Docetaxel plus oral metronomic cyclophosphamide: A phase ii study with pharmacodynamic and pharmacogenetic analyses in castration-resistant prostate cancer patients

Cancer

Volumn 120, Issue 24, 2014, Pages 3923-3931

  Derosa, Lisa ^a   Galli, Luca ^a   Orlandi, Paola ^b   Fioravanti, Anna ^b   Di Desidero, Teresa ^b   Fontana, Andrea ^a   Antonuzzo, Andrea ^a   Biasco, Elisa ^a   Farnesi, Azzurra ^a   Marconcini, Riccardo ^a   Francia, Giulio ^c   Danesi, Romano ^b   Falcone, Alfredo ^d   Bocci, Guido ^b,d  

^a UNIVERSITY HOSPITAL OF PISA   (Italy)

^b UNIVERSITY OF PISA   (Italy)

^c UNIVERSITY OF TEXAS AT EL PASO   (United States)

^d ISTITUTO TOSCANO TUMORI   (Italy)

Author keywords

Cyclophosphamide; Docetaxel; Metronomic chemotherapy; Pharmacodynamic markers; Pharmacogenetics; Prostate cancer

Indexed keywords

CELECOXIB; CYCLOPHOSPHAMIDE; DOCETAXEL; FIBROBLAST GROWTH FACTOR; PREDNISONE; PROSTATE SPECIFIC ANTIGEN; VASCULOTROPIN; ANTINEOPLASTIC AGENT; TAXOID;

ADULT; AGED; ALLERGY; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CARDIOVASCULAR DISEASE; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; DIARRHEA; DOSE RESPONSE; DRUG SAFETY; DYSPNEA; GENOTYPE; HUMAN; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; ONYCHOLYSIS; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHARMACOGENETICS; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEIN BLOOD LEVEL; RASH; SINGLE NUCLEOTIDE POLYMORPHISM; STOMATITIS; THROMBOCYTOPENIA; VEGF GENE; VOMITING; ADENOCARCINOMA; CLINICAL TRIAL; DISEASE COURSE; METABOLISM; METRONOMIC DRUG ADMINISTRATION; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; TREATMENT OUTCOME;

ADENOCARCINOMA; ADMINISTRATION, METRONOMIC; ADMINISTRATION, ORAL; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DISEASE PROGRESSION; HUMANS; MALE; MIDDLE AGED; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; TAXOIDS; TREATMENT OUTCOME;

EID: 84918802711     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28953     Document Type: Article

References (50)

1. Zhao S, Yu EY. Castrate-resistant prostate cancer: postdocetaxel management. Curr Opin Urol. 2013; 23: 201-207.
2. Petrylak DP, Ankerst DP, Jiang CS, et al. Evaluation of prostatespecific antigen declines for surrogacy in patients treated on SWOG 99-16. J Natl Cancer Inst. 2006; 98: 516-521.
3. Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008; 26: 242-245.
4. Gross M, Higano C, Pantuck A, et al. A phase II trial of docetaxel and erlotinib as first-line therapy for elderly patients with androgenindependent prostate cancer. BMC Cancer. 2007; 7: 142.
5. Araujo JC, Trudel GC, Paliwal P. Long-term use of dasatinib in patients with metastatic castration-resistant prostate cancer after receiving the combination of dasatinib and docetaxel. Cancer Manag Res. 2013; 6: 25-30.
6. Tannock IF, Fizazi K, Ivanov S, et al. Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3, double-blind randomised trial. Lancet Oncol. 2013; 14: 760-768.
7. Kelly WK, Halabi S, Carducci M, et al. Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol. 2012; 30: 1534-1540.
8. Fizazi KS, Higano CS, Nelson JB, et al. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013; 31: 1740-1747.
9. Sonpavde G, Matveev V, Burke JM, et al. Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT- 101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer. Ann Oncol. 2012; 23: 1803-1808.
10. Arlen PM, Gulley JL, Parker C, et al. A randomized phase II study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen-independent prostate cancer. Clin Cancer Res. 2006; 12: 1260-1269.
11. Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013; 18: 687-688.
12. Beer TM, Eilers KM, Garzotto M, Egorin MJ, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol. 2003; 21: 123-128.
13. 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.
14. Man S, Bocci G, Francia G, et al. Antitumor effects in mice of lowdose (metronomic) cyclophosphamide administered continuously through the drinking water. Cancer Res. 2002; 62: 2731-2735.
15. Emmenegger U, Shaked Y, Man S, et al. Pharmacodynamic and pharmacokinetic study of chronic low-dose metronomic cyclophosphamide therapy in mice. Mol Cancer Ther. 2007; 6: 2280-2289.
16. Nelius T, Rinard K, Filleur S. Oral/metronomic cyclophosphamidebased chemotherapy as option for patients with castration-refractory prostate cancer: review of the literature. Cancer Treat Rev. 2011; 37: 444-455.
17. Penel N, Adenis A, Bocci G. Cyclophosphamide-based metronomic chemotherapy: after 10 years of experience, where do we stand and where are we going? Crit Rev Oncol Hematol. 2012; 82: 40-50.
18. Glode LM, Barqawi A, Crighton F, Crawford ED, Kerbel R. Metronomic therapy with cyclophosphamide and dexamethasone for prostate carcinoma. Cancer. 2003; 98: 1643-1648.
19. Fontana A, Galli L, Fioravanti A, et al. Clinical and pharmacodynamic evaluation of metronomic cyclophosphamide, celecoxib, and dexamethasone in advanced hormone-refractory prostate cancer. Clin Cancer Res. 2009; 15: 4954-4962.
20. Fontana A, Bocci G, Galli L, et al. Metronomic cyclophosphamide in elderly patients with advanced, castration-resistant prostate cancer. J Am Geriatr Soc. 2010; 58: 986-988.
21. 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.
22. Orlandi P, Fontana A, Fioravanti A, et al. VEGF-A polymorphisms predict progression-free survival among advanced castration-resistant prostate cancer patients treated with metronomic cyclophosphamide. Br J Cancer. 2013; 109: 957-964.
23. Eng L, Azad AK, Habbous S, et al. Vascular endothelial growth factor pathway polymorphisms as prognostic and pharmacogenetic factors in cancer: a systematic review and meta-analysis. Clin Cancer Res. 2012; 18: 4526-4537.
24. Jain L, Vargo CA, Danesi R, et al. The role of vascular endothelial growth factor SNPs as predictive and prognostic markers for major solid tumors. Mol Cancer Ther. 2009; 8: 2496-2508.
25. Pasqualetti G, Danesi R, Del Tacca M, Bocci G. Vascular endothelial growth factor pharmacogenetics: a new perspective for antiangiogenic therapy. Pharmacogenomics. 2007; 8: 49-66.
26. Calleri A, Bono A, Bagnardi V, et al. Predictive Potential of Angiogenic Growth Factors and Circulating Endothelial Cells in Breast Cancer Patients Receiving Metronomic Chemotherapy Plus Bevacizumab. Clin Cancer Res. 2009; 15: 7652-7657.
27. Clarke NW. Landmarks in non-hormonal pharmacological therapies for castration-resistant prostate cancer. BJU Int. 2012; 110(Suppl 1): 14-22.
28. Scher HI, Jia X, Chi K, et al. Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer. J Clin Oncol. 2011; 29: 2191-2198.
29. Ning YM, Gulley JL, Arlen PM, et al. Phase II trial of bevacizumab, thalidomide, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010; 28: 2070-2076.
30. Dahut WL, Gulley JL, Arlen PM, et al. Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer. J Clin Oncol. 2004; 22: 2532-2539.
31. Oh WK, Halabi S, Kelly WK, et al. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813. Cancer. 2003; 98: 2592-2598.
32. Picus J, Halabi S, Kelly WK, et al. A phase 2 study of estramustine, docetaxel, and bevacizumab in men with castrate-resistant prostate cancer: results from Cancer and Leukemia Group B Study 90006. Cancer. 2011; 117: 526-533.
33. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004; 351: 1513-1520.
34. Fontana A, Falcone A, Derosa L, Di Desidero T, Danesi R, Bocci G. Metronomic chemotherapy for metastatic prostate cancer: a 'young' concept for old patients? Drugs Aging. 2010; 27: 689-696.
35. Cardillo I, Spugnini EP, Galluzzo P, et al. Functional and pharmacodynamic evaluation of metronomic cyclophosphamide and docetaxel regimen in castration-resistant prostate cancer. Future Oncol. 2013; 9: 1375-1388.
36. 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.
37. Pietras K, Hanahan D. A multitargeted, metronomic, and maximum-tolerated dose "chemo-switch" regimen is antiangiogenic, producing objective responses and survival benefit in a mouse model of cancer. J Clin Oncol. 2005; 23: 939-952.
38. Shaked Y, Henke E, Roodhart JM, et al. Rapid chemotherapyinduced acute endothelial progenitor cell mobilization: implications for antiangiogenic drugs as chemosensitizing agents. Cancer Cell. 2008; 14: 263-273.
39. Keyes K, Cox K, Treadway P, et al. An in vitro tumor model: analysis of angiogenic factor expression after chemotherapy. Cancer Res. 2002; 62: 5597-5602.
40. Tran J, Master Z, Yu JL, Rak J, Dumont DJ, Kerbel RS. A role for survivin in chemoresistance of endothelial cells mediated by VEGF. Proc Natl Acad Sci U S A. 2002; 99: 4349-4354.
41. 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.
42. 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.
43. Garcia M, Velez R, Romagosa C, et al. Cyclooxygenase-2 inhibitor suppresses tumour progression of prostate cancer bone metastases in nude mice. BJU Int. 2014; 113: E164-177.
44. Patel MI, Subbaramaiah K, Du B, et al. Celecoxib inhibits prostate cancer growth: evidence of a cyclooxygenase-2-independent mechanism. Clin Cancer Res. 2005; 11: 1999-2007.
45. 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.
46. 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.
47. Solomon SD, McMurray JJ, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med. 2005; 352: 1071-1080.
48. Solomon SD, Wittes J, Finn PV, et al. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008; 117: 2104-2113.
49. Lambrechts D, Storkebaum E, Morimoto M, et al. VEGF is a modifier of amyotrophic lateral sclerosis in mice and humans and protects motoneurons against ischemic death. Nat Genet. 2003; 34: 383-394.
50. Koukourakis MI, Papazoglou D, Giatromanolaki A, Bougioukas G, Maltezos E, Sivridis E. VEGF gene sequence variation defines VEGF gene expression status and angiogenic activity in non-small cell lung cancer. Lung Cancer. 2004; 46: 293-298.