Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients.
OBJECTIVE
Chemotherapy regimens containing anthracyclines and taxanes represent the landmark of neoadjuvant systemic therapy of breast cancer. In advanced breast cancer patients liposomal anthracyclines (LA) have shown similar efficacy and less cardiac toxicity when compared to conventional anthracyclines. We performed this retrospective analysis in order to evaluate the efficacy and tolerability of neoadjuvant regimens including LA outside of clinical trials in routine clinical practice.


METHODS
Fifty operable or locally advanced, HER2 negative, breast cancer patients were retrospectively identified in 5 Italian cancer centres. Nineteen patients had received 4 cycles of non-pegylated liposomal doxorubicin (NPLD) and cyclophosphamide, followed by 4 cycles of docetaxel, every 3 weeks. In 25 patients the reverse sequence was employed, and a third subgroup of 6 patients received 4 cycles of NPLD/cyclophosphamide every 3 weeks followed by 4 cycles of weekly carboplatin and paclitaxel.


RESULTS
We observed 10 pathological complete responses (pCR) (20.0%, 95%CI, 9% to 31%), and 35 (70%, 95%CI, 57.3% to 82.7%) partial responses (pPR), whereas no patients progressed onto therapy. In the small subset of triple negative tumors the pCR rate was 37.5%, and in tumors expressing ER and/or PgR it was 16.7%. A pCR rate of 26.5% was observed in tumors with high Ki-67, whereas in tumors with low Ki-67 only one (6.2%) pCR was observed (p=0.14). Treatments were well tolerated. The most common toxicities were myelosuppression and palmar-plantar erytrodysesthesia; 4 asymptomatic and transient LVEF decrease have been recorded, without any case of clinical cardiotoxicity.


CONCLUSIONS
NPLD-cyclophosphamide and taxanes sequential regimens were proven effective and well tolerated in breast cancer patients with contra-indication to conventional anthracyclines undergoing neoadjuvant chemotherapy, even outside of clinical trials in everyday clinical practice.
1. Department of Medical Oncology B, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy, Rome, Italy.
Patrizia
P
Vici
1. Department of Medical Oncology B, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy, Rome, Italy.
Laura
L
Pizzuti
2. Medical Oncology Unit ASL Frosinone, Via Armando Fabi, 03100, Frosinone, Italy.
Teresa
T
Gamucci
1. Department of Medical Oncology B, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy, Rome, Italy.
Domenico
D
Sergi
1. Department of Medical Oncology B, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy, Rome, Italy.
Francesca
F
Conti
3. Oncology Unit, Nuovo Regina Margherita Hospital, Via Emilio Morosini 30, 00153, Rome, Italy.
Germano
G
Zampa
4. Department of Medical Oncology, Reggio Calabria General Hospital, via Melacrino, 89100 Reggio Calabria, Italy.
Pietro
P
Del Medico
5. Department of Plastic and Reconstructive Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Roy
R
De Vita
5. Department of Plastic and Reconstructive Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Marcello
M
Pozzi
6. Department of Breast Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Claudio
C
Botti
7. Department of Hepatobiliary Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Simona
S
Di Filippo
8. Department of Gynecologic and Obstetric Sciences, La Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy.
Federica
F
Tomao
9. Biostatistics Unit, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Isabella
I
Sperduti
1. Department of Medical Oncology B, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy, Rome, Italy.
Luigi
L
Di Lauro
Breast cancer; everyday clinical practice; neoadjuvant chemotherapy; non-pegylated liposomal doxorubicin; retrospective analysis