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• W2014136545 abstract "Dysphagia is a common, acute toxicity of combined chemoradiotherapy (CT/RT) to manage locally advanced non–small-cell lung cancer (NSCLC). Palifermin (Kepivance, a recombinant human keratinocyte growth factor) prevents severe oral mucositis in patients undergoing high-dose chemotherapy, total body irradiation, and stem cell transplantation for hematologic malignancies. This study assessed the efficacy and safety of palifermin in reducing dysphagia-induced by CT/RT followed by consolidation CT in locally-advanced NSCLC patients. This multinational, randomized, double-blind, placebo-controlled, Phase II trial enrolled adults with unresected Stage IIIA,B/IV NSCLC receiving CT/RT (standard RT 2 Gy/day to 66 Gy and concurrent paclitaxel 50 mg/m2 and carboplatin AUC 2.0 on Days 1, 8, 15, 22, 29, 36 and optionally on Day 43) followed by two cycles of consolidation CT (paclitaxel 225 mg/m2 and carboplatin AUC 6.0). Subjects were randomized 1:1 to receive IV palifermin (180 μg/kg) or placebo 3 days before starting CT/RT, and once weekly during a 6 to 7 week CT/RT course. Patients were evaluated for dysphagia twice weekly until week 12, then once weekly until dysphagia resolved to ≤Grade 1 or up to week 16. The primary endpoint was the incidence of dysphagia Grade 2 or greater. One hundred patients were enrolled; 51 to palifermin, and 49 to placebo. Incidence of dysphagia (Grade ≥2) was numerically lower in palifermin patients vs. placebo patients (63% vs. 69%; p = 0.314). Mean duration of dysphagia (Grade ≥2) was 25 days for palifermin patients and 33 days for placebo patients. More palifermin patients completed the acute dysphagia evaluation (80% vs. 59%). The incidence of ≥Grade 3 dysphagia was numerically lower in palifermin patients (24% vs. 31%), and unresolved dysphagia at Month 6 was reported in no palifermin patients (0%) vs. 4% of placebo patients. Treatment-related serious adverse events (AEs) occurred in 42% of palifermin patients and 65% of placebo patients. For palifermin patients, lower rates of AEs leading to study and investigational product discontinuation (4% vs. 10%) and fewer on-study deaths (4% vs. 8%) were reported. Tumor progression or recurrence at Month 6 was reported for 18% of palifermin patients vs. 27% of placebo patients, in line with higher exposure to RT and CT in the palifermin group. Median overall survival (OS) and progression-free survival (PFS) were longer for palifermin patients vs. placebo patients (OS: 513 days vs. 319 days, PFS: 262 days vs. 227 days) using the Kaplan-Meier method. In this exploratory study, there is a suggestion of benefit from palifermin in reducing dysphagia and improving OS and PFS time, which may warrant investigation in larger trials." @default.
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• W2014136545 date "2009-11-01" @default.
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• W2014136545 title "Palifermin Reduces Dysphagia in Patients with Locally-advanced Unresected Non–small-cell Lung Cancer Undergoing Concurrent Chemoradiotherapy" @default.
• W2014136545 doi "https://doi.org/10.1016/j.ijrobp.2009.07.275" @default.
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