Saw this update on Provenge today.
Bloomberg News (7/28, Randall) reported, "Dendreon Corp.'s prostate cancer vaccine, Provenge, extended lives by 4.1 months," a discovery that "led to the drug's US approval in April." Even though the scientific community still doesn't "know precisely how the vaccine works or who is most likely to benefit," Harvard researchers explained that "Provenge is the first drug designed to train the body's immune system to fight cancer and is the most effective treatment for certain patients with advanced prostate tumors."
The "active cellular immunotherapy," also known as sipuleucel-T, "consists of the patient's own peripheral-blood mononuclear cells, including antigen-presenting cells, that have been activated outside the body using an engineered protein called PA2024," MedPage Today (7/28, Smith) reported. The "protein is a fusion of prostatic acid phosphatase, a prostate antigen, and granulocyte-macrophage colony-stimulating factor, which activates immune cells." Scientists tested its efficacy by randomizing 512 men to either sipuleucel-T or a placebo, which "consisted of peripheral-blood mononuclear cells that were not activated."
Investigators eventually noted that the "average survival was 25.8 months for men in the Provenge group, compared with 21.7 months for men in the placebo group, meaning that Provenge extended survival by 22 to 25 percent," HealthDay (7/28, Reinberg) reported. "If the vaccine was used by men with less severe disease survival, it might be extended for even longer," and "compared with other treatments, such as chemotherapy, radiation and hormone therapy, Provenge has been touted as having fewer and less severe side effects," according to the study published in the New England Journal of Medicine. "However, the availability and cost of Provenge are issues that need to be resolved."
The "current cost of care for men with prostate cancer has been estimated at around $1,800 per month," Medscape (7/28, Chustecka) reported. The "vaccine costs $93,000, which works out at $23,000 per month of survival advantage." Meanwhile, the author of an accompanying editorial pointed out that, while the "improvement in overall survival seen is 'important,' the lack of any measurable antitumor effect was 'surprising.'" It also, noted Dan Longo, MD, "raises the concern that the results could have been influenced by an unmeasured prognostic variable that was accidentally imbalanced in the study-group assignments."
Age 52 at diagnosis, father died of PCa
PSA: 10/16/09 - 2.8; 1/11/10 - 3.8
Biopsy 11/25/09, 11 core samples - HG PIN on right side
Biopsy 2/17/10, 11 core samples - left side, adenocarcinoma, Gleason 6, one core at 5%
Notified of dx on 3/12/10 (27th wedding anniversary) via phone by the nurse! (dropped this Uro!)
MRI 3/17/10 and bone scan, 3/23/10, indicate: gland volume is 27mL, PCa is confined to prostate, seminal vesicles and vas deferens are unremarkable.
RALP conducted 19 May 2010 by Dr. Lee at U. Penn Presbyterian
Pathology report on 10 Jun 2010: Gleason 6; gland involvement by carcinoma < 2%; tumor in peripheral zone on BOTH sides; no capsular, extracapsular extension, lymph node, or seminal vesical involvement; and no positive margins.
Incontinence: first four days after catheter removal - only1-3 pads/day (but urethra was inflammed); 2d week (after inflammation) - 8-10 pads/day (sometimes more!); 3d week - 4-6 pads; 4th and 5th weeks - 3-4 pads; 6th week down to 2 pads. Of course, all this depends on how much I stand and it gets worse later in the day.
ED: started the pump the 4th week after the catheter removal. Four sets, twice a day per instructions. Not as fun as it sounded.