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Simona Aloe Medical Affair Le nanobiotecnologie tra ricerca e sviluppo d impresa Palazzo delle Stelline Milano, 23-24 G

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Simona Aloe Medical Affair Le nanobiotecnologie tra ricerca e sviluppo d impresa Palazzo delle Stelline Milano, 23-24 G

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    7. Speaker Notes: Taxanes are a recognized part of the standard of care for the treatment of early-stage and metastatic breast cancer.1 Weekly dosing, not higher dosing, has been the only effective strategy that enhances the efficacy endpoints of solvent-based (sb)-paclitaxel. 2,3 Docetaxel has greater efficacy when compared to paclitaxel on a Q3W dosing schedule, although the former was associated with significantly more toxicities.4 nab-Paclitaxel was shown to have superior efficacy when compared to sb-paclitaxel in a phase III study of patients with metastatic breast cancer.5 Because the optimal dosing schedule for nab-Paclitaxel was not known prior to this study, multiple arms were assigned to nab®paclitaxel at varying doses and schedules. References: Conlin AK, Seidman AD: Taxanes in breast cancer: An update. Curr Oncol Rep 9:22-30, 2007 Winer EP, Berry DA, Woolf S, et al: Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: Cancer and Leukemia Group B trial 9342. J Clin Oncol 22:2061-2068, 2004 Verrill MW, Lee J, Cameron DA, et al: Anglo-Celtic IV: first results of a UK National Cancer Research Network randomised phase 3 pharmacogenetic trial of weekly versus 3 weekly paclitaxel in patients with locally advanced or metastatic breast cancer (ABC). J Clin Oncol 25:33s, 2007 (suppl; abstr LBA1005) Jones SE, Erban J, Overmoyer B, et al: Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542-5551, 2005 Gradishar WJ, Tjulandin S, Davidson N, et al: Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil-Based Paclitaxel in Women With Breast Cancer. J Clin Oncol 23:7794-803, 2005 Speaker Notes: Taxanes are a recognized part of the standard of care for the treatment of early-stage and metastatic breast cancer.1 Weekly dosing, not higher dosing, has been the only effective strategy that enhances the efficacy endpoints of solvent-based (sb)-paclitaxel. 2,3 Docetaxel has greater efficacy when compared to paclitaxel on a Q3W dosing schedule, although the former was associated with significantly more toxicities.4 nab-Paclitaxel was shown to have superior efficacy when compared to sb-paclitaxel in a phase III study of patients with metastatic breast cancer.5 Because the optimal dosing schedule for nab-Paclitaxel was not known prior to this study, multiple arms were assigned to nab®paclitaxel at varying doses and schedules. References: Conlin AK, Seidman AD: Taxanes in breast cancer: An update. Curr Oncol Rep 9:22-30, 2007 Winer EP, Berry DA, Woolf S, et al: Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: Cancer and Leukemia Group B trial 9342. J Clin Oncol 22:2061-2068, 2004 Verrill MW, Lee J, Cameron DA, et al: Anglo-Celtic IV: first results of a UK National Cancer Research Network randomised phase 3 pharmacogenetic trial of weekly versus 3 weekly paclitaxel in patients with locally advanced or metastatic breast cancer (ABC). J Clin Oncol 25:33s, 2007 (suppl; abstr LBA1005) Jones SE, Erban J, Overmoyer B, et al: Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23:5542-5551, 2005 Gradishar WJ, Tjulandin S, Davidson N, et al: Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil-Based Paclitaxel in Women With Breast Cancer. J Clin Oncol 23:7794-803, 2005

    11. This was an international, multicentre, randomised Phase III trial conducted in 460 patients 40 US patients (22 sites), 67 UK patients (20 sites) and 353 Russian patients (28 sites) participated 6 patients did not receive study drug. Patients were randomised to either the nab-paclitaxel arm or the paclitaxel (paclitaxel injection) arm. nab-Paclitaxel arm (n=233): 260 mg/m˛ over 30 minutes once every 3 weeks with no standard premedication Standard paclitaxel arm (n = 227): 175 mg/m˛ over 3 hours once every 3 weeks with standard premedications of steroids and antihistamines Patients were randomly assigned to receive treatment every 3 weeks with nab-paclitaxel 260 mg/m2 or standard paclitaxel 175 mg/m2. The median and mean number of cycles delivered were higher for patients in the nab-paclitaxel group than for those in the paclitaxel group (6 vs 5 median cycles per patient, respectively; 5.6 vs 5.2 mean cycles per patient, respectively). The percentage of planned dose delivery was the same between the arms – 98%. The mean dose per cycle (m2) was similar in the two treatment arms. As expected, the mean dose was higher in the nab-paclitaxel group (255 mg). The planned dose delivered was 98% in both arms, but the mean total paclitaxel per patient (m2) was higher by >50% in the nab-paclitaxel group. In other words, the amount of active paclitaxel delivered per patient was higher in the nab-paclitaxel group than in the paclitaxel group. This was possible because the solvent-free formulation of nab-paclitaxel allows for preferential uptake in the tumour as well as linear pharmacokinetics.This was an international, multicentre, randomised Phase III trial conducted in 460 patients 40 US patients (22 sites), 67 UK patients (20 sites) and 353 Russian patients (28 sites) participated 6 patients did not receive study drug. Patients were randomised to either the nab-paclitaxel arm or the paclitaxel (paclitaxel injection) arm. nab-Paclitaxel arm (n=233): 260 mg/m˛ over 30 minutes once every 3 weeks with no standard premedication Standard paclitaxel arm (n = 227): 175 mg/m˛ over 3 hours once every 3 weeks with standard premedications of steroids and antihistamines Patients were randomly assigned to receive treatment every 3 weeks with nab-paclitaxel 260 mg/m2 or standard paclitaxel 175 mg/m2. The median and mean number of cycles delivered were higher for patients in the nab-paclitaxel group than for those in the paclitaxel group (6 vs 5 median cycles per patient, respectively; 5.6 vs 5.2 mean cycles per patient, respectively). The percentage of planned dose delivery was the same between the arms – 98%. The mean dose per cycle (m2) was similar in the two treatment arms. As expected, the mean dose was higher in the nab-paclitaxel group (255 mg). The planned dose delivered was 98% in both arms, but the mean total paclitaxel per patient (m2) was higher by >50% in the nab-paclitaxel group. In other words, the amount of active paclitaxel delivered per patient was higher in the nab-paclitaxel group than in the paclitaxel group. This was possible because the solvent-free formulation of nab-paclitaxel allows for preferential uptake in the tumour as well as linear pharmacokinetics.

    12. Esposizione ai farmaci This was an international, multicentre, randomised Phase III trial conducted in 460 patients 40 US patients (22 sites), 67 UK patients (20 sites) and 353 Russian patients (28 sites) participated 6 patients did not receive study drug. Patients were randomised to either the nab-paclitaxel arm or the paclitaxel (paclitaxel injection) arm. nab-Paclitaxel arm (n=233): 260 mg/m˛ over 30 minutes once every 3 weeks with no standard premedication Standard paclitaxel arm (n = 227): 175 mg/m˛ over 3 hours once every 3 weeks with standard premedications of steroids and antihistamines Patients were randomly assigned to receive treatment every 3 weeks with nab-paclitaxel 260 mg/m2 or standard paclitaxel 175 mg/m2. The median and mean number of cycles delivered were higher for patients in the nab-paclitaxel group than for those in the paclitaxel group (6 vs 5 median cycles per patient, respectively; 5.6 vs 5.2 mean cycles per patient, respectively). The percentage of planned dose delivery was the same between the arms – 98%. The mean dose per cycle (m2) was similar in the two treatment arms. As expected, the mean dose was higher in the nab-paclitaxel group (255 mg). The planned dose delivered was 98% in both arms, but the mean total paclitaxel per patient (m2) was higher by >50% in the nab-paclitaxel group. In other words, the amount of active paclitaxel delivered per patient was higher in the nab-paclitaxel group than in the paclitaxel group. This was possible because the solvent-free formulation of nab-paclitaxel allows for preferential uptake in the tumour as well as linear pharmacokinetics. This was an international, multicentre, randomised Phase III trial conducted in 460 patients 40 US patients (22 sites), 67 UK patients (20 sites) and 353 Russian patients (28 sites) participated 6 patients did not receive study drug. Patients were randomised to either the nab-paclitaxel arm or the paclitaxel (paclitaxel injection) arm. nab-Paclitaxel arm (n=233): 260 mg/m˛ over 30 minutes once every 3 weeks with no standard premedication Standard paclitaxel arm (n = 227): 175 mg/m˛ over 3 hours once every 3 weeks with standard premedications of steroids and antihistamines Patients were randomly assigned to receive treatment every 3 weeks with nab-paclitaxel 260 mg/m2 or standard paclitaxel 175 mg/m2. The median and mean number of cycles delivered were higher for patients in the nab-paclitaxel group than for those in the paclitaxel group (6 vs 5 median cycles per patient, respectively; 5.6 vs 5.2 mean cycles per patient, respectively). The percentage of planned dose delivery was the same between the arms – 98%. The mean dose per cycle (m2) was similar in the two treatment arms. As expected, the mean dose was higher in the nab-paclitaxel group (255 mg). The planned dose delivered was 98% in both arms, but the mean total paclitaxel per patient (m2) was higher by >50% in the nab-paclitaxel group. In other words, the amount of active paclitaxel delivered per patient was higher in the nab-paclitaxel group than in the paclitaxel group. This was possible because the solvent-free formulation of nab-paclitaxel allows for preferential uptake in the tumour as well as linear pharmacokinetics.

    13. Tassi di risposta 13

    14. Tempo alla progressione Reference Gradishar et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005; 23: 7794–7803. Reference Gradishar et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005; 23: 7794–7803.

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    17. Building New Therapeutic Franchises: Oncology

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