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Journal of Clinical Oncology, Vol 22, No 5 (March 1), 2004: pp. 961-962 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.143
Validation of the 2001 St Gallen Risk Categories for Node-Negative Breast Cancer Using a Database From the Spanish Breast Cancer Research Group (GEICAM)
Institut Català d'Oncologia, Girona, Spain To the Editor:
The International Consensus Panel that was developed during the St Gallen Conference 2001 defined two risk categories for patients with node-negative breast cancer [1]. Patients with all of the following factors were classified as low risk: positive estrogen and/or progesterone receptors (ER-positive/PgR-positive, respectively), grade 1, T1 tumors ( Validation of the 2001 St Gallen risk categories is relevant for clinical practice because these criteria represent the basis to recommend or not recommend the use of systemic adjuvant therapy for node-negative breast cancer since 1998 [1,2]. This validation, however, has not been done for the 2001 consensus classification [2]. The Spanish Breast Cancer Research Group recently has completed a survey, in which demographic, therapeutic, and follow-up data were recorded in 4,532 breast cancer patient cases from 32 Spanish hospitals, from 1990 to 1993 [3]. This population represents approximately 10% of the breast cancers diagnosed in Spain in that period. We have performed a retrospective study using the ALAMO data in order to validate the St Gallen prognostic categories. From the 1,800 node-negative patients of the ALAMO study with complete follow-up, we selected those with known grade and hormone receptor status, and tumor size T1 or T2 (excluding T0, Tis, T3, and T4) [4]. From the resulting 924 patients, 131 (14%) were classified as low risk and 793 were classified as high risk (86%). The median follow-up period of the whole cohort was 7.54 years. Some form of adjuvant chemotherapy, hormone therapy, or both was received by 716 patients, and 208 patients did not receive adjuvant systemic therapy (surgery alone with or without radiation therapy). Patients with low risk were premenopausal in a proportion similar to that of the high-risk patients (27.4% v 30.2%). We analyzed treatment characteristics by the risk category (Table 1). High-risk patients were treated more frequently with radical mastectomy and less frequently with radiotherapy.
The Kaplan-Meier plot for disease-free survival (DFS) is shown in Figure 1. The two curves are significantly different using the log-rank test (P < .01). Estimated 8-year DFS was determined for both risk categories. The DFS at 8 years was significantly greater for the patients in the low-risk category compared with those in the high-risk category (85.0% v 72.7%, respectively).
In conclusion, our study shows that the 2001 St Gallen classification for patients with node-negative breast cancer does actually distinguish two different risk categories. Future prognostic classifications of breast cancer that are based on genetic profiling [5,6] will need independent validation before they can be used routinely. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.
REFERENCES
1. Goldhirsh A, Glick JH, Gelber RD, et al: Meeting highlights: International consensus panel on the treatment of primary breast cancer. J Clin Oncol 19:38173827, 2001
2. Iwamoto E, Fukutomi T, Akashi-Tanaka S: Validation and problems of St-Gallen recommendations of adjuvant therapy for node-negative invasive breast cancer in Japanese patients. Jpn J Clin Oncol 31:259262, 2001 3. Proyecto El ÁLAMO: Encuesta de evolución de pacientes con cáncer de mama en hospitales del grupo GEICAM (19901993). Madrid, Spain, GEICAM, 2002 4. Héry M, Delozier T, Ramaioli A, et al: Natural history of node-negative breast cancer: Are conventional prognostic factors predictors of time to relapse? Breast 11:442448, 2002[CrossRef][Medline] 5. van't Veer LJ, Dai H, van de Vijver MJ, et al: Gene expression profiling predicts clinical outcome of breast cancer. Nature 415:530535, 2002[CrossRef][Medline] 6. Comings DE, Gade-Andavolu R, Cone LA, et al: A multigene test for the risk of sporadic breast carcinoma. Cancer 97:21602170, 2003[CrossRef][Medline]
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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