Email updates

Keep up to date with the latest news and content from BMC Cancer and BioMed Central.

Open Access Research article

Weekly paclitaxel plus trastuzumab in metastatic breast cancer pretreated with anthracyclines-a phase II multipractice study

Matthias John1*, Axel Hinke2, Martina Stauch3, Heiner Wolf4, Benno Mohr5, Hans-Joachim Hindenburg6, Jens Papke7, Joachim Schlosser8 and for the FAKT Study Group

Author affiliations

1 Practice for Gynecology, Dr.-Doerffel-Strasse 1, 08371, Glauchau, Germany

2 WiSP Research Institute, Karl-Benz-Str. 1, 40764, Langenfeld, Germany

3 Practice for Medical Oncology, Niederbonner Arnoldstrasse 2, 96317, Kronach, Germany

4 Practice for Medical Oncology, Arnoldstrasse 18, 01307, Dresden, Germany

5 Practice for Medical Oncology, Breite Strasse 52, 13597, Berlin, Germany

6 Practice for Medical Oncology, Pichelsdorfer Str. 105, 13595, Berlin, Germany

7 Praxis for Medical Oncology, Rosa-Luxemburg-Strasse 6, 01844, Neustadt/Sachsen, Germany

8 Practice for Gynecology, Clausstrasse 76-80, 09126, Chemnitz, Germany

For all author emails, please log on.

Citation and License

BMC Cancer 2012, 12:165  doi:10.1186/1471-2407-12-165

Published: 4 May 2012

Abstract

Background

The 3-weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examined the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.

Methods

Patients with histologically confirmed metastatic breast cancer overexpressing HER2 were eligible if pretreated with anthracycline in either the adjuvant or palliative setting. Treatment consisted of weekly trastuzumab (2 mg/kg/week for up to one year after a loading dose of 4 mg/kg in week 1) and paclitaxel (90 mg/m², administered in weeks 1–6 and 8–13).

Results

Twenty-seven German centers enrolled 121 patients. The median number of metastatic sites was two (range 1–5); 38% of patients had received chemotherapy for advanced disease. After a median 42 weeks of trastuzumab treatment, limited by disease progression in roughly half the patients, a best objective response rate (complete response + partial response) of 76% was achieved, including complete remissions in 29%. 74% of patients lived without tumor progression at six months. Median progression-free and overall survival were 9.4 (95% confidence interval [CI]: 8.1–11.3) and 22 months (95% CI: 17–46). After alopecia, Common Toxicity Criteria grade ≥2 toxicity was predominantly hematological (leukopenia [31%] and anemia [41%]); however, thrombocytopenia occurred in only 5%. Neurotoxicity was remarkably low. Two cardiac events (grades 2 and 3) were presumed treatment-related.

Conclusions

Weekly paclitaxel plus trastuzumab allows an increased dose density and offers an attractive and effective alternative to the conventional schedule. Limiting the duration of cytotoxic therapy to 3 months seems to be an option to reduce neurotoxicity without impairing long-term outcome.