Journal of Clinical Oncology, Vol 15, 2526-2535, Copyright © 1997 by American Society of Clinical Oncology

ARTICLES

Overview of randomized perioperative polychemotherapy trials in women with early-stage breast cancer

PC Clahsen, CJ van de Velde, A Goldhirsch, J Rossbach, MR Sertoli, L Bijnens and RJ Sylvester
European Organization for Research and Treatment of Cancer (EORTC), EORTC Data Center, Brussels, Belgium. clahsen@pi.net

PURPOSE: To determine whether perioperative polychemotherapy (PeCT) can significantly prolong the overall survival of women with early-stage breast cancer. METHODS: A meta-analysis that used updated individual patient data from all available randomized trials of PeCT, both published and unpublished, was conducted. Data on 6,093 patients (1,124 deaths and 1,912 recurrences) from five clinical trials were available (median follow-up duration, 5.3 years; maximum, 11.3 years). RESULTS: No significant effect of PeCT on overall survival was observed. However, patients who received PeCT had a significantly longer disease- free survival (hazards ratio [HR], 0.89; 95% confidence interval [CI], 0.82 to 0.98; P = .02). Time to local recurrence was significantly prolonged in the PeCT arm (HR, 0.68; 95% CI, 0.58 to 0.80; P < .0001). Likewise, there was a borderline significant difference in favor of PeCT in terms of time to distant metastases (HR, 0.90; 95% CI, 0.81 to 1.00; P = .05). Subgroup analyses suggest that node-negative women benefited the most from treatment. CONCLUSION: At present, there is no evidence that PeCT is able to prolong overall survival in patients with early-stage breast cancer; however, further follow-up evaluation is required. PeCT significantly prolongs disease-free survival, especially in node-negative women, which emphasizes once more the need for clinical trials in this subgroup.

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