title: Nab-Paclitaxel in Advanced HER2-negative Breast Cancer Patients: Efficacy and Safety Beyond Clinical Trials.
abstract: Few data are available regarding efficacy and safety of nanoparticle albumin-bound (nab)-paclitaxel in advanced breast cancer patients outside a controlled trial, especially for the weekly schedule.
  
  
  
  We prospectively collected data of advanced breast cancer patients who were candidates to be treated with weekly (125 mg/m2for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m2) schedules of nab-paclitaxel, according to physician's decision.
  
  
  
  The study enrolled 209 patients, of whom 92 (39.3%) received weekly nab-paclitaxel. The median age was 58 (range, 31-84) years; 21.8% of the patients were classified as triple-negative breast cancer (estrogen-recetor/progesteron-receptor-negative). The median number of cycles was 5.5. The overall response rate was 32.1% in the whole population, without any significant difference according to schedule, previous paclitaxel exposure, presence of visceral metastases, or line of treatment. The median time to disease progression was 6 months (95% confidence interval, 1-34), with no differences according to the schedule of treatment. Severe adverse events (Grade 3-4) were observed in 60.6% of the patients. The main toxicities were alopecia (53.4%), neutropenia (3%), and sensory neuropathy (2.1%).
  
  
  
  Our real-life data indicate that both schedules of nab-paclitaxel are manageable and safe in advanced breast cancer patients, even if previously treated with other taxanes.
authors.affiliation: Oncology Department Unit, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Bernardo
authors.affiliation: Oncology Department Unit, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Palumbo
authors.affiliation: Oncology Unit, ASST degli Spedali Civili di Brescia, Brescia, Italy.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Pedersini
authors.affiliation: Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Rota Caremoli
authors.affiliation: Oncology Unit, ASST Fatebenefratelli-Sacco, Milano, Italy.
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Gambaro
authors.affiliation: Oncology Unit, ASST Ovest-Milanese, Legnano, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Ferzi
authors.affiliation: Oncology Unit, ASST Monza - Ospedale San Gerardo, Monza, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Riva
authors.affiliation: Oncology Unit, Fondazione S. Matteo, Pavia, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Grasso
authors.affiliation: Oncology and Medicine Unit, ASST Pavia - Ospedale di Vigevano, Vigevano, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Danova
authors.affiliation: Oncology Unit Falck, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
authors.forename: Emiliana
authors.initials: E
authors.lastname: Tarenzi
authors.affiliation: Laboratorio Metodologia per la Ricerca Clinica, Dipartimento di Oncologia, IRCCS Ist Mario Negri, Milano, Italy.
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.affiliation: Oncology Unit, ASST Monza - Ospedale San Gerardo, Monza, Italy. Electronic address: marina.cazzaniga@asst-monza.it.
authors.forename: Marina E
authors.initials: ME
authors.lastname: Cazzaniga
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015331:Cohort Studies; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; C520255:130-nm albumin-bound paclitaxel; C508053:ERBB2 protein, human
keywords: Elderly patient; Neuropathy; Real-life; Taxane exposure; Weekly schedule