title: Feasibility of two schedules of weekly paclitaxel in HER2-negative early breast cancer in a Brazilian community setting.
abstract: BACKGROUND
  Weekly paclitaxel has been shown more effective and less toxic than the conventional three-weekly administration. The GEICAM 9906 demonstrated effectiveness and safety of a dose-dense schedule of 100 mg/m(2) of paclitaxel given over 8 weeks (w). This schedule has been adopted at our institution in 2009 for HER2-negative disease, and herein, we present the first off-trial experience and compare its safety profile with that of a historical cohort of patients treated with the conventional 80 mg/m(2) over 12 w schedule.
  
  
  METHODS
  Retrospective single-center chart review of patients with locally advanced breast cancer treated with (neo)adjuvant paclitaxel-based therapy from 2008 to 2012 with (1) 80 mg/m(2) for 12 w or (2) 100 mg/m(2) for 8 w. Adverse events were graded according to common terminology criteria for adverse events (CTCAE) 4.0.
  
  
  RESULTS
  A total of 326 patients were analyzed. Median age was 52 (±10.9). Seventy and 256 patients received schedule (1) and (2), respectively. No significant difference was observed in the incidence of grade (G) 3/4 toxicity: pneumonitis (2.8 vs 0.3 % p = 0.097); neuropathy (2.8 vs 0.7 % p = 0.303); hand-foot syndrome (1.4 vs 0.3 % p = 0.538); anemia (0 vs 0.6 % p = 0.624); and neutropenia (5.7 vs 6.2 % p = 0.408). Also, no significant difference was seen when comparing all grades toxicity. Schedule (2) had higher dose intensity: 97.72 vs 77.07 mg/m(2) per week (p < 0.0001).
  
  
  CONCLUSIONS
  Weekly paclitaxel given according to GEICAM 9906 is pragmatic and well tolerated, with safety profile consistent with the conventional schedule. In addition to being convenient to patients, it may also be cost-effective because of a lower number of clinic visits and infusions.
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil. iurisantana@gmail.com.
authors.forename: Iuri A
authors.initials: IA
authors.lastname: Santana
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil.
authors.forename: Julia Andrade
authors.initials: JA
authors.lastname: Oliveira
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil.
authors.forename: Julianne Maria
authors.initials: JM
authors.lastname: da Silva Lima
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil.
authors.forename: Laura
authors.initials: L
authors.lastname: Testa
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil.
authors.forename: José Roberto M
authors.initials: JR
authors.lastname: Piato
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil.
authors.forename: Paulo M
authors.initials: PM
authors.lastname: Hoff
authors.affiliation: Division of Medical Oncology, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo 251, 5º andar, CEP: 01246-000, São Paulo, SP, Brazil.
authors.forename: Max S
authors.initials: MS
authors.lastname: Mano
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001938:Brazil; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007124:Immunoenzyme Techniques; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000627:therapeutic use*; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D012189:Retrospective Studies; D015996:Survival Rate
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014408:Biomarkers, Tumor; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; C508053:ERBB2 protein, human
keywords: Adverse events; Breast cancer; Neoadjuvant; Paclitaxel; Toxicities