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.
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.


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.
Jassem
Jacek
J
Dept. of Oncology and Radiotherapy, Medical University of Gdańsk, Gdansk, Poland. jjassem@amg.gda.pl
Pienkowski
Tadeusz
T
Pluzanska
Anna
A
Jelic
Svetislav
S
Gorbunova
Vera
V
Berzins
Juris
J
Nagykalnai
Thomas
T
Biganzoli
Laura
L
Aloe
Alessandra
A
Astier
Ludovic
L
Munier
Stephane
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005060:Europe / Q000453:epidemiology; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use; D015995:Prevalence; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil