Skip Navigation



Annals of Oncology Advance Access published online on July 19, 2005
Annals of Oncology, doi:10.1093/annonc/mdi321
This Article
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
16/10/1624    most recent
mdi321v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Schmid, P.
Right arrow Articles by Flath, B.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Schmid, P.
Right arrow Articles by Flath, B.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 2005 European Society for Medical Oncology
Received April 13, 2005
Revised June 13, 2005
Accepted June 14, 2005

Original article

Primary chemotherapy with gemcitabine as prolonged infusion, non-pegylated liposomal doxorubicin and docetaxel in patients with early breast cancer: final results of a phase II trial

P. Schmid 1*, J. Krocker 2, C. Jehn 1, K. Michniewicz 2, S. Lehenbauer-Dehm 1, H. Eggemann 2, V. Heilmann 3, S. Kümmel 4, C. O. Schulz 1, A. Dieing 1, M. B. Wischnewsky 5, S. Hauptmann 6, D. Elling 2, K. Possinger 1, and B. Flath 1

1 Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Mitte, Humboldt Universität zu Berlin, Berlin
2 Frauenklinik, Oskar-Ziethen-Krankenhaus, Berlin
3 Frauenklinik, Universitätsklinikum Ulm, Ulm
4 Klinik für Gynäkologie und Geburtshilfe, Charité Campus Mitte, Humboldt Universität zu Berlin, Berlin
5 Department for Intelligent Systems, University of Bremen, Bremen
6 Department of Pathology, University of Halle, Halle, Germany

* To whom correspondence should be addressed.
P. Schmid, E-mail: peter.schmid{at}charite.de


  Abstract

Background: Combinations of anthracyclines, taxanes and gemcitabine have shown high activity in breast cancer. This trial was designed to evaluate a modified combination regimen as primary chemotherapy. Non-pegylated liposomal doxorubicin (NPLD) was used instead of conventional doxorubicin to improve cardiac safety. Gemcitabine was given 72 h after NPLD and docetaxel as a prolonged infusion over 4 h in order to optimize synergistic effects and accumulation of active metabolites.

Patients and methods: Forty-four patients with histologically confirmed stage II or III breast cancer were treated with NPLD (60 mg/m2) and docetaxel (75 mg/m2) on day 1 and gemcitabine as 4-h infusion (350 mg/m2) on day 4. Treatment was repeated every 3 weeks for a maximum of six cycles. All patients received prophylactically recombinant granulocyte colony-stimulating factor. Patients with axillary lymph node involvement after primary chemotherapy received adjuvant treatment with cyclophosphamide, methotrexate and fluorouracil.

Results: The clinical response rate was 80%, and complete remissions of the primary tumor occurred in 10 patients (25%). Breast conservation surgery was performed in 19 out of 20 patients (95%) with an initial tumor size of less than 3 cm and in 14 patients (70%) with a tumor size ≤3 cm. Seven patients had histologically confirmed complete responses accounting for a pCR rate of 17.5%. Expression of Ki-67 was the most important predictive parameter for response with high 38.9% breast pCR rate in patients with elevated Ki-67 expression. Although the predominant toxicity was myelosuppression with grade 3/4 neutropenia in 61% of patients few neutropenic complications resulted. Non-hematological toxicity was generally moderate with grade 3 or 4 toxicity in 10.0% of cycles. Most common non-hematologic toxicities were nausea, vomiting, alopecia, mucositis, asthenia and elevation of liver enzymes.

Conclusion: The evaluated schedule provides a safe and highly effective combination treatment for patients with early breast cancer, which is suitable for phase III studies.

Keywords: adjuvant treatment; docetaxel; gemcitabine; liposomal doxorubicin; locally advanced breast cancer; neoadjuvant treatment; primary chemotherapy.
Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?




Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.