Taxane-based Combination Therapies for Metastatic Prostate Cancer

National Comprehensive Cancer Network, 2017 Vaishampayan, 2014, Therapeutic options and multifaceted treatment paradigms in metastatic castrate-resistant prostate cancer, Curr Opin Oncol, 26, 265, 10.1097/CCO.0000000000000066 Tannock, 2004, Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer, N Engl J Med, 351, 1502, 10.1056/NEJMoa040720 Petrylak, 2004, Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer, N Engl J Med, 351, 1513, 10.1056/NEJMoa041318 National Comprehensive Cancer Network, 2016 Azarenko, 2014, Antiproliferative mechanism of action of the novel taxane cabazitaxel as compared with the parent compound docetaxel in MCF7 breast cancer cells, Mol Cancer Ther, 13, 2092, 10.1158/1535-7163.MCT-14-0265 Vrignaud, 2013, Preclinical antitumor activity of cabazitaxel, a semi-synthetic taxane active in taxane-resistant tumors, Clin Cancer Res, 19, 2973, 10.1158/1078-0432.CCR-12-3146 de Bono, 2010, Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial, Lancet, 376, 1147, 10.1016/S0140-6736(10)61389-X Sartor, 2016, Cabazitaxel vs docetaxel in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer: a three-arm phase III study (FIRSTANA), J Clin Oncol, 34, 5006, 10.1200/JCO.2016.34.15_suppl.5006 Eisenberger, 2017, Phase III study comparing a reduced dose of cabazitaxel (20 mg/m2) and the currently approved dose (25 mg/m2) in postdocetaxel patients with metastatic castration-resistant prostate cancer—PROSELICA, J Clin Oncol, 35, 3198, 10.1200/JCO.2016.72.1076 Sanofi PI. JEVTANA® (cabazitaxel) injection, prescribing information, FDA. Revised 2017. Tannock, 1996, Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points, J Clin Oncol, 14, 1756, 10.1200/JCO.1996.14.6.1756 Berry, 2002, Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer, J Urol, 168, 2439, 10.1016/S0022-5347(05)64163-8 Kantoff, 1999, Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B 9182 study, J Clin Oncol, 17, 2506, 10.1200/JCO.1999.17.8.2506 Hurwitz, 2015, Chemotherapy in prostate cancer, Curr Oncol Rep, 17, 44, 10.1007/s11912-015-0468-7 Fizazi, 2007, Addition of estramustine to chemotherapy and survival of patients with castration-refractory prostate cancer: a meta-analysis of individual patient data, Lancet Oncol, 8, 994, 10.1016/S1470-2045(07)70284-X Ravery, 2011, The use of estramustine phosphate in the modern management of advanced prostate cancer, BJU Int, 108, 1782, 10.1111/j.1464-410X.2011.10201.x Sweeney, 2015, Chemohormonal therapy in metastatic hormone-sensitive prostate cancer, N Engl J Med, 373, 737, 10.1056/NEJMoa1503747 Guise, 2003, Role of endothelin-1 in osteoblastic bone metastases, Cancer, 97, 779, 10.1002/cncr.11129 Quinn, 2013, Docetaxel and atrasentan versus docetaxel and placebo for men with advanced castration-resistant prostate cancer (SWOG S0421): a randomised phase 3 trial, Lancet Oncol, 14, 893, 10.1016/S1470-2045(13)70294-8 Fizazi, 2013, Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer, J Clin Oncol, 31, 1740, 10.1200/JCO.2012.46.4149 Araujo, 2013, Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial, Lancet Oncol, 14, 1307, 10.1016/S1470-2045(13)70479-0 Goyal, 2012, Bone-targeting radiopharmaceuticals for the treatment of prostate cancer with bone metastases, Cancer Lett, 323, 135, 10.1016/j.canlet.2012.04.001 Parker, 2013, Alpha emitter radium-223 and survival in metastatic prostate cancer, N Engl J Med, 369, 213, 10.1056/NEJMoa1213755 Morris, 2016, Updated results: a phase 1/2a randomized trial of radium -223 + docetaxel versus docetaxel in patients with castration-resistant prostate cancer and bone metastases, J Clin Oncol, 34, 5075, 10.1200/JCO.2016.34.15_suppl.5075 van Dodewaard-de-Jong, 2016, A randomized, phase II study of repeated rhenium-188-HEDP (rhenium) combined with docetaxel versus docetaxel alone in castration resistant prostate cancer (CRPC) metastatic to bone: the Taxium II trial, J Clin Oncol, 34, 5081, 10.1200/JCO.2016.34.15_suppl.5081 Bouman-Wammes, 2016, A phase I trial of cabazitaxel plus/minus rhenium -188-HEDP in patients with metastatic castration-resistant prostate cancer who progressed on or after a docetaxel containing treatment, J Clin Oncol, 34, e16508, 10.1200/JCO.2016.34.15_suppl.e16508 Kelly, 2012, Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401, J Clin Oncol, 30, 1534, 10.1200/JCO.2011.39.4767 Tannock, 2013, Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3, double-blind randomised trial, Lancet Oncol, 14, 760, 10.1016/S1470-2045(13)70184-0 Hussain, 2012, J Clin Oncol, 30, 97, 10.1200/jco.2012.30.5_suppl.97 Petrylak, 2015, Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial, Lancet Oncol, 16, 417, 10.1016/S1470-2045(15)70025-2 Madan, 2016, Phase II trial of docetaxel, bevacizumab, lenalidomide, and prednisone in patients with metastatic castration-resistant prostate cancer, BJU Int, 118, 590, 10.1111/bju.13412 Small E, Demkov T, Gerritsen WR, et al. A phase 3 trial of GVAX immunotherapy for prostate cancer in combination with docetaxel versus docetaxel plus prednisone in symptomatic, castration-resistant prostate cancer (CRPC) Abstract 7. Prell, 2006, The anti-tumor efficacy of a GM-CSF-secreting tumor cell vaccine is not inhibited by docetaxel administration, Cancer Immunol Immunother, 55, 1285, 10.1007/s00262-005-0116-4 Garnett, 2008, Combination of docetaxel and recombinant vaccine enhances T-cell responses and antitumor activity: effects of docetaxel on immune enhancement, Clin Cancer Res, 14, 3536, 10.1158/1078-0432.CCR-07-4025 Beer, 2015, Autologous dendritic cell immunotherapy (DCVAC/PCa) added to docetaxel chemotherapy in a phase III trial (viable) in men with advanced (mCRPC) prostate cancer, J Immunother Cancer, 3, P164, 10.1186/2051-1426-3-S2-P164 Clinicaltrials.gov. 2016 https://clinicaltrials.gov/ Podrazil, 2015, Phase I/II clinical trial of dendritic-cell based immunotherapy (DCVAC/PCa) combined with chemotherapy in patients with metastatic, castration-resistant prostate cancer, Oncotarget, 6, 18192, 10.18632/oncotarget.4145 Kantoff, 2010, Overall survival analysis of a phase II randomized controlled trial of a poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer, J Clin Oncol, 28, 1099, 10.1200/JCO.2009.25.0597 Kantoff, 2017, Revised overall survival analysis of a phase II, randomized, double-blind, controlled study of PROSTVAC in men with metastatic castration-resistant prostate cancer, J Clin Oncol, 35, 124, 10.1200/JCO.2016.69.7748 Kwon, 2014, Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial, Lancet Oncol, 15, 700, 10.1016/S1470-2045(14)70189-5 Beer, 2017, Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer, J Clin Oncol, 35, 40, 10.1200/JCO.2016.69.1584 Topalian, 2012, Safety, activity, and immune correlates of anti-PD-1 antibody in cancer, N Engl J Med, 366, 2443, 10.1056/NEJMoa1200690 Graff, 2016, Early evidence of anti-PD-1 activity in enzalutamide-resistant prostate cancer, Oncotarget, 7, 52810, 10.18632/oncotarget.10547 Gao, 2017, VISTA is an inhibitory immune checkpoint that is increased after ipilimumab therapy in patients with prostate cancer, Nat Med, 23, 551, 10.1038/nm.4308 Morris, 2016, Phase Ib study of enzalutamide in combination with docetaxel in men with metastatic castration-resistant prostate cancer, Clin Cancer Res, 22, 3774, 10.1158/1078-0432.CCR-15-2638 Petrylak, 2015, Phase 1/2 study of orteronel (TAK-700), an investigational 17,20-lyase inhibitor, with docetaxel-prednisone in metastatic castration-resistant prostate cancer, Invest New Drugs, 33, 397, 10.1007/s10637-014-0199-x Tagawa, 2016, Phase 1b study of abiraterone acetate plus prednisone and docetaxel in patients with metastatic castration-resistant prostate cancer, Eur Urol, 70, 718, 10.1016/j.eururo.2016.01.028 Duran, 2015, J Clin Oncol, 33, e16022, 10.1200/jco.2015.33.15_suppl.e16022 Massard, 2017, Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone, Ann Oncol, 28, 90, 10.1093/annonc/mdw441 Slovin, 2016, Exploring the role of RB and AR in a phase 2 randomized multicenter trial of abiraterone acetate with or without cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC), J Clin Oncol, 34 Petrylak, 2013, A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): updated phase II results, J Clin Oncol, 31, 59, 10.1200/jco.2013.31.6_suppl.59 Ross, 2008, A phase 2 study of carboplatin plus docetaxel in men with metastatic hormone-refractory prostate cancer who are refractory to docetaxel, Cancer, 112, 521, 10.1002/cncr.23195 Nakabayashi, 2008, Response to docetaxel/carboplatin-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer, BJU Int, 101, 308, 10.1111/j.1464-410X.2007.07331.x Regan, 2010, Efficacy of carboplatin-taxane combinations in the management of castration-resistant prostate cancer: a pooled analysis of seven prospective clinical trials, Ann Oncol, 21, 312, 10.1093/annonc/mdp308 Derosa, 2014, Docetaxel plus oral metronomic cyclophosphamide: a phase II study with pharmacodynamic and pharmacogenetic analyses in castration-resistant prostate cancer patients, Cancer, 120, 3923, 10.1002/cncr.28953 Porsch, 2014, A randomised phase II trial comparing docetaxel plus prednisone with docetaxel plus prednisone plus low-dose cyclophosphamide in castration-resistant prostate cancer, Chemotherapy, 60, 129, 10.1159/000369781 Dhawan, 2016, A multicenter phase 1 study of cabazitaxel, mitoxantrone, and prednisone for chemotherapy-naive patients with metastatic castration-resistant prostate cancer, J Clin Oncol, 34, 202, 10.1200/jco.2016.34.2_suppl.202 Lockhart, 2014, Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors, Invest New Drugs, 32, 1236, 10.1007/s10637-014-0145-y Corn, 2009, Confirmatory analysis to determine associations between platinum-sensitivity and molecular signature of combined tumor suppressor defects and aggressive variant prostate carcinomas (AVPC), J Clin Oncol, 34, 5020 Sternberg, 2009, Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer, Ann Oncol, 20, 1264, 10.1093/annonc/mdn784 Sonpavde, 2012, 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, 23, 1803, 10.1093/annonc/mdr555 Fizazi, 2016, Final overall survival (OS) from the AFFINITY phase 3 trial of custirsen and cabazitaxel/prednisone in men with previously treated metastatic castration-resistant prostate cancer (mCRPC), Ann Oncol, 27 Chi, 2015, Phase 3 SYNERGY trial: docetaxel plus/minus custirsen and overall survival in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and poor prognosis, J Clin Oncol, 33, 5009, 10.1200/jco.2015.33.15_suppl.5009 Scher, 2011, Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer, J Clin Oncol, 29, 2191, 10.1200/JCO.2010.32.8815 Dreicer, 2013, A randomized, double-blind, placebo-controlled, phase II study with and without enzastaurin in combination with docetaxel-based chemotherapy in patients with castration-resistant metastatic prostate cancer, Invest New Drugs, 31, 1044, 10.1007/s10637-013-9940-0 de Bono, 2014, Phase II randomized study of figitumumab plus docetaxel and docetaxel alone with crossover for metastatic castration-resistant prostate cancer, Clin Cancer Res, 20, 1925, 10.1158/1078-0432.CCR-13-1869 Singal, 2015, Phase I/II study of azacitidine, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy, Clin Genitourin Cancer, 13, 22, 10.1016/j.clgc.2014.07.008 Tso, 2000, Androgen deprivation induces selective outgrowth of aggressive hormone-refractory prostate cancer clones expressing distinct cellular and molecular properties not present in parental androgen-dependent cancer cells, Cancer J, 6, 220 Craft, 1999, Evidence for clonal outgrowth of androgen-independent prostate cancer cells from androgen-dependent tumors through a two-step process, Cancer Res, 59, 5030 Sweeney, 2016, Long term efficacy and QOL data of chemohormonal therapy (C-HT) in low and high volume hormone naïve metastatic prostate cancer (PrCa): E3805 CHAARTED trial, Ann Oncol, 27 Gravis, 2016, Androgen deprivation therapy (ADT) plus docetaxel versus ADT alone in metastatic non castrate prostate cancer: impact of metastatic burden and long-term survival analysis of the randomized phase 3 GETUG-AFU15 trial, Eur Urol, 70, 256, 10.1016/j.eururo.2015.11.005 James, 2016, Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial, Lancet, 387, 1163, 10.1016/S0140-6736(15)01037-5 James, 2017, Abiraterone for prostate cancer not previously treated with hormone therapy, N Engl J Med, 377, 338, 10.1056/NEJMoa1702900 Fizazi, 2017, Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer, N Engl J Med, 377, 352, 10.1056/NEJMoa1704174 Sydes, 2017, Adding abiraterone acetate plus prednisolone (AAP) or docetaxel for patients (pts) with high-risk prostate cancer (PCa) starting long-term androgen deprivation therapy (ADT): directly randomised data from STAMPEDE (NCT 00268476), Ann Oncol, 28 Lavaud, 2016, How should we treat castration-resistant prostate cancer patients who have received androgen deprivation therapy (ADT) plus docetaxel upfront for hormone-sensitive disease? Mature analysis of the GETUG-AFU 15 phase III trial, Ann Oncol, 27, 761P, 10.1093/annonc/mdw372.45 Ogura, 2016, Docetaxel induces Bcl-2- and pro-apoptotic caspase-independent death of human prostate cancer DU145 cells, Int J Oncol, 48, 2330, 10.3892/ijo.2016.3482 Fitzpatrick, 2014, Taxane mechanisms of action: potential implications for treatment sequencing in metastatic castration-resistant prostate cancer, Eur Urol, 65, 1198, 10.1016/j.eururo.2013.07.022 Darshan, 2011, Taxane-induced blockade to nuclear accumulation of the androgen receptor predicts clinical responses in metastatic prostate cancer, Cancer Res, 71, 6019, 10.1158/0008-5472.CAN-11-1417 Zhu, 2010, Tubulin-targeting chemotherapy impairs androgen receptor activity in prostate cancer, Cancer Res, 70, 7992, 10.1158/0008-5472.CAN-10-0585 Komlodi-Pasztor, 2011, Mitosis is not a key target of microtubule agents in patient tumors, Nat Rev Clin Oncol, 8, 244, 10.1038/nrclinonc.2010.228 Mateo, 2015, DNA-repair defects and olaparib in metastatic prostate cancer, N Engl J Med, 373, 1697, 10.1056/NEJMoa1506859 Robinson, 2015, Integrative clinical genomics of advanced prostate cancer, Cell, 161, 1215, 10.1016/j.cell.2015.05.001 Antonarakis, 2017, Randomized, noncomparative, phase II trial of early switch from docetaxel to cabazitaxel or vice versa, with integrated biomarker analysis, in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer, J Clin Oncol, 35, 3181, 10.1200/JCO.2017.72.4138 Sonpavde, 2017, Circulating tumor (ct)-DNA alterations in metastatic castration-resistant prostate cancer (mCRPC): association with outcomes and evolution with therapy, J Clin Oncol, 35, 149, 10.1200/JCO.2017.35.6_suppl.149