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Breast Cancer

Long-Term Outcomes in Stage IIIB Breast Cancer Patients Who Achieved Less Than a Pathological Complete Response (<pCR) After Primary Chemotherapy

^aDepartment of Medical Oncology and ^bDepartment of Public Health, Azienda Ospedaliero-Universitaria, Cagliari, Italy; ^cDepartment of Medical Oncology, Policlinico Universitario, Palermo, Italy

Key Words. Stage IIIB breast cancer • Neoadjuvant chemotherapy • Pathological response • Long-term outcomes

Correspondence: Maria Teresa Ionta, M.D., Department of Medical Oncology, Azienda Ospedaliero-Universitaria, Cagliari, Italy. Telephone: 3907051096208; Fax: 3907051096208; e-mail: mtionta{at}yahoo.it

Received April 14, 2009; accepted for publication October 6, 2009; first published online in THE ONCOLOGIST Express on November 6, 2009.

Disclosures

Maria Teresa Ionta: None; Francesco Atzori: None; Maria Cristina Deidda: None; Valeria Pusceddu: None; Sergio Palmeri: None; Barbara Frau: None; Monica Murgia: None; Michela Barca: None; Luigi Minerba: None; Bruno Massidda: None.

Section editors Gabriel Hortobagyi and Kathleen Pritchard have disclosed no financial relationships relevant to the content of this article.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias.

Purpose. Pathological complete response (pCR) to primary chemotherapy is the main determinant for improved disease-free survival (DFS) and overall survival (OS). The primary endpoints of our study were the long-term DFS and OS rates in homogeneously treated stage IIIB breast cancer patients who failed to achieve a pCR (<pCR), in relation to residual tumor burden. The secondary endpoint was the prognostic relevance of hormone receptor (HR) and human epidermal growth factor receptor (HER)-2 status.

Methods. We analyzed 58 of 74 consecutive stage IIIB patients treated between 1996 and 2001 who achieved <pCR following a primary cisplatin, epirubicin, and vinorelbine regimen for up to six cycles. At the time of patient accrual, trastuzumab was not available. After definitive surgery, pathological residual disease remained in 40 (69%) patients in both the breast and axilla, in 14 (24%) patients in only the breast, and in four (7%) patients in only the axilla.

Results. Fifty-eight (78%) of 74 patients achieved <pCR and 16 (22%) had pCR both in the breast and axilla. After a median follow-up of 99 months (range, 72–134 months), in patients with <pCR the estimated 10-year DFS and OS rates were 37.6% and 50.3%, respectively, significantly worse than in the pCR group (p = .003 and p = .008, respectively). Patients with four or more axillary nodes involved had a significantly worse 10-year DFS rate (28.9% versus 62.7%; p = .036). Patients with HR^– tumors had significantly lower 10-year DFS (17.3% versus 46.4%; p = .018) and OS (17.3% versus 70.2%; p = .002) rates. Overall, the triple-negative (TN) group showed only a marginally significantly worse OS rate (p = .048). HER-2 status alone, in the absence of trastuzumab, did not appear to significantly affect outcomes.

Conclusions. Our data suggest that, in stage IIIB patients who achieve <pCR, the number of residual nodes and HR^– status are strong predictors of poor outcomes. After a long follow-up time, HER-2 expression does not appear to significantly affect DFS and OS. TN patients showed a trend toward early recurrence and death.