November 08, 2013
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Oral S-1 with cisplatin, radiotherapy appears safe, effective in advanced NSCLC

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Patients with advanced non–small cell lung cancer treated with the oral fluoropyrimidine derivative S-1 in combination with cisplatin and concurrent radiotherapy demonstrated encouraging responses, according to results of a phase 2 study.

The regimen also appeared well tolerated, researchers said.

The analysis included 41 patients with unresectable stage III NSCLC. All patients received S-1 50 mg/m2 orally twice daily for 14 days, along with cisplatin 40 mg/m2 on days 1 and 8 of each 3-week cycle. Patients underwent two to four cycles of treatment.

Patients also underwent concurrent thoracic radiation therapy, which was administered in 2 Gy fractions five times weekly for a total dose of 60 Gy.

Response rate served as the primary endpoint. Secondary endpoints were PFS, OS and safety.

Researchers calculated an objective response rate of 87.8% (98% CI, 77.8-97.8), a median PFS of 15.4 months and a median OS of 29.7 months. Results showed 85.7% of patients were alive at 1 year and 52.9% were alive at 2 years.

Grade 3 and grade 4 hematologic toxicities included leukopenia (27%) and neutropenia (17%). Researchers did not observe any incidence of grade 3 febrile neutropenia. One patient developed grade 3 gastrointestinal hemorrhage. Other grade 3 and grade 4 non-hematologic toxicities were mild, according to the investigators.

“The combination of oral S-1 plus cisplatin with concurrent radiotherapy is a promising treatment with a high efficacy and lower toxicity in patients with locally advanced NSCLC,” the researchers wrote.