British Men Who Have Had Abiraterone Will Not Get Enzalutamide Despite Its Life Extending Ability
Our brothers in England hit a major snag last week as NHS placed a burdensome restriction on the use of enzalutamide (Xtandi) for men with advanced prostate cancer who have already had abiraterone (Zytiga). Because of this ridiculous decision thousands of men with advanced prostate cancer will be denied this life-extending drug.
The reality is that enzalutamide prolongs life by at least five months in men who have run out of treatment options – with some surviving more than 18 months.
This NHS guidance means men with advanced prostate cancer will only be able to get one of the two new drugs used for advanced prostate cancer; Zytiga or Xtandi – both of which British scientists helped to develop.
Up to 3,000 British men a year would benefit from the use of these new drugs, which have been use for many men either before or after chemotherapy. Until now, The Cancer Drugs Fund and the NHS have funded these drugs while awaiting a decision from the National Institute for Health and Care Excellence (Nice) on whether enzalutamide should be routinely paid for to treat men with castrate resistant prostate cancer.
Initially it was funded, but in January Nice proposed that it should be banned for men in England and Wales previously treated with abiraterone. Men in Scotland are getting it without any of these restrictions.
An outcry over this plan led to Prostate Cancer UK spearheading a campaign to fund enzalutamide, with over 13,500 people signing its petition. The protest also had widespread support from high profile figures such as Sir Michael Parkinson and other organizations such as Tackle Prostate Cancer.
Under this pressure Nice performed another U-turn and in April it went back to its original position of recommending enzalutamide regardless of a man’s previous treatment history.
However, last Wednesday another new contrary guidance from Nice came out that says there is not enough evidence to make a recommendation about how the two drugs should be used. This is true, but the response should not be to restrict either of these drugs. Clearly, this is a pure economic decision.
NHS England, the body which advises local area cancer teams on which drugs to fund, says as a result of the lack of evidence men who have been treated with abiraterone cannot have enzalutamide.
It goes further, saying men who have received enzalutamide cannot then have the other drug, Zytiga – effectively restricting men to only one of these drugs during their treatment, or maybe I should say their now their unnecessarily abbreviated life.
Joel T. Nowak, M.A., M.S.W.
There are conferences for doctors and conferences for researchers, but there is also a conference just for prostate cancer survivors and their caretakers! The Prostate Cancer Research Institute (PCRI), a partner of Malecare, annually sponsors the only patient conference in the world.
I have attended the conference over the last five years and strongly recommend that you join me at the conference in September. Prior conferences have been very interesting and informative. Beyond the education I have especially enjoyed meeting other survivors, especially people who I am acquainted with through the blog and the Advanced Prostate Cancer Online support group.
Malecare will again be participating at the conference by running three different support groups. Darryl, our Executive Director, will be running two sessions of a support group for gay men with prostate cancer, Dr. Wendy Lebowitz, our in-house Psychologist, will run two sessions for women only and I will run two support groups about advanced prostate cancer.
Malecare will also have a table at the conference where you will be able to pick up information about the Malecare programs as well as to have a formal chat with our many programs. Of course, we will be at the conference and look forward to having an opportunity to also talk in the hall and over a cup of coffee.
The real reason to come to the conference is to hear outstanding speakers talk about the concerns we all have about prostate cancer. Our concerns, not those of the medical and research communities. The following is the current schedule:
David Krasne, M.D., St. John’s Health Center
Active Surveillance for Low-Risk Prostate Cancer
Maha Hussain, M.D., University of Michigan Medical Center
Advanced Prostate Cancer
Anthony Zietman, M.D., Massachusetts General Hospital
Intermediate and High Risk Disease
Eugene Kwon, M.D., Mayo Clinic Cancer Center
Treating Oligometastatic Disease with Multimodality Therapy
John Mulhall, M.D., Memorial Sloan-Kettering Cancer Institute
Sexual Complications of Treatment
Mark Moyad, M.D., University of Michigan Medical Center
Diet, Dietary Supplements and Prostate Health
Charles “Snuffy” Myers, M.D., American Institute for Diseases of the Prostate
Mark Scholz, M.D., Prostate Oncology Specialists
Treating PSA-Relapsed Disease
Consider joining us at the conference this September 5th through the 7th in Los Angeles. The conference is held at the LAX Marriott hotel and rooms are available at a significant discount.
To learn more about the conference and to register go to:
Joel T. Nowak, M.A., M.S.W.
In my most humble opinion among the most vital and impactful program in the world, which supports prostate cancer research funding and prostate cancer research resources, is in trouble. It is the only government program that funds only prostate cancer research. All of its research funding mechanisms are designed to fund high risk and potentially high return research, research that makes a major impact on out lives.
Shockingly, some members of the United States Senate have decided to take aim at our program. They are threatening to make major financial cuts, cuts that will affect your survival and your quality of life.
The PCRP has been, year after year, the leader in the development of our newest treatments. The next drug that will extend your life or the life of your loved one is being threatened. Don’t let this happen. We need this program intact.
The Senate is preparing to cut $16 million (20% of our budget) from our PCRP budget. Each year we ask for a budget increase and breath a sigh of relief when we are maintained at $80 million dollars (which is ½ of what is received for the DOD Breast Cancer Program). Now, they want to cut our budget. Now they want to cut short our life and fail to protect our quality of life.
This is not acceptable. We need to immediately let our Senate members known that cutting the Department of Defense Prostate Cancer Research Program is unacceptable. You, your partner, your children and your friends need to immediately make contact with your senators and demand that they stand firm and make sure that our budget is not cut.
The sad thing is that the House of Representatives which is usually the more aggressive budget cutting part of the legislature has already passed a resolution to continue the DOD PCRP’s budget for the fiscal year 2015 at the $80 million level.
The U.S. Senate is prepared to cut $16 million in critical research dollars – 20 percent of Prostate Cancer Research Program funding – from the 2015 federal budget.
The Department of Defense (DOD) plays a key role in the war on cancer, and the Prostate Cancer Research Program (PCRP) within the DOD has helped save countless lives by funding the discovery of three new and powerful prostate cancer treatments in the last three years.
Now is the time when we all must act. Each of us needs to make contact with your senators and press them to support the full funding for fiscal year 2014 of $80 million for the Prostate Cancer Research Program in the Department of Defense.
HOW TO CONTACT YOUR SENATOR:
Joel T. Nowak, M.A., M.S.W.
Disclosure: I am a proud consultant to the DOD PCRP
Yesterday’s post was about the use of chemotherapy (with docetaxel) for the treatment of men with advanced prostate cancer who were 80 years old or older. Today’s post is about the use of chemotherapy in men 60 years or younger. The research for both of these posts was performed by the same team of scientists in a multicenter retrospective study in Italy.
A large portion of prostate cancer is diagnosed in men over the age of 60 years so castration-resistant prostate cancer (CRPC) is rarely observed in men younger than 60 years. As a result the clinical outcomes of these younger men have not been clearly defined. There is a common feeling of a worse prognosis for these younger men. In the study which is the topic of this post the aim is to assess the clinical outcomes of this specific population.
The researchers reviewed the clinical records of all the men younger than 60 with CRPC from participating institutions, treated with docetaxel (DOC), both in clinical trials and in clinical practice. They recorded the pre- and post-DOC clinical history, the DOC treatment details and outcomes.
As of the date of publication they have collected a consecutive series of information on 128 men from 24 Italian hospitalsThe median age was 57 (range 41 to 60). The median baseline prostate-specific antigen (PSA) was 85 ng/ml (range 1 to 3,020); 87% of the pts had bone metastases while 47%, 10%, and 13% showed nodal, liver and lung metastases, respectively.
All but 12 of the men received DOC with a 3 week standard schedule, the remaining being treated with a weekly, reduced dosage schedule.
A PSA reduction greater than 50% was observed in 61% of the the men; among the 86 men with measurable disease who underwent a radiological re-evaluation at the treatment end, four and 13 men achieved complete and partial response, respectively (response rate 20%).
The main grade 3-4 toxicities were anemia (five men), neutropenia (18 men), febrile neutropenia (one man), fatigue (five men), peripheral neuropathy (three men). The median progression-free survival (PFS) and overall survival (OS) were 7 months and 21 months, while the 1 year PFS and OS rates were 17.6% and 74.9%, respectively.
Their data seems to not confirm that younger men with CRPC have a worse prognosis compared to the older men since their survival outcomes and response rate are similar to those observed in general population of men with CRPC.
J Clin Oncol 32, 2014 (suppl 4; abstr 214); Antonello Veccia, Cinzia Ortega, Giuseppe di Lorenzo, Francesca La Russa, Salvatore Luca Burgio, Gaetano Facchini, Caterina Messina, Cosimo Sacco, Gilbert Spizzo, Michele Aieta, Michele Lodde, Giovanni Mansueto, Paolo A. Zucali, Alessandro D’Angelo, Roberto Iacovelli, Francesco Massari, Franco Morelli, Giuseppe Procopio, Fiorella Ruatta, Orazio Caffo, CYCLOP Study Group.
Joel T. Nowak, M.A., M.S.W.
Chemotherapy (chemo with docetaxel) has a reputation for being a difficult therapy loaded with many side effects. I believe that this reputation is overblown given that all of our new non-chemotherapies (other than Provenge) come with their own list of significant side effects. However, its reputation is in the minds of many, so men who are elderly will often choose to forgo chemo because of the age and comorbidities as well as an underlying cynicism around the possible survival advantages at this older age.
Is this the right decision? Should older men 80 years and older have chemotherapy to treat their advanced prostate cancer?
A group of Italian researchers performed a retrospective study aimed to assess the clinical outcomes in this very elderly castrate resistant advanced prostate cancer (CRPC) population.
They reviewed a consecutive series of 115 men from 28 Italian hospitals with a median age was 82 (range 80 to 90) and a median baseline prostate-specific antigen (PSA) of 92 ng/ml (range 3 to 2,981); 83% of the men had bone metastases, while nodal, lung and liver metastases were observed in 39%, 9%, and 8% of the men respectively.
They found a PSA reduction greater than 50% in 55% of the men; an objective response was observed in 15% of the 60 men who underwent a radiological re-evaluation at the treatment end.
Grade 3-4 toxicities were: anemia (2%), neutropenia (10%) , thrombocytopenia (2%), fatigue (10%), diarrhea (4%), nausea (2%), renal (2%), and febrile neutropenia (2%). The median progression-free survival (PFS) and overall survival (OS )were 7 months and 20 months, while the 1 year PFS and OS rates were 21.2% and 71.5%, respectively.
This data suggests that a population of selected very older (age 80 and older) advanced prostate cancer survivors can safely have chemotherapy with a good toxicity profile. In this older population chemotherapy is able to produce survival outcomes comparable to pivotal trials (18
J Clin Oncol 32, 2014 (suppl 4; abstr 92); Antonello Veccia, Salvatore Luca Burgio, Giuseppe di Lorenzo, Cinzia Ortega, Florinda Scognamiglio, Michele Aieta, Fable Zustovich, Rodolfo Mattioli, Giovanni Mansueto, Gaetano Facchini, Giuseppe Procopio, Alessandro D’Angelo, Gilbert Spizzo, Maddalena Donini, Roberto Bortolus, Giovanni Vicario, Paolo A. Zucali, Umberto Basso, Giovanni Lo Re, Orazio Caffo, DELPHY Study Group
Joel T. Nowak, M.A., M.S.W.