Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naïve and anthracycline pretreated metastatic breast cancer patients.
BACKGROUND
The aim of the study was to assess the toxicity profile, activity in terms of response rate, time to progression, overall survival, and quality of life of pegylated liposomal doxorubicin (PLD) and gemcitabine combination in chemo-naïve and pretreated metastatic breast cancer (MBC) women.


METHODS
Patients were eligible if they had disease progression to prior chemotherapy (anthracycline-including or not) for early breast cancer or MBC. Patients received PLD 25 mg/m(2) intravenously on day 1 plus gemcitabine 800 mg/m(2) intravenously on days 1 and 8 of each 21-day cycle.


RESULTS
Of 50 patients enrolled, 37 had received prior adjuvant chemotherapy (24 with an anthracycline) and 23 prior chemotherapy for metastatic disease (6 with an anthracycline). Two complete responses and 20 partial responses were achieved in 46 assessable patients (overall response rate: 47.8%). Responses were observed in 14 (46.6%) of 30 patients with previous anthracycline exposure. Median response duration was 7 months, median duration of clinical benefit 8 months, time to progression 7 months. At a median follow-up of 10 months, 79.4% patients were alive at 1 year. No neutropenic complication was observed. Non-hematological toxicities were mild. One patient previously treated with an anthracycline developed a transient decrease (26%) in the left ventricular ejection fraction, with cardiac function recovering within 6 months.


CONCLUSIONS
Because of the non-overlapping toxicity profiles of both PLD and gemcitabine, this combination can be regarded as a reliable therapeutic option for patients who have failed previous treatments, including anthracycline, for MBC.
Fabi
Alessandra
A
Division of Medical Oncology "A", Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy. alessandra.fabi@virgilio.it
Ferretti
Gianluigi
G
Papaldo
Paola
P
Salesi
Nello
N
Ciccarese
Mariangela
M
Lorusso
Vito
V
Carlini
Paolo
P
Carpino
Armando
A
Mottolese
Marcella
M
Cianciulli
Anna Maria
AM
Giannarelli
Diana
D
Sperduti
Isabella
I
Felici
Alessandra
A
Cognetti
Francesco
F
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D018943:Anthracyclines; C506643:liposomal doxorubicin; D003841:Deoxycytidine; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000093542:Gemcitabine