 28, 2011.
FDA expands Zytiga'due south employ for late-stage prostate cancer. [FDA News Release]. U.S. Food and Drug Administration website.
Fizazi K, Maldonado X, Foulon S, et al. A phase iii trial with a 2×2 factorial design of abiraterone acetate plus prednisone and/or local radiotherapy in men with de novo metastatic castration-sensitive prostate cancer (mCSPC): starting time results of PEACE-1. J Clin Oncol. 2021;39:(suppl fifteen; abstr 5000). doi:ten.1200/JCO.2021.39.15_suppl.5000