Prospective study on nanoparticle albumin-bound paclitaxel in advanced breast cancer. Clinical results and biological observations in taxane-pretreated patients
| Autor: | M. Mottolese, Francesco Cognetti, Laura Iacorossi, Alessandra Fabi, Mauro Caterino, Paola Papaldo, Cecilia Nisticò, Paola Malaguti, Gianluigi Ferretti, Roy De Vita, Sabrina Vari, Diana Giannarelli |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Oncology medicine.medical_specialty Paclitaxel medicine.medical_treatment Pharmaceutical Science Triple Negative Breast Neoplasms Disease-Free Survival Young Adult chemistry.chemical_compound nab-paclitaxel Albumins Internal medicine Drug Discovery medicine Clinical endpoint Humans Prospective Studies Neoplasm Metastasis Prospective cohort study Survival rate Original Research Aged Aged 80 and over Pharmacology anthracyclines Chemotherapy Taxane Drug Design Development and Therapy business.industry metastatic breast cancer lcsh:RM1-950 Cancer Middle Aged medicine.disease Antineoplastic Agents Phytogenic Metastatic breast cancer Surgery Survival Rate lcsh:Therapeutics. Pharmacology chemistry Nanoparticles Female Taxoids business Follow-Up Studies |
| Zdroj: | Drug Design, Development and Therapy, Vol 2015, Iss default, Pp 6177-6183 (2015) Drug Design, Development and Therapy |
| Popis: | Alessandra Fabi,1 Diana Giannarelli,2 Paola Malaguti,1 Gianluigi Ferretti,1 Sabrina Vari,1 Paola Papaldo,1 Cecilia Nisticò,1 Mauro Caterino,3 Roy De Vita,4 Marcella Mottolese,5 Laura Iacorossi,6 Francesco Cognetti1 1Department of Medical Oncology, 2Biostatistic Unit, 3Service of Radiology, 4Operative Unit of Plastic and Reconstructive Surgery, Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy; 5Department of Pathology, 6Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome, Italy Background: There is a deep need to improve the care of metastatic breast cancer (MBC) patients, since even today it remains an incurable disease. Taxanes are considered the most effective cytotoxic drugs for the treatment of MBC, both in monotherapy and in combined schedules, but the need for synthetic solvents contributes to the severe toxicities and may have a negative impact on the efficacy. Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a colloidal suspension of paclitaxel and human serum albumin initially developed to avoid the toxicities associated with conventional taxanes.Patients and methods: The aim of this prospective, single-center open-label, noncomparative study was to evaluate the efficacy and safety of nab-paclitaxel in MBC patients pretreated with taxanes. The patients were treated with nab-paclitaxel as a single agent, 260mg/m2 on day 1 of each 3-week cycle or 125mg/m2 weekly. The primary endpoint was the overall response rate (ORR). Secondary objectives were duration of response, clinical benefit rate, progression-free survival (PFS), overall survival, and safety.Results: A total of 42 patients (median age 48years, median Eastern Cooperative Oncology Group performance status 0, triple-negative MBC 19%, all pretreated with a taxane-based therapy, mainly in advanced disease) were enrolled in the study. The ORR was 23.8%, including one complete response (2.4%) and nine partial responses (21.4%); the disease control rate was 50%. The median duration of response was 7.2months. After a median follow-up of 9months, the median PFS was 4.6months. ORR and PFS were similar irrespective of the previous chemotherapy lines, metastatic sites, and biomolecular expression. Nab-paclitaxel was well tolerated, and the most frequent treatment-related toxicities were mild to moderate (grades 1–2).Conclusion: This real-life study shows that nab-paclitaxel has a significant antitumor activity and a manageable safety profile in patients pretreated with taxanes and experiencing a treatment failure after at least one line of chemotherapy. Keywords: nab-paclitaxel, metastatic breast cancer, anthracyclines |
| Databáze: | OpenAIRE |
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