Hematologic Safety of Radium-223 Dichloride: Baseline Prognostic Factors Associated With Myelosuppression in the ALSYMPCA Trial

Clinical Genitourinary Cancer

Volumn 15, Issue 1, 2017, Pages 42-52.e8

  Vogelzang, Nicholas J ^a   Coleman, Robert E ^b   Michalski, Jeff M ^c   Nilsson, Sten ^d   O'Sullivan, Joe M ^e   Parker, Christopher ^f   Widmark, Anders ^g   Thuresson, Marcus ^h   Xu, Lei ⁱ   Germino, Joseph ⁱ   Sartor, Oliver ^j  

^a Department of Hematology Oncology   (United States)

^b WESTON PARK HOSPITAL   (United Kingdom)

^c WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^f INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^g UMEÅ UNIVERSITY   (Sweden)

^h STATISTICON AB   (Sweden)

ⁱ BAYER CORPORATION   (United States)

^j TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

Alpha emitting radiopharmaceutical; Anemia; Castration resistant prostate cancer; Myelotoxicity; Thrombocytopenia

Indexed keywords

DOCETAXEL; HEMOGLOBIN; PLACEBO; PROSTATE SPECIFIC ANTIGEN; RADIUM CHLORIDE RA 223; ANTINEOPLASTIC AGENT; RADIOISOTOPE; RADIUM;

ANEMIA; BLOOD TRANSFUSION; BONE MARROW DEPRESSION; BONE MARROW SUPPRESSION; CONFERENCE PAPER; FEBRILE NEUTROPENIA; FOLLOW UP; HUMAN; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; NEUTROPENIA; PANCYTOPENIA; RISK FACTOR; SIDE EFFECT; THROMBOCYTOPENIA; AGED; BONE NEOPLASMS; CHEMICALLY INDUCED; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; INCIDENCE; MALE; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PROGNOSIS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RANDOMIZED CONTROLLED TRIAL; SECONDARY; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; DOUBLE-BLIND METHOD; HUMANS; INCIDENCE; MALE; MIDDLE AGED; NEUTROPENIA; PROGNOSIS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RADIOISOTOPES; RADIUM; RISK FACTORS; THROMBOCYTOPENIA;

EID: 84995387197     PISSN: 15587673     EISSN: 19380682     Source Type: Journal    
DOI: 10.1016/j.clgc.2016.07.027     Document Type: Conference Paper

References (30)

1. 1 Gartrell, B.A., Saad, F., Managing bone metastases and reducing skeletal related events in prostate cancer. Nat Rev Clin Oncol 11 (2014), 335–345.
2. 2 Cathomas, R., Bajory, Z., Bouzid, M., et al. Management of bone metastases in patients with castration-resistant prostate cancer. Urol Int 92 (2014), 377–386.
3. 3 Butoescu, V., Tombal, B., Practical guide to bone health in the spectrum of advanced prostate cancer. Can J Urol 21 (2014), 84–92.
4. 4 Broder, M.S., Gutierrez, B., Cherepanov, D., et al. Burden of skeletal-related events in prostate cancer: unmet need in pain improvement. Support Care Cancer 23 (2015), 237–247.
5. 5 Nieder, C., Haukland, E., Pawinski, A., et al. Anaemia and thrombocytopenia in patients with prostate cancer and bone metastases. BMC Cancer, 10, 2010, 284.
6. 6 Beer, T.M., Bergenstock, M., Birt, K., et al. Darbepoetin alfa administered every 4 weeks for anemia in patients with advanced prostate cancer. Clin Genitourin Cancer 5 (2007), 329–333.
7. 7 Picus, J., Schultz, M., Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol 26 (1999), 14–18.
8. 8 Hwang, C., Overcoming docetaxel resistance in prostate cancer: a perspective review. Ther Adv Med Oncol 4 (2012), 329–340.
9. 9 de Bono, J.S., Oudard, S., Ozguroglu, M., et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 376 (2010), 1147–1154.
10. 10 Xofigo (Radium-223 Dichloride) [Package Insert], 2013, Bayer HealthCare Pharmaeuticals Inc, Wayne, NJ.
11. 11 Parker, C., Nilsson, S., Heinrich, D., et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 369 (2013), 213–223.
12. 223Ra: adjuvant or alternative to conventional modalities?. Clin Cancer Res 12 (2006), 6250s–6257s.
13. 89Sr in mice. J Nucl Med 44 (2003), 252–259.
14. 223Ra demonstrated in an experimental skeletal metastases model. Cancer Res 62 (2002), 3120–3125.
15. 15 Nilsson, S., Larsen, R.H., Fossa, S.D., et al. First clinical experience with alpha-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res 11 (2005), 4451–4459.
16. 223Ra: new measurements and review of 2008 data. J Res Natl Inst Stand Technol 120 (2015), 37–57.
17. 17 Nilsson, S., Franzen, L., Parker, C., et al. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol 8 (2007), 587–594.
18. 18 Nilsson, S., Radium-223 dichloride for the treatment of bone metastatic castration-resistant prostate cancer: an evaluation of its safety. Expert Opin Drug Saf 14 (2015), 1127–1136.
19. 19 Sartor, O., Coleman, R., Nilsson, S., et al. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol 15 (2014), 738–746.
20. 20 Therneau, T.M., Grambsch, P.M., Pankratz, V.S., Penalized survival models and frailty. J Comput Graph Stat 12 (2003), 156–175.
21. 21 Provenge (Sipuleucel-T) Suspension for Intravenous Infusion [Package Insert], 2014, Dendreon Corporation, Seattle, WA.
22. 22 Jetvana (Cabazitaxel) Injection, 60 mg/1.5 mL, for Intravenous Infusion Only [Package Insert], 2014, Sanofi-Aventis US LLC, Bridgewater, NJ.
23. 23 Zytiga (Abiraterone Acetate) Tablets for Oral Administration [Package Insert], 2014, Janssen Biotech Inc, Horsham, PA.
24. 24 Xtandi (Enzalutamide) Capsules for Oral Use [Package Insert], 2014, Astellas Pharma US Inc, Northbrook, IL.
25. 25 Hoskin, P., Sartor, O., O'Sullivan, J.M., et al. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol 15 (2014), 1397–1406.
26. 26 Cookson, S., Roth, B.J., Dahm, P., et al. Castration-Resistant Prostate Cancer: AUA Guideline. 2014, AUA Education and Research Inc, Linthicum, MD.
27. 27 Omlin, A., Pezaro, C., Gillessen Sommer, S., Sequential use of novel therapeutics in advanced prostate cancer following docetaxel chemotherapy. Ther Adv Urol 6 (2014), 3–14.
28. 28 Basch, E., Loblaw, D.A., Oliver, T.K., et al. Systemic therapy in men with metastatic castration-resistant prostate cancer: American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol 32 (2014), 3436–3448.
29. 29 Parker, C., Gillessen, S., Heidenreich, A., et al. Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 26:suppl 5 (2015), v69–v77.
30. 30 Sartor, O., Hoskin, P., Coleman, R.E., et al. Chemotherapy following radium-223 dichloride treatment in ALSYMPCA. Prostate 76 (2016), 905–916.