Universität zu Köln

von Minckwitz, Gunter, Schweller, Kathrin, Schmidt, Marcus ORCID: 0000-0003-1365-2414, Barinoff, Jana, Mundhenke, Christoph ORCID: 0000-0002-6989-6250, Cufer, Tanja, Maartense, Eduard ORCID: 0000-0002-5891-031X, de Jongh, Felix E., Baumann, Klaus H., Bischoff, Joachim, Harbeck, Nadia, Lueck, Hans-Joachim, Maass, Nicolai, Zielinski, Christoph, Andersson, Michael, Stein, Robert C., Nekljudova, Valentina and Loibl, Sibylle (2011). Trastuzumab beyond progression: Overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer. Eur. J. Cancer, 47 (15). S. 2273 - 2282. OXFORD: ELSEVIER SCI LTD. ISSN 0959-8049

Full text not available from this repository.

Abstract

Background: Continuation of trastuzumab plus capecitabine (XH) showed a significantly improved overall response rate and time to progression compared with capecitabine (X) alone in women with HER2-positive breast cancer progressing during trastuzumab treatment. Here, we report the final analysis on overall survival. Patients and methods: Patients with HER2-positive, advanced breast cancer who progressed during treatment with trastuzumab with or without 1st-line metastatic chemotherapy were prospectively randomised to X (2500 mg/m(2) on days 1-14, q3w) or XH (6 (8) mg/kg, q3w). Overall survival was a pre-specified secondary end-point. Results: Median follow-up at June 2010 was 20.7 months. Fifty nine of 74 and 60 of 77 patients died in the X and XH arm, respectively. Median overall survival was 20.6 and 24.9 months with X and XH, respectively (HR = 0.94 [0.65-1.35]; p = 0.73). Performance status and metastatic site were independent prognosticators for overall survival. No difference between treatment arms was observed for patients who achieved clinical response or clinical benefit, respectively. Patients who continued/restarted anti-HER2 treatment (trastuzumab or lapatinib) after 2nd progression (N = 52) had a post-progression survival of 18.8 compared with 13.3 months for those who did not receive 3rd line treatment with anti-HER2 agents (N = 88) (HR 0.63; p = 0.02). Conclusions: Final overall survival analysis of the GBG-26 study did not demonstrate a significant survival benefit for treatment beyond progression with trastuzumab. However, in a post-hoc analysis, patients receiving anti-HER2 treatment as 3rd line therapy showed a better post-progression survival than those not receiving this targeted treatment. (C) 2011 Elsevier Ltd. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code von Minckwitz, Gunter UNSPECIFIED UNSPECIFIED UNSPECIFIED Schweller, Kathrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, Marcus UNSPECIFIED orcid.org/0000-0003-1365-2414 UNSPECIFIED Barinoff, Jana UNSPECIFIED UNSPECIFIED UNSPECIFIED Mundhenke, Christoph UNSPECIFIED orcid.org/0000-0002-6989-6250 UNSPECIFIED Cufer, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Maartense, Eduard UNSPECIFIED orcid.org/0000-0002-5891-031X UNSPECIFIED de Jongh, Felix E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baumann, Klaus H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bischoff, Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Harbeck, Nadia UNSPECIFIED UNSPECIFIED UNSPECIFIED Lueck, Hans-Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Maass, Nicolai UNSPECIFIED UNSPECIFIED UNSPECIFIED Zielinski, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Andersson, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Stein, Robert C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nekljudova, Valentina UNSPECIFIED UNSPECIFIED UNSPECIFIED Loibl, Sibylle UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-488399
DOI:	10.1016/j.ejca.2011.06.021
Journal or Publication Title:	Eur. J. Cancer
Volume:	47
Number:	15
Page Range:	S. 2273 - 2282
Date:	2011
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	0959-8049
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language LAPATINIB PLUS CAPECITABINE; TRIAL; WOMEN Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48839