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• W2247753953 abstract "e17504 Background: One third of patients (pts) with NSCLC present with localized, unresectable disease. Concurrent chemoradiotherapy (e.g. weekly paclitaxel + C) is well established with median survival ≈14 mo. Nanoparticle albumin-bound (nab) paclitaxel is a cremophor-free formulation of paclitaxel designed to improve solubility and intratumor delivery of active drug. This phase I trial evaluates weekly nab-P + C + concurrent TRT in pts with unresectable stage III NSCLC. Methods: Pts entered escalating dose cohorts in a 3+3 design of nab- P weekly, beginning at 40 mg/m2 and increasing by 20 mg/m2, in combination with C (AUC 2) weekly for 7 weeks and concurrent RT 66Gy/33 fractions. Pts received 2 cycles of consolidation therapy with full dose nab-P (100 mg/m2 weekly for 3 weeks) and C (AUC 6 on day one of each cycle) every 21d. The DLT period is defined as the concurrent chemoradiation period. Results: Eight pts have been treated at 2 dose levels of nab-P, 40mg/m2 and 60mg/m2. One pt signed consent and then withdrew. Seven pts have completed all cycles of therapy. Three pts were treated at 40 mg/m2 with no DLT. Four pts were treated at 60 mg/m2 with 2 DLT of G3 radiation dermatitis and G3 esophagitis. The 40 mg/m2 cohort is expanded and 1 pt remains on concurrent treatment. Grade 2-3 toxicities during concurrent treatment include: neutropenia, neutropenic fever, anemia, thrombocytopenia, fatigue, esophagitis, nausea, dermatitis, hypoxia, and dehydration. No grade 4 toxicities have been seen during concurrent treatment. Seven pts are evaluable for response with 7 partial responses. Three patients have progressed 5, 7, and 8 mo after enrollment, and 4 patients remain stable 5, 7, 13, and 18 mo. Conclusions: Weekly nab-P at 60 mg/m2 exceeds the maximally tolerated dose, but appears to be safe and well tolerated at 40 mg/m2 when used in combination with weekly C and RT and enrollment in this cohort continues. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abraxis BioScience Abraxis BioScience Abraxis BioScience" @default.
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• W2247753953 date "2010-05-20" @default.
• W2247753953 modified "2023-09-25" @default.
• W2247753953 title "A phase I study of nab-paclitaxel (nab-P) with carboplatin (C) and thoracic radiation (RT) in patients with locally advanced NSCLC." @default.
• W2247753953 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.e17504" @default.
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