Our previous phase III trial has demonstrated that S-1 in combination with carboplatin has promising activity as well as superior toxicity profile compared with carboplatin/paclitaxel for the first-line treatment of advanced non-small-cell lung cancer (NSCLC) (JCO vol 28, 2010). This study evaluated the efficacy and safety of new combination of S-1 and carboplatin plus bevasizumab (Cb/S1/Bev) followed by continuation maintenance of S-1 and bevacizumab (S1/Bev) in chemo-naïve patients (patients) with advanced non-squamous NSCLC.Methods
Patients receive carboplatin AUC 5 and bevacizumab 15 mg/kg on day 1 plus oral S-1 (40 mg/m2 b.i.d.) on days 1 to 14. Treatment is repeated every 21 days up to 6 cycles. For the patients with SD or PR, S-1 combined with bevacizumab are continued every 21 days until disease progression or toxicity. Primary end point of this study was response rate (RR).Results
Between April 2010 to October 2011, 48 patients were enrolled. Median age was 65 years (range: 35–77), male/female = 33/15, PS 0/1 = 15/33, Adeno/Non-adeno = 42/6. Median cycles of Cb/S1/Bev treatment were 4 (range = 1–6), and 59% (n = 28) of patients shifted to maintenance therapy. Among patients who shifted to maintenance phase, median cycles treated with S1/Bev were 3.5 (range = 1–10). During treatment with Cb/S1/Bev, grade 3/4 toxic effects included: neutropenia (23.4%/4.3%), anemia (4.3%/6.4%), thrombocytopenia (6.4%/6.4%) and hypertension (8.3%/0%). No treatment-related death was occurred. Forty-six patients were evaluable for response. Overall RR was 50% and disease control rate was 78%, with a median time to progression of 7.4 months (95% CI: 3.9–10.8).Conclusions
Treatment with S-1 and carboplatin plus bevacizumab with maintenance S-1 and bevacizumab in patients with advanced non-squamous NSCLC is feasible with an acceptable toxicity profile. The encouraging activity justifies further development of this new regimen.