Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients: Randomized phase 2 study of ixabepilone or mitoxantrone and prednisone

Cancer

Volumn 110, Issue 3, 2007, Pages 556-563

  Rosenberg, Jonathan E ^a   Weinberg, Vivian K ^b   Kelly, W Kevin ^c   Michaelson, Dror ^d   Hussain, Maha H ^e   Wilding, George ^f   Gross, Mitchell ^g   Hutcheon, Douglass ^a   Small, Eric J ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF SAN FRANCISCO   (United States)

^c MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^d Harvard Cancer Center   (United States)

^e UNIVERSITY OF MICHIGAN   (United States)

^f UNIVERSITY OF WISCONSIN   (United States)

^g CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

Hormone; Ixabepilone; Mitoxantrone; Prednisone; Prostate cancer; Refractory; Second line therapy; Taxane

Indexed keywords

DOCETAXEL; ESTRAMUSTINE; IXABEPILONE; LACTATE DEHYDROGENASE; MITOXANTRONE; PREDNISONE; TAXANE DERIVATIVE;

ADULT; ANEMIA; ANOREXIA; ARTICLE; BRAIN ISCHEMIA; CANCER SURVIVAL; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG RESPONSE; FATIGUE; FEBRILE NEUTROPENIA; HEART ARRHYTHMIA; HEART ATRIUM ARRHYTHMIA; HUMAN; HYPERCALCEMIA; HYPERURICEMIA; HYPOGLYCEMIA; HYPOKALEMIA; HYPOPHOSPHATEMIA; HYPOTENSION; INJECTION SITE REACTION; KIDNEY DISEASE; LIVER DISEASE; LIVER FUNCTION; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; MOTOR NEUROPATHY; MULTICENTER STUDY; MUSCLE WEAKNESS; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROBABILITY; PROSTATE CANCER; PROTHROMBIN TIME; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SEPSIS; SIDE EFFECT; STOMATITIS; SURVIVAL TIME; SYNCOPE; THORAX PAIN; THROMBOCYTOPENIA; THROMBOSIS; URINARY TRACT OBSTRUCTION; VOMITING;

ADENOCARCINOMA; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CROSS-OVER STUDIES; DRUG RESISTANCE, NEOPLASM; EPOTHILONES; HUMANS; MALE; MIDDLE AGED; MITOXANTRONE; NEOPLASMS, HORMONE-DEPENDENT; PREDNISONE; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SALVAGE THERAPY; SURVIVAL RATE; TAXOIDS; TREATMENT OUTCOME;

EID: 34547119271     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.22811     Document Type: Article

References (15)

1. 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.
2. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.
3. Gerth K, Bedorf N, Hofle G, Irschik H, Reichenbach H. Epothilons A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria). Production, physico-chemical and biological properties. J Antibiot (Tokyo). 1996;49:560-563.
4. Bollag DM, McQueney PA, Zhu J, et al. Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res. 1995;55:2325-2333.
5. Galsky MD, Small EJ, Oh WK, et al. Multi-institutional randomized phase II trial of the epothilone B analog ixabepilone (BMS-247550) with or without estramustine phosphate in patients with progressive castrate metastatic prostate cancer. J Clin Oncol. 2005;23:1439-1446.
6. Hussain M, Tangen CM, Lara PN Jr, et al. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol. 2005;23:8724-8729.
7. Therasse P, Arbuck SG, Eisenhauer EA, 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. 2000;92:205-216.
8. 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. Erratum in: J Clin Oncol. 2000;18:2644;
9. J Clin Oncol. 2007;25:1154.
10. Ozer H, Armitage JO, Bennett CL, et al. 2000 update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. American Society of Clinical Oncology Growth Factors Expert Panel. J Clin Oncol. 2000;18:3558-3585.
11. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719-748.
12. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
13. Peto R, Peto J. Asymptotically efficient Rank Invariant Procedures. J Royal Stat Soc Series A. 1972;135:185-207.
14. Cox DR. Regression models and life tables. J Royal Stat Soc Series B. 1972;34:187-220.
15. Rosenberg JE, Galsky MD, Rohs NC, et al. A retrospective evaluation of second-line chemotherapy response in hormone-refractory prostate carcinoma: second line taxane-based therapy after first-line epothilone-B analog ixabepilone (BMS-247550) therapy. Cancer 2006;106:58-62.