Patupilone in cancer treatment

Expert Opinion on Investigational Drugs

Volumn 20, Issue 1, 2011, Pages 107-117

  Bystricky, Branislav ^a   Chau, Ian ^a  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

Author keywords

bowel cancer; breast cancer; cabazitaxel; diarrhoea; docetaxel; ixabepilone; lung cancer; ovarian cancer; paclitaxel; patupilone; pharmacodynamics; pharmacokinetics; prostate cancer

Indexed keywords

ALBUMIN; ANTINEOPLASTIC AGENT; CABAZITAXEL; CAPECITABINE; CARBOPLATIN; CELECOXIB; CISPLATIN; CREMOPHOR; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; EPOTHILONE B; EVEROLIMUS; FLUOROURACIL; GEMCITABINE; IXABEPILONE; LOPERAMIDE; MITOXANTRONE; NANOPARTICLE; NAVELBINE; PACLITAXEL; POLYSORBATE 80; PREDNISOLONE; PREDNISONE; TRASTUZUMAB;

ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BLEEDING; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BRAIN CANCER; BRAIN METASTASIS; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COLITIS; COLON CANCER; COLORECTAL CANCER; DEHYDRATION; DESQUAMATION; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG WITHDRAWAL; ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FLUID RETENTION; GOVERNMENT REGULATION; HEAD AND NECK CARCINOMA; HUMAN; KAPOSI SARCOMA; KIDNEY CANCER; KIDNEY CARCINOMA; LIVER CANCER; LIVER CELL CARCINOMA; LUNG CANCER; LUNG NON SMALL CELL CANCER; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NONHUMAN; ONYCHOLYSIS; OVARY CANCER; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PERITONEUM CANCER; PROSTATE CANCER; RECOMMENDED DRUG DOSE; SENSORY NEUROPATHY; SEPSIS; SIDE EFFECT; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; STOMACH ADENOCARCINOMA; STOMACH CANCER; UTERINE TUBE TUMOR; VOMITING;

ANIMALS; ANTINEOPLASTIC AGENTS; APOPTOSIS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; EPOTHILONES; HUMANS; NEOPLASMS; SURVIVAL RATE; TUBULIN MODULATORS;

EID: 78650256256     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543784.2011.542148     Document Type: Article

References (75)

1. Altmann KH, Wartmann M, O'Reilly T. Epothilones and related structures - a new class of microtubule inhibitors with potent in vivo antitumor activity. Biochim Biophys Acta 2000;1470:M79-91
2. Aebi S, Davidson T, Gruber G, et al. Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v9-14
3. Cardoso F, Senkus-Konefka E, Fallowfield L, et al. Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v15-19
4. Carlson RW, Allred DC, Anderson BO, et al. NCCN clinical practice guidelines in oncology-breast cancer. (V1.2011), National Comprehensive Cancer Network, Fort Washington, PA; 2010. Available from: http://www.nccn.org/ professionals/physician-gls/PDF/breast.pdf [Last accessed 23 November 2010]
5. Colombo N, Peiretti M, Parma G, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v23-30
6. Morgan RJ, Alvarez RD, Armstrong DK, et al. NCCN clinical practice guidelines in oncology-ovarian cancer, including fallopian tube cancer and primary peritoneal cancer (v.2.2011). National Comprehensive Cancer Network, Fort Washington, PA; 2010. Available from: http://www.nccn.org/professionals/ physician-gls/PDF/ovarian.pdf [Last accessed 23 November 2010]
7. D'Addario G, Fruh M, Reck M, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v116-19
8. Crino L, Weder W, van Meerbeeck J, Felip E. Early stage and locally advanced (non-metastatic) non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v103-15
9. Ettinger DS, Akerley W, Borghaei H, et al. NCCN clinical practice guidelines in oncology - non-small cell lung cancer (V.1.2011). National Comprehensive Cancer Network, Fort Washington, PA; 2010. Available from: http://www.nccn.org/professionals/physician-gls/PDF/nscl. pdf [Last accessed 23 November 2010]
10. Horwich A, Parker C, Bangma C, et al. Prostate cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v129-133
11. Mohler J, Armstrong AJ, Bahnson RR, et al. NCCN clinical practice guidelines in oncology-prostate cancer (V.3.2010). National Comprehensive Cancer Network, Fort Washington, PA; 2010. Available from: http://www.nccn.org/ professionals/physician-gls/PDF/prostate.pdf [Last accessed 23 November 2010]
12. Okines A, Verheij M, Allum W, et al. Gastric cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v50-54
13. Ajani JA, Barthel JS, Bekaii-Saab T, et al. NCCN clinical practice guidelines in oncology-gastric cancer. (V.2.2010). National Comprehensive Cancer Network, Fort Washington PA; 2010. Available from: www.nccn.org/professionals/ physician-gls/PDF/gastric. pdf [Last accessed 23 November 2010]
14. U.S Cancer Statistics Working Group. United States Cancer Statistics: 1999-2006 Incidence and Mortality Web-based Report. Centers for Disease Control and Prevention, Atlanta, GA 2010. Available from: www.cdc.gov/uscs [Last accessed 23 November 2010]
15. Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007;18:581-92
16. Sledge GW, Neuberg D, Bernardo P, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003;21:588-92
17. Piccart-Gebhart MJ, Burzykowski T, Buyse M, et al. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol 2008;26:1980-6
18. Henderson IC, Berry DA, Demetri GD, et al. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 2003;21:976-83
19. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355:2542-50
20. Piccart MJ, Bertelsen K, James K, et al. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst 2000;92:699-708
21. Bookman MA, Greer BE, Ozols RF. Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. Int J Gynecol Cancer 2003;13:735-40
22. International Collaborative Ovarian Neoplasm Group, Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial. Lancet 2002;360:505-15
23. TAXOL® (paclitaxel) INJECTION, in Prescribing Information. Bristol-Myers Squibb Company, Princeton. NJ08543 USA 2007
24. Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999;17:2341-54
25. Nabholtz JM, Falkson C, Campos D, et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, Phase III trial. J Clin Oncol 2003;21:968-75
26. Roche H, Fumoleau P, Spielmann M, et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol 2006;24:5664-71
27. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000;18:2095-103
28. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, Phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 2003;21:3016-24
29. 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;351:1502-12
30. Van Cutsem E, Moiseyenko VM, Tjulandin S, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 2006;24:4991-7
31. Vermorken JB, Remenar E, van Herpen C, et al. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med 2007;357:1695-704
32. TAXOTERE® (docetaxel) Injection Concentrate, in Prescribing Information., Sanofi-Aventis U.S. LLC, Bridgewater USA. NJ08807; 2010
33. Desai N, Trieu V, Yao Z, et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res 2006;12:1317-24
34. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005;23:7794-803
35. Thomas ES. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 2007;25:5210-17
36. Sparano JA, Vrdoljak E, Rixe O, et al. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2010;28:3256-63
37. Small E, Harzstark A, Weinberg VK, et al. Ixabepilone, mitoxantrone, and prednisone in patients with metastatic castration-resistant prostate cancer refractory to docetaxel-based therapy: a phase II study of the DOD prostate cancer clinical trials consortium. J Clin Oncol 2009;27(15s):, abstract 5058
38. 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;23:1439-46
39. De Bono JS, 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 2010;376:1147-54
40. Goodin S, Novel cytotoxic agents. epothilones. Am J Health Syst Pharm 2008;65(10 Suppl 3):S10-15
41. PubChemProject. Bethesda, MD: National Center for Biotechnology Information. 2010. Available from: http://pubchem.ncbi.nlm.nih.gov/. [Last accessed 23 November 2010]
42. McDaid HM, Mani S, Shen HJ, et al. Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a Phase I clinical study. Clin Cancer Res 2002;8:2035-43
43. Lee FY, Borzilleri R, Fairchild CR, et al. BMS-247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res 2001;7:1429-37
44. Swanton C, Tomlinson I, Downward J. Chromosomal instability, colorectal cancer and taxane resistance. Cell Cycle 2006;5:818-23
45. Rubin EH, Rothermel J, Tesfaye F, et al. Phase I dose-finding study of weekly single-agent patupilone in patients with advanced solid tumors. J Clin Oncol 2005;23:9120-9
46. Takimoto CH, Fu S, Dhillon N, et al. Evaluation of pharmacokinetics (PK) and pharmacodynamics (PD) of patupilone and warfarin in patients (pts) with advanced solid tumors: an open-label, phase I study. J Clin Oncol 2008;26(15s): abstract 2548
47. Casado E, Tabernero J, Melicher B, et al. Patupilone in chemotherapy pretreated patients with advanced colorectal cancer receiving nutritional support and intensive diarrhea management. A phase I multicenter trial. Proc Am Soc Clin Oncol 2006;24:3593a
48. Ten Bokkel Huinink WW, Sufliarsky J, Smit WM, et al. Safety and efficacy of patupilone in patients with advanced ovarian, primary fallopian, or primary peritoneal cancer: a Phase I, open-label, dose-escalation study. J Clin Oncol 2009;27:3097-103
49. Benson AB III, Ajani JA, Catalano RB, et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol 2004;22(14):2918-26
50. Bergstralh D, Ting J. Microtubule stabilizing agents: their molecular signaling consequences and the potential for enhancement by drug combination. Cancer Treat Rev 2006;32:166-79
51. Iqbal S, El-Khoueiry AB, Yang D, et al. A phase I study of celecoxib (C) and patupilone (EPO906) in patients (pts) with metastatic colorectal cancer (mCRC). J Clin Oncol 2010;28(15s): abstract 2533
52. Fracasso PM, Ravaud A, Baggstrom MQ, et al. Patupilone combined with carboplatin in patients (pts) with advanced solid tumors: preliminary safety and activity results. J Clin Oncol 2008;26:(20 Suppl): abstract 13544
53. Forster M, Kaye S, Oza A, et al. A Phase Ib and pharmacokinetic trial of patupilone combined with carboplatin in patients with advanced cancer. Clin Cancer Res 2007;13:4178-84
54. Schelman W, Morgan-Meadows S, Bailey H, et al. A phase I trial of gemcitabine in combination with patupilone in patients with advanced solid tumors. Cancer Chemother Pharmacol 2008;62:727-33
55. Stein MN, Knox B, Wesolowsky E, et al. Phase I trial of patupilone (P) and RAD001 in patients (pts) with advanced solid tumors. J Clin Oncol 2009;27(15s): abstract 2529
56. Fogh S, Machtay M, Werner-Wasik M, et al. Phase I trial using patupilone (epothilone B) and concurrent radiotherapy for central nervous system malignancies. Int J Radiat Oncol Biol Phys 2010;77:1009-16
57. Reid TR, Takimoto CH, Verschraegen CF, et al. Evaluation of safety, tolerability and pharmacokinetics (PK) of patupilone in patients (pts) with advanced solid tumors and varying degrees of hepatic function: An open-label phase I study. J Clin Oncol 2008;26(20 suppl):, abstract 2557
58. Dicker A. EPO906 plus radiation therapy for the treatment of cancer patients, Bethesda, MD: clinicaltrials.gov 2010. Available from: http://clinicaltrials.gov/ct2/show/NCT00328458?term=NCT00328458&rank=1 [Last accessed 24 November 2010]
59. Murphy C, Nulsen B, Rump M, et al. Phase II trial of patupilone in patients (pts) with breast cancer brain metastases (BCBM) progressing or recurring after whole brain radiotherapy (WBXRT). in ASCO Breast Cancer Symposium. Abstract 234. 2009
60. Abrey LE, Wen P, Govindan R, et al. Patupilone for the treatment of recurrent/progressive brain metastases in patients (pts) with non-small cell lung cancer (NSCLC): an open-label phase II study. J Clin Oncol 2008;26:(20 Suppl): abstract 2033
61. Anthony LB, Carlisle T, Pommier R, et al. An open-label phase IIA trial evaluating the safety and efficacy of EPO906 as therapy in patients with metastatic carcinoid and other neuroendocrine tumors. Proc Am Soc Clin Oncol 2003;22(Suppl): abstract 1413
62. Poplin E, Moore M, O'Dwyer P, et al. Safety and efficacy of EPO906 in patients with advanced colorectal cancer: a review of 2 phase II trials. Proc Am Soc Clin Oncol 2003;22: abstract 1135
63. Hsin KW, Boyer M, Ducreux M, et al. Efficacy of patupilone in advanced local or metastatic gastric cancer: a phase IIa trial. J Clin Oncol 2006;24(18s): abstract 4069
64. Smit WM, Sufliarsky J, Werner TL, et al. A phase II study evaluating the safety and efficacy of patupilone in patients with platinum refractory/resistant ovarian, primary fallopian, or peritoneal cancer. J Clin Oncol 2009;27(15s): abstract 5563
65. Novartis Pharmaceuticals. Patupilone versus doxorubicin in patients with ovarian, primary fallopian, or peritoneal cancer Bethesda, MD: clinicaltrials.gov 2010. Available from: http://clinicaltrials.gov/ct2/show/ NCT00262990?term=NCT00262990&rank=1 [Last accessed 24 November 2010]
66. 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;17:3461-7
67. Beardsley EK, Saad F, Eigl B, et al. A phase II study of patupilone in patients (pts) with metastatic castration- resistant prostate cancer (CRPC) who have progressed after docetaxel. J Clin Oncol 2009;27(15s): abstract 5139
68. Hussain A, DiPaola RS, Baron AD, et al. Phase II trial of weekly patupilone in patients with castration-resistant prostate cancer. Ann Oncol 2009;20:492-7
69. De Souza PL, Mellado B, Pfister C, et al. Randomized phase II trial of patupilone plus prednisone versus docetaxel plus prednisone in patients with chemotherapy-naive, metastatic, castrate-resistant prostate cancer (CRPC). J Clin Oncol 2010;28(15s): abstract 4553
70. Sridhar SS, Hotte SJ, Kollmannsberger CK, et al. Preventing patupilone-induced diarrhea with high-dose corticosteroids. J Clin Oncol 2010;28(15s): abstract e13069
71. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24
72. Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010;116(18):4256-65
73. Thompson JA, Swerdloff J, Escudier B, et al. Phase II trial evaluating the safety and efficacy of EPO906 in patients with advanced renal cancer. Proc Am Soc Clin Oncol 2003;22: abstract 1628
74. Colombo N, Schwartz PE, Bamias A, et al. Results of a randomized, open-label, Phase III trial of patupilone versus pegylated liposomal doxorubicin in taxane/platinum refractory/resistant patients with recurrent ovarian, fallopian, or peritoneal cancer. (ESMO Congress, 2010) Ann Oncol 21:viii11:LBA24
75. Venook AP, Poon R, Kang YK, et al. Evaluation of patupilone as monotherapy in patients with advanced hepatocellular carcinoma (HCC). J Clin Oncol 2007;25(18s):, abstract 15055