Advanced Prostate Cancer Newsletter

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Cancer survivors have many additional problems in their life. I guess the most significant problem is that we have a life threatening illness. So, why are we forced to have to worry if our medications will be paid for or if we are able to afford to pay for them? When we are fighting for our life we shouldn’t also have to fight to get or medications, especially chemotherapy.

Most people don’t realize it but the type of treatment your doctor prescribes might determine how your insurance company will pay. When you are prescribed intravenous (IV) chemotherapy you will go to an office or hospital. Since you are required to go to see a healthcare professional your insurance company will pay the bill as a medical benefit requiring you to just pay a limited co-pay.

When the doctor prescribes oral anti-cancer medications like Zytiga or Xtandi your insurance coverage will usually come under your prescription drug benefit. In most cases you’re your co-pay or co-insurance will be significantly higher than if the treatment was administered in a doctors office or in the hospital! This can translate to thousands of dollars of extra cost to an oral chemotherapy drug user.

For some survivors their oral medications can only be administered using this more expensive option (like Xtandi and Zytiga.

This higher cost can run into thousands of dollars forcing too many people to not be able to purchase their drugs. People who fail to take their drugs become sicker and eventually require even more treatment at possibly even a greater cost to the insurance company and to society.

The good news is that a number of states have adopted or are considering legislation that requires health insurance companies to cover oral anti-cancer drugs like they cover IV cancer therapies. These bills are called parity bills.

Does your state have a parity bill? You can find out by going to Prescription Princess. Prescription Princess also has a link where you can obtain coupons for medications.

https://www.prescriptionprocess.com/know-the-facts/barriers-to-prescription-access/OralChemoParity.aspx

Joel T Nowak, M.A., M.S.W.

In a new study it was shown that smoking doubles the chances that a prostate cancer survivor will have the cancer spread and that he would die from the cancer.

Study co-author Dr. Michael Zelefsky, Vice Chair of Clinical Research in the Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center said, “Basically we found that people who smoke had a higher risk of their tumor coming back, of it spreading and, ultimately, even dying of prostate cancer.”

He also said that this “ this applied only to ‘current smokers’ who were smoking around the time they received external beam therapy.” He also said, “Former smokers did not have the increased risk for disease spread and recurrence that current smokers have.

Zelefsky did say that the side effects of the radiation seemed to affect all smokers, both past and prior equally. He included in potential side effects rectal bleeding and/or frequent and urgent urination.
These findings were reported online on Jan. 27 in the journal BJU International.

According to the researchers 19 percent of American adults smoke. The study looked at nearly 2,400 men who underwent treatment for prostate cancer between 1988 and 2005. Nearly 50 percent in the study were identified as “former smokers,” even if they had only kicked their habit shortly before beginning cancer treatment.

Disease progression, relapse, symptoms and deaths were all tracked for an average of eight years, as were all reactions to the radiation treatment.

The researchers determined that men surviving prostate cancer for a decade without experiencing any disease recurrence were about 66% in those men who never smoked. However, that figure fell to 52% among men who were current smokers.

Former smokers fared better than current smokers, with about 62 percent projected to hit the 10-year survival mark.

They also found that compared with those who had never smoked, both current and former smokers faced a notably higher risk for the toxic urinary side effects that can occur with radiation treatment.

Men need to curb their smoking, especially men with prostate cancer. We all need to become proactive and make smokers former smokers. Our hospitals need to devise and encourage men (actually all people) to join smoking cessation programs.

According to Dr. Stephen Freedland, a professor of surgery at Cedars-Sinai Health System in Los Angeles these finding adds to growing evidence that smoking is associated with aggressive prostate cancer. He did add that a cause-and-effect link was not proven in this new study.

Freedland said, “… that the risk of dying from prostate cancer goes up for smokers…. So, I would say that quitting smoking is better than not quitting, and not starting in the first place is the best thing.”

http://www.newsmaxhealth.com/Health-News/prostate-cancer-patients-smoke/2015/01/27/id/620988/

Joel T. Nowak, M.A., M.S.W.

In a recent publication it was suggested that radiographic progression-free survival (rPFS) in men with metastatic castration-resistant prostate cancer (mCRPC) was highly consistent and highly associated with overall survival. This reproducible quantitative find could have implications for the interim measurement of treatment response in future studies, according to Dr. Michael J. Morris of Memorial Sloan Kettering Cancer Center, New York, and his colleagues.

Dr. Morris points to the Cougar-Abiraterone Acetate Study 302 (COU-AA-302), a randomized, placebo-controlled phase III study of 1,088 men with mCRPC, where radiographic progression-free survival (rPFS) which was defined as the time from randomization of the subjects to the first occurrence of progression was highly positively associated with overall survival.

Dr. Morris said, “There has long been a need to develop additional time-to-event endpoints short of [overall survival] to accelerate drug development. (J. Clin. Oncol. 2015 Jan. 26 [doi:10.1200/JCO.2014.55.3875]). There exists a specific unmet need to validate a reproducible assay that can be interpreted and reported consistently and quantitatively as a biomarker in the assessment of bone disease (the vast majority of men with mCRPC have significant bone disease that leads to their death) with radionuclide bone scans.

A Prostate Cancer Working Group 2 (PCSG2) proposal to use a time-to-event progression endpoint for bone scan interpretation – with progression defined as two or more new lesions on an initial post treatment bone scan, followed by two additional lesions on the subsequent scan – was evaluated along with a bone scan data capture assay developed through the Prostate Cancer Clinical Consortium in COU-AA-302.

In the trial chemotherapy-naive men were randomly assigned to receive 1,000 mg abiraterone plus prednisone daily or prednisone alone.

When rPFS was based on investigator-reviewed assessments of scans at the first analysis, the decrease in the hazard of radiographic progression or death in the abiraterone group vs. the prednisone-only group was similar at 51%. At the second interim analysis for overall survival, 607 rPFS events were observed on investigator review. Treatment with abiraterone plus prednisone led to a 47% reduction in the risk of radiographic progression or death, compared with prednisone.

The this study – the first to use rPFS as a registration endpoint for evaluating chemotherapy-naive mCRPC men per FDA provides the highest level of evidence to date that rPFS is highly associated with overall survival.

Morris and his associates said that “the rigor of the independently validated data showing significant benefit in rPFS and a strong trend in [overall survival] as co-primary endpoints in combination with clinically relevant secondary endpoints” supported the regulatory approval of abiraterone acetate plus prednisone in chemotherapy-naive mCRPC patients.

“The results suggest that this objective, prospectively defined endpoint may serve as a response indicator biomarker that is evaluable in future studies,” they said, adding that while the findings demonstrate a highly positive association between rPFS and overall survival in mCRPC, they do not provide support for the use of rPFS as a substitute for overall survival.

This study was supported by Ortho Biotech Oncology Research and Development, the Prostate Cancer Clinical Trials Consortium, sponsored by the Department of Defense, and by Janssen Global Services.

rPFS May Predict Treatment Response in mCRPC Trials
Frontline Medical News · January 27, 2015

Joel T. Nowak, M.A., M.S.W.

It was recently discovered that if hormone therapy (ADT) is added to radiation cancer deaths are lowered by nearly 50 % in men with locally advanced prostate cancer aged 76 to 85 compared to men who only received hormone therapy. Prior studies have shown that 40% of men with aggressive prostate cancers are treated with hormone therapy alone, which creates a substantial gap in curative cancer care amongst men in their 70s and 80s.

“Failure to use powerful remedies for older individuals with cancer is a well being care excellent concern in the United States. Radiation plus hormone therapy is such a remedy for males with aggressive prostate cancers,” mentioned lead author Justin E. Bekelman, MD, an assistant professor of Radiation Oncology, Healthcare Ethics and Health Policy at Penn’s Perelman School of Medicine and Abramson Cancer Center. “Patients and their physicians ought to cautiously go over curative therapy solutions for prostate cancer and lessen the use of hormone therapy alone.”

Locally advanced prostate cancer must be taken seriously. It is cancer that has spread out of the gland, but still close to the prostate gland. Locally advanced prostate cancer is an aggressive malignancy that is prone to metastasize to other body parts and cause cancer deaths.

There are two prior clinical trials have shown that radiation plus hormone therapy produces a large and important improvement in survival in younger men relative to hormone therapy alone, but till now there has been no comparable research on therapy for older men.

The researchers compared the combination of radiation plus hormone therapy versus hormone therapy alone among 541 men with prostate cancer ranging in age from 65 years to 85 years. In the men aged 65 to 75 years old radiation plus hormone therapy was linked with a reduction in prostate cancer deaths of 57% relative to hormone therapy alone. In the men aged 76 to 85 years old, radiation plus hormone therapy was connected with a reduction in prostate cancer deaths of 49% relative to hormone therapy alone.

Based on the prior studies as well as this study it becomes very clear that no matter what your age in men with locally advanced prostate cancer hormone therapy (ADT) should be added to radation therapy to extend survival.

http://www.asiaeu.com/science/radiation-plus-hormone-therapy-prolongs-survival-for-older-men-with-prostate-cancer-h129849.html

Joel T Nowak, M.A., M.S.W.

Liver metastases are uncommon in men with castrate resistant prostate cancer (CRPC). Having liver metastases is associated with more serious disease and shorter survival.

How to treat men with liver metastases is still not very clear. It is felt that more active treatment might benefit these men. A standard regimen for treating gastric cancer is Epirubicin, Cisplatin and Flurouracil (ECF). This regimen has been reported to also have a response in CRPC in men with liver metastases.

In a research survey of the use of ECF in CRPC was evaluated with the primary objective of determining its anti-tumor activity in men with liver metastatic CRPC. The survey excluded men with tumors showing neuroendocrine features.

The researchers identified 8 men meeting the inclusion criteria. They received a median of 6 cycles of ECF
(range: 1-10). Of the 8 men with liver metastases, 5 had experienced a partial remission.
The researchers found that in a small selected group of younger men with liver metastases and with a poor prognosis ECF was highly active. Despite these limitations, this is the third report of high objective response rates with ECF in CRPC. Since objective response rates are low with current therapies ECF should be considered.

Can Urol Assoc J. 2014 Sep;8(9-10):353-7.
doi: 10.5489/cuaj.2029; Gupta S, Potvin K, Ernst DS, Whiston F, Winquist E.

PubMed Abstract
PMID: 25408803

It isn’t here yet, but it very much is here! What am I talking about? Circulating tumor cells (CTCs) are going to become a clear winner for us as the concept of using them finds its way into commercialization.

Metastatic castration resistant prostate cancer (mCRPC) is difficult to evaluate using our less than stellar conventional assessments. Poor evaluative measures only means we end up with poor therapeutic decision-making.

The presence of CTCs in the peripheral circulation appears to be common in mCRPC. There have been multiple studies that show that counting these cells in men with mCRPC is relevant to predicting survival, therapy response and the biology of the disease. Furthermore, the kinetics of response of CTC levels to chemotherapy are rapid.

By performing regular measurements of CTCs in blood samples we can take advantage of these properties. When you add a count of the CTCs to the other traditional information we have from conventional assessments (imaging and serum PSA levels) we end up with a much more accurate picture of the prostate cancer.

Now we need to hope that some company will come along and submit an application to the FDA so we can finally release this great tool out of the lab and into the clinic.

Joel T Nowak, M.A., M.S.W.