Safety and tolerability of adjuvant dose dense chemotherapy in elderly patients with node-positive early breast cancer.

1093 Background: Intensive chemotherapy confers benefit to older and younger patients with early breast cancer (BC). We aim to characterize the feasibility and toxicity profile of adjuvant dose-dense chemotherapy (ADDC) in older women with early node positive (BC). Methods: Available data from women who received ADDC for BC within three randomized trials between 1997 and 2008 were retrieved from our electronic database. These trials included HE 10/97: epirubicin and cyclophosphamide, methotrexate and fluorouracil (CMF) with or without paclitaxel, HE 10/00: epirubicin and concurrent or sequential paclitaxel and CMF and HE 10/05: a sequential three arm study of epirubicin, paclitaxel and CMF compared with epirubin, CMF and either weekly paclitaxel or docetaxel. We identified women aged >65 years and we looked at differences in tolerability and delivery of chemotherapy, toxicity, and treatment outcome. Results: From a total of 2,640 patients with a median age of 52 years, who received ADDC, we identified 453 patients (17%) > 65 years, hormonal positive in 76%, all node negative. At least 90% of the planned doses were delivered in 37% of the elderly, compared to 49% of the younger patients (p < 0.0001). Grade 3 and 4 hematological toxicity was observed in 32% of elderly patients compared to 21% of younger (p < 0.0001). Febrile neutropenia occurred in 4.5% of elderly patients as opposed to 2% of younger (p < 0.002). Elderly patients experienced more frequently grade 3 and 4 fatigue, mucositis and sensory neuropathy, though the incidence of these toxicities was relatively low (all p < 0.0001). Relative dose intensities were significantly lower in elderly patients, mainly affected docetaxel and paclitaxel administration. Treatment discontinuation, regardless causality, was not different in both groups. At a median follow-up of 120 months, there was no significant difference in disease free survival. Conclusions: Elderly node positive BC patients treated with ADDC derive comparable clinical benefit as younger patients, mainly in the cost of increased risk of hematological toxicity. This should be taken into account in decision making and treatment individualization in high risk BC patients.