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A Randomized Trial Comparing Immediate versus Delayed Treatment of Anemia with Once-Weekly Epoetin Alfa in Patients with Non-small Cell Lung Cancer Scheduled to Receive First-Line Chemotherapy Jeffrey Crawford, MD, Francisco Robert, MD, Michael C. Perry, MD, Chandra Belani, MD, Denise Williams, MD Journal of Thoracic Oncology Volume 2, Issue 3, Pages (March 2007) DOI: /JTO.0b013e318031cd9a Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 1 Treatment schema. SC, subcutaneously; QW, once weekly; Hb, hemoglobin; ↓, decrease; ↑, increase. Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 2 Patient disposition. *One patient was randomized to immediate epoetin alfa but did not meet eligibility criteria and was excluded from the study before receiving treatment. †Modified intent-to-treat analysis; patients who were randomized and had at least one postbaseline efficacy evaluation. ‡Includes seven patients who received epoetin alfa despite having Hb >10 g/dl. §A patient was considered to have completed the study at the week 16 visit after completing the final study evaluations. Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 3 Linear analogue scale assessment (LASA) overall quality-of-life scores (last observation carried forward). Baseline QOL scores were not carried forward. *p = 0.01 versus immediate epoetin alfa group. †p = 0.02 versus immediate epoetin alfa group. ‡p = 0.09 versus immediate epoetin alfa group. §p = 0.06 versus immediate epoetin alfa group. Delayed: Data were analyzed as a whole, irrespective of whether a patient received epoetin alfa for declining Hb. Censored analysis (delayed): All measurements taken once a patient received epoetin alfa were excluded. Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 4 Hemoglobin (Hb) over time by treatment group (last observation carried forward). *p = versus epoetin alfa group. Delayed: Data were analyzed as a whole, irrespective of whether a patient received epoetin alfa for declining Hb. Censored analysis (delayed): All measurements taken once a patient received epoetin alfa were excluded. Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 5 Kaplan–Meier curve for time to hemoglobin (Hb) <10 g/dl. *p < (Fisher's exact test). Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 6 Frequency distribution of hemoglobin (Hb) strata (last observation carried forward) for (A) immediate epoetin alfa group and (B) delayed group. Horizontal bars indicate Hb = 12 g/dl. Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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FIGURE 7 Overall survival. Treatment group comparison p value = (log rank). Journal of Thoracic Oncology 2007 2, DOI: ( /JTO.0b013e318031cd9a) Copyright © 2007 International Association for the Study of Lung Cancer Terms and Conditions
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