title: Long-term follow-up of a phase II trial studying a weekly doxorubicin-based multiple drug adjuvant therapy for stage II node-positive carcinoma of the breast.
abstract: BACKGROUND
  Combination chemotherapy improves outcomes in women with breast cancer (BC) that involves axillary nodes. This single-arm study aimed to evaluate the effectiveness of an intensive doxorubicin-based multidrug regimen as adjuvant therapy in women with stage II, node positive breast cancer.
  
  
  METHODS
  Between 7/80 and 8/85, 654 women, aged 25-73, who had a mastectomy for stage IIB BC were accrued. Patients with prior RT, chemotherapy, or surgical or radiation castration within 1 year of diagnosis were excluded. Treatment consisted of: 6 weekly courses of IV cyclophosphamide (C) 400 mg/m2, doxorubicin (A) 10 mg/m2, vincristine (V) I mg/m2, fluorouracil (F) 400 mg/m2, and a tapering course of prednisone followed by 12 courses of C 400 mg/m2, A 20mg/m2, V 1 mg/m2, F 400 mg/m2 given every 2 weeks. Patients with estrogen receptor positive tumors received Tamoxifen 10 mg bid between weeks 8 and 30. Treatment did not exceed 8 months. Median follow-up is 13.1 years.
  
  
  RESULTS
  Six hundred thirty six patients are eligible. Fewer positive (+) nodes, premenopausal status, and positive progesterone receptor status are significantly (p < 0.05) associated with longer survival. At 10 years, 61% were relapse-free in the 1-3 +node group compared to 37 and 21% in the 4-9 and > or = 10 +node groups, respectively (p = 0.0001). Relapse-free survival at 10 years is 50% for premenopausal and 45% for postmenopausal patients. Severe or life-threatening hematological toxicity was seen in 6/630 (< 1%) patients. Four patients had severe (grade 3) neurotoxicity which resolved. No cardiac toxicity was observed.
  
  
  CONCLUSIONS
  This adjuvant regimen compares favorably to other published adjuvant treatments with similar length of follow-up.
authors.affiliation: The Comprehensive Cancer Center of Wake Forest University, Winston-Salem, NC 27157-1082, USA. gkimmick@wfubmc.edu
authors.forename: Gretchen G
authors.initials: GG
authors.lastname: Kimmick
authors.forename: Brent J
authors.initials: BJ
authors.lastname: Shelton
authors.forename: L Douglas
authors.initials: LD
authors.lastname: Case
authors.forename: M Robert
authors.initials: MR
authors.lastname: Cooper
authors.forename: Hyman B
authors.initials: HB
authors.lastname: Muss
mesh_terms: D000277:Adjuvants, Pharmaceutic / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008593:Menopause; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D000277:Adjuvants, Pharmaceutic; D004317:Doxorubicin