A randomized phase II trial of sipuleucel-T with concurrent versus sequential abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer

Clinical Cancer Research

Volumn 21, Issue 17, 2015, Pages 3862-3869

  Small, Eric J ^a   Lance, Raymond S ^b   Gardner, Thomas A ^c   Karsh, Lawrence I ^d   Fong, Lawrence ^a   McCoy, Candice ^e   De Vries, Todd ^e   Sheikh, Nadeem A ^e   GuhaThakurta, Debraj ^e,h   Chang, Nancy ^e   Redfern, Charles H ^f   Shore, Neal D ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^c INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d Urology Center of Colorado   (United States)

^e Dendreon   (United States)

^f Sharp Clinical Oncology Research   (United States)

^g Carolina Urologic Research Center   (United States)

^h MICROSOFT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABIRATERONE ACETATE; PREDNISONE; SIPULEUCEL T; ANTINEOPLASTIC AGENT; TISSUE EXTRACT;

ADULT; ANTIGEN PRESENTING CELL; ARTHRALGIA; ARTICLE; BACKACHE; CANCER PATIENT; CASTRATION RESISTANT PROSTATE CANCER; CELL ACTIVATION; CELL COUNT; CELLULAR IMMUNITY; CHILL; CONSTIPATION; CONTROLLED STUDY; COUGHING; DRUG DOSE REGIMEN; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; EX VIVO STUDY; FATIGUE; FEVER; HUMAN; HUMORAL IMMUNITY; IMMUNE RESPONSE; IN VIVO STUDY; LIMB PAIN; LYMPHOCYTE PROLIFERATION; MAJOR CLINICAL STUDY; MALE; METASTASIS; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; MULTIPLE CYCLE TREATMENT; MUSCLE SPASM; NAUSEA; OPEN STUDY; ORAL PARESTHESIA; PARESTHESIA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; AGED; CANCER GRADING; CLINICAL TRIAL; IMMUNOLOGY; LYMPHOCYTE ACTIVATION; LYMPHOCYTE COUNT; METABOLISM; MIDDLE AGED; MORTALITY; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; T LYMPHOCYTE SUBPOPULATION; TREATMENT OUTCOME; VERY ELDERLY;

ABIRATERONE ACETATE; AGED; AGED, 80 AND OVER; ANTIGEN-PRESENTING CELLS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; HUMANS; LYMPHOCYTE ACTIVATION; LYMPHOCYTE COUNT; MALE; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM METASTASIS; PREDNISONE; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; T-LYMPHOCYTE SUBSETS; TISSUE EXTRACTS; TREATMENT OUTCOME;

EID: 84942882550     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-15-0079     Document Type: Article

References (21)

1. Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis 2014; 17: 259-64.
2. Madan RA, Gulley JL, Fojo T, Dahut WL. Therapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progression. Oncologist 2010; 15: 969-75.
3. Schlom J. Therapeutic cancer vaccines: current status and moving forward. J Natl Cancer Inst 2012; 104: 599-613.
4. Mercader M, Bodner BK, Moser MT, Kwon PS, Park ES, Manecke RG, et al. T cell infiltration of the prostate induced by androgen withdrawal in patients with prostate cancer. Proc Natl Acad Sci U S A 2001; 98: 14565-70.
5. Drake CG, Doody AD, Mihalyo MA, Huang CT, Kelleher E, Ravi S, et al. Androgen ablation mitigates tolerance to a prostate/prostate cancer-restricted antigen. Cancer Cell 2005; 7: 239-49.
6. Gannon PO, Poisson AO, Delvoye N, Lapointe R, Mes-Masson AM, Saad F. Characterization of the intra-prostatic immune cell infiltration in androgen-deprivedprostate cancerpatients. J Immunol Methods 2009; 348: 9-17.
7. Sutherland JS, Goldberg GL, Hammett MV, Uldrich AP, Berzins SP, Heng TS, et al. Activation of thymic regeneration in mice and humans following androgen blockade. J Immunol 2005; 175: 2741-53.
8. Koh YT, Gray A, Higgins SA, Hubby B, Kast WM. Androgen ablation augments prostate cancer vaccine immunogenicity only when applied after immunization. Prostate 2009; 69: 571-84.
9. Madan RA, Gulley JL, Schlom J, Steinberg SM, Liewehr DJ, Dahut WL, et al. Analysis of overall survival in patients with nonmetastatic castration-resistant prostate cancer treated with vaccine, nilutamide, and combination therapy. Clin Cancer Res 2008; 14: 4526-31.
10. Cha E, Fong L. Immunotherapy for prostate cancer: biology and therapeutic approaches. J Clin Oncol 2011; 29: 3677-85.
11. Sheikh NA, Petrylak D, Kantoff PW, Dela Rosa C, Stewart FP, Kuan LY, et al. Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer. Cancer Immunol Immunother 2013; 62: 137-47.
12. Ribas A, Timmerman JM, Butterfield LH, Economou JS. Determinant spreading and tumor responses after peptide-based cancer immunotherapy. Trends Immunol 2003; 24: 58-61.
13. Disis ML Immunologic biomarkers as correlates of clinical response to cancer immunotherapy. Cancer Immunol Immunother 2011; 60: 433-42.
14. Gulley JL Therapeutic vaccines: the ultimate personalized therapy? Hum Vaccine Immunother 2013; 9: 219-21.
15. Hall S, GuhaThakurta D, Fan L-Q, Stewart F, Vu T, Kantoff P, et al. Sipuleucel-t-induced antigen spread: immune response to prostate-specific antigen correlates with improved overall survival. J Urol 2014; 191: e765-6.
16. Drake CG, Fan L-Q, GuhaThakurta D, Stewart F, Kantoff PW, Small EJ, et al. Antigen spread and survival with sipuleucel-T in patients with advanced prostate cancer. J Clin Oncol 2014; 32: 88.
17. GuhaThakurta D, Sheikh NA, Fan L-Q, Kandadi H, Meagher TC, Hall SJ, et al. Humoral immune response against non-targeted tumor antigens after treatment with sipuleucel-t and its association with improved clinical outcome. Clin Cancer Res 2015 Feb 3. [Epub ahead of print].
18. Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the prostate cancer clinical trials working group. J Clin Oncol 2008; 26: 1148-59.
19. Sheikh NA, Jones LA. CD54 is a surrogate marker of antigen presenting cell activation. Cancer Immunol Immunother 2008; 57: 1381-90.
20. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363: 411-22.
21. Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013; 368: 138-48.