Efficacy of a New 5-Fluorouracil Derivative, Bof-A2, in Advanced Non-Small Cell Lung Cancer a Multi-Center Phase Ii Study |
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| Authors: | Yushi Nakai Kiyoyuki Furuse Mitsuo Ohta Yutaka Yamaguchi Masafumi Fujii Mitsuo Asakawa Masahiro Fukuoka Kiyokazu Yoshida Hisanobu Niitani |
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| Affiliation: | a Sertdai Kosei Hospital, Sendaib National Kinki Central Hospital for Chest Diseases, Osakac National Kyushu Cancer Center Hospital, Fukuokad Institute of Pulmonary Cancer Research, Chiba University, Chibae Shikoku Cancer Center Hospital, Matsuyamaf Sapporo Medical University, School of Medicine, Sapporog Osaka Prefectural Habikino Hospital, Osakah Saitama Cancer Center, Saitamai Nippon Medical College, Tokyo |
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| Abstract: | Oral BOF-A2 (Emitefur), a new derivative of 5-fluorouracil (5-FU) containing both 1-ethoxymethyl-5-FU (EMFU), a masked form of 5-FU, and 3-cyano-2,6-dihydroxypyridine (CNDP), an inhibitor of 5-FU degradation, was administered to 71 non-small cell lung cancer (NSCLC) patients in a multi-center phase II study. The patients were scheduled to receive at least 2 courses of treatment, each consisting of 200 mg twice daily for 2 weeks followed by a 2-week rest period. Out of 62 evaluable patients, 11 (18%) responded (8 of 44 adeno- and 3 of 15 squamous cell carcinomas). Thirty-four patients showed no change and 17 progressive disease. The incidences of grade ≥ 2 hematologic toxicity were 5-8% for leukopenia, thrombocytopenia, and anemia. The incidences of non-hematologic toxicity of grade ≥ 2, such as anorexia, nausea/vomiting, and diarrhea, were close to 20% or lower. |
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