title: Weekly paclitaxel in the adjuvant treatment of breast cancer.
abstract: BACKGROUND
  We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer.
  
  
  METHODS
  We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival.
  
  
  RESULTS
  As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P=0.006), 1.23 among those receiving docetaxel every 3 weeks (P=0.02), and 1.09 among those receiving weekly docetaxel (P=0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P=0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%).
  
  
  CONCLUSIONS
  Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125 [ClinicalTrials.gov].).
authors.affiliation: Eastern Cooperative Oncology Group, Philadelphia, USA. jsparano@montefiore.org
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Sparano
authors.forename: Molin
authors.initials: M
authors.lastname: Wang
authors.forename: Silvana
authors.initials: S
authors.lastname: Martino
authors.forename: Vicky
authors.initials: V
authors.lastname: Jones
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
authors.forename: Tom
authors.initials: T
authors.lastname: Saphner
authors.forename: Antonio C
authors.initials: AC
authors.lastname: Wolff
authors.forename: George W
authors.initials: GW
authors.lastname: Sledge
authors.forename: William C
authors.initials: WC
authors.lastname: Wood
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Davidson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011987:Receptors, Steroid; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011987:Receptors, Steroid; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel