Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: Exploratory analysis of data from the COU-AA-301 randomised trial

The Lancet Oncology

Volumn 13, Issue 12, 2012, Pages 1210-1217

  Logothetis, Christopher J ^a   Basch, Ethan ^b   Molina, Arturo ^c   Fizazi, Karim ^d   North, Scott A ^e   Chi, Kim N ^f   Jones, Robert J ^g   Goodman, Oscar B ^h   Mainwaring, Paul N ⁱ   Sternberg, Cora N ^j   Efstathiou, Eleni ^a   Gagnon, Dennis D ^k   Rothman, Margaret ^l   Hao, Yanni ^l   Liu, Cameron S ^c   Kheoh, Thian S ^c   Haqq, Christopher M ^c   Scher, Howard I ^b   de Bono, Johann S ^m  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e CROSS CANCER INSTITUTE   (Canada)

^f BRITISH COLUMBIA CANCER AGENCY   (Canada)

^g BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

^h NEVADA CANCER INSTITUTE   (United States)

ⁱ Haematology and Oncology Clinics of Australia   (Australia)

^j SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^k IBM WATSON HEALTH   (United States)

^l JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^m INSTITUTE OF CANCER RESEARCH   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ABIRATERONE ACETATE; DOCETAXEL; PLACEBO; PREDNISONE;

ADULT; AGED; ARTICLE; BONE METASTASIS; BRIEF PAIN INVENTORY SHORT FORM QUESTIONNAIRE; CANCER CHEMOTHERAPY; CANCER PAIN; CANCER PALLIATIVE THERAPY; CASTRATION RESISTANT PROSTATE CANCER; DAILY LIFE ACTIVITY; FOLLOW UP; FRACTURE; HUMAN; MAJOR CLINICAL STUDY; MALE; ORTHOPEDIC SURGERY; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUESTIONNAIRE; RADIATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SPINAL CORD COMPRESSION;

ADULT; AGED; AGED, 80 AND OVER; ANDROGEN ANTAGONISTS; ANDROSTADIENES; BONE NEOPLASMS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FRACTURES, SPONTANEOUS; GLUCOCORTICOIDS; HUMANS; MALE; MIDDLE AGED; PAIN MANAGEMENT; PAIN MEASUREMENT; PALLIATIVE CARE; PREDNISONE; PROSTATIC NEOPLASMS; SPINAL CORD COMPRESSION; STEROID 17-ALPHA-HYDROXYLASE;

EID: 84870243969     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(12)70473-4     Document Type: Article

References (31)

1. Efstathiou E, Logothetis CJ A new therapy paradigm for prostate cancer founded on clinical observations. Clin Cancer Res 2010, 16:1100-1107.
2. Oudard S, Banu E, Medioni J, et al. What is the real impact of bone pain on survival in patients with metastatic hormone-refractory prostate cancer treated with docetaxel?. BJU Int 2009, 103:1641-1646.
3. Sathiakumar N, Delzell E, Morrisey MA, et al. Mortality following bone metastasis and skeletal-related events among men with prostate cancer: a population-based analysis of US Medicare beneficiaries, 1999-2006. Prostate Cancer Prostatic Dis 2011, 14:177-183.
4. Armstrong AJ, Garrett-Mayer E, de Wit R, Tannock I, Eisenberger M Prediction of survival following first-line chemotherapy in men with castration-resistant metastatic prostate cancer. Clin Cancer Res 2010, 16:203-211.
5. Berruti A, Tucci M, Mosca A, et al. Predictive factors for skeletal complications in hormone-refractory prostate cancer patients with metastatic bone disease. Br J Cancer 2005, 93:633-638.
6. Sabbatini P, Larson SM, Kremer A, et al. Prognostic significance of extent of disease in bone in patients with androgen-independent prostate cancer. J Clin Oncol 1999, 17:948-957.
7. Drake JM, Danke JR, Henry MD Bone-specific growth inhibition of prostate cancer metastasis by atrasentan. Cancer Biol Ther 2010, 9:607-614.
8. Fizazi K, Beuzeboc P, Lumbroso J, et al. Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol 2009, 27:2429-2435.
9. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet 2011, 377:813-822.
10. Sartor AO, Heinrich D, O'Sullivan JM, et al. Radium-223 chloride (Ra-223) impact on skeletal-related events (SREs) and ECOG performance status (PS) in patients with castration-resistant prostate cancer (CRPC) with bone metastases: interim results of a phase III trial (ALSYMPCA). Proc Am Soc Clin Oncol 2012, 30(suppl). abstr 4551.
11. Saad F, Gleason DM, Murray R, et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 2002, 94:1458-1468.
12. Parker C, Nilsson S, Heinrich D, et al. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). Proc Am Soc Clin Oncol 2012, 30(suppl). abstr LBA4512.
13. Pienta KJ, Bradley D Mechanisms underlying the development of androgen-independent prostate cancer. Clin Cancer Res 2006, 12:1665-1671.
14. Logothetis CJ, Lin SH Osteoblasts in prostate cancer metastasis to bone. Nat Rev Cancer 2005, 5:21-28.
15. Chen CD, Welsbie DS, Tran C, et al. Molecular determinants of resistance to antiandrogen therapy. Nat Med 2004, 10:33-39.
16. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011, 364:1995-2005.
17. Cai C, Chen S, Ng P, et al. Intratumoral de novo steroid synthesis activates androgen receptor in castration-resistant prostate cancer and is upregulated by treatment with CYP17A1 inhibitors. Cancer Res 2011, 71:6503-6513.
18. Efstathiou E, Titus M, Tsavachidou D, et al. Effects of abiraterone acetate on androgen signaling in castrate-resistant prostate cancer in bone. J Clin Oncol 2012, 30:637-643.
19. Atkinson TM, Mendoza TR, Sit L, et al. The Brief Pain Inventory and its "pain at its worst in the last 24 hours" item: clinical trial endpoint considerations. Pain Med 2010, 11:337-346.
20. Cleeland CS, Ryan KM Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994, 23:129-138.
21. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158.
22. Sloan JA Assessing the minimally clinically significant difference: scientific considerations, challenges and solutions. COPD 2005, 2:57-62.
23. Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 1995, 61:277-284.
24. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012, 13:983-992.
25. Halabi S, Vogelzang NJ, Kornblith AB, et al. Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. J Clin Oncol 2008, 26:2544-2549.
26. Sartor O, Halstead M, Katz L Improving outcomes with recent advances in chemotherapy for castrate-resistant prostate cancer. Clin Genitourin Cancer 2010, 8:23-28.
27. Hussain M, Smith MR, Sweeney C, et al. Cabozantinib (XL184) in metastatic castration-resistant prostate cancer (mCRPC): results from a phase II randomized discontinuation trial. Proc Am Soc Clin Oncol 2011, 29(suppl). abstr 4516.
28. Farrar JT, Pritchett YL, Robinson M, Prakash A, Chappell A The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain 2010, 11:109-118.
29. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008, 9:105-121.
30. Tannock I, Gospodarowicz M, Meakin W, Panzarella T, Stewart L, Rider W Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response. J Clin Oncol 1989, 7:590-597.
31. Fossa SD, Slee PH, Brausi M, et al. Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European Organization for Research and Treatment of Cancer genitourinary group. J Clin Oncol 2001, 19:62-71.