Treatment of axillary lymph node-negative, estrogen receptor-negative breast cancer: Updated findings from National Surgical Adjuvant Breast and Bowel Project clinical trials

Journal of the National Cancer Institute

Volumn 96, Issue 24, 2004, Pages 1823-1831

  Fisher, Bernard ^a,c   Jeong, Jong Hyeon ^b   Anderson, Stewart ^b   Wolmark, Norman ^a  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^c NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; ESTROGEN RECEPTOR; FLUOROURACIL; METHOTREXATE; TAMOXIFEN;

ADULT; AGE; ARTICLE; AXILLARY LYMPH NODE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER MORTALITY; CANCER RECURRENCE; CANCER SURGERY; CANCER SURVIVAL; CLINICAL STUDY; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COVARIANCE; DRUG FATALITY; FEMALE; FOLLOW UP; HUMAN; INTESTINE CANCER; MAJOR CLINICAL STUDY; MENOPAUSE; NONBIOLOGICAL MODEL; POSTOPERATIVE CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; RISK ASSESSMENT; STATISTICAL SIGNIFICANCE;

ADULT; AGE FACTORS; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; LYMPHATIC METASTASIS; MENOPAUSE; METHOTREXATE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; RECEPTORS, ESTROGEN; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 11844257023     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/djh338     Document Type: Article

References (32)

1. Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, et al. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med 1989;320:473-8.
2. Fisher B, Dignam J, Mamounas EP, Costantino JP, Wickerham DL, Redmond C, et al. Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol 1996;14:1982-92.
3. Fisher B, Anderson S, Tan-Chiu E, Wolmark N, Wickerham DL, Fisher ER, et al. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-23. J Clin Oncol 2001;19:931-42.
4. Efron B. Forcing a sequential experiment to be balanced. Biometrika 1971;58:403-17.
5. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
6. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-70.
7. Cox DR. Regression models and life tables. J R Stat Soc 1972;34:187-200.
8. Grambsch P, Therneau T. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994;81:515-26.
9. Bonetti M, Gelber RD. A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data. Stat Med 2000; 19:2595-2609.
10. Cleveland WS, Devlin SJ. Locally weighted regression: an approach to regression analysis by local fitting. J Am Stat Assoc 1988;83:596-610.
11. Gaynor JJ, Feuer EJ, Tan CC, Wu DH, Little CR, Straus DJ, et al. On the use of cause-specific failure and conditional failure probabilities: examples from clinical oncology data. J Am Stat Assoc 1993;88:400-9.
12. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. New York: Wiley; 1980.
13. Kay R. Treatment effects in competing-risks analysis of prostate cancer data. Biometrics 1986;42:311-23.
14. Fisher B. Highlights from recent National Surgical Adjuvant Breast and Bowel Project studies in the treatment and prevention of breast cancer. CA Cancer J Clin 1999;49:159-77.
15. Bertino JR, Sawicki W, Lindquist C, Gupta VS. Schedule-dependent antitumor effects of methotrexate and 5-fluorouracil. Cancer Res 1977;37:327-8.
16. Gewirtz AM, Cadman E. Preliminary report on the efficacy of sequential methotrexate and 5-fluorouracil in advanced breast cancer. Cancer 1981; 47:2552-5.
17. Pitman SW, Kowal CD, Papac RJ, Bertino JR. A sequential methotrexate-5-fluorouracil: a highly active drug combination in advanced squamous cell carcinoma of the head and neck. Proc Am Soc Clin Oncol 1980;21:473 (abstr).
18. Shapiro CL, Gelman RS, Hayes DF, Osteen R, Obando A, Canellos GP, et al. Comparison of adjuvant chemotherapy with methotrexate and fluorouracil with and without cyclophosphamide in breast cancer patients with one to three positive axillary lymph nodes. J Natl Cancer Inst 1993;85:812-7.
19. Sutherland RL, Green MD, Hall RE, et al. Tamoxifen induces accumulation of MCF-7 human mammary carcinoma cells in the G0/G1 phase of the cell cycle. Eur J Cancer Clin Oncol 1983;19:615-21.
20. O'Brian CA, Liskamp RM, Solomon DH, Weinstein IB. Inhibition of protein kinase C by tamoxifen. Cancer Res 1985;45:2462-5.
21. Lam H-Y P. Tamoxifen is a calmodulin antagonist in the activation of cAMP phosphodiesterase. Biochem Biophys Res Commun 1984;118:27-32.
22. Pollak M, Costantino J, Polychronakos C, et al. Effect of tamoxifen on serum insulin-like growth factor - I levels of stage I breast cancer patients. J Natl Cancer Inst 1990;82:1693-7.
23. Berry J, Green BJ, Matheson DS. Modulation of natural killer cell activity by tamoxifen in stage I postmenopausal breast cancer. Eur J Cancer Clin Oncol 1987;23:517-20.
24. Mandeville R, Ghali SS, Chausseau JP. In vitro stimulation of human NK activity by estrogen antagonist (tamoxifen). Eur J Cancer Clin Oncol 1984;20:983-5.
25. Albain KS, Green SJ, Ravdin PM, Cobau CD, Levine EG, Ingle JN, et al. Adjuvant chemohormonal therapy for primary breast cancer should be sequential instead of concurrent: initial results from intergroup trial 0100 (SWOG-8814). Proc Am Soc Clin Oncol 2002;21:143 (abstr).
26. Fisher B. From Halsted to prevention and beyond: advances in the management of breast cancer during the twentieth century. Eur J Cancer 1999;35:1963-73.
27. Fisher B, Jeong J-H, Bryant J, Anderson S, Dignam J, Fisher ER, et al. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet 2004;364:858-68.
28. Fisher B, Redmond C, Brown A, Wickerham DL, Wolmark N, Allegra J, et al. Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancer. J Clin Oncol 1983;1:227-41.
29. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 1998; 352:930-42.
30. Fisher B, Redmond C, Legault-Poisson S, Dimitrov NV, Brown AM, Wickerham DL, et al. Postoperative chemotherapy and tamoxifen compared with tamoxifen alone in the treatment of positive-node breast cancer patients aged 50 years and older with tumors responsive to tamoxifen: results from the National Surgical Adjuvant Breast and Bowel Project B-16. J Clin Oncol 1990;8:1005-18.
31. Hutchins L, Green S, Ravdin P, Lew D, Martino S, Abeloff M, et al. CMF versus CAF with and without tamoxifen in high-risk node-negative breast cancer patients and a natural history follow-up study in low-risk node-negative patients: first results of Intergroup Trial Int 0102. Proc Am Soc Clin Oncol 1998;17:1a (abstr).
32. Martin M, Villar A, Sole-Calvo A, Gonzalez R, Massuti B, Lizon J, et al. Doxorubicin in combination with fluorouracil and cyclophosphamide i.v. FAC regimen, day 1, 21) versus methotrexate in combination with fluorouracil and cyclophosphamide (i.v. CMF regimen, day 1, 21) as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group (Spanish Breast Cancer Research Group). Ann Oncol 2003;14:833-42.