49PACKARD, I forget add about
bone scan. You said that you will have bone scan in December. May you ask your doctor why he choose that month? I am curios about
it because on September 6-8 NEAUA ( New England Section of the American Urological Association) had its Annual meeting and Dendrion presented two abstracts for PROVENGE.
One of them:
"Bone Scans Associated with Prolonged Overall Survival in Patients with Metastatic Castrate Resistant Prostate Cancer Treated with Sipuleucel-T
Ron S. Israeli, MD1, Adam S. Kibel, MD2, Albert Azose, MD3, Robert B. Sims, MD4, Todd DeVries, PhD4, E. David Crawford, MD5.
1Staten Island Urologic Oncology, Staten Island, NY, USA, 2Dana-Farber Cancer Institute, Boston, MA, USA, 3Seattle Radiologists, Seattle, WA, USA, 4Dendreon, Seattle, WA, USA, 5University of Colorado, Denver, CO, USA.
BACKGROUND: The Phase 3 IMPACT trial reported a 22% reduction in risk of death with sipuleucel−T in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (mCRPC). In this analysis, baseline bone metastasis burden and changes following treatment were assessed as predictors of overall survival (OS).
METHODS: 111/512 IMPACT patients had bone scans at baseline and weeks 6, 10, 14 and 18, with no additional CRPC treatment. Sipuleucel−T patients who were among the 20 longest or shortest survivors had bone scans reviewed by a blinded board certified nuclear radiologist to predict long or short OS.
RESULTS: 26 sipuleucel−T patients were assessed: n=16 in the long OS group (median OS=54.2 months; Halabi predicted=27.1 months); n=10 in the short OS group (median OS=10.8 months; Halabi predicted=17.9 months). Long/short OS was correctly predicted in 76%/67% of patients (81% sensitivity, 60% specificity, 73% crude agreement [P=0.029 vs uninformed 50% rate of correct prediction]). Patients with long OS prediction had: <7 baseline lesions, an increase of ≤2 lesions at week 10, and an increase of ≤5 lesions at week 18.
CONCLUSIONS: Patients receiving sipuleucel−T with low baseline tumor burden found on bone scans and slow rate of progression may have an increased likelihood of prolonged OS. "
meeting.neaua.org/abstracts/2012/23.cgi But from other hand NCCN Guidelines said "that the common markers of benefit, such as a decline in PSA or improvement in bone or CT scans, are not seen usually, and therefore benefit to an individual patient cannot be ascertained using currently available testing. "
www.jnccn.org/content/10/9/1081.long Second abstract:
"Overall Survival Benefit with Sipuleucel-T by Baseline PSA: Exploratory Analysis from the IMPACT Trial
Philip W. Kantoff, MD1, Gerald Chodak, MD2, Paul Schellhammer, MD3, James B. Whitmore, PhD4, Robert B. Sims, MD4.
1Dana-Farber Cancer Institute of Harvard Medical School, Boston, MA, USA, 2Louis A Weiss Memorial Hospital, Chicago, IL, USA, 3Eastern Virginia Medical School / Urology of Virginia, Norfolk, VA, USA, 4Dendreon, Seattle, WA, USA.
BACKGROUND: : In the IMPACT trial, sipuleucel−T reduced risk of death by 22.5% (P=0.032). A pre−specified subgroup analysis for baseline prognostic variables showed homogeneous treatment effects consistently favoring sipuleucel−T. In patients with baseline PSA below vs above the median, there was a trend toward greater treatment effect (HR=0.685 vs. 0.865). In this exploratory analysis, we further sub−divided baseline PSA into quartiles to evaluate potential treatment effect patterns.
METHODS: All randomized IMPACT patients (n=512) were categorized by baseline PSA quartile, ECOG, and other prognostic variables (LDH, PAP, ALP in bone−only disease, Hgb). Median overall survival (OS) and hazard ratio (HR) were estimated using Kaplan−Meier and Cox models, respectively.
RESULTS: Increasing baseline PSA quartile was associated with markers of advanced disease. Although there was inadequate power to demonstrate inter−quartile significance, data suggest a consistent treatment effect in all subsets and a trend toward an increased effect with lower baseline PSA. A similar benefit was suggested for other prognostic variables, with the exception of baseline Hgb.
CONCLUSIONS: This analysis supports a consistent OS benefit with sipuleucel−T across PSA quartiles, and suggests that patients with less advanced disease may benefit more from treatment with sipuleucel−T."
So we see:
PSA<22,1 PROVENGE-41,3 month; PLACEBO-27.1 month; DIFFERENCE-13,0 month;
PSA>22,1-50,1 PROVENGE-27,1 month; PLACEBO-20,1 month; DIFFERENCE-7,1 month;
PSA>50,1-134,1 PROVENGE-20,4 month; PLACEBO-5,4 month; DIFFERENCE-5,4 month;
PSA>134,1 PROVENGE-18,4 month; PLACEBO-15,6 month; DIFFERENCE-2,8 month
meeting.neaua.org/abstracts/2012/22.cgiProvenge so new and different from other drugs that it established substantial survival benefit without available testing biomarkers.
I think it is certainly that the correlation between APC(antigen presenting cells) increases and OS is real. We discussed it in this topic.