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Prognostic Value of Histologic Grade and Proliferative Activity in Axillary Node–Positive Breast Cancer: Results From the Eastern Cooperative Oncology Group Companion Study, EST 4189

From the Department of Pathology, Vanderbilt University Medical Center, Nashville, TN; Dana Farber Cancer Institute, Boston, MA; University of North Carolina, Chapel Hill, NC; Flower Memorial Hospital, Sylvania, OH; University of Pretoria, Pretoria, South Africa; University of Wisconsin Comprehensive Cancer Center, Madison, WI; University of Rochester Cancer Center, Rochester, NY; and Fairfax Hospital, Falls Church, VA.

Address reprint requests to Jean F. Simpson, MD, Department of Pathology, MCN C3321, Vanderbilt University Medical Center, Nashville, TN 37232.

PURPOSE: The identification of a subset of patients with axillary lymph node–positive breast cancer with an improved prognosis would be clinically useful. We report the prognostic importance of histologic grading and proliferative activity in a cohort of patients with axillary lymph node–positive breast cancer and compare these parameters with other established prognostic factors.

PATIENTS AND METHODS: This Eastern Cooperative Oncology Group laboratory companion study (E4189) centered on 560 axillary lymph node–positive patients registered onto one of six eligible clinical protocols. Flow cytometric (ploidy and S-phase fraction [SPF]) and histopathologic analyses (Nottingham Combined Histologic Grade and mitotic index) were performed on paraffin-embedded tissue from 368 patients.

RESULTS: Disease recurred in 208 patients; in 161 (77%), within the first 5 years. Mitotic index and grade were associated with both ploidy and SPF (P .01). Within the first 5 years of follow-up, mitotic index (P = .004), grade (P = .004), ploidy (P = .006), and SPF (P = .05) were associated with time to recurrence; there was also a significant association with survival. The effect of mitotic index was largely a result of the difference between 0 to 2 mitoses/10 high-power fields (HPF; 5-year recurrence of 31%) and more than 2 mitoses/10 HPF (5-year recurrence of 52%). The 0 to 2 mitoses/10 HPF group was independently associated with improved prognosis at 5 years (P = .002) in regression models that included other standard prognostic factors.

CONCLUSION: A subset of axillary lymph node–positive patients with improved prognosis may be identified using a lower (< 3 mitoses/10 HPF) mitotic count than is usually performed.

Conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service grants no. CA49957, CA23318, CA59307, CA21076, CA11083, CA66636, and CA21115 from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services, Bethesda, MD.

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