FDA Aproves Provenge for Metastatic Prostate Cancer

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FDA Approves vaccine
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Comparison of the new FDA approved vaccine for prostate cancer with hyperthermia treatment for prostate cancer!

 From Medscape Medical News "The availability of [sipuleucel-T] provides a new treatment option for men with advanced prostate cancer who currently have limited effective therapies available," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, in a press statement

In the pivotal phase 3 study, with a median follow-up of 36.5 months, men treated with sipuleucel-T (n = 341) had a median survival of 25.8 months, compared with men treated with placebo (n = 171), who had a median survival of 21.7 months

Thus, with the new therapy, there was a 4.1-month median survival advantage and a 24.1% reduction in the risk for death (hazard ratio, 0.759; P = .017), compared with placebo.

This 4-month extension in survival is very, very significant.” Said David F. Penson, MD, MPH, at the AUA meeting. Dr. Penson is a professor of medicine at the University of Southern California Los Angeles.

"These patients have a life expectancy of about 2 years, so giving them 4 more months is pretty important. It gives them about 20% more life. And [sipuleucel-T] does it with minimal adverse events. So there is improved survival with good quality of life," he added.

Us: Hyperthermia Treatment for prostate cancer has an 87% success rate in 5 years, which means out of 100 people that got treated with hyperthermia 87 of them would be alive in 5 years! Sipuleuce-T has been proven to extend prostate cancer patients’ lives for only an extra 4 months!!! Can you see the significance in this?

According to the FDA press release, the most common adverse reactions reported with the new product are chills, fatigue, fever, back pain, nausea, joint ache, and headache. The majority of adverse reactions were mild or moderate. Serious adverse reactions, which were reported in approximately one quarter of the patients receiving sipuleucel-T, included some acute infusion reactions and stroke.

Us: Hyperthermia is the proven prostate cancer treatment with minimal to absolutely No side effects in most cases! No hair loss, nausea, pain.. And most importantly after the treatment NO impotence, incontinence, diarrhea for the rest of people’s life? Who wants to live with that if you don’t have to?

In 2007, the FDA deferred approval of sipuleucel-T until a statistically significant improvement in survival could be shown.

The study investigators revealed such an improvement at the 2009 AUA annual meeting.

We don't have anything for patients with hormone-refractory disease.

At the time, AUA spokesman J. Brantley Thrasher, MD, chair of the Department of Urology at the University of Kansas Medical Center in Kansas City, said that "this will cause a big splash."

"We don't have anything for patients with hormone-refractory disease, which is very aggressive. . . . Improved survival with T cell immunotherapy is really very significant," he said.

 

HYPERTHERMIA, the Cancer Treatment with the best success rate in the world,

that allows you to maintain your normal lifestyle while, undergoing treatment

and does not compromise your quality of life DURING OR AFTER THE TREATMENT.

Valley Cancer Institute has been treating and healing people for over 25 years.

It’s time the world knew more about it…         www.vci.org

 

 

Prostate Cancer Treatment Results

Response Rate of Prostate Cancer Patients

No. of Patients

Response

Recurrence

Dissemination
(metastasis)

5 years
Survival

 

Complete

# [%]

Partial

# [%]

# [%]

# [%]

# [%]

19

18 [93]

1 [7]

3 [14]

3 [14]

17 [87]

 

Breast Cancer Treatment ResultsA

Response Rate of Breast Cancer Patients

No. of Patients

Response

Recurrence

Dissemination

(metastasis)

5 years
Survival

 

Complete

#   [%]

Partial

#  [%]

 

#  [%]

 

#  [%]

 

#   [%]

50

41 [82]

9 [18]

8 [15]

14 [27]

40 [80]

 

 

Head and Neck (base of Tongue) Cancer Treatment ResultsA

Response Rate of Head and Neck Cancer Patients

No. of Patients

Response

Recurrence

Dissemination
(metastasis)

5 years
Survival

 

Complete

#   [%]

Partial

#   [%]

 

#  [%]

 

#  [%]

 

#  [%]

30

26 [88]

4 [12]]

2 [12]

2 [12]

15 [88]]

 

 

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Last modified: August 19, 2010