Trastuzumab treatment in elderly patients with advanced breast cancer (ABC) – results from a large observational study.
Authors: Jackisch C , Hinke A , Schoenegg W , Söling U , Stauch M , Göhler T , Kühn W , Krieger G , Reichert D 
Published: December 2010

Abstract #3144

Background: During the last decade, efficacy and safety of the HER2 antibody trastuzumab (T) has been established in a number of randomized clinical trials (RCT). However, both in the adjuvant and the palliative setting, inclusion of elderly patients (pts) in RCT is comparatively low in the light of the high prevalence of breast cancer in this group. Data on pts older than 65 years (y) were obtained from a prospective observation study that documents the routine usage of T as monotherapy, in combination with chemo- or with endocrine therapy for the treatment of ABC in Germany since 2001 outside the setting of RCT.&#x2028; Material and methods: Anamnestic and treatment records of 1316 pts from more than 150 German centres have currently been entered into the database, 910 of which form the basis of the interim analysis in this abstract. Additional information on long-term outcome, progression-free and overall survival (PFS, OS) were retrieved in a subgroup of 485 pts, in which the treatment documentation was finalized before July 2004. An update analysis is scheduled for Oct 2008.&#x2028; Results: 180 pts (20%) were older than 65y, with an increasing tendency during this study. 8% were &gt;70y and only 2% &gt;80y. The mean time from initial BC diagnosis was 4.1y in this subgroup compared to 3.6y in the whole population. 35% were ER and 47% PR negative. 37% suffered from hepatic involvement. Significantly less pts in the elderly group had received adjuvant chemotherapy compared to pts ≤65y (56% vs. 80%, p&lt;0.0001).&#x2028; In the elderly group T was given distinctly more often as single drug (14% vs 11%) or in combination with endocrine treatment with only (14% vs 9%) and less frequent with chemotherapy (72% vs 80%)(p=0.034, across all groups). There was a slight trend towards a lesser use of taxanes. In the elderly more often capecitabine and vinorelbine were administered. Best overall response rate was 62% (CR: 15%), compared to 60% in the younger group. Long term results were rather similar in elderly/younger pts with medians for PFS of 12.9/9.9 months and, unexpectedly, also for OS with 27/26.6 months (p=0.66 and 0.65, respectively). The main focus was on reported adverse event percentages among elderly/younger pts: Infections 5/6, vomiting 6/4, diarrhea 5/5, neuropathy 8/6, arrhythmia 2/0.5, cardiac function 4/1, thromboembolic events 2/1, edema 5/3.&#x2028; Discussion: The observation of routine T treatment over 6 years revealed that the antibody is increasingly applied in elderly women, albeit more frequently without simultaneous chemotherapy when compared to younger pts. Short and long term efficacy outcomes are comparable to those in pts ≤65y. Toxicity profile in the elderly was unremarkable. Cardiovascular toxicity seems to be slightly increased, but remains clearly within expected and acceptable ranges. These data should encourage to use T in the recommended combination treatment for ABC.

Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 3144.