Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated with Eribulin

CPT: Pharmacometrics and Systems Pharmacology

Volumn 4, Issue 7, 2015, Pages 386-395

  Van Hasselt, J G C ^a,b   Gupta, A ^c   Hussein, Z ^c   Beijnen, J H ^a,d   Schellens, J H M ^a,d   Huitema, A D R ^a  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

^c EISAI CO LTD   (Japan)

^d UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ERIBULIN; PROSTATE SPECIFIC ANTIGEN;

AREA UNDER THE CURVE; ARTICLE; CANCER GROWTH; CANCER RESISTANCE; CASTRATION RESISTANT PROSTATE CANCER; DRUG EFFECT; DRUG EFFICACY; GROWTH RATE; HUMAN; MALE; OVERALL SURVIVAL; PRIORITY JOURNAL; TREATMENT RESPONSE;

EID: 84937952583     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1002/psp4.49     Document Type: Article

References (50)

1. Bray, F., Lortet-Tieulent, J., Ferlay, J., Forman, D. & Auvinen, A. Prostate cancer incidence and mortality trends in 37 European countries: an overview. Eur. J. Cancer 46, 3040-3052 (2010).
2. Siegel, R., Ward, E., Brawley, O. & Jemal, A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA. Cancer J. Clin. 61, 212-236 (2011).
3. Fu, Q., Moul, J.W. & Sun, L. Contemporary radical prostatectomy. Prostate Cancer 2011, 645030 (2011).
4. Hammad, F.T. Radical prostatectomy. Ann. N. Y. Acad. Sci. 1138, 267-277 (2008).
5. Shapiro, D. & Tareen, B. Current and emerging treatments in the management of castration-resistant prostate cancer. Expert Rev. Anticancer Ther. 12, 951-964 (2012).
6. DeVita, V., Lawrence, T. & Rosenberg, S. Cancer Principles and Practice of Oncology (Wolters Kluwer Health/Lippincott Williams and Wilkins, Philadelphia, PA, 2011).
7. Sasaki, T., Onishi, T. & Hoshina, A. Cutoff value of time to prostate-specific antigen nadir is inversely correlated with disease progression in advanced prostate cancer. Endocr. Relat. Cancer 19, 725-730 (2012).
8. Harzstark, A.L. & Small, E.J. Castrate-resistant prostate cancer: therapeutic strategies. Expert Opin. Pharmacother. 11, 937-945 (2010).
9. Tannock, I.F. et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N. Engl. J. Med. 351, 1502-1512 (2004).
10. de Bono, J.S. et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 376, 1147-1154 (2010).
11. Scher, H.I. et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N. Engl. J. Med. 367, 1187-1197 (2012).
12. Kantoff, P. W. et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N. Engl. J. Med. 363, 411-422 (2010).
13. de Bono, J.S. et al. Abiraterone and increased survival in metastatic prostate cancer. N. Engl. J. Med. 364, 1995-2005 (2011).
14. Stein, W.D. et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clin. Cancer Res. 17, 907-917 (2011).
15. Stein, W.D. et al. Tumor growth rates derived from data for patients in a clinical trial correlate strongly with patient survival: a novel strategy for evaluation of clinical trial data. Oncologist 13, 1046-1054 (2008).
16. Petrylak, D. Therapeutic options in androgen-independent prostate cancer: building on docetaxel. BJU Int. 96 (suppl. 2), 41-46 (2005).
17. Sharifi, N., Gulley, J.L. & Dahut, W. L. Androgen deprivation therapy for prostate cancer. J. Am. Med. Assoc. 294, 238-244 (2005).
18. El-Amm, J. & Aragon-Ching, J.B. The changing landscape in the treatment of metastatic castration-resistant prostate cancer. Ther. Adv. Med. Oncol. 5, 25-40 (2013).
19. Antonarakis, E.S. & Eisenberger, M.A. Phase III trials with docetaxel-based combinations for metastatic castration-resistant prostate cancer: Time to learn from past experiences. J. Clin. Oncol. 31, 1709-12 (2013).
20. Hanninen, M., Venner, P. & North, S. A rapid PSA half-life following docetaxel chemotherapy is associated with improved survival in hormone refractory prostate cancer. Can. Urol. Assoc. J. 3, 369-374 (2009).
21. Scher, H.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. 26, 1148-1159 (2008).
22. Fleming, M.T., Morris, M.J., Heller, G. & Scher, H.I. Post-therapy changes in PSA as an outcome measure in prostate cancer clinical trials. Nat. Clin. Pract. Oncol. 3, 658-667 (2006).
23. Emmenegger, U. & Ko, Y.-J. PSA-based treatment response criteria in castrationresistant prostate cancer: promises and limitations. Can. Urol. Assoc. J. 3, 375-376 (2009).
24. Therasse, P. 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. 92, 205-216 (2000).
25. Bubley, G.J. 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. 17, 3461-3467 (1999).
26. Hirata, Y., Akakura, K., Higano, C.S., Bruchovsky, N. & Aihara, K. Quantitative mathematical modeling of PSA dynamics of prostate cancer patients treated with intermittent androgen suppression. J. Mol. Cell Biol. 4, 127-132 (2012).
27. Jain, H.V., Clinton, S.K., Bhinder, A. & Friedman, A. Mathematical modeling of prostate cancer progression in response to androgen ablation therapy. Proc. Natl. Acad. Sci. U. S. A. 108, 19701-19706 (2011).
28. Claret, L. et al. Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J. Clin. Oncol. 27, 4103-4108 (2009).
29. Wang, Y. et al. Elucidation of relationship between tumor size and survival in nonsmall-cell lung cancer patients can aid early decision making in clinical drug development. Clin. Pharmacol. Ther. 86, 167-174 (2009).
30. Proust-Lima, C. & Taylor, J.M.G. Development and validation of a dynamic prognostic tool for prostate cancer recurrence using repeated measures of posttreatment PSA: a joint modeling approach. Biostatistics 10, 535-549 (2009).
31. Lin, H., Turnbull, B.W., McCulloch, C.E. & Slate, E.H. Latent class models for joint analysis of longitudinal biomarker and event process data: application to longitudinal prostate-specific antigen readings and prostate cancer. JASA J. Am. Stat. Assoc. 97, 53-65 (2002).
32. Halabi, S. et al. Prostate-specific antigen changes as surrogate for overall survival in men with metastatic castration-resistant prostate cancer treated with second-line chemotherapy. J. Clin. Oncol. 31, 3944-3950 (2013).
33. de Bono, J.S. et al. Phase II study of eribulin mesylate (E7389) in patients with metastatic castration-resistant prostate cancer stratified by prior taxane therapy. Ann. Oncol. 23, 1241-1249 (2012).
34. Majid, O., Gupta, A., Reyderman, L., Olivo, M. & Hussein, Z. Population pharmacometric analyses of eribulin in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. J. Clin. Pharmacol. 54, 1134-1143 (2014).
35. van Hasselt, J.G.C. et al. Population pharmacokinetic-pharmacodynamic analysis for eribulin mesilate-associated neutropenia. Br. J. Clin. Pharmacol. 76, 412-424 (2013).
36. Jacqmin, P. et al. Modelling response time profiles in the absence of drug concentrations: definition and performance evaluation of the K-PD model. J. Pharmacokinet. Pharmacodyn. 34, 57-85 (2007).
37. Bonate, P. Pharmacokinetic-Pharmacodynamic Modeling and Simulation (Springer US, 2011).
38. Beal, S.L., Boeckman, A.J. & Sheiner, L.B. NONMEM user guides. (1988).
39. R Development Core Team. R: A Language and Environment for Statistical Computing (Vienna, Austria, 2011).
40. Claret, L. et al. Evaluation of tumor-size response metrics to predict overall survival in Western and Chinese patients with first-line metastatic colorectal cancer. J. Clin. Oncol. 31, 2110-2114 (2013).
41. Claret, L. & Bruno, R. Reply to U.R. Mansmann et al and M.-W. An et al. J. Clin. Oncol. 31, 4374-4375 (2013).
42. Patel, J.C. et al. Emerging molecularly targeted therapies in castration refractory prostate cancer. Prostate Cancer 2013, 981684 (2013).
43. Bhavsar, T., McCue, P. & Birbe, R. Molecular diagnosis of prostate cancer: are we up to age? Semin. Oncol. 40, 259-275 (2013).
44. Armstrong, A.J. & Febbo, P.G. Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature. Oncologist 14, 816-827 (2009).
45. Vicini, P. & Van Der Graaf, P.H. Systems pharmacology for drug discovery and development: paradigm shift or flash in the pan. Clin. Pharmacol. Ther. 93, 379-381 (2013).
46. Kronik, N. et al. Predicting outcomes of prostate cancer immunotherapy by personalized mathematical models. PLoS One 5, e15482 (2010).
47. Bruno, R., Lu, J.-F., Sun, Y.-N. & Claret, L. A modeling and simulation framework to support early clinical drug development decisions in oncology. J. Clin. Pharmacol. 51, 6-8 (2011).
48. Bruno, R., Mercier, F. & Claret, L. Model-based drug development in oncology: what's next? Clin. Pharmacol. Ther. 93, 303-305 (2013).
49. van Hasselt, J.G.C., van Eijkelenburg, N.K.A., van Beijnen, J.H., Schellens, J.H.M. & Huitema, A.D.R. Design of a drug-drug interaction study of vincristine with azole antifungals in pediatric cancer patients using clinical trial simulation. Pediatr. Blood Cancer 61, 2223-2229 (2014).
50. Teoh, J.Y.C. et al. Prognostic significance of time to prostate-specific antigen (PSA) nadir and its relationship to survival beyond time to PSA nadir for prostate cancer patients with bone metastases after primary androgen deprivation therapy. Ann. Surg. Oncol. 22, 1385-1391 (2014).