Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 108, Issue 2, 2008, Pages 241-250

  Lee, Keun Seok ^a,h   Chung, Hyun Cheol ^b,h   Im, Seock Ah ^c,h   Park, Yeon Hee ^d,h   Kim, Chul Soo ^e,h   Kim, Sung Bae ^f,h   Rha, Sun Young ^b,h   Lee, Min Young ^g   Ro, Jungsil ^a,h  

^a National Cancer Center   (South Korea)

^b Yonsei University College of Medicine   (South Korea)

^c Seoul National University College of Medicine   (South Korea)

^d Korea Cancer Center Hospital   (South Korea)

^e Inha University Hospital   (South Korea)

^f University of Ulsan College of Medicine   (South Korea)

^g Samyang Corporation   (South Korea)

^h Korean Liver Cancer Study Association   (South Korea)

Author keywords

Breast cancer; Clinical trial; Genexol PM; Phase II

Indexed keywords

ANTIHISTAMINIC AGENT; CORTICOSTEROID; PACLITAXEL; POLYMER;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONSTIPATION; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FORMULATION; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEVER; HISTOLOGY; HUMAN; HYPERSENSITIVITY REACTION; LEUKOPENIA; METASTASIS; MICELLE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; SENSORY NEUROPATHY; SEPSIS; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BREAST NEOPLASMS; CHEMISTRY, PHARMACEUTICAL; DRUG ADMINISTRATION SCHEDULE; DRUG CARRIERS; DRUG COMPOUNDING; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KAPLAN-MEIERS ESTIMATE; KOREA; MICELLES; MIDDLE AGED; NEOPLASM METASTASIS; PACLITAXEL; POLYETHYLENE GLYCOLS; POLYMERS; TIME FACTORS; TREATMENT OUTCOME;

EID: 39749178252     PISSN: 01676806     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10549-007-9591-y     Document Type: Article

References (34)

1. Bernard-Marty C, Cardoso F, Piccart MJ (2003) Use and abuse of taxanes in the management of metastatic breast cancer. Eur J Cancer 39:1978-1989
2. Gelderblom H, Verweij J, Nooter K, Sparreboom A (2001) Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 37:1590-1598
3. Kintzel PE (2001) Prophylaxis for paclitaxel hypersensitivity reactions. Ann Pharmacother 35:1114-1117
4. Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, Gianni L, Myles J, van der Burg ME, Kerr I, Vermorken JB, Buser K, Colombo N, Bacon M, Santabarbara P, Onetto N, Winograd B, Canetta R (1994) European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol 12:2654-2666
5. Kloover JS, den Bakker MA, Gelderblom H, van Meerbeeck JP (2004) Fatal outcome of a hypersensitivity reaction to paclitaxel: a critical review of premedication regimens. Br J Cancer 90:304-305
6. Mielke S, Sparreboom A, Mross K (2006) Peripheral neuropathy: a persisting challenge in paclitaxel-based regimes. Eur J Cancer 42:24-30
7. Ganning AE, Brunk U, Dallner G (1984) Phthalate esters and their effect on the liver. Hepatology 4:541-547
8. Hill SS, Shaw BR, Wu AH (2001) The clinical effects of plasticizers, antioxidants, and other contaminants in medical polyvinylchloride tubing during respiratory and non-respiratory exposure. Clin Chim Acta 304:1-8
9. Hennenfent KL, Govindan R (2006) Novel formulations of taxanes: a review. Old wine in a new bottle? Ann Oncol 17:735-749
10. Kim TY, Kim DW, Chung JY, Shin SG, Kim SC, Heo DS, Kim NK, Bang YJ (2004) Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies. Clin Cancer Res 10:3708-3716
11. Kim SC, Kim DW, Shim YH, Bang JS, Oh HS, Kim SW, Seo MH (2001) In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy. J Control Release 72:191-202
12. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) 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 92:205-216
13. Common Toxicity Criteria v 2.0 (April 30, 1999), Cancer therapy evaluation program. National Cancer Institute, Bethestha, MD
14. Chang MN, Therneau TM, Wieand HS, Cha SS (1987) Designs for group sequential phase II clinical trials. Biometrics 43:865-874
15. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481
16. Kim SC, Yoon HJ, Lee JW, Yu J, Park ES, Chi SC (2005) Investigation of the release behavior of DEHP from infusion sets by paclitaxel-loaded polymeric micelles. Int J Pharm 293:303-310
17. Ibrahim NK, Samuels B, Page R, Doval D, Patel KM, Rao SC, Nair MK, Bhar P, Desai N, Hortobagyi GN (2005) Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol 23:6019-6026
18. Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN, Michaelson RA, Kirshner JA, Fleming GF, Perry MC, Graham ML, Sharp SA, Keresztes R, Henderson IC, Hudis C, Muss H, Norton L (2004) Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 22:2061-2068
19. Paridaens R, Biganzoli L, Bruning P, Klijn JG, Gamucci T, Houston S, Coleman R, Schachter J, Van Vreckem A, Sylvester R, Awada A, Wildiers J, Piccart M (2000) Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over. J Clin Oncol 18:724-733
20. Sledge GW, Neuberg D, Bernardo P, Ingle JN, Martino S, Rowinsky EK, Wood WC (2003) 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 21:588-592
21. Bishop JF, Dewar J, Toner GC, Smith J, Tattersall MH, Olver IN, Ackland S, Kennedy I, Goldstein D, Gurney H, Walpole E, Levi J, Stephenson J, Canetta R (1999) Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer. J Clin Oncol 17:2355-2364
22. Smith RE, Brown AM, Mamounas EP, Anderson SJ, Lembersky BC, Atkins JH, Shibata HR, Baez L, DeFusco PA, Davila E, Tipping SJ, Bearden JD, Thirlwell MP (1999) Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26. J Clin Oncol 17:3403-3411
23. Nabholtz JM, Gelmon K, Bontenbal M, Spielmann M, Catimel G, Conte P, Klaassen U, Namer M, Bonneterre J, Fumoleau P, Winograd B (1996) Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol 14:1858-1867
24. Seidman AD, Reichman BS, Crown JP, Yao TJ, Currie V, Hakes TB, Hudis CA, Gilewski TA, Baselga J, Forsythe P et al (1995) Paclitaxel as second and subsequent therapy for metastatic breast cancer: activity independent of prior anthracycline response. J Clin Oncol 13:1152-1159
25. Gianni L, Munzone E, Capri G, Villani F, Spreafico C, Tarenzi E, Fulfaro F, Caraceni A, Martini C, Laffranchi A et al (1995) Paclitaxel in metastatic breast cancer: a trial of two doses by a 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines. J Natl Cancer Inst 87:1169-1175
26. Fountzilas G, Athanassiades A, Giannakakis T, Bafaloukos D, Karakousis K, Dombros N, Kosmidis P, Skarlos D (1996) A phase II study of paclitaxel in advanced breast cancer resistant to anthracyclines. Eur J Cancer 32A:47-51
27. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O'Shaughnessy J (2005) Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 23:7794-7803
28. ten Tije AJ, Verweij J, Loos WJ, Sparreboom A (2003) Pharmacological effects of formulation vehicles : implications for cancer chemotherapy. Clin Pharmacokinet 42:665-685
29. Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, Tao C, De T, Beals B, Dykes D, Noker P, Yao R, Labao E, Hawkins M, Soon-Shiong P (2006) 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 12:1317-1324
30. Liggins RT, Burt HM (2002) Polyether-polyester diblock copolymers for the preparation of paclitaxel loaded polymeric micelle formulations. Adv Drug Deliv Rev 54:191-202
31. Bradley MO, Webb NL, Anthony FH, Devanesan P, Witman PA, Hemamalini S, Chander MC, Baker SD, He L, Horwitz SB, Swindell CS (2001) Tumor targeting by covalent conjugation of a natural fatty acid to paclitaxel. Clin Cancer Res 7:3229-3238
32. Lee JJ, Swain SM (2006) Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol 24:1633-1642
33. Essayan DM, Kagey-Sobotka A, Colarusso PJ, Lichtenstein LM, Ozols RF, King ED (1996) Successful parenteral desensitization to paclitaxel. J Allergy Clin Immunol 97:42-46
34. Scher NS, Dagher R, Ryan S (2005) Clinical review of a new drug application (ABRAXANE). Available from URL: http://www.fda.gov/cder/foi/nda/ 2005/21660_ABRAXANE_medr.PDF. [accessed Jun 14, 2006]