Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer

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674 Background: This study determined if adding trastuzumab (Herceptin, T) to P modified the QOL of HER-2 non-overexpressors and examined QOL differences between patients treated with weekly versus standard P. Methods: Of the 585 patients treated in CALGB 9840, 394 provided QOL data. Eligibility criteria and main trial results were reported, indicating greater efficacy in weekly versus standard P, but no greater efficacy with T in HER-2 negatives (Seidman AD et al., Proc ASCO 2004, Vol. 22, No 14S, abstract 512). HER-2 non-overexpressors were randomized to 1 of 4 groups: 1) P 175 mg/m2 over 3 hrs every 3 wks; 2) P 80 mg/m2 over 1 hr weekly; 3) P 175 mg/m2 over 3 hrs every 3 wks + T 4 mg/kg load, then 2 mg/kg weekly; and 4) P l 80 mg/m2 over 1 hr weekly + T 4 mg/kg load, then 2 mg/kg weekly, all IV. All HER-2 overexpressors received T and were randomized to group 3 or 4. Patients completed QOL interviews prior to randomization, and at 3, 6, and 9 months. Main outcome measures were the EORTC-C30 with the Breast Module (QLQ-BR23). Data were analyzed using general linear models for repeated measures, with the following covariates: treatment arm, assessment point, patient age, race, education, marital status, performance status, prior chemotherapy, and prior radiation therapy. Results: HER-2 negative patients receiving weekly P with/without T as compared to standard P with/without T reported better global QOL (p=.022) and fewer cancer symptoms (p=.036). No QOL differences were observed among the HER-2 overexpressors. The use of T in the HER-2 negatives, regardless of P schedule, resulted in better role (p=.002) and emotional functioning (p=.039), and fewer arm (p=.045) and breast (p=.033) symptoms than HER-2 negative patients not receiving T. No differences in physical, social, and cognitive functioning were observed across any of these treatment groups. Conclusions: Both weekly P and T improved the QOL of HER-2 negative patients. There were no QOL differences by P schedule among the HER-2 overexpressors. The higher QOL in HER-2 negatives receiving T was unexpected, inconsistent with clinical data, and needs further exploration in the dataset. [Table: see text]