Janssen’s Zytiga Approved for Earlier Use in Prostate Cancer

Excerpt:

“European regulators are allowing earlier use of Janssen’s Zytiga in the treatment pathway for metastatic prostate cancer.

“Zytiga (abiraterone) plus prednisone/prednisolone has been approved to treat newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

“The drug is already available in Europe for metastatic castration-resistant prostate cancer (mCRPC) in adults who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated and in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.”

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Video: Dr. Kantoff on Docetaxel Plus Androgen Deprivation Therapy in Prostate Cancer

Excerpt:

“Philip W. Kantoff, MD, chair of the Department of Medicine, Memorial Sloan Kettering Cancer Center and a 2014 Giants of Cancer Care winner for Genitourinary Cancer, discusses the combination of docetaxel (Taxotere) chemotherapy and androgen deprivation therapy (ADT) in the setting of metastatic hormone-sensitive prostate cancer.

“Considering the positive results in overall survival from the CHAARTED and STAMPEDE trials, which combined ADT with docetaxel, the next step became determining which patients would benefit from this combination.”

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Metastatic Hormone-Sensitive Prostate Cancer Should Include Docetaxel Alongside ADT

“Treatment initiation for hormone-sensitive metastatic prostate cancer should include the addition of docetaxel to androgen deprivation therapy (ADT) as standard of care. This recommendation is based on a meta-analysis1 of three large, relatively recent, randomized trials showing that docetaxel improves survival and failure-free survival (FFS) in metastatic hormone-sensitive prostate cancer. These findings move docetaxel up to the hormone-sensitive setting from its previous role as upfront treatment in the castrate-resistant setting.

“In men with metastatic hormone-sensitive prostate cancer, docetaxel added to ADT improved 4-year survival by an absolute value of 9% and reduced FFS by an absolute value of 16%.”


'Bipolar' Therapy: New Twist in Advanced Prostate Cancer

“Preliminary data suggest that a new twist on manipulating hormones in prostate cancer shows some benefit. The standard approach to treatment is androgen deprivation therapy (ADT), but the new approach intersperses this with bipolar androgen therapy (BAT) with intramuscular testosterone injections.

“Results from a small phase 2 study in 29 men with advanced hormone-sensitive prostate cancer show that the primary endpoint was met, with nearly 60% of men achieving a prostate-specific antigen (PSA) level <4 ng/mL after undergoing two cycles of BAT.

“The findings, which were presented at Genitourinary Cancers Symposium (GUCS) 2016, also suggest that BAT may have a positive impact on quality of life.”


Two-Drug Combination Boosts Survival in Metastatic Prostate Cancer

“Newly diagnosed patients with metastatic, hormone-sensitive prostate cancer gained a dramatic survival benefit when started on two drugs simultaneously, rather than delaying the second drug until the cancer began to worsen, according to results of a clinical trial led by a Dana-Farber Cancer Institute scientist.

“Patients who underwent six cycles of treatment with the chemotherapy drug docetaxel along with a hormone blocker survived for a median of 57.6 months, more than a year longer than the median 44-month survival for men who received only the hormone-blocker, according to a report in The New England Journal of Medicine. The immediate combination also prolonged the period before the cancer began to worsen – a median of 20.2 months versus 11.7 months with the single agent.

“The multi-center, phase III trial, involving 790 patients, ‘is the first to identify a strategy that prolongs survival in men newly diagnosed with metastatic, hormone-sensitive prostate cancer,’ said Christopher J. Sweeney, MBBS, of Dana-Farber’s Lank Center for Genitourinary Oncology. He said the results of the multi-center phase III trial should change the way doctors have routinely treated such patients since the 1940s.”


Cixutumumab Adds No Benefit in ADT-Sensitive Prostate Cancer

“Adding cixutumumab to androgen deprivation therapy (ADT) did not significantly increase the undetectable prostate-specific antigen (PSA) rate in men with newly diagnosed, metastatic, hormone-sensitive prostate cancer, according to results of the Southwest Oncology Group (SWOG) S0925 study published in the Journal of Clinical Oncology.

“Evan Y. Yu, MD, of the Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, and colleagues randomized 210 patients to receive either ADT (bicalutamide and luteinizing hormone–releasing hormone agonist) alone or ADT plus cixutumumab. At 28 weeks, the undetectable PSA rate (≤ 0.2 ng/mL) was 40% (42 of 105 patients) in the cixutumumab arm compared with 32.3% (34 of 105 patients) in the ADT-alone arm (relative risk = 1.24, P = .16).

“The median age of patients in the trial was 65, and the median PSA levels in the control and cixutumumab arms were 31 ng/mL and 37 ng/mL, respectively…

“ ‘Although these results fail to confirm preclinical evidence supporting the combination of castration with IGF-1R inhibition by cixutumumab, it is possible that the primary endpoint of undetectable PSA at 28 weeks does not fully capture cixutumumab efficacy,’ concluded the authors.”


ADT Plus Docetaxel for Prostate Ca: Home Run or Foul Ball?

“A ‘home run’ in advanced prostate cancer did not clear the fence in a second evaluation of androgen deprivation therapy (ADT) with docetaxel, according to a study reported here.

“An updated analysis of a French study showed that adding chemotherapy to ADT did not significantly improve overall survival for men with hormone-sensitive, metastatic prostate cancer. However, the 13-month difference in favor of the docetaxel arm was comparable to the statistically significant 14-month improvement observed in a larger U.S. trial reported last year.

“The French study also failed to show a survival benefit in patients with high-volume disease, which accounted for two-thirds of the patients in the U.S. trial.

” ‘We are awaiting the analysis of [a third randomized trial], and we hope to come up with a common analysis of the three studies altogether in order to give the good [best] treatment for the good [best] patient,’ Gwenaelle Gravis, MD, of Institut Paoli-Calmettes in Marseilles, France, said here at the Genitourinary Cancers Symposium.

“For more than 40 years, ADT has represented standard of care for metastatic hormone-sensitive advanced prostate cancer. The emergence of effective chemotherapy for castration-resistant prostate cancer led to speculation that use of cytotoxic therapy in hormone-sensitive advanced prostate cancer might improve outcomes as compared with ADT alone.”


Medivation and Astellas Announce Phase 3 Study of Enzalutamide In Men With High-Risk, Hormone-Sensitive, Non-Metastatic Prostate Cancer That Has Recurred Following Definitive Local Therapy

The gist: Two drug companies are partnering to figure out how to treat patients who already had radical prostatectomy and/or radiation therapy to treat their high-risk, hormone-sensitive, non-metastatic prostate cancer, but who then experienced rising PSA levels. The companies will use a clinical trial with volunteer patients to test whether the drug enzalutamide might help. If you are a patient interested in participating in the trial, find out more at clinicaltrials.gov.

“Medivation Inc. (NASDAQ: MDVN) and Astellas today announced plans to initiate a global Phase 3 clinical trial that will evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (rising prostate-specific antigen [PSA] level) following definitive local therapy with radical prostatectomy and/or radiation therapy. Currently, there is no prescription medicine specifically approved in the United States for these patients.

“ ‘It is estimated that approximately one third of men in the United States experience a rising PSA, also known as biochemical recurrence, after localized therapy for the treatment of prostate cancer,’ said Lynn Seely, M.D., chief medical officer of Medivation, Inc.  ‘This trial will determine if enzalutamide can delay the development of metastatic prostate cancer in high-risk men with a rapidly rising PSA.  The initiation of this trial in collaboration with our partner Astellas showcases our mutual commitment to continue exploring the potential of enzalutamide in areas of significant unmet medical need.’ ”

“ ‘Following enzalutamide’s continued positive impact on overall survival and progression-free survival versus placebo in metastatic castration-resistant prostate cancer, we are looking forward to continuing to explore the medicine’s potential impact on patients at earlier stages of the disease,’ said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc.”


Hormones After Breast Cancer: Not Fuel for the Fire After All?

Editor’s note: This study used mice in a lab to explore the question of whether hormone therapy can improve survival and quality of life for postmenopausal women diagnosed with breast cancer. The results were promising, but more research needs to be done.

“A new study supports a growing body of research suggesting a safe and effective role for natural steroid hormones in treating postmenopausal breast cancer, with fewer detrimental side effects and improved health profile than with standard anti-hormone therapies. The study will be published in final format today in the open-access journal Reproductive Biology and Endocrinology.

“Breast cancer is the most frequently diagnosed cancer in women in the United States. Approximately 70% of breast cancers are diagnosed in postmenopausal women. Major clinical trials and experimental studies showed that a class of anti-estrogen drugs called aromatase inhibitors (AIs) is effective against postmenopausal . Yet despite their effectiveness in reducing tumor recurrence, aromatase inhibitors have adverse effects on the cardiovascular system and increase osteoporosis and bone fractures, which may explain their lack of overall survival improvement versus the older treatment, tamoxifen. These effects, together with undesirable side effects such as incontinence and bone and joint pain, cause many women to discontinue using AIs. Alternatives are needed.

“In their study, researchers at the Center of Excellence in Cancer Research at the Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center, set out to explore a radical and counterintuitive hypothesis: Could an optimal choice of hormones lead to improved survival factors and quality of life, enough to outweigh any negative effect on tumor recurrence? Radical—because current standard of practice considers hormone treatment of any type absolutely contraindicated following hormone-receptor-positive breast cancer. Counterintuitive— because estrogen-blocking aromatase inhibitors, a nearly opposite treatment, are the current adjuvant treatment for women after hormone-sensitive breast cancer.

“Results from this study in a mouse model suggest the answer to their question is ‘yes,’—well-chosen hormones could improve both survival and quality of life.”