one more important SABCS abstract
For those with primarily bone metastases, combining herceptin and antihormonal therapy made a significant difference. Interestingly, in this study overall, 63% of the her2+ patients with metastatic breast cancer were ER+
SABCS 2007: ABSTRACT #4059: Clinical use of trastuzumab (Herceptin) in metastatic breast cancer (MBC) in Germany from 2001 to 2006
Background: Trastuzumab (T) was registered in Germany in 2001 for MBC in combination with paclitaxel or as single drug. In this prospective, non-interventional observation study the actual routine practice T is reviewed.
Material and methods: A total of 910 patients (pts) were recorded in 142 german centres. The median duration of documented therapy was 49 weeks. Information on long-term outcomes, progression-free and overall survival (PFS, OS) was retrieved in a subgroup of 485 pts, in which the treatment documentation had been finalized before July 2004. Pts were stratified in three cohorts:
T single drug therapy ("T"), 102 pt (11%)
T combined with chemotherapy (CT) with or without endocrine therapy ("T+CT"), 715 pt (79%)
T combined with endocrine therapy only ("T+HT"), 91 pt (10%)
Results: Median age was 57 years. Mean relapse-free interval was 2.7 years; 37% of pts were receptor negative. At start of T treatment, 9% suffered from locally advanced cancer, only. Liver (40%) and lung (30%) involvement was higher in the T+CT group, while the majority of T+HT pts suffered from bone metastasis. 45% of pts had previously received 1 to 4 chemotherapy regimens for MBC. 79% were pre-treated with anthracyclines either adjuvant or for MBC. No major changes in the distribution of combination type cohorts was discernable during the study The proportion of pts receiving a combination with taxanes (paclitaxel:docetaxel relation 2:1) decreased over time, replaced by polychemotherapy (34%), vinorelbine (18%) and capecitabine (4%). In 20% T treatment was initiated on a 3weekly schedule. Overall response rate (RR) was 56%. RR were higher for any first-line treatment (table. 1). Pts previously treated with anthracyclines and taxanes had the lowest (47%), pts pretreated with (CT) but with neither of these drugs had the highest RR (62%).
Based on 417 events in 485 pts with long-term observation, the estimated median PFS was 9.8 months (mo) in the total group, 7.1 mo on T, 10.1 mo on T+CT and 11.9 mo on T+HT. The respective OS medians were 30, 27, 28 and 44 mo, based on 299 reported deaths. Treatment was generally well tolerated. Cardiovascular toxicity grade 3/4 was reported in 7 (1%) pts, only (T: 2, T+CT:4, T+HT:1).
Discussion: T treatment over time revealed, that T is used in a variety of combinations clearly noted as off label use during this time period. RR after first line treatment are within the expected range, but were remarkably high also after previous palliative chemotherapy. In the T+HT cohort, with predominantly bone metastases , RR were lower, but OS reached almost four years.
|