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HER-2 Expression and Cell Proliferation: Prognostic Markers in Patients With Node-Negative Breast Cancer

Annalisa Volpi, Oriana Nanni, Franca De Paola, Anna Maria Granato, Annita Mangia, Franco Monti, Francesco Schittulli, Mario De Lena, Emanuela Scarpi, Paola Rosetti, Manlio Monti, Lorenzo Gianni, Dino Amadori, Angelo Paradiso

From the Department of Medical Oncology, Pierantoni Hospital; Istituto Oncologico Romagnolo, Forlì; Department of Medical Oncology, Infermi Hospital, Rimini; Clinical Experimental Oncology Laboratory, National Oncology Institute; Breast Unit, National Oncology Institute, Bari; and Department of Medical Oncology, S. Maria delle Croci Hospital, Ravenna, Italy.

Address reprint requests to Dino Amadori, MD, Dept of Medical Oncology, Pierantoni Hospital, via Forlanini 34, 47100 Forlì, Italy; email: segronco{at}ausl.fo.it or a.volpi{at}ausl.fo.it.

Purpose: We analyzed the clinical relevance of HER-2 expression, widely investigated in breast cancer but with contradictory results, in the largest case series of node-negative breast cancer patients investigated to date.

Patients and Methods: The pure prognostic value of HER-2 expression was investigated in 529 patients treated with locoregional therapy alone until early relapse. Proliferative activity was evaluated as [³H]thymidine labeling index and HER-2 expression by immunohistochemistry. All biologic determinations were conducted within the context of an intra- and interlaboratory National Quality Control Program.

Results: HER-2 expression was not related to relapse-free survival in the overall series but was a significant discriminant of prognosis in the subgroup of patients with rapidly proliferating tumors. Six-year rate of relapse was 40% for patients with highly (30%) positive tumors and 26% for those with weakly HER-2-expressing tumors (P = .039).

Conclusion: HER-2 expression in association with proliferative activity identifies a subgroup of node-negative breast cancer patients with the worst prognosis, who are candidates for specific intensive adjuvant therapy.

This study was funded by the National Research Council (CNR-Progetto Strategico MIUR, grant nos. 02.00452.ST97 and 02.00105.ST97), Rome, and by Istituto Oncologico Romagnolo, Forlì, Italy.

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