Clinical and pharmacodynamic evaluation of metronomic cyclophosphamide, celecoxib, and dexamethasone in advanced hormone-refractory prostate cancer

Clinical Cancer Research

Volumn 15, Issue 15, 2009, Pages 4954-4962

  Fontana, Andrea ^a   Galli, Luca ^a   Fioravanti, Anna ^a   Orlandi, Paola ^a   Galli, Costanza ^a   Landi, Lorenza ^a   Bursi, Simona ^a   Allegrini, Giacomo ^b   Fontana, Eloise ^c   Di Marsico, Roberta ^a   Antonuzzo, Andrea ^a   D'Arcangelo, Manolo ^a   Danesi, Romano ^a   Del Tacca, Mario ^a   Falcone, Alfredo ^a   Bocci, Guido ^a  

^a UNIVERSITY OF PISA   (Italy)

^b Azienda USL 5   (Italy)

^c Azienda USL 2   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CADHERIN; CELECOXIB; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOCETAXEL; PROSTATE SPECIFIC ANTIGEN; THROMBOSPONDIN 1; VASCULOTROPIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CARDIOVASCULAR DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; ENZYME LINKED IMMUNOSORBENT ASSAY; GENE EXPRESSION; HUMAN; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL BLOOD MONONUCLEAR CELL; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

AGED; AGED, 80 AND OVER; ANTIGENS, CD; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CADHERINS; CYCLOPHOSPHAMIDE; DEXAMETHASONE; HUMANS; LEUKOCYTES, MONONUCLEAR; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; PYRAZOLES; SULFONAMIDES; THROMBOSPONDIN 1; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 68049137904     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-08-3317     Document Type: Article

References (49)

1. Dellapasqua S, Bertolini F, Bagnardi V, et al. Metronomic cyclophosphamide and capecitabine combined with bevacizumab in advanced breast cancer. J Clin Oncol 2008;26: 4899-4905
2. Garcia AA, Hirte H, Fleming G, et al. Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia. J Clin Oncol 2008;26:76-82.
3. Bocci G, Nicolaou KC, Kerbel RS. Protracted low-dose effects on human endothelial cell proliferation and survival in vitro reveal a selective antiangiogenic window for various chemotherapeutic drugs. Cancer Res 2002;62:6938-6943 (Pubitemid 35424084)
4. Lord R, Nair S, Schache A, et al. Low dose metronomic oral cyclophosphamide for hormone resistant prostate cancer: a phase II study. J Urol 2007;177:2136-40; discussion 40. (Pubitemid 46726410)
5. Glode LM, Barqawi A, Crighton F, Crawford ED, Kerbel R. Metronomic therapy with cyclophosphamide and dexamethasone for prostate carcinoma. Cancer 2003;98:1643-1648 (Pubitemid 37238620)
6. Blansfield JA, Caragacianu D, Alexander HR III, et al. Combining agents that target the tumor microenvironment improves the efficacy of anticancer therapy. Clin Cancer Res 2008; 14:270-280
7. Yap R, Veliceasa D, Emmenegger U, et al. Metronomic low-dose chemotherapy boosts CD95-dependent antiangiogenic effect of the thrombospondin peptide ABT-510: a complementation antiangiogenic strategy. Clin Cancer Res 2005;11:6678-6685 (Pubitemid 41339009)
8. Leahy KM, Ornberg RL, Wang Y, Zweifel BS, Koki AT, Masferrer JL. Cyclooxygenase-2 inhibition by celecoxib reduces proliferation and induces apoptosis in angiogenic endothelial cells in vivo. Cancer Res 2002;62:625-631 (Pubitemid 34126930)
9. Narayanan BA, Narayanan NK, Pttman B, Reddy BS. Adenocarcina of the mouse prostate growth inhibition by celecoxib: downregulation of transcription factors involved in COX-2 inhibition. Prostate 2006;66:257-265 (Pubitemid 43191225)
10. Gupta S, Adhami VM, Subbarayan M, et al. Suppression of prostate carcinogenesis by dietary supplementation of celecoxib in transgenic adenocarcinoma of the mouse prostate model. Cancer Res 2004;64:3334-3343 (Pubitemid 38581441)
11. Pruthi RS, Derksen JE, Moore D. A pilot study of use of the cyclooxygenase-2 inhibitor celecoxib in recurrent prostate cancer after definitive radiation therapy or radical prostatectomy. BJU Int 2004;93:275-278 (Pubitemid 38253569)
12. Pruthi RS, Derksen JE, Moore D, et al. Phase II trial of celecoxib in prostate-specific antigen recurrent prostate cancer after definitive radiation therapy or radical prostatectomy. Clin Cancer Res 2006;12:2172-2177
13. Smith MR, Manola J, Kaufman DS, Oh WK, Bubley GJ, Kantoff PW. Celecoxib versus placebo for men with prostate cancer and a rising serum prostate-specific antigen after radical prostatectomy and/or radiation therapy. J Clin Oncol 2006;24:2723-2728 (Pubitemid 46630568)
14. Herr I, Pfitzenmaier J. Glucocorticoid use in prostate cancer and other solid tumours: implications for effectiveness of cytotoxic treatment and metastases. Lancet Oncol 2006;7:425-430
15. Yano A, Fujii Y, Iwai A, Kageyama Y, Kihara K. Glucocorticoids suppress tumor angiogenesis and in vivo growth of prostate cancer cells. Clin Cancer Res 2006;12:3003-3009 (Pubitemid 43837344)
16. Morioka M, Kobayashi T, Furukawa Y, et al. Prostate-specific antigen levels and prognosis in patients with hormone-refractory prostate cancer treated with low-dose dexamethasone. Urol Int 2002;68:10-15 (Pubitemid 34102566)
17. Nishimura K, Nonomura N, Yasunaga Y, et al. Low doses of oral dexamethasone for hormonerefractory prostate carcinoma. Cancer 2000;89: 2570-2576 (Pubitemid 32011601)
18. Bubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17: 3461-3467 (Pubitemid 29517916)
19. Allegrini G, Falcone A, Fioravanti A, et al. A pharmacokinetic and pharmacodynamic study on metronomic irinotecan in metastatic colorectal cancer patients. Br J Cancer 2008;98:1312-1319 (Pubitemid 351543577)
20. Scher HI, Halabi S, Tannock I, 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;26:1148-1159
21. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-1512 (Pubitemid 39315317)
22. Petrylak DP, Tangen CM, HussainMH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513-1520 (Pubitemid 39315318)
23. Berthold DR, Sternberg CN, Tannock IF. Management of advanced prostate cancer after first-line chemotherapy. J Clin Oncol 2005;23: 8247-8252 (Pubitemid 46211562)
24. Bertolini F, Paul S, Mancuso P, et al. Maximum tolerable dose and low-dose metronomic chemotherapy have opposite effects on the mobilization and viability of circulating endothelial progenitor cells. Cancer Res 2003;63:4342-4346 (Pubitemid 36951001)
25. Bocci G, Francia G, Man S, Lawler J, Kerbel RS. Thrombospondin 1, a mediator of the antiangiogenic effects of low-dose metronomic chemotherapy. Proc Natl Acad Sci U S A 2003;100: 12917-12922 (Pubitemid 37340000)
26. Ghiringhelli F, Menard C, Puig PE, et al. Metronomic cyclophosphamide regimen selectively depletes CD4+CD25+ regulatory T cells and restores T and NK effector functions in end stage cancer patients. Cancer Immunol Immunother 2007;56:641-648 (Pubitemid 46348738)
27. Bocci G, Tuccori M, Emmenegger U, et al. Cyclophosphamide- methotrexate 'metronomic' chemotherapy for the palliative treatment of metastatic breast cancer. A comparative pharmacoeconomic evaluation. Ann Oncol 2005;16: 1243-1252
28. Di Lorenzo G, Autorino R, De Laurentiis M, et al. Thalidomide in combination with oral daily cyclophosphamide in patients with pretreated hormone refractory prostate cancer: a phase I clinical trial. Cancer Biol Ther 2007;6:313-317 (Pubitemid 47328294)
29. Nishimura K, Nonomura N, Ono Y, et al. Oral combination of cyclophosphamide, uracil plus tegafur and estramustine for hormone-refractory prostate cancer. Oncology 2001;60:49-54. (Pubitemid 32041431)
30. Koretz RL. Considerations of study design. Nutr Clin Pract 2007;22:593-598
31. Nelius T, Klatte T, de Riese W, Filleur S. Clinical outcome of patients (pts) with taxane-resistant (TR) hormone-refractory prostate cancer (HRPC) treated with second-line cyclophosphamide (CP) -based metronomic chemotherapy. In: J Clin Oncol 2007, ASCO Annual Meeting Proceedings Part 1 Vol25, No 18S [June 20 Supplement]: 15647.
32. Albouy B, Tourani JM, Allain P, et al. Preliminary results of the Prostacox phase II trial in hormonal refractory prostate cancer.BJU Int 2007;100:770-774
33. Oh WK, Manola J, Babcic V, Harnam N, Kantoff PW. Response to second-line chemotherapy in patients with hormone refractory prostate cancer receiving two sequences of mitoxantrone and taxanes. Urology 2006;67:1235-1240 (Pubitemid 43818095)
34. Rosenberg JE, Weinberg VK, Kelly WK, et al. Activity of second-line chemotherapy in docetaxel- refractory hormone-refractory prostate cancer patients: randomized phase 2 study of ixabepilone or mitoxantrone and prednisone. Cancer 2007;110:556-563
35. Michels J, Montemurro T, Murray N, Kollmannsberger C, Nguyen Chi K. First- and second- line chemotherapy with docetaxel or mitoxantrone in patients with hormone-refractory prostate cancer: does sequence matter? Cancer 2006;106:1041-1046
36. Armstrong AJ, George DJ. Satraplatin in the treatment of hormone-refractory metastatic prostate cancer. Ther Clin Risk Manag 2007;3: 877-883 (Pubitemid 350162086)
37. Shaked Y, Emmenegger U, Francia G, et al. Low-dose metronomic combined with intermittent bolus-dose cyclophosphamide is an effective long-term chemotherapy treatment strategy. Cancer Res 2005;65:7045-7051 (Pubitemid 41161230)
38. Pietras K, Hanahan D. A multitargeted, metronomic, and maximum-tolerated dose "chemoswitch" regimen is antiangiogenic, producing objective responses and survival benefit in a mouse model of cancer. J Clin Oncol 2005;23: 939-952
39. Browder T, Butterfield CE, Kraling BM, et al. Antiangiogenic scheduling of chemotherapy improves efficacy against experimental drug-resistant cancer. Cancer Res 2000;60:1878-1886 (Pubitemid 30207647)
40. Rabascio C, Muratori E, Mancuso P, et al. Assessing tumor angiogenesis: increased circulating VE-cadherin RNA in patients with cancer indicates viability of circulating endothelial cells. Cancer Res 2004;64:4373-4377 (Pubitemid 38802446)
41. Shaked Y, Henke E, Roodhart JM, et al. Rapid chemotherapy-induced acute endothelial progenitor cell mobilization: implications for antiangiogenic drugs as chemosensitizing agents. Cancer Cell 2008;14:263-273
42. Twardowski PW, Smith-Powell L, Carroll M, et al. Biologic markers of angiogenesis: circulating endothelial cells in patients with advanced malignancies treated on phase I protocol with metronomic chemotherapy and celecoxib. Cancer Invest 2008;26:53-59
43. Colleoni M, Rocca A, Sandri MT, et al. Lowdose oral methotrexate and cyclophosphamide in metastatic breast cancer: antitumor activity and correlation with vascular endothelial growth factor levels. Ann Oncol 2002;13:73-80. (Pubitemid 34436728)
44. Duque JL, Loughlin KR, Adam RM, Kantoff PW, Zurakowski D, Freeman MR. Plasma levels of vascular endothelial growth factor are increased in patients with metastatic prostate cancer. Urology 1999;54:523-527 (Pubitemid 29407032)
45. George DJ, Halabi S, Shepard TF, et al. Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormonerefractory prostate cancer treated on Cancer and Leukemia Group B 9480. Clin Cancer Res 2001;7: 1932-1936 (Pubitemid 32994827)
46. Duque JL, Loughlin KR, Adam RM, Kantoff P, Mazzucchi E, Freeman MR. Measurement of plasma levels of vascular endothelial growth factor in prostate cancer patients: relationship with clinical stage, Gleason score, prostate volume, and serum prostate-specific antigen. Clinics 2006;61:401-408 (Pubitemid 44639399)
47. Shafer MW, Mangold L, Partin AW, Haab BB. Antibody array profiling reveals serum TSP-1 as a marker to distinguish benign from malignant prostatic disease. Prostate 2007;67:255-267 (Pubitemid 46255784)
48. Doll JA, Reiher FK, Crawford SE, Pins MR, Campbell SC, Bouck NP. Thrombospondin-1, vascular endothelial growth factor and fibroblast growth factor-2 are key functional regulators of angiogenesis in the prostate. Prostate 2001; 49:293-305. (Pubitemid 33117005)
49. Filleur S, Volpert OV, Degeorges A, et al. In vivo mechanisms by which tumors producing thrombospondin 1 bypass its inhibitory effects. Genes Dev 2001;15:1373-1382