We conducted a phase I/II trial of cisplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (NSCLC) to determine the recommended dose (RD) of nab-paclitaxel and to evaluate the safety and efficacy of this regimen.
In the phase I study, escalating doses of weekly nab-paclitaxel were administered together with cisplatin at 75 mg/m every 3 weeks and concurrent radiotherapy. In the phase II study, nab-paclitaxel was administered at the RD.
In the phase I study, whereas no dose-limiting toxicity (DLT) was observed with nab-paclitaxel at 50 or 60 mg/m , one of six patients experienced DLT (esophagitis of grade 3) at 70 mg/m , determined as the RD. Twenty-four patients at RD were evaluable for safety and efficacy in phase II. Common toxicities included esophagitis (87.5%) and leukopenia (79.2%). Pneumonitis and treatment-related deaths were not observed, but 20 patients (83.3%) experienced radiation pneumonitis, with one case of grade 3 and four of grade 2, after completion of concurrent chemoradiotherapy. The 2-year overall survival and progression-free survival rates were 73.9% and 56.5% (95% CI, 34.3%-74.7%), respectively.
Concurrent chemoradiation with nab-paclitaxel at 70 mg/m and cisplatin at 75 mg/m every 3 weeks showed encouraging feasibility and activity for locally advanced NSCLC.
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