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Clinical Trial
. 2009 Sep;32(8-9):468-72.
doi: 10.1159/000226210. Epub 2009 Jul 20.

Doxorubicin and paclitaxel versus fluorouracil, doxorubicin and cyclophosphamide as first-line therapy for women with advanced breast cancer: long-term analysis of the previously published trial

Jacek Jassem  1 , Tadeusz Pienkowski, Anna Pluzanska, Svetislav Jelic, Vera Gorbunova, Juris Berzins, Thomas Nagykalnai, Laura Biganzoli, Alessandra Aloe, Ludovic Astier, Stephane Munier
Affiliations
Clinical Trial

Doxorubicin and paclitaxel versus fluorouracil, doxorubicin and cyclophosphamide as first-line therapy for women with advanced breast cancer: long-term analysis of the previously published trial

Jacek Jassem et al. Onkologie. 2009 Sep.

Abstract

Background: The aim of this study was to perform an independent review of the efficacy data and to determine whether the efficacy difference observed in a phase III randomised clinical trial that compared doxorubicin plus paclitaxel (AT) versus fluorouracil/doxorubicin/cyclophosphamide (FAC) in first-line chemotherapy of metastatic breast cancer was maintained after a longer follow-up period.

Material and methods: A blinded independent review of original radiological images and original case report forms (CRFs) was conducted by an expert radiologist and an expert medical oncologist, respectively. The analysis of the updated data included time to progression (TTP) and overall survival (OS).

Results: CRFs for all 267 patients randomised in the study were available for medical review. The results of the independent review were consistent with the original analysis. At a median follow-up of 69 months, the difference in median TTP and OS in favour of the AT arm remained significant (median TTP 8.1 vs. 6.2 months, (p = 0.036); OS 23.0 vs. 18.3 months, (p = 0.005), respectively).

Conclusions: This blinded independent review and analysis of updated data confirmed the advantage for AT over FAC with regard to TTP and OS in patients with metastatic breast cancer.

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