Advanced Prostate Cancer Newsletter

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Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure of androgen therapy (ADT) in whom chemotherapy is not yet clinically indicated.

CHMP’s decision is driven by the positive phase 3 results of the Prevail trial where Xtandi reduced the risk of death by 29% compared to placebo. Additionally, men who were treated with Xtandi had a 17 month delay in time to their initiating chemotherapy over the placebo group.

In normal circumstances the actual decision by the European Commission usually takes 60 days from the release of CHMP’s opinion. Once this last hurdle is cleared we should finally see Xtandi available in Europe.

It is good to see that Europe will catch up and this vital treatment be made available to men prior to their having chemotherapy.

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

In a poster presentation at the recent European Society of Medical Oncologists (ESMO) there was a very interesting poster presented updating a phase 3 clinical trial (CA184-043) which evaluated the overall survival (OS) with radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. This trial did not meet its endpoint and was considered to have failed (Kwon ED, et al. Lancet Oncol 2014 in press), but it still remains of significant interest. The update included an additional year of data.

In the trial 799 men were randomized to receive a single dose of radio therapy to their bone metastases followed by either Ipi (N = 399) or placebo (N = 400). An updated overall survival analysis was performed.

Updated OS analysis with survival rates up to 3 years was consistent with the primary analysis. Also consistent with previous reports, pre-specified subgroup analyses suggest greater activity in men with lower disease burden [e.g., Ipi vs. placebo with (HR 1.17, 0.89–1.53) or without (0.74, 0.61–0.89) visceral metastases].

The safety profile with extended follow-up was similar to that reported previously, which included immune-related AEs (irAEs) (gastrointestinal, dermatologic, endocrine, and hepatic). Most irAEs were manageable with established Ipi treatment algorithms.

With an additional year of follow-up, the activity observed for Ipi + RT in post-docetaxel mCRPC pts is maintained. In addition, subgroup analyses suggest men with lower disease burden may be more likely to benefit from Ipi treatment. Long-term OS and Ipi benefit in mCRPC men with lower disease burden (i.e., no visceral metastases) will be evaluated in the ongoing phase 3 study, CA184-095.

These results are not surprising and are totally consistent with what we have learned about immune therapy. IT TAKES TIME TO WORK, so men with lower disease burdens will survive longer allowing the immune therapy the time it requires to become active and effective. This is why treatments like Provenge should be taken as soon as a man becomes castrate resistant, while their disease burden is lower.

Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336; K. Fizazi1, C.G. Drake2, E.D. Kwon3, A. Bossi4, A.J. van den Eertwegh5, H.I. Scher6, T.M. Beer7, M.B. McHenry8, D. Liu8, W.R. Gerritsen9, C. Logotheti

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

Its day 20 since Xofigo production stopped. How are you? Please email Joel at about how the Xofigo shutdown has affected your life.

Bayer has issued a public statement about the shortage of Xofigo (radium Ra 223 dichloride). After reviewing their statement I find that there is no new information that we haven’t already shared on this blog.

To summarize the important points in the release:

1- Bayer detected foreign material in the drug during its normal and routine inspection process.
2- Because of the existence of this foreign material Bayer suspended production of Xofigo
3- Bayer continues to search for the point at which this foreign substance has been introduced so they can prevent it from entering into the Xofigo.
4- Bayer is working to resolve the problem around the clock and will not begin production until the problem is resolved.
5- Bayer is also working with the FDA to insure the safety of all patients taking the drug.
6- Bayer again said that any product that had been released and used prior to the development of this problem passed all inspections and was safe.
7- Bayer suggests that patients speak with their doctors about their individual situation given the lack of Xofigo.

This release did not provide any projected dates for the resolution of this problem and for when production will again commence.

Bayer has stated that men whose protocol was interrupted should speak with their doctor to help them decide what should be their next step. Malecare believes that this is very important since it will most likely be many weeks, if not months, before Xofigo might be available to patients.

Malecare is committed to keeping everyone fully informed about this situation. We hope that the engineers at Bayer are able to quickly resolve this problem so that the flow of this vital drug can again become available to the many men in need.

Bayer’s formal statement can be seen at: Bayer Xofigo Statement 10/21.

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


How has Xofigo shutdown affected you?

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Its day 19 since Xofigo production stopped. Malecare continues to dig deep, trying to learn when production might start up again.
Meanwhile, How are you? Please email Joel at about how the Xofigo shutdown has affected your life.

Categories : Uncategorized, Xofigo
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It would be of great advantage to us if we were able to improve the early detection of responders to salvage external beam radiotherapy (RT) after failed radical prostatectomy (RP). Early detection would allow us to make earlier treatment decisions which should provide for better results.
In an attempt to better improve our understanding of early detection, between 2002 and 2007, at a single institution, 136 consecutive men received salvage radiation treatment (RT) to a dose of 66Gy without androgen-deprivation therapy (ADT) aftera prostatectomy (surgery) for a rising prostate-specific antigen (PSA) level. PSA measurements were systematically performed before radiation therapy at the fifth week of radiotherapy, and in the follow-up at least twice a year (every 6mo).

The median follow-up was 60 months. The 5-year freedom from biochemical and clinical failure rates were 57% (95% CI: 48%-66%) and 92% (95% CI: 87%-97%), respectively. The mean PSA5 was 0.61ng/ml (range: 0-7) and the mean PSA ratio was 0.67 (0-1.7). A PSA ratio< 1 was a significant prognostic factor in multivariate analysis for both definitions of biochemical failure (P = 0.01 for both) and for clinical failure (P = 0.005).

For men undergoing salvage radiotherapy, without ADT after surgery with a rising PSA level, the absence of PSA decline during radiation therapy is predictive of biochemical and clinical failure and may be used to rapidly identify poor responders.

Reference: Urol Oncol. 2014 Aug 28. pii: S1078-1439(14)00277-4.
doi: 10.1016/j.urolonc.2014.07.020; Gustave Roussy,

PMID: 25176583

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

The good news for us is that the survival of men diagnosed with prostate cancer has improved over time. The current 10-year relative survival rate is 99.7%! However, the long survival of men who have prostate cancer raises questions about their risk of a second primary cancer and the need for continued surveillance.

A very large population-based cohort of 441,504 men diagnosed with prostate cancer between 1992 and 2010 was identified from the Surveillance, Epidemiology and End Results Program (SEER) data (SEER13). The standardized incidence ratio (SIR) was calculated as an estimate of the risk of a second primary cancers (malignancy) based on the incidence in the general population.

The analysis of the data showed that men who survived prostate cancer had a lower risk of being diagnosed with another cancer overall compared with the US population. The risks of leukemia and cancers of the oral cavity and pharynx, esophagus, stomach, colon and rectum, liver, gallbladder, pancreas, lung and bronchus, and larynx were significantly lower.

However, prostate cancer survivors had a greater risk of developing bladder, kidney, and endocrine and soft tissue cancers.

Men who received treatment with radiation therapy (external-beam radiation therapy) had long-term increases in their risk of bladder cancer and rectal cancer risk compared with who did not receive radiation.

It was also found that there were significant racial differences in the risk of being diagnosed with a second primary cancer, and the magnitude and direction of these risks depended on tumor type.

Prostate cancer survivors remain at risk of subsequent cancers, particularly bladder kidney, endocrine and soft tissue cancers. Additionally, race and treatment choice plays an important role for long-term risk.

Prostate cancer survivors must remain vigilant in monitoring themselves as they are at an increased risk for certain second primary cancers.

Cancer. 2014 Sep 1;120(17):2735-41. doi: 10.1002/cncr.28769. Epub 2014 May 19. Davis EJ1, Beebe-Dimmer JL, Yee CL, Cooney KA.

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


Why You Must Get Provenge Now

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A recent announcement stated that Dendreon’s immunotherapy Provenge (sipuleucel-T) is too expensive to be used as a treatment for advanced prostate cancer under the National Health Service in England.

In preliminary draft guidelines out this morning, the National Institute for Health and Care Excellence has rejected the drug’s use to treat men with metastatic prostate cancer before they have received chemotherapy.

It is my personal opinion, Dendreon’s economic plans for survival is directly hitched to getting the drug used in Europe where it has been approved by regulators. Given the massive economic woes Dendreon faces, the decision in the UK to not use Provenge can be described only as a major setback which greatly increases the risk that the treatment might soon no longer be available to men with advanced prostate cancer.

I’ve always felt quite frustrated and very unhappy that Dendreon has not been able to flourish so that we could be secure in always having Provenge available as a treatment modality. This guidance issued by the National Health Service is a major blow and increases the risk that Provenge might become unavailable in the very near future.

So what does this mean, I urge each and everyone of you who may qualify to get Provenge NOW as it might not be available in the near future. I hate being a naysayer, I hope I am 100% wrong, but if I am not I urge that you take advantage now while it is still available.

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