Abstract P5-10-09: Comparison of the (Non-)Hematological Toxicity and Compliance of Different Anthracycline Containing Regimen with the Standard AC/EC in Elderly Patients with Primary Breast Cancer

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Abstract Background: There is a paucity on toxicity (tox) data in elderly patients (pts) above 65 years (yrs) treated with anthracycline containing standard chemotherapy (ct) for primary breast cancer. We investigated the tox of standard anthracycline based regimen (AC/EC) and compared those with alternatives like dose-dense monotherapies and combinations (Edd; ADdd), intensified combinations (Canadian FEC) and taxane/anthracycline combinations (TAC) in various age groups. Patients and methods: In this pooled analysis, individual pts data from 4 German randomized trials (n= 4775) were evaluated regarding tox and compliance. Docetaxel/doxorubicin/cyclophosphamide (75/500/500mg/m2) 3qw (A=TAC), 5-fluorouracil/epirubicin (500/60mg/m2) iv d1+8 followed by cyclophosphamide (75mg/m2) po d1-14 q4w (B=cFEC), doxorubicin (epirubicin)/cyclophosphamide (60(90)/600mg/m2) q3w followed by docetaxel (100mg/m2) or paclitaxel (175mg/m2) q3w (C= AC/EC-D/p), doxorubicin/docetaxel (50/75mg/m2) q2w (D= AD dose dense(dd)) and epirubicin-paclitaxel q2w (120/175 mg/m2) (E= sequence dd) were given. Only the anthracycline containing cycles were investigated. A descriptive analysis was performed on compliance and (non-) hematological tox. Pts were grouped according to their age: < 60yrs [1], 60-64 yrs [2] and >64yrs [3]. Primary G-CSF support was given in A, D, E. Results: 73.6% were <60 yrs, 15.8% were 60-64 and 10.6% were > 64. A total of 22,306 anthracycline containing cycles were administered, of those 74.6% were given to [1], 15.2% to [2] and 10.0 % to [3]. 41.6% of the pts received TAC; 11.5% cFEC; 29.2% AC/EC-D/P; 8.2% ADoc dd and 9.5% Edd-Pdd. The incidence of febrile neutropenia (FN) did not significantly differ between the 3 age groups (overall A:10.0%; B:2.9%; C:1.0%; D:4.7%) apart from E with 0.9% ([1]0%; [2]6.4%; [3]0% P<0.001). FN in pts >64 was lower in B (2.4%) than in A (14.4%) and D (5.1%). Diarrhea grade 3+4 increased with age to 8.2% for [3] under TAC (p= 0.01) and mucositis grade 3+4 under E to 12% for >64 (P<0.001). Conclusion: In total, range and intensity of tox increased with age. Neutropenia did significantly increase with age in standard regimen but not in the dd groups Rate of dose reduction increased with age in A ([1] 6.1%; [2]6.5%; [3] 11.5; p=0.02) and B ([1]15.7%; [2]26.9%; [3]39.3%; p< 0.001). Similar significant results were observed for discontinuations and hospitalizations in A, B, D. Neutropenia grade 3+4 in [3] was 77% with cFEC, vs 55%with TAC (with primary G-CSF). Leucopenia Grade 3+4 in % (D, E). The severity of the non-hematotox differed between age groups and regimen. Monotherapies and sequential regimen seem more favorable in elderly pts. cFEC without G-CSF is not an option in pts >64. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-10-09.

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