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

Abstract

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. 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. 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. 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.