Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer

被引：28

作者：

Furuse K. ^{[1
]}

Kawahara M. ^{[2
]}

Hasegawa K. ^{[3
]}

Kudoh S. ^{[4
]}

Takada M. ^{[5
]}

Sugiura T. ^{[6
]}

Ichinose Y. ^{[7
]}

Fukuoka M. ^{[8
]}

Ohashi Y. ^{[9
]}

Niitani H. ^{[10
]}

机构：

[1] Division of Respiratory Diseases, Health Insurance Union Osaka Central Hospital, Sakai, Osaka 590-0133

[2] Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Osaka

[3] Department of Internal Medicine, Tsuboi Hospital, Fukushima

[4] Department of Respiratory Diseases, Nippon Medical School, Tokyo

[5] Second Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Osaka

[6] Department of Pulmonary Diseases, Aichi Cancer Center, Nagoya

[7] Department of Chest Surgery, National Kyushu Cancer Center, Fukuoka

[8] Department of Respiratory Diseases, Osaka City General Hospital, Osaka

[9] Department of Biostatistics, School of Health Sciences and Nursing, University of Tokyo, Tokyo

[10] Tokyo Cooperative Oncology Group, Tokyo

来源：

International Journal of Clinical Oncology | 2001年 / 6卷 / 5期

关键词：

Early phase II study; Non-small-cell lung cancer (NSCLC); S-1;

D O I：

10.1007/PL00012111

中图分类号：

学科分类号：

摘要：

Background. The efficacy and safety of S-1, a new oral fluoropyrimidine, were evaluated in patients with nonsmall-cell lung cancer (NSCLC). The objective of this study was to determine whether the drug should be investigated in a late phase II study. Methods. Each treatment course consisted of an oral dose of S-1, 50mg/body or 75mg/body, twice a day for 28 days, followed by a 2-week washout period. Results. Fifty-six eligible patients were enrolled. Five of the 40 previously untreated patients (12.5%; 90% confidence interval, 6.2%-23.5%) showed a partial response (PR), and no tumor response was observed in the 16 previously treated patients. The median survival duration in all eligible patients was 8.4 months, with a 1-year survival rate of 27.3%. The incidences of grade 3 or more severe adverse effects were: anemia, 5.4%; leukopenia, 5.4%; neutropenia, 5.4%; thrombocytopenia, 1.8%; anorexia, 3.6%; diarrhea, 3.6%; and general fatigue, 5.4%. These effects disappeared after cessation of the drug or appropriate treatment. One patient died as a result of aggravated interstitial pneumonitis, but the relationship of this event to S-1 was not clear. Conclusion. S-1 showed modest activity with mild toxicity in the treatment of non-small-cell lung cancer. Based on this result, we will progress to the next stage of a late phase II study for advanced NSCLC, and a phase II study of S-1 and cisplatin for advanced gastric cancer. Final results will be reported as they are obtained.

引用

页码：236 / 241

页数：5

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