Article

Phase II Trial of S-1 as Second-Line Therapy in Patients with Advanced Non-small Cell Lung Cancer

Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri 63110, USA.
Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer (Impact Factor: 5.8). 02/2011; 6(4):790-5. DOI: 10.1097/JTO.0b013e3182103b51
Source: PubMed

ABSTRACT Currently available agents for the treatment of advanced stage non-small cell lung cancer (NSCLC) have limited efficacy. S-1 is a novel formulation of oral fluoropyrimidine shown to be tolerable and active in patients with NSCLC in Japan. We conducted a multicenter phase II study in previously treated patients with NSCLC to evaluate the efficacy of single-agent S-1 in a predominantly non-Asian population.
Patients with advanced NSCLC and previously treated with only one line of chemotherapy received oral S-1 at 30 mg/m every 12 hours for 14 consecutive days followed by a 7-day rest until meeting discontinuation criteria. The primary end point was to evaluate the overall response rate.
Fifty-seven patients were accrued from 21 centers across the United States. Overall response rates and stable disease according to independent review were 7.1% and 48.2%, respectively, with a disease control rate of 55.3%. Progression-free survival was 2.9 months, median overall survival 7.3 months, and 1-year survival 31.6%. There were no significant differences in survival according to histologic subtype. The treatment was well tolerated, with the most common treatment-related side effects being nausea (54%) and diarrhea (49%).
Single-agent S-1 is well tolerated and has activity comparable with the other agents approved for use in recurrent/relapsed NSCLC.

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    • "Switch maintenance chemotherapy is considered to enhance the efficacy of adjuvant chemotherapy. Previous phase II trials have demonstrated that S-1 monotherapy produced a response rate of 7–14%, a median progression-free survival (PFS) of 3–4 months, and a median OS of 7–16 months as a second-line treatment for advanced NSCLC (Totani et al, 2009; Govindan et al, 2011; Shiroyama et al, 2011). Pemetrexed is effective against nonsquamous NSCLC; on the other hand, S-1 is effective against both non-squamous and squamous NSCLC. "
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