Abstract P5-12-01: Elderly Patients in a Prospective Observation Study on Trastuzumab (Herceptin®) in the Adjuvant Treatment of Breast Cancer
Authors: Dall P , Siedentopf F , Klausmann G , Khandan F , Urbanczyk H , Selbach J , Eggert J , Tesch H , Hinke A , Lerchenmueller C. 
Published: April 2011

Abstract
Purpose: Trastuzumab (T) was registered in 2006 for the treatment of early stage, HER2+ breast cancer, after surgery, (neo)adjuvant chemotherapy and/or radiotherapy, without specific age restrictions. However, the amount of data on elderly patients (EP) from the randomized studies is only sparse. E.g., in the HERA study, only 16% were ≥60 years (y) of age. In this prospective observation study the routine practice of HER2 antibody treatment in this setting was examined, with a special focus on the EP subgroup.
Methods: At present, 1888 patients (pt) have been enrolled in this ongoing study; 1791 pt from 220 German centres were already sufficiently documented to be analysed. 38 were non-eligible due to either M1 or negative HER2 status.
Results: The proportion of EP (≥65 y) steadily increased during the course of the project, with currently 436/176 (25%/10%) ≥65/≥70 y. As to be expected, performance status was more impaired in elderly compared to younger pt (ECOG 0: 51 vs 65%). EP more often presented with a larger tumor (pT≥2: 58 vs. 51%), while lymph node involvement was rather similar (52% vs. 49%). A positive hormone receptor status was recorded in 60 vs 61%. 92% received chemotherapy (CT), with neoadjuvant placement distinctly less common in EP (8 vs 18%), as well as anthracycline (A, 88 vs 95%) and taxane (Ta, 54 vs 64%) administration. An ATa combination was applied in 47 vs 59% only (p&lt;.0001). A median of 6 CT cycles were given in both age groups. No relevant differences were recorded with respect to concurrent T/CT (15%), endocrine treatment (55%), initial T dosage (median 8 mg/kg) and T duration (mean: 50 weeks). Treatment delays were required in 20%, but not more frequent in EP. Slightly more EP stopped treatment prematurely (11% vs 8%, p=.094). Cardiac status was examined by echocardiography (echo) in 81%, with similar baseline LVEF (median: 65%), but some difference at end of treatment (61 vs 64%, p=.017), with an overall rate of pathologic findings in echo/ECG of 13 vs 6% (p&lt;.0001). However, the rate with LVEF &lt;40% was similar with 2%. Grade ≥2 adverse reactions on cardiac function were reported in 3.7 vs 2.1%. No other severe toxicities related to T occurred with a frequency &gt;1%. After a follow-up period of up to a maximum of 5 years, 111 relapses were hitherto reported. The estimated recurrence-free survival is 95% (95% CI: 94 - 96%) and 89% (87 - 92%) after 2 and 3 years, respectively, with no detectable differences between age groups (p = 0.87). Conclusion: T can be applied safely in early breast cancer, without restrictions with respect to age, with higher age often accounted for by the choice of less aggressive CT. In the elderly, differences in cardiac toxicity and premature withdrawal can be detected, but seem to be of limited absolute magnitude and clinical relevance.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-12-01.