Non-pegylated liposomal doxorubicin combined with gemcitabine as first-line treatment for metastatic or locally advanced breast cancer. Final results of a phase I/II trial

Breast Cancer Research and Treatment

Volumn 116, Issue 2, 2009, Pages 351-358

  Del Barco, S ^a   Colomer, R ^b   Calvo, L ^c   Tusquets, I ^d   Adrover, E ^e   Sanchez P ^f   Rifa J ^g   De La Haba, J ^h   Virizuela, J A ⁱ  

^a HOSPITAL JOSEP TRUETA   (Spain)

^b MD ANDERSON CANCER CENTER   (Spain)

^c HOSPITAL JUAN CANALEJO   (Spain)

^d HOSPITAL DEL MAR   (Spain)

^e HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

^f Hosp Univ Ciudad de Jaén   (Spain)

^g HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^h HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

ⁱ HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

Author keywords

Advanced breast cancer; Gemcitabine; Liposomal doxorubicin

Indexed keywords

DOXORUBICIN; GEMCITABINE;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BONE MARROW TOXICITY; BRAIN METASTASIS; BREAST CANCER; BREAST METASTASIS; CANCER LOCALIZATION; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; HEART LEFT VENTRICLE EJECTION FRACTION; HEMATOLOGIC DISEASE; HUMAN; HYDROTHORAX; LEUKOPENIA; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLAQUETOPENIA; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOXORUBICIN; HUMANS; KAPLAN-MEIERS ESTIMATE; LIPOSOMES; MIDDLE AGED; NEOPLASM STAGING; TREATMENT OUTCOME;

EID: 67649210643     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-008-0218-8     Document Type: Article

References (31)

1. Jemal A, Siegel R, Ward E et al (2007) Cancer statistics, 2007. CA Cancer J Clin 57:43-66
2. Cinieri S, Orlando L, Fedele P et al (2007) Adjuvant strategies in breast cancer: new prospectives, questions and reflections at the end of 2007 St Gallen International Expert Consensus Conference. Ann Oncol 18(6):63-65. doi:10.1093/annonc/mdm227
3. Cuzick J (2001) A brief review of the International Breast Cancer Intervention Study (IBIS), the other current breast cancer prevention trials, and proposals for future trials. Ann N Y Acad Sci 949:123-133
4. Slamon DJ, Romond EH, Perez EA (2006) Advances in adjuvant therapy for breast cancer. Clin Adv Hematol Oncol 4(Suppl 1): 4-9 (discussion suppl. 10: quiz 12 p following suppl. 10)
5. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365(9472):1687-1717. doi:10.1016/ S0140-6736(05)66544-0
6. Sledge GW, Rugo HS, Burstein HJ (2006) The role of angiogenesis inhibition in the treatment of breast cancer. Clin Adv Hematol Oncol 4(Suppl 21):1-12
7. Slamon DJ, Leyland-Jones B, Shak S et al (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783-792. doi:10.1056/NEJM200103153441101
8. Moy B, Kirkpatrick P, Kar S, Goss P (2007) Lapatinib. Nat Rev Drug Discov 6:431-432. doi:10.1038/nrd2332
9. Von Hoff DD, Layard MW, Basa P et al (1979) Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 91:710-717
10. Von Hoff DD, Rozencweig M, Piccart M (1982) The cardiotoxicity of anticancer agents. Semin Oncol 9:23-33
11. Swain SM, Whaley FS, Ewer MS (2003) Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer 97(11):2869-2879. doi:10.1002/cncr.11407
12. Batist G (2007) Cardiac safety of liposomal anthracyclines. Cardiovasc Toxicol 7:72-74. doi:10.1007/s12012-007-0014-4
13. Lorusso V, Manzione L, Silvestris N (2007) Role of liposomal anthracyclines in breast cancer. Ann Oncol 18(Suppl 6): 70-73. doi:10.1093/annonc/mdm229
14. Batist G, Barton J, Chaikin P et al (2002) Myocet (liposomeencapsulated doxorubicin citrate): a new approach in breast cancer therapy. Expert Opin Pharmacother 3:1739-1751. doi: 10.1517/14656566.3.12.1739
15. Batist G, Harris L, Azarnia N et al (2006) Improved anti-tumor response rate with decreased cardiotoxicity of non-pegylated liposomal doxorubicin compared with conventional doxorubicin in first-line treatment of metastatic breast cancer in patients who had received prior adjuvant doxorubicin: results of a retrospective analysis. Anticancer Drugs 17:587-595. doi:10.1097/00001813- 200606000-00014
16. Swenson CE, Bolcsak LE, Batist G et al (2003) Pharmacokinetics of doxorubicin administered i.v. as Myocet (TLC D-99; liposomeencapsulated doxorubicin citrate) compared with conventional doxorubicin when given in combination with cyclophosphamide in patients with metastatic breast cancer. Anticancer Drugs 14:239-246. doi:10.1097/00001813-200303000-00008
17. Harris L, Batist G, Belt R et al (2002) Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast carcinoma. Cancer 94:25-36. doi:10.1002/cncr.10201
18. Batist G, Ramakrishnan G, Rao CS et al (2001) Reduced cardiotoxicity and preserved antitumor efficacy of liposomeencapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. J Clin Oncol 19:1444-1454
19. Shapiro CL, Ervin T, Welles L et al (1999) Phase II trial of highdose liposome-encapsulated doxorubicin with granulocyte colony- stimulating factor in metastatic breast cancer. TLC D-99 study group. J Clin Oncol 17:1435-1441
20. Valero V, Buzdar AU, Theriault RL et al (1999) Phase II trial of liposome-encapsulated doxorubicin, cyclophosphamide, and fluorouracil as first-line therapy in patients with metastatic breast cancer. J Clin Oncol 17:1425-1434
21. Modi S, Seidman AD (2004) Single-agent gemcitabine in the treatment of advanced breast cancer. Clin Breast Cancer 4(Suppl 3):S101-S106. doi:10.3816/CBC.2004.s.002
22. Seidman AD (2001) The evolving role of gemcitabine in the management of breast cancer. Oncology 60:189-198. doi: 10.1159/000055318
23. Modi S, Currie VE, Seidman AD et al (2005) A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane. Clin Breast Cancer 6:55-60. doi:10.3816/CBC.2005.n. 009
24. Perez-Manga G, Lluch A, Alba E et al (2000) Gemcitabine in combination with doxorubicin in advanced breast cancer: final results of a phase II pharmacokinetic trial. J Clin Oncol 18: 2545-2552
25. 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(3):205-216. doi:10.1093/jnci/92.3.205
26. Kaplan E, Meier P (1959) Non-parametric estimation from incomplete observations. J Am Stat Assoc 53:457-481. doi: 10.2307/2281868
27. Cox DR (1970) The analysis of binary data. Methuen, London
28. Rivera E, Valero V, Arun B et al (2003) Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. J Clin Oncol 21:3249-3254. doi:10.1200/JCO.2003.03.111
29. Fabi A, Ferretti G, Papaldo P et al (2006) Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naive and anthracycline pretreated metastatic breast cancer patients. Cancer Chemother Pharmacol 57:615-
30. doi:10.1007/s00280-005-0116-2
31. Campone M, Fumoleau P, Viens P et al (2006) Gemcitabine and epirubicin in patients with metastatic breast cancer: a phase I/II study. Breast 15:601-609. doi:10.1016/j.breast.2005.11.010