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Open Access Research article

Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments

Lucia Del Mastro1*, Alessandra Fabi2, Mauro Mansutti3, Michele De Laurentiis45, Antonio Durando6, Domenico Franco Merlo7, Paolo Bruzzi7, Ignazia La Torre8, Matteo Ceccarelli8, Gbenga Kazeem9, Paolo Marchi8, Davide Boy8, Marco Venturini10, Sabino De Placido4 and Francesco Cognetti2

Author Affiliations

1 IRCCS AOU San Martino - IST - National Institute for Cancer Research, UO Sviluppo Terapie Innovative, Genoa, Italy

2 Division Oncology, Regina Elena Institute, Rome, Italy

3 Department Oncology, S. Maria della Misericordia Hospital, Udine, Italy

4 Department of Endocrinology and Molecular and Clinical Oncology, University of Naples Federico II, Naples, Italy

5 Department of Senology, Division of Breast Oncology, National Cancer Institute “Fondazione Pascale”, Naples, Italy

6 A.O.O.I. Regina Margherita S. Anna, Turin, Italy

7 IRCCS AOU San Martino - IST - National Institute for Cancer Research, UO Epidemiologia Clinica, Genoa, Italy

8 Eli Lilly Italy, Medical Department, Sesto Fiorentino, FI, Italy

9 Eli Lilly UK, Erl Wood, Surrey, UK

10 Division Oncology, S. Cuore – Don Calabria Hospital, Verona, Italy

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BMC Cancer 2013, 13:164  doi:10.1186/1471-2407-13-164

Published: 28 March 2013

Abstract

Background

This open-label study compared docetaxel/gemcitabine vs. paclitaxel/gemcitabine and a weekly (W) vs. 3-weekly (3 W) schedule in metastatic breast cancer (MBC).

Methods

Patients relapsed after adjuvant/neoadjuvant anthracycline-containing chemotherapy were randomized to: A) gemcitabine 1000 mg/m2 Day 1,8 + docetaxel 75 mg/m2 Day 1 q3W; B) gemcitabine 1250 mg/m2 Day 1,8 + paclitaxel 175 mg/m2 Day 1 q3W; C) gemcitabine 800 mg/m2 Day 1,8,15 + docetaxel 30 mg/m2 Day 1,8,15 q4W; D) gemcitabine 800 mg/m2 Day 1,15 + paclitaxel 80 mg/m2 Day 1,8,15 q4W. Primary endpoint was time-to-progression (TTP). Secondary endpoints were overall survival (OS) and overall response rate (ORR).

Results

Interim analysis led to accrual interruption (241 patients enrolled of 360 planned). Median TTP (months) was 8.33 (95% CI: 6.19-10.16) with W and 7.51 (95% CI: 5.93-8.33) with 3 W (p=0.319). No differences were observed in median TTP between docetaxel and paclitaxel, with 85.6% and 87.0% of patients progressing, respectively. OS did not differ between regimens/schedules. ORR was comparable between regimens (HR: 0.882; 95% CI: 0.523-1.488; p=0.639), while it was significantly higher in W than in the 3 W (HR: 0.504; 95% CI: 0.299-0.850; p=0.010) schedule. Grade 3/4 toxicities occurred in 69.2% and 71.9% of patients on docetaxel and paclitaxel, and in 65.8% and 75.2% in W and 3 W.

Conclusions

Both treatment regimens showed similar TTP. W might be associated with a better tumour response compared with 3 W.

Trial registration

Clinicaltrial.gov ID NCT00236899

Keywords:
Metastatic breast cancer; Weekly schedule; 3-weekly schedule