A phase II study of concurrent nab-paclitaxel/carboplatin combined with thoracic radiotherapy in locally advanced squamous cell lung cancer

Abstract

Background: The development of chemoradiotherapy is urgently needed for locally advanced squamous cell lung cancer due to its poor prognosis and significant toxicity. Carboplatin combined with nab-paclitaxel is a useful choice as first-line therapy in advanced squamous cell lung cancer. This prospective phase II study aimed to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin, and thoracic radiotherapy in unresectable locally advanced squamous cell lung cancer. Methods: Patients with unresectable stage III squamous cell lung cancer were eligible. All patients received nab-paclitaxel weekly at a dose of 60 mg/m2, in combination with carboplatin [area under the plasma concentration time curve (AUC) 2] weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions. The consolidation chemotherapy consisted of nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 days was administered in two cycles after the concurrent chemoradiotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Results: Initially, enrollment of 21 patients was planned; however, the trial was prematurely closed due to slow recruitment. Finally, a total of 8 patients were enrolled between January 2012 and July 2015 from one institute. All patients completed concurrent chemoradiotherapy, and 6 patients (75.0%) received consolidation chemoradiotherapy. The ORR was 75%, with complete response (CR) 1 (12.5%), partial remission 6 (62.5%), stable disease 1 (12.5%), progressive disease 1 (12.5%), respectively. After a median follow-up of 15.2 (range, 2.3–51.5) months, 7 patients were dead, and 1 was alive. The median PFS and OS were 12.1 and 15.2 months, respectively. According to Common Terminology Criteria for Adverse Events version 4.0, 6 patients (75.0%) experienced acute radiation esophagitis, 4 (50.0%) were grade 2 (G2), and 2 (25.0%) were G3; 4 patients (50%) experienced acute radiation pneumonitis, 3 (37.5%) were G2, and 1 (12.5%) was G3. No late radiation-induced esophageal and pulmonary toxicity was observed after 1-year follow-up. Conclusions: Concurrent nab-paclitaxel, carboplatin, and thoracic radiotherapy was shown to be an effective regimen for patients with unresectable locally advanced squamous cell lung cancer; however, further study should exercise caution due to the severe radiation esophagitis.