Patient-Reported Neuropathy and Taxane-Associated Symptoms in a Phase 3 Trial of nab-Paclitaxel Plus Carboplatin versus Solvent-Based Paclitaxel Plus.

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Patient-Reported Neuropathy and Taxane-Associated Symptoms in a Phase 3 Trial of nab-Paclitaxel Plus Carboplatin versus Solvent-Based Paclitaxel Plus Carboplatin for Advanced Non–Small-Cell Lung Cancer Vera Hirsh, MD, FRCPC, Isamu Okamoto, MD, PhD, Jeremy K. Hon, MD, Ray D. Page, DO, PhD, James Orsini, MD, Hiroshi Sakai, MD, Hui Zhang, MS, Markus F. Renschler, MD, Mark A. Socinski, MD Journal of Thoracic Oncology Volume 9, Issue 1, Pages 83-90 (January 2014) DOI: 10.1097/JTO.0000000000000011 Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1 Composite change from baseline for the 16-item taxane subscale. Symptoms were reported prior to dosing on day 1 of each cycle. Note that larger bars represent greater deteriorations from baseline as perceived by patients. BL, baseline; nab-P/C, nab-paclitaxel + carboplatin; sb-P/C, solvent-based paclitaxel + carboplatin; SEM, standard error of the mean. aP value for treatment effect based on repeated measures over treatment period (cycle 2 through end of treatment). Journal of Thoracic Oncology 2014 9, 83-90DOI: (10.1097/JTO.0000000000000011) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2 Peripheral neuropathy subscore and individual statements. Symptoms were reported prior to dosing on day 1 of each cycle. A, composite peripheral neuropathy subscore, (B) subscore for the statement “I have numbness or tingling in my hands,” (C) subscore for the statement “I have numbness or tingling in my feet,” (D) subscore for the statement “I have trouble buttoning buttons,” (E) subscore for the statement “I have pain in my fingertips,” and (F) subscore for the statement “I have trouble feeling the shape of small objects when they are in my hands.” BL, baseline; nab-P/C, nab-paclitaxel + carboplatin; sb-P/C, solvent-based paclitaxel + carboplatin; SEM, standard error of the mean. a = *P value for treatment effect based on repeated measures over treatment period (cycle 2 through end of treatment). Journal of Thoracic Oncology 2014 9, 83-90DOI: (10.1097/JTO.0000000000000011) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 3 Physician assessment of peripheral neuropathy by cycle. BL, baseline; nab-P/C, nab-paclitaxel + carboplatin; sb-P/C, solvent-based paclitaxel + carboplatin. a At the final evaluation, 1 patient in the sb-P/C arm reported grade 4 peripheral neuropathy (none in the nab-P/C arm). Journal of Thoracic Oncology 2014 9, 83-90DOI: (10.1097/JTO.0000000000000011) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 4 Pain subscore and individual statements. Symptoms were reported prior to dosing on day 1 of each cycle. A, composite pain subscore. B, subscore for the statement “I feel discomfort in my hands.” C, subscore for the statement “I feel discomfort in my feet.” BL, baseline; nab-P/C, nab-paclitaxel + carboplatin; sb-P/C, solvent-based paclitaxel + carboplatin; SEM, standard error of the mean. aP value for treatment effect based on repeated measures over treatment period (cycle 2 through end of treatment). Journal of Thoracic Oncology 2014 9, 83-90DOI: (10.1097/JTO.0000000000000011) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 5 Composite hearing subscore. Symptoms were reported prior to dosing on day 1 of each cycle. BL, baseline; nab-P/C, nabpaclitaxel + carboplatin; sb-P/C, solvent-based paclitaxel + carboplatin; SEM, standard error of the mean. aP value for treatment effect based on repeated measures over treatment period (cycle 2 through end of treatment). Journal of Thoracic Oncology 2014 9, 83-90DOI: (10.1097/JTO.0000000000000011) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 6 Composite edema subscore. Each timepoint represents day 1 of the corresponding cycle, prior to administration of treatment in that cycle. BL, baseline; nab-P/C, nabpaclitaxel + carboplatin; sb-P/C, solvent-based paclitaxel + carboplatin; SEM, standard error of the mean. a = *P value for treatment effect based on repeated measures over treatment period (cycle 2 through end of treatment). Journal of Thoracic Oncology 2014 9, 83-90DOI: (10.1097/JTO.0000000000000011) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions