Adjuvant Cytotoxic and Endocrine Therapy in Pre- and Postmenopausal Patients With Breast Cancer and One to Nine Infiltrated Nodes

• DOI: 10.1097/01.coc.0000046121.51504.b9
• Publication Date: 2004-01-30T09:04:36Z
• Authors: George Fountzilas; G. Stathopoulos; G. Kouvatseas; A. Polychronis; G. Klouvas; E. Samantas; N. Zamboglou; K. Kyriakou; A. Adamou; D. Pectasidis; Th. Ekonomopoulos; H. P. Kalofonos; D. Bafaloukos; V. Georgoulias; E. Razis; D. Koukouras; V. Zombolas; P. Kosmidis; D. Skarlos; N. Pavlidis
• Keywords: Mitoxantrone; Lumpectomy

The present randomized phase III trial was designed to detect a 15% benefit in relapse-free survival (RFS) or overall (OS) from the incorporation of adjuvant tamoxifen combination CNF [cyclophosphamide, 500 mg/m2; mitoxantrone (Novantrone), 10 fluorouracil, mg/m2 chemotherapy and ovarian ablation premenopausal patients with node-positive breast cancer conversely postmenopausal patients. From April 1992 until March 1998, 456 operable one nine infiltrated axillary nodes entered study. Premenopausal were treated six cycles followed by monthly injections triptoreline 3.75 mg for 1 year (Group A, 84 patients) same treatment 5 years B, 92 patients). Postmenopausal received C, 145 6 D, 135 Adjuvant radiation administered all partial mastectomy. After median follow-up period years, 125 (27%) relapsed 79 (17%) died. 5-year actuarial RFS 65% Group A 68% B (p = 0.86) 70% C 67% D 0.36). Also, respective OS rates 77% 80% 0.68) 84% 78% 0.10) Severe toxicities infrequently seen, exception leukopenia (18%), among 311 CNF. In conclusion, study failed demonstrate difference favor an additional after ablation. Similarly, preceding did not translate