Sargramostim (GM-CSF) and lenalidomide in castration-resistant prostate cancer (CRPC): Results from a phase I-II clinical trial

Urologic Oncology: Seminars and Original Investigations

Volumn 32, Issue 1, 2014, Pages 33.e11-33.e17

  Garcia, Jorge A ^a   Elson, Paul ^b   Tyler, Allison ^a   Triozzi, Pierre ^a   Dreicer, Robert ^a  

^a TAUSSIG CANCER INSTITUTE   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Castration resistant prostate cancer (CRPC); Granulocyte macrophage colony stimulating factor (GM CSF); Immunomodulation; Lenalidomide

Indexed keywords

LENALIDOMIDE; PROSTATE SPECIFIC ANTIGEN; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; ANTINEOPLASTIC AGENT; CYTOKINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IMMUNOLOGIC FACTOR; RECOMBINANT PROTEIN; SARGRAMOSTIM; THALIDOMIDE;

ADULT; AGED; ARTICLE; ASYMPTOMATIC DISEASE; CANCER PATIENT; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; CYTOKINE PRODUCTION; DEEP VEIN THROMBOSIS; DENDRITIC CELL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; HYPERTHYROIDISM; HYPOTHYROIDISM; INJECTION SITE REACTION; LUNG EMBOLISM; MALE; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; REGULATORY T LYMPHOCYTE; TH1 CELL; THROMBOCYTOPENIA; VERY ELDERLY; VOMITING; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; CYTOLOGY; DRUG ADMINISTRATION; IMMUNOTHERAPY; METABOLISM; PROCEDURES; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; SURVIVAL ANALYSIS; TIME FACTOR; TREATMENT OUTCOME;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYTOKINES; DENDRITIC CELLS; DRUG ADMINISTRATION SCHEDULE; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOTHERAPY; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RECOMBINANT PROTEINS; SURVIVAL ANALYSIS; T-LYMPHOCYTES, REGULATORY; THALIDOMIDE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84890797560     PISSN: 10781439     EISSN: 18732496     Source Type: Journal    
DOI: 10.1016/j.urolonc.2012.12.004     Document Type: Article

References (26)

1. Antonarakis E.S., Drake C.G. Current status of immunological therapies for prostate cancer. Curr Opin Urol 2010, 20(3):241-246.
2. Garcia J.A., Dreicer R. Immunotherapy in castration-resistant prostate cancer: integrating sipuleucel-T into our current treatment paradigm. Oncology (Williston Park) 2011, 25(3):242-249.
3. Small E.J., Tchekmedyian N.S., Rini B.I., Fong L., Lowy I., Allison J.P., et al. A pilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer. Clin Cancer Res 2007, 13:1810-1815.
4. Fong L., Kwek S.S., O'Brien S., et al. Potentiating endogenous antitumor immunity to prostate cancer through combination immunotherapy with CTLA4 blockade and GM-CSF. Cancer Res 2009, 2:609-615.
5. Kaufman H.L., Wang W., Manola J. Phase II randomized study of vaccine treatment of advanced prostate cancer (E7897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2004, 22:2122-2132.
6. DiPaola R.S., Plante M., Kaufman H., et al. A phase I trial of pox PSA vaccines (PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM) in patients with prostate cancer. J Transl Med 2006, 4:1-5.
7. Higano C.S., Corman J.M., Smith D.C., Centeno A.S., Steidle C.P., Gittleman M., et al. Phase 1/2 dose-escalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer. Cancer 2008, 113(5):975-984.
8. Kantoff P.W., Schuetz T.J., Blumenstein B.A., et al. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol 2010, 28:1099-1105.
9. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010, 363:411-422. IMPACT Study Investigators.
10. Eksioglu E.A., Mahmood S.S., Chang M., Reddy V. GM-CSF promotes differentiation of human dendritic cells and T lymphocytes toward a predominantly type 1 proinflammatory response. Exp Hematol 2007, 35:1163-1171.
11. Young M.R.I., Wright M.A., Pandit R. Myeloid differentiation treatment to diminish the presence of immune-suppressive CD34+ cells within human head and neck squamous cell carcinomas. J Immunol 1997, 159:990-996.
12. Bhattacharya P., Gopisetty A., Ganesh B.B., Sheng J.R., Prabhakar B.S. GM-CSF-induced, bone-marrow-derived dendritic cells can expand natural Tregs and induce adaptive Tregs by different mechanisms. J Leukoc Biol 2011, 89:235-249.
13. Small E.J., Reese D.M., Um B., Whisenant S., Dixon S.C., Figg W.D. Therapy of advanced prostate cancer with granulocyte macrophage colony-stimulating factor. Clin Cancer Res 1999, 5:1738-1744.
14. Small E.J., Reese D., Um B., et al. Therapy of advanced prostate cancer with granulocyte macrophage colony-stimulating factor. Clin Cancer Res 1999, 5:1738-1744.
15. Rini B.I., Weinberg V., Bok R., et al. Prostate-specific antigen kinetics as a measure of the biologic effect of granulocyte macrophage colony-stimulating factor in patients with serologic progression of prostate cancer. J Clin Oncol 2003, 21:99-105.
16. Dreicer R., See W.A., Klein E.A. Phase II trial of GM-CSF in advanced prostate cancer. Invest New Drugs 2001, 19:261-265.
17. Dredge K., Horsfall R., Robinson S., Zhang L.-H., Lu L., et al. Orally administered lenalidomide (lenalidomide) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res 2005, 69:56-63.
18. Corral L.F., Haslett P.A.J., Muller F.W., Chen R., Wong L.M., Ocampo C.J., et al. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol 1993, 163:380-386.
19. Schafer P.H., Gandhi A.K., Loveland M.A., Chen R.S., Man H.-W., et al. Enhancement of cytokine production and AP-1 transcriptional activity in T cells by thalidomide-related immunomodulatory drugs. J Pharmacol Exp Ther 2003, 305:1222-1232.
20. Figg W.D., Dahut W., Duray P., et al. A randomized phase II trial of thalidomide, an angiogenesis inhibitor, in patients with androgen-independent prostate cancer. Clin Cancer Res 2001, 7:1888-1893.
21. Drake M.J., Robson W., Mehta P., et al. An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer. Br J Cancer 2003, 88:822-827.
22. Dahut W.L., Gulley J.L., Arlen P.M., et al. Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer. J Clin Oncol 2004, 22:2532-2539.
23. Dreicer R., Klein E.A., Elson P., et al. Phase II trial of GM-CSF + thalidomide in patients with androgen-independent metastatic prostate cancer. Urol Oncol 2005, 23(2):82-86.
24. Garcia J.A., Klein E.A., Magi-Galluzzi C., Elson P., Triozzi P., Dreicer R. Clinical and biological effects of neoadjuvant sargramostim and thalidomide in patients with locally advanced prostate carcinoma. Clin Cancer Res 2008, 14(10):3052-3059.
25. Therasse P., Arbuck S.G., Eisenhauer E.A., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216.
26. Keizman K., Zahurak M., Sinibaldi V., et al. Randomized study prostate cancer: results of a phase I/II double-blinded, lenalidomide in nonmetastatic biochemically relapsed. Clin Cancer Res 2010, 16:5269-5276.