Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer.

Abstract

BACKGROUND:

The International Breast Cancer Study Group Trial VIII compared long-term efficacy of endocrine therapy (goserelin), chemotherapy [cyclophosphamide, methotrexate and fluorouracil (CMF)], and chemoendocrine therapy (CMF followed by goserelin) for pre/perimenopausal women with lymph-node-negative breast cancer.

PATIENTS AND METHODS:

From 1990 to 1999, 1063 patients were randomized to receive (i) goserelin for 24 months (n = 346), (ii) six courses of 'classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or (iii) six courses of CMF plus 18 months goserelin (CMF→ goserelin; n = 357). Tumors were classified as estrogen receptor (ER) negative (19%), ER positive (80%), or ER unknown (1%); 19% of patients were younger than 40. Median follow-up was 12.1 years.

RESULTS:

For the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%) (P = 0.04 for each comparison), due largely to the effect in younger patients. Patients with ER-negative tumors whose treatment included CMF had similar DFS (12-year DFS CMF = 67%; 12-year DFS CMF→ goserelin = 69%) compared with goserelin alone (12-year DFS = 61%, P= NS).

CONCLUSIONS:

For pre/perimenopausal women with lymph-node-negative ER-positive breast cancer, CMF followed by goserelin improved DFS in comparison with either modality alone. The improvement was the most pronounced in those aged below 40, suggesting an endocrine effect of prolonged CMF-induced amenorrhea.

• Authors: P Karlsson, Z Sun, D Braun, K N Price, M Castiglione-Gertsch, M Rabaglio, R D Gelber, D Crivellari, J Collins, E Murray, K Zaman, M Colleoni, B A Gusterson, G Viale, M M Regan, A S Coates, A Goldhirsch
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 22 Issue 10 Pg. 2216-26 (Oct 2011) ISSN: 1569-8041 [Electronic] England
• PMID: 21325445 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Hormonal
• Receptors, Estrogen
• Goserelin
• Cyclophosphamide
• Fluorouracil
• Methotrexate

Topics

• Adult
• Antineoplastic Agents, Hormonal (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Breast Neoplasms (drug therapy, metabolism, pathology, surgery)
• Chemotherapy, Adjuvant
• Cyclophosphamide (administration & dosage)
• Disease-Free Survival
• Female
• Fluorouracil (administration & dosage)
• Goserelin (administration & dosage)
• Humans
• Lymph Nodes (pathology)
• Methotrexate (administration & dosage)
• Middle Aged
• Neoplasm Staging
• Premenopause
• Receptors, Estrogen (biosynthesis)