Bi-weekly liposomal doxorubicin for advanced breast cancer in elderly women (≥ 70 years).
BACKGROUND
We conducted a multicenter prospective trial to assess tolerability and activity of pegylated liposomal doxorubicin (PLD) in women ≥ 70 years with locally-advanced or metastatic breast cancer.


METHODS
All patients underwent Multidimensional Geriatric Assessment (MGA). Frail patients were excluded. Normal cardiac function was required for inclusion. A bi-weekly schedule of PLD at 20mg/mq was adopted.


RESULTS
Thirty-two patients were enrolled with a median age of 78 years, 78.1% with visceral involvement, and 37.6% previously treated with chemotherapy for advanced disease. A mean of 7.8 cycles were delivered (range 1 to 20), with a median cumulative dose intensity of 8.9 mg/m(2)/week. Grade 3-4 toxicities were anemia (6.3%), palmar-plantar erythrodysesthesia (6.3%), mucositis (6.3%), infection (3.1%), and pulmonary embolism (3.1%). No cardiac events were registered. Causes of treatment interruption were maximal response (15.6%), progression (40.6%), refusal/loss to follow-up (28.1%), toxicities (9.4%), or other (6.3%). Response was obtained in 33.3% of 27 evaluable patients; median time to progression (TTP) was 10.3 months. MGA status (vulnerable vs. fit) did not have an impact on response, progression, and toxicity.


CONCLUSIONS
Bi-weekly PLD is well tolerated in both fit and vulnerable patients, with an apparently fairly good response rate and TTP (possibly biased by subsequent endocrine therapy and loss to follow-up). Close observation of patients is recommended in order to avoid early refusal/loss to follow-up.
Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy. Electronic address: umberto.basso@ioveneto.it.
Umberto
U
Basso
Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy.
Anna
A
Roma
Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy.
Antonella
A
Brunello
Division of Medical Oncology 2, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy.
Cristina
C
Falci
Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy.
Pasquale
P
Fiduccia
Division of Cardiology, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy.
Alberto
A
Banzato
Medical Oncology, Azienda ULSS 18, Rovigo, Italy.
Antonio
A
Bononi
Medical Oncology, Azienda ULSS 18, Rovigo, Italy.
Milena
M
Gusella
University General Hospital, Heraklion, Greece.
Lampros
L
Vamvakas
Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy.
Vittorina
V
Zagonel
Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy; Geriatric Oncology Program, Fondazione Don Gnocchi, Milan, Italy.
Silvio
S
Monfardini
D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D005260:Female; D006801:Humans; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin
Anthracyclines; Breast cancer; Chemotherapy; Elderly; Liposomal doxorubicin; Toxicity