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S-1 Plus Cisplatin Combination Chemotherapy in Patients with Advanced Non–Small Cell Lung Cancer

A Multi-Institutional Phase II Trial

¹ Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan; ² Department of Respiratory Organs, Fukujuji Hospital Anti-TB Association, Tokyo, Japan; ³ Department of Respiratory Disease, Saitama Cancer Center, Saitama, Japan; ⁴ Department of Internal Medicine, Sendai Kohsei Hospital, Miyagi, Japan; ⁵ Department of Pulmonary Disease, Aichi Cancer Center, Aichi, Japan; ⁶ Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Osaka, Japan; and ⁷ Tokyo Cooperative Oncology Group, Tokyo, Japan

Purpose: To evaluate the efficacy and toxicity of a novel combination chemotherapeutic regimen including cisplatin with an oral anticancer agent, S-1 that consisted of tegafur, 5-chloro-2, 4-dihydroxypyridine, and potassium oxonate, for non–small-cell lung cancer (NSCLC) patients.

Experimental Design: In this phase II trial, patients with locally advanced and metastatic NSCLC were treated with the oral administration of S-1 at 40 mg/m² twice a day for 21 consecutive days while cisplatin (60 mg/m²) was administered intravenously on day 8. This schedule was repeated every 5 weeks.

Results: Of 56 patients enrolled in the study, 55 patients were eligible and analyzed. The median number of cycles administered was 3 (range, 1–12 cycles). Among these 55 patients, one complete response and 25 partial responses were observed with an overall response rate of 47% (95% confidence interval, 34–61%). The median survival time was 11 months and the 1-year survival rate was 45%. Hematologic toxicities of grades 3 and 4 included neutropenia (29%) and anemia (22%). No grade 4 nonhematologic toxicity was observed. Grade 3 toxicity included anorexia (13%), vomiting (7%), or diarrhea (7%).

Conclusions: S-1 plus cisplatin combination chemotherapy showed a promising effectiveness with acceptable toxicity rates in patients with advanced NSCLC. These results warrant further investigations of this regimen including a randomized controlled trial for its use as a first line treatment for NSCLC.

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