Nab-Paclitaxel in patients with advanced solid tumors and hepatic dysfunction: A pilot study

Expert Opinion on Drug Safety

Volumn 9, Issue 4, 2010, Pages 515-523

  Biakhov, Mikhail Y ^a   Kononova, Galina V ^b   Iglesias, Jose ^c   Desai, Neil ^c   Bhar, Paul ^c   Schmid, Anita N ^c   Loibl, Sibylle ^d  

^a Min of Railroad Transport of the RF   (Russian Federation)

^b Arkhangelsk Regional Clinical Hospital   (Russian Federation)

^c Abraxis BioScience   (United States)

^d GERMAN BREAST GROUP   (Germany)

Author keywords

clinical study; hepatic impairment; nab paclitaxel; solid tumors

Indexed keywords

ASPARTATE AMINOTRANSFERASE; BILIRUBIN; PACLITAXEL; 130-NM ALBUMIN-BOUND PACLITAXEL; ALBUMINOID; ANTINEOPLASTIC AGENT;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPERTENSION; LIVER DYSFUNCTION; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; SENSORY NEUROPATHY; SIDE EFFECT; SOLID TUMOR; UROGENITAL TRACT DISEASE; AGED; COMPLICATION; LIVER DISEASE; METABOLISM; METASTASIS; MIDDLE AGED; NEOPLASMS; PILOT STUDY;

ADULT; AGED; ALBUMINS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; FEMALE; HUMANS; LIVER DISEASES; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASMS; PACLITAXEL; PILOT PROJECTS;

EID: 77953749578     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.2010.487063     Document Type: Article

References (21)

1. Lorenz W, Reimann HJ, Schmal A, et al. Histamine release in dogs by Cremophor E1 and its derivatives: oxethylated oleic acid is the most effective constituent. Agents Actions 1977;7(1):63-67
2. Weiss RB, Donehower RC, Wiernik PH, et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990;8(7):1263-1268
3. Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001;37(13):1590-1598
4. Ibrahim NK, Desai N, Legha S, et al. Phase I and pharmacokinetic study of ABI-007, a cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel. Clin Cancer Res 2002;8(5):1038-1044
5. 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(4):1317-1324
6. Blum JL, Savin MA, Edelman G, et al. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer 2007;7(11):850-856
7. Gardner ER, Dahut WL, Scripture CD, et al. Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-Paclitaxel. Clin Cancer Res 2008;14(13):4200-4205
8. Nyman DW, Campbell KJ, Hersh E, et al. Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. J Clin Oncol 2005;23(31):7785-7793
9. 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(31):7794-7803
10. Rosenberg LJ. nab-Paclitaxel for treatment of solid tumors: beyond breast cancer. Commun Oncol 2008;5(6 Suppl 7):8-15
11. Venook AP, Egorin MJ, Rosner GL, et al. Phase I and pharmacokinetic trial of paclitaxel in patients with hepatic dysfunction: Cancer and Leukemia Group B 9264. J Clin Oncol 1998;16(5):1811-1819
12. Monsarrat B, Alvinerie P, Wright M, et al. Hepatic metabolism and biliary excretion of taxol in rats and human. J Natl Cancer Inst Monogr 1993;15:39-46
13. Taxol (paclitaxel) injection: package insert. Bristol-Myers Squibb, Co., Princeton, NJ; 2003
14. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45(2):228-247
15. Sparreboom A, Scripture CD, Trieu V, et al. Comparative preclinical and clinical pharmacokinetics of a cremophor-free, nanoparticle albumin-bound paclitaxel (ABI-007) and paclitaxel formulated in cremophor (taxol). Clin Cancer Res 2005;11(11):4136-4143
16. Joerger M, Huitema AD, Huizing MT, et al. Safety and pharmacology of paclitaxel in patients with impaired liver function: a population pharmacokinetic-pharmacodynamic study. Br J Clin Pharmacol 2007;64(5):622-633
17. Henningsson A, Sparreboom A, Sandstrom M, et al. Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients. Eur J Cancer 2003;39(8):1105-1114
18. Donelli MG, Zucchetti M, Munzone E, et al. Pharmacokinetics of anticancer agents in patients with impaired liver function. Eur J Cancer 1998;34(1):33-46
19. Perry MC. Chemotherapeutic agents and hepatoxicity. Semin Oncol 1992;19:551-565
20. Eklund J, Trifilio S, Mulcahy M. Chemotherapy dosing in the setting of liver dysfunction. Oncology 2005;19:1057-1069
21. Superfin D, Iannucci AA, Davies AM. Commentary: oncologic drugs inpatients with organ dysfunction: a summary. Oncologist 2007;12:1070-1083