Phase I/Iistudy Of Cisplatin Plusnab-Paclitaxelwith Concurrent Thoracic Radiotherapy For Patients With Locally Advancednon-Smallcell Lung Cancer

Lessons LearnedThe combination of cisplatin plus nab-paclitaxel with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer is a promising therapeutic strategy. Further investigation is warranted. Background 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. Methods In the phase I study, escalating doses of weekly nab-paclitaxel were administered together with cisplatin at 75 mg/m(2)every 3 weeks and concurrent radiotherapy. In the phase II study, nab-paclitaxel was administered at the RD. Results In the phase I study, whereas no dose-limiting toxicity (DLT) was observed with nab-paclitaxel at 50 or 60 mg/m(2), one of six patients experienced DLT (esophagitis of grade 3) at 70 mg/m(2), 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% confidence interval [CI], 34.3%-74.7%), respectively. Conclusion Concurrent chemoradiation with nab-paclitaxel at 70 mg/m(2)and cisplatin at 75 mg/m(2)every 3 weeks showed encouraging feasibility and activity for locally advanced NSCLC.