Furuse K, Fukuoka M, Kurita Y, Ariyoshi Y, Niitani H, Yoneda S, Fujii M, Hasegawa K, Nishiwaki Y, Tamura M
Dept. of Internal Medicine, National Kinki Central Hospital for Chest Diseases.
Gan To Kagaku Ryoho. 1992 Jun;19(6):879-84.
A phase II clinical study of 254-S, a new anticancer platinum complex, for primary lung cancer was conducted by the 254-S Lung Cancer Study Group consisting of 15 institutions nation-wide. Considering the results of the phase I clinical study, 254-S was administered at 100 mg/m2 by intravenous drip infusion and this administration was repeated at least 2 times at 4-week intervals. Of 75 patients registered, 61 patients consisting of 22 with small cell lung cancer (SCLC) and 39 with non-small cell lung cancer (NSCLC) were evaluable for complete tumor response. Partial response (PR) was obtained in 17 patients, for a 27.9% response rate. The response rate for SCLC was 40.9% (9 PR in 22 patients) and that for NSCLC was 20.5% (8 PR in 39 patients). In SCLC patients with no prior chemotherapy, a 50.0% (5 PR in 10 patients) response rate was obtained. In those with prior chemotherapy, the response rate was 33.3% (4 PR in 12 patients). In NSCLC patients with no prior chemotherapy, a 22.6% (7 PR in 31 patients) response rate was obtained. In hose with prior chemotherapy, the response rate was 12.5% (1 PR in 8 patients). Major toxic effects observed were hematotoxicity such as thrombocytopenia and leukopenia, and gastrointestinal toxicity such as nausea, vomiting and anorexia. Nephrotoxicity observed was mild and infrequent in spite of the low-volume hydration performed. Based on these results, it was concluded that 254-S is a useful anticancer agent for the treatment of primary lung cancer.
由全国15家机构组成的254 - S肺癌研究小组开展了一项针对原发性肺癌的新型抗癌铂类复合物254 - S的II期临床研究。考虑到I期临床研究结果，254 - S以100 mg/m²的剂量通过静脉滴注给药，且该给药方式每4周重复至少2次。在登记的75例患者中，61例患者可评估完全肿瘤反应，其中包括22例小细胞肺癌（SCLC）患者和39例非小细胞肺癌（NSCLC）患者。17例患者获得部分缓解（PR），缓解率为27.9%。SCLC的缓解率为40.9%（22例患者中有9例PR），NSCLC的缓解率为20.5%（39例患者中有8例PR）。在未接受过化疗的SCLC患者中，缓解率为50.0%（1
