Radiographic progression by Prostate Cancer Working Group (PCWG)-2 criteria as an intermediate endpoint for drug development in metastatic castration-resistant prostate cancer

BJU International

Volumn 114, Issue 6, 2014, Pages E25-E31

  Sonpavde, Guru ^a   Pond, Gregory R ^b   Armstrong, Andrew J ^c   Galsky, Matthew D ^d   Leopold, Lance ^e   Wood, Brian A ^e   Wang, Shaw Ling ^f,g   Paolini, Jolanda ^f   Chen, Isan ^f,h   Chow Maneval, Edna ^f,h   Mooney, David J ^a   Lechuga, Mariajose ^f   Smith, Matthew R ⁱ   Dror Michaelson, M ⁱ  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b MCMASTER UNIVERSITY   (Canada)

^c DUKE UNIVERSITY   (United States)

^d Mt Sinai Tisch Cancer Institute   (United States)

^e Ascenta Therapeutics   (United States)

^f PFIZER INC   (United States)

^g ICON CLINICAL RESEARCH   (United States)

^h Department of Biology   (United States)

ⁱ MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

castration resistant prostate cancer; metastatic; overall survival (OS); Prostate Cancer Working Group (PCWG) 2; radiographic progression

Indexed keywords

DOCETAXEL; ISOSORBIDE; PREDNISONE; SUNITINIB; ANTINEOPLASTIC AGENT; GOSSYPOL; GOSSYPOL ACETIC ACID; INDOLE DERIVATIVE; PYRROLE DERIVATIVE; TAXOID;

ADULT; ARTICLE; ASYMPTOMATIC DISEASE; BONE SCINTISCANNING; BRIEF PAIN INVENTORY; CANCER DIAGNOSIS; CANCER GROWTH; CANCER MORTALITY; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CONTROLLED STUDY; HAZARD RATIO; HUMAN; MAJOR CLINICAL STUDY; MALE; METASTASIS POTENTIAL; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRACTICE GUIDELINE; PROGNOSIS; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; PROSTATE CANCERWORKING GROUP 2; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG DEVELOPMENT; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RADIOGRAPHY; RETROSPECTIVE STUDY; SURVIVAL RATE; TIME;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG DISCOVERY; GOSSYPOL; HUMANS; INDOLES; MALE; PREDNISONE; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; PYRROLES; RETROSPECTIVE STUDIES; SURVIVAL RATE; TAXOIDS; TIME FACTORS;

EID: 84906990474     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/bju.12589     Document Type: Article

References (22)

1. Petrylak DP, Ankerst DP, Jiang CS, etal. Evaluation of prostate-specific antigen declines for surrogacy in patients treated on SWOG 99-16. J Natl Cancer Inst 2006; 98: 516-521
2. Armstrong AJ, Garrett-Mayer E, Ou Yang YC, etal. Prostate-specific antigen and pain surrogacy analysis in metastatic hormone-refractory prostate cancer. J Clin Oncol 2007; 25: 3965-3970
3. Hussain M, Goldman B, Tangen C, etal. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol 2009; 27: 2450-2456
4. Sonpavde G, Pond GR, Berry WR, etal. The association between radiographic response and overall survival in men with metastatic castration-resistant prostate cancer receiving chemotherapy. Cancer 2011; 117: 3963-3971
5. Halabi S, Vogelzang NJ, Ou SS, Owzar K, Archer L, Small EJ,. Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer. J Clin Oncol 2009; 27: 2766-2771
6. Eisenhauer EA, Therasse P, Bogaerts J, etal. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-247
7. Scher HI, Halabi S, Tannock I, etal. 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
8. Scher HI, Warren M, Heller G,. The association between measures of progression and survival in castrate-metastatic prostate cancer. Clin Cancer Res 2007; 13: 1488-1492
9. Sonpavde G, Matveev V, Burke JM, etal. 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. Michaelson MD, Oudard S, Ou YC, etal. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol 2014; 32: 76-82
11. Therasse P, Arbuck SG, Eisenhauer EA, etal. 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 2000; 92: 205-216
12. Ryan CJ, Morris M, Molina A, etal. Association of radiographic progression-free survival adapted from Prostate Cancer Working Group-2 consensus criteria with overall survival in patients wuth metastatic castration-resistant prostate cancer. ESMO Congress September 2012, Vienna, Austria, abstract 8940
13. Sternberg CN, Petrylak DP, Sartor O, etal. Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial. J Clin Oncol 2009; 27: 5431-5438
14. Halabi S, Armstrong AJ, Sartor O, etal. 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 2013; 31: 3944-3950
15. 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
16. Dennis ER, Jia X, Mezheritskiy IS, etal. Bone scan index: a quantitative treatment response biomarker for castration-resistant metastatic prostate cancer. J Clin Oncol 2012; 30: 519-524
17. Lipton A, Cook R, Saad F, etal. Normalization of bone markers is associated with improved survival in patients with bone metastases from solid tumors and elevated bone resorption receiving zoledronic acid. Cancer 2008; 113: 193-201
18. Scher H, Heller G, Molina A, etal. Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC): planned final analysis (FA) of COU-AA-301, a randomized double-blind, placebo-controlled phase III study of abiraterone acetate (AA) plus low-dose prednisone (P) post docetaxel. J Clin Oncol 2011; 29 (Suppl.); abstr LBA4517
19. de Bono JS, Scher HI, Montgomery RB, etal. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res 2008; 14: 6302-6309
20. Even-Sapir E, Metser U, Mishani E, Lievshitz G, Lerman H, Leibovitch I,. The detection of bone metastases in patients with high-risk prostate cancer: 99mTc-MDP Planar bone scintigraphy, single- and multi-field-of-view SPECT, 18F-fluoride PET, and 18F-fluoride PET/CT. J Nucl Med 2006; 47: 287-297
21. Halabi S, Lin CY, Small EJ, etal. Prognostic model predicting metastatic castration-resistant prostate cancer survival in men treated with second-line chemotherapy. J Natl Cancer Inst 2013; 105: 1729-1737
22. Armstrong AJ, Garrett-Mayer ES, Yang YC, de Wit R, Tannock IF, Eisenberger M,. A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: a TAX327 study analysis. Clin Cancer Res 2007; 13: 6396-6403