Leukine drug in hrpca useage on patients-abstract

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Date Joined Dec 2008
Total Posts : 3149
   Posted 8/14/2010 5:29 PM (GMT -6)   
Got a guy here in Michigan seeing Dr. Scholz 1-2 times a year and doing Leukine in his journey with PCa, of about 13 yrs. now.  He has failed on LHRH (Lupron and such) and he gets this injectable drug locally in Michigan, injects himself with it so as not to fly to Califorina to see Dr. Scholz.  He is using this with very good results in controlling his psa levels and he claims no side effects when I asked him about such. He keeps the drug in the refrigerator to keep it fresh for useage, so has a stock of such to use.
Here is some information on this drug an abstract (partial), you would have to do your own research into this one.  I don't claim to know anything on it, but it is being used on some hrpca patients as another choice. It is expensive your decent insurance will pay for it his did ($20 co-pay).  Price in Canada in USA dollars  (probably is 50% less than here and not the installed into your body price like at the docs office...add on..????)
Leukine solution   500 mcg/ml   10 of them at 1ml=   $3435   (this is discounted price)
(also Abiraterone looks like FDA approval for next year...another newbie coming soon).
GM-CSF at an Anti-PCa Agent


GM-CSF( Sargramostim, Leukine) as a monotherapy has had several clinical trials and leukine clearly does have activity against hrpca.(3, 4, 5, 6, 7, 8) The dosing schedule in these papers has generally been 250 mcg/m2 at either 14 days continuously followed by 14 days off or 14 days continuously followed by a Mon-Wed-Fri schedule for 14 days of a 28 day cycle with the more continuous schedule providing better PSA control. While the attempt to limit toxicity by reducing the dosing schedule has merit, the lack of consistent PSA control argues for continuous daily dosing. B. K. Dieckgraefe, et al (9) found that continuous tx with leukine (8 weeks straight) had no more side effects than intermittent treatment. Additionally, C. I. Rivas et al (3) discuss leukine receptors and PCa and concluded that "These findings imply that both hyperplastic and neoplastic prostatic tissues may be responsive to GM-CSF."

Clinical Trials.

E J Small et al (5) studied Hrpca patients using 250mcg/m2(about 500mcg) leukine. Their cohort I had 14 days on leukine and 14 days off (23 men). about 50% of the men in cohort I experienced declines in PSA while on tx and rising PSA when tx was stopped in a sawtooth PSA pattern. Also 25% had a > 50% decline in PSA. Median response duration was 3.5 months with some men having responses longer than 9 months. Cohort II(13 men) had 14 days on leukine plus 3 days/week for the next 2 weeks. In cohort II, 12 of 13 had a median PSA decline of 32% with one patient having a >99% decline and an improved bone scan. The median survival of all patients was 15.8 months. Toxicity was stated to be minimal.

R. Dreicer et al (7) published a study using 250mcg of leukine on a M-W-F dosing schedule for 4 weeks and then repeated the treatment. There were 7 hormonally naïve and 9 androgen independent patients. Three of the 9 androgen independent patients had PSA responses "below baseline" and received all 6 months of tx. This suggests PSA stabilization in these patients. None of the 4 patients with measurable disease(1 – BS positive only, 3 – BS and CT scan positive) responded to leukine therapy. The lack of response is not surprising given the short time frame of the trial (6 months).

Rini et al (8) treated 30 patients with rising PSA post primary therapy(RP or RT.) The dose of leukine used was 250mcg/m2, 14 days of injections, followed by 14 days of no injections and then the cycle was repeated. Three of 29 patients (10%) had A PSA response (50% decrease). Twenty-six (90%) patients saw their PSA doubling time increase from 8.4 months to 15 months(the other 3 patients had PSA declines.)

On the basis of the above studies, it seems reasonable to use leukine as a therapy during the off period from chemotherapy. The lengthening of the PSA doubling time or achieving some disease stabilization, may translate into a longer off period than would otherwise be achievable. The question also arises as to whether or not there is a dosing schedule for the leukine that will improve on the intermittent leukine results noted above – say by daily injections. Daily dosing as used in (9), for Crohn’s disease, indicates that no additional toxicity accrues when using daily leukine injections for at least 8 weeks in a row. With the objective of having at least 6 months off chemotherapy, daily injections of leukine may be warranted.

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