J Cancer 2014; 5(6):398-405. doi:10.7150/jca.9132

Research Paper

Non-Pegylated Liposomal Doxorubicin-Cyclophosphamide in Sequential Regimens with Taxanes as Neoadjuvant Chemotherapy in Breast Cancer Patients

Patrizia Vici1✉, Laura Pizzuti1, Teresa Gamucci2, Domenico Sergi1, Francesca Conti1, Germano Zampa3, Pietro Del Medico4, Roy De Vita5, Marcello Pozzi5, Claudio Botti6, Simona Di Filippo7, Federica Tomao8, Isabella Sperduti9, Luigi Di Lauro1

1. Department of Medical Oncology B, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy, Rome, Italy
2. Medical Oncology Unit ASL Frosinone, Via Armando Fabi, 03100, Frosinone, Italy
3. Oncology Unit, Nuovo Regina Margherita Hospital, Via Emilio Morosini 30, 00153, Rome, Italy
4. Department of Medical Oncology, Reggio Calabria General Hospital, via Melacrino, 89100 Reggio Calabria, Italy
5. Department of Plastic and Reconstructive Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy
6. Department of Breast Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy
7. Department of Hepatobiliary Surgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy
8. Department of Gynecologic and Obstetric Sciences, La Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy
9. Biostatistics Unit, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy

Abstract

Purpose: 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.

Keywords: Breast cancer, neoadjuvant chemotherapy, non-pegylated liposomal doxorubicin, retrospective analysis, everyday clinical practice

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How to cite this article:
Vici P, Pizzuti L, Gamucci T, Sergi D, Conti F, Zampa G, Del Medico P, De Vita R, Pozzi M, Botti C, Di Filippo S, Tomao F, Sperduti I, Di Lauro L. Non-Pegylated Liposomal Doxorubicin-Cyclophosphamide in Sequential Regimens with Taxanes as Neoadjuvant Chemotherapy in Breast Cancer Patients. J Cancer 2014; 5(6):398-405. doi:10.7150/jca.9132. Available from http://www.jcancer.org/v05p0398.htm