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SOLTI (Solid Tumor Intensification) Group experience with high-dose chemotherapy treatment for early breast carcinoma


Primary carcinoma of the breast is a worldwide public-health problem; despite conventional treatment, long-term prognosis is poor, especially for large tumors or in cases with axillary involvement. In an attempt to improve these results, phase II high-dose chemotherapy trials were performed by the SOLTI Group.


A total of 416 patients were included in three high-dose chemotherapy trials in the adjuvant setting, as follows. The 9301 trial included 297 patients with stage II/III breast carcinoma with more than 10 axillary lymph nodes involved. After conventional adjuvant chemotherapy (FEC regimen), high-dose chemotherapy (STAMP V regimen) with peripheral stem cell support was performed. The 9302 trial included 66 patients with inflamatory breast carcinoma treated with three to six cycles of FEC neoadjuvant therapy. Responding patients were treated with high-dose chemotherapy after surgery with STAMP V regimen and blood stem cell support. The 9702 trial included 53 patients with stage III breast cancer treated with neoadjuvant doxorubicin and paclitaxel. Patients with pathologic axillary involvement in the surgical specimen were treated with adjuvant STAMP V high-dose chemotherapy.


In trial 9301, with a median follow up of 63 months, 5-year disease-free survival (DFS) was 59% and overall survival (OS) was 80%. In trial 9302, median DFS was 30 months and median OS 75 months, with 55.3% of patients alive at 5 years. In trial 9702, with a median follow up of 31 months, the median DFS and OS have not yet been determined. No toxic deaths were reported. Most common nonhematological toxicities were emesis, mucositis, hepatic and alopecia. Neutropenia was easily resolved with G-CSF support; and anemia and trombopenia were frequent (50–60% patients).


The toxicity of treatment with high-dose chemotherapy is acceptable and similar to that described in other series. Although the results obtained are promising, their comparison with historic controls and the information derived from other reported trials do not enable us to recommend high-dose chemotherapy with bone-marrow rescue as a routine treatment in high-risk breast cancer. It nevertheless remains a valid investigational strategy.

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Funes, H.C., Lluch, A., Climent, M. et al. SOLTI (Solid Tumor Intensification) Group experience with high-dose chemotherapy treatment for early breast carcinoma. Breast Cancer Res 7 (Suppl 1), S24 (2005).

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