title: Prospective study on nanoparticle albumin-bound paclitaxel in advanced breast cancer: clinical results and biological observations in taxane-pretreated patients.
abstract: 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.
  
  
  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, 260 mg/m(2) on day 1 of each 3-week cycle or 125 mg/m(2) 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 48 years, 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 7.2 months. After a median follow-up of 9 months, the median PFS was 4.6 months. 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Fabi
authors.affiliation: Biostatistic Unit, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Malaguti
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Ferretti
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Vari
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Papaldo
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nisticò
authors.affiliation: Service of Radiology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Caterino
authors.affiliation: Operative Unit of Plastic and Reconstructive Surgery, Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Roy
authors.initials: R
authors.lastname: De Vita
authors.affiliation: Department of Pathology, University of Rome "Tor Vergata", Rome, Italy.
authors.forename: Marcella
authors.initials: M
authors.lastname: Mottolese
authors.affiliation: Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Iacorossi
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D053758:Nanoparticles; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D055815:Young Adult
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D017239:Paclitaxel
keywords: anthracyclines; metastatic breast cancer; nab-paclitaxel