Pharmacokinetics and its relation to toxicity of pegylated-liposomal doxorubicin in chinese patients with breast tumours

Journal of Clinical Pharmacy and Therapeutics

Volumn 35, Issue 5, 2010, Pages 593-601

  Xu, L ^a   Wang, W ^b   Sheng, Y C ^a   Zheng, Q S ^a  

^a SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^b Shanghai Fudan Zhangjiang Bio pharmaceutical Co Ltd   (China)

Author keywords

anthracyclines; breast tumour; liposomes; pharmacokinetics; population pharmacokinetics; toxicity

Indexed keywords

DOXORUBICIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BREAST CANCER; CHEMOTHERAPY INDUCED EMESIS; CHINESE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DARIER DISEASE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG ERUPTION; DRUG FATALITY; DRUG INFUSION; ECG ABNORMALITY; FEMALE; HEART PALPITATION; HEART RIGHT BUNDLE BRANCH BLOCK; HUMAN; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; PIGMENTATION; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; ST SEGMENT; STOMATITIS; T WAVE;

ADULT; ANTIBIOTICS, ANTINEOPLASTIC; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DOXORUBICIN; DRUG CARRIERS; FEMALE; HUMANS; LIPOSOMES; MAXIMUM TOLERATED DOSE; MIDDLE AGED; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME;

EID: 77956637114     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2009.01128.x     Document Type: Article

References (27)

1. Smith PJ, Soues S (1994) Multilevel therapeutic targeting by topoisomerase inhibitors. British Journal of Cancer, 23 (Suppl. S47 S51.
2. Martin FM (1998) Clinical pharmacology and anti-tumor efficacy of Doxil (pegylated liposomal doxorubicin). In: Lasic DD, Papahadjopoulos D, eds. Medical applications of liposomes.
3. Allen TM (1994) Long-circulating (sterically stabilized) liposomes for targeted drug delivery. Trends in Pharmacological Sciences, 15, 215 220.
4. Cowens JW, Creaven PJ, Greco WR et al. (1993) Initial clinical (Phase I) trial of TLC D-99 (doxorubicin encapsulated in liposomes). Cancer Research, 53, 2796 2802.
5. Rahman A, Treat J, Roh JK, Potkul LA, Alvord WG, Forst D, Woolley PV (1990) A Phase I clinical trial and pharmacokinetic evaluation of liposome-encapsulated doxorubicin. Journal of Clinical Oncology, 8, 1093 1100.
6. Allen TM, Hansen C, Martin F, Redemann C, Yau-Young A (1991) Liposomes containing synthetic lipid derivatives of poly(ethylene glycol) show prolonged circulation half-lives in vivo. Biochimica et Biophysica Acta, 1066, 29 36.
7. Allen TM, Chonn A (1987) Large unilamellar liposomes with low uptake into the reticuloendothelial system. FEBS Letters, 223, 42 46.
8. Allen TM, Hansen C, Rutledge J (1989) Liposomes with prolonged circulation times: factors affecting uptake by reticuloendothelial and other tissues. Biochimica et Biophysica Acta, 981, 27 35.
9. Papahadjopoulos D, Gabizon A (1987) Targeting of liposomes to tumor cells in vivo. Annals of the New York Academy of Sciences, 507, 64 74.
10. Gabizon A, Papahadjopoulos D (1988) Liposome formulations with prolonged circulation time in blood and enhanced uptake by tumors. Proceedings of the National Academy of Sciences of the United States of America, 85, 6949 6953.
11. Papahadjopoulos D, Allen TM, Gabizon A, Mayhew E, Matthay K, Huang SK (1991) Sterically stabilized liposomes: improvements in pharmacokinetics and antitumor therapeutic efficacy. Proceedings of the National Academy of Sciences of the United States of America, 88, 11460 11464.
12. Wu NZ, Da D, Rudoll TL, Needham D, Whorton AR, Dewhirst MW (1993) Increased microvascular permeability contributes to preferential accumulation of Stealth liposomes in tumor tissue. Cancer Research, 53, 3765 3770.
13. Yuan F, Leunig M, Huang SK, Berk DA, Papahadjopoulos D, Jain RK (1994) Microvascular permeability and interstitial penetration of sterically stabilized (Stealth) liposomes in a human tumor xenograft. Cancer Research, 54, 3352 3356.
14. Lokich JJ, Moore C (1984) Chemotherapy-associated palmar-plantar erythrodysesthesia syndrome. Annals of Internal Medicine, 101, 798 800.
15. Uziely B, Jeffers S, Isacson R et al. (1995) Liposomal doxorubicin: antitumor activity and unique toxicities during two complementary phase I studies. Journal of Clinical Oncology, 13, 1777 1785.
16. Stewart S, Jablonowski H, Goebel FD et al. (1998) Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. Journal of Clinical Oncology, 16, 683 691.
17. Northfelt DW, Dezube BJ, Thommes JA et al. (1998) Pegylated liposomal doxorubicin versus doxorubicin, bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial. Journal of Clinical Oncology, 16, 2445 2451.
18. Muggia FM, Hainsworth JD, Jeffers S et al. (1997) Phase II study of liposomal doxorubicin in refractory ovarian cancer: antitumor activity and toxicity modification by liposomal encapsulation. Journal of Clinical Oncology, 15, 987 993.
19. Ranson MR, Carmichael J, O'Byrne K, Stewart S, Smith D, Howell A (1997) Treatment of advanced breast cancer with sterically-stabilized liposomal doxorubicin: results of a multicenter phase II trial. Journal of Clinical Oncology, 15, 3185 3191.
20. O'Brien MER, Wigler N, Inbar M et al. (2004) Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Annals of Oncology, 15, 440 449.
21. Gabizon AA (2001) Pegylated liposomal doxorubicin: metamorphosis of an old drug into a new form of chemotherapy. Cancer Investigation, 19, 424 436.
22. Muggia FM (2001) Liposomal encapsulated anthracyclines: new therapeutic horizons. Current Oncology Reports, 3, 156 162.
23. Sharpe M, Easthope SE, Keating GM, Lamb HM (2002) Polyethylene glycol-liposomal doxorubicin: a review of its use in the management of solid and haematological malignancies and AIDS related Kaposi's sarcoma. Drugs, 62, 2089 2126.
24. Gabizon A, Catane R, Uziely B et al. (1994) Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. Cancer Research, 54, 987 992.
25. Hamilton A, Biganzoli L, Coleman R et al. (2002) EORTC 10968: a phase I clinical and pharmacokinetic study of polyethylene glycol liposomal doxorubicin (Caelyx®, Doxil®) at a 6-week interval in patients with metastatic breast cancer. European Organization for Research and Treatment of Cancer. Annals of Oncology, 13, 910 918.
26. Lyass O, Uziely B, Ben-Yosef R et al. (2000) Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer, 89, 1037 1047.
27. Yasuhito F, Atsushi H, Toshio S, Noboru Y, Yasuhide Y, Tomohide T (2006) Phase 1 clinical study of pegylated liposomal doxorubicin (JNS002) in Japanese patients with solid tumors. Japanese Journal of Clinical Oncology, 36, 768 774.