A haemophilia-specific health-related quality-of-life questionnaire (named 'Hemofilia-QoL') was developed to assess quality-of-life in adults with haemophilia, and was psychometrically tested. Seventy-three interviews with haemophilia patients and health care professionals were used to generate the items included in the questionnaire, and expert ratings on the items formulated were used to screen them for potential omission. This was followed by psychometric testing in a sample of 35 patients. Preliminary psychometric testing of the revised questionnaire version, which contains 10 domains (physical health, physical role, joint damage, pain, treatment satisfaction, emotional role, mental health, social support), showed acceptable reliability (alpha = 0.94 for the Hemofilia-QoL total score) and validity, and this will be examined in a subsequent study with a larger patient sample.

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Aims: nab-paclitaxel is an innovative chemotherapy that consists of nano-particles of human serum albumin bound paclitaxel. It exploits the role of albumin as the natural carrier of hydrophobic molecules in human to increase paclitaxel delivery to tumor cells. Weekly nab-paclitaxel showed a superior efficacy compared to every 3-weeks docetaxel in a randomized phase II study in metastatic breast cancer (Gradishar JCO 2009, Clin. Breast Cancer 2012). This single arm phase II trial has been designed to evaluate the activity and safety of weekly nab-paclitaxel as neoadjuvant treatment of early stage breast cancer patients with positive estrogen receptors and negative HER2. Methods: Stage II-III patients were included and treated with nab-paclitaxel weekly at a dose of 150 mg/m2 on days 1, 8 and 15 every 4 weeks for 4 cycles. Following chemotherapy, patients undergo surgery and adjuvant therapy (with radiation, chemo and endocrine therapy) under the investigator criteria. The primary objective is to determine the residual cancer burden class III as measured by the Symmans criteria (JCO 25:4422,2007). Secondary objectives include pathological complete response, overall response, invasive disease free survival, safety and potential correlative biomarkers. Results: Eighty-three patients have been recruited in the study in 13 Spanish institutions. Here we report safety data from 77 patients. Median age was 48 years, 62% were postmenopausal and 94% had ECOG PS 0; most patients were stage II (23% IIa and 36% IIb). A total of 259 cycles have been administered to date; 47 patients completed 4 cycles as planned, 5 patients discontinued treatment early (due to grade 2-3 sensory neuropathy in 4 patients), the remaining patients are still under treatment. The treatment was delayed in 8.1% of patients; nab-paclitaxel doses were omitted and reduced in 3.9% and 9.7% of cycles respectively, for a relative dose intensity of nab-paclitaxel of 97.3%. The most frequent reasons for dose modifications were neutropenia (5.4%) and neuropathy (2.7%). The main grade 2/3 adverse events are described in table 1. Table 1Related adverse events.Per patient (N = 74)Per Cycle (N = 259)NCI-CTCAE vs 4.0. (>5% grade 2-4)Grade 2, N (%)Grade 3, N (%)Grade 2, N (%)Grade 3, N (%)Leukopenia6 (8.1)1 (1.4)11 (4.2)1 (0.4)Neutropenia17(23)7 (9.5)30 (11.6)9 (3.5)Alopecia47(63.5)—121 (46.7)—Fatigue11 (14.9)2 (2.7)17 (6.6)2 (0.8)Neuropathy: Sensory17 (23)2 (2.7)25(9.6)5 (1.9)Musculoskeletal Pain11 (14.9)0 (0)13 (5.0)0 (0) Conclusions: Neoadjuvant therapy with weekly nab-paclitaxel at dose of 150 mg/m2 on days 1, 8 and 15 every 4 weeks was well tolerated. Final safety data for the entire treated patients will be mature and presented at the meeting. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-14-15.

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