Non-pegylated liposomal doxorubicin and docetaxel in metastatic breast cancer: final results of a phase II trial.
BACKGROUND
Non-pegylated liposomal doxorubicin (NPLD) has demonstrated equivalent antitumor activity to conventional doxorubicin and a significantly lower risk of cardiotoxicity when given as single agent or in combination with cyclophosphamide, but there is limited experience with the combination of NPLD and taxanes. This phase II study was performed to evaluate the efficacy and safety of the NPLD and docetaxel in patients with metastatic breast cancer.


METHODS
A total of 51 patients were treated with NPLD (60 mg/m(2)) and docetaxel (75 mg/m(2)) in 3-weeks intervals for up to eight cycles.


RESULTS
The overall response rate was 50% and 78% of patients derived a clinical benefit. Median time to progression and overall survival were 10.0 months (95% CI, 6.9-13.1 months) and 25 months (95% CI, 22.1-29.8 months), respectively. Median duration of response was 12.0 months (95% CI 7.1-16.9). The treatment was generally well tolerated and associated with toxicities that were consistent with the known side-effects of the individual agents and of anthracycline/taxane combinations. There were no symptomatic cardiac averse events and mild asymptomatic LVEF changes were reported in five patients.


CONCLUSIONS
The combination of NPLD and docetaxel is well tolerated and has high antitumour activity in MBC patients.
Schmid
Peter
P
Department of Medical Oncology, Charing Cross Hospital, Imperial College London, Fulham Palace Road, London, W6 8RF, UK. p.schmid@imperial.ac.uk
Krocker
J
J
Kreienberg
R
R
Klare
P
P
Kittel
K
K
Sommer
H
H
Heinrich
G
G
Steck
T
T
Lichtenegger
W
W
Elling
D
D
Kümmel
S
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011379:Prognosis; D012449:Safety; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000556:secondary; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; C506643:liposomal doxorubicin; D000077143:Docetaxel; D011092:Polyethylene Glycols; D004317:Doxorubicin