Furuse K, Fukuoka M, Asamoto H, Niitani H, Kimura I, Sakuma A, Yamaguchi Y
Department of Internal Medicine, National Kinki Central Hospital for Chest Disease, Sakai, Japan.
Gan To Kagaku Ryoho. 1992 Jul;19(7):1019-26.
It has been shown in phase II studies that 254-S, a new anticancer platinum complex, is effective in the treatment of various cancers. In order to more objectively evaluate the clinical usefulness of this compound, a randomized comparative study of 254-S plus VDS vs. CDDP plus VDS was conducted in patients with advanced NSCLC. 254-S or CDDP was intravenously administered at 90 mg/m2, at least 2 times at 4-week intervals. VDS was intravenously administered at 3 mg/m2 on Days 1 and 8 of each treatment of 254-S or CDDP. Of 136 patients registered, 121 (64 of the 254-S/VDS group and 57 of the CDDP/VDS group) were evaluable for tumor response (complete cases). There was no significant intergroup difference in the tumor response rate (254-S/VDS group: 12.5% [8/64], CDDP/VDS group: 15.8% [9/57]), nor by cancer staging, histological type or survival. As for toxic effects, leukopenia was significantly less frequent in the 254-S/VDS group while thrombocytopenia was significantly less frequent in the CDDP/VDS group. Nephrotoxicity such as an elevation of BUN and a decrease in serum creatinine was significantly less frequent in the 254-S/VDS group in spite of the lower volume hydration performed. In addition, nausea and vomiting as well as anorexia were observed with significantly lower incidences in the 254-S/VDS group despite the less frequent anti-emetic treatment. Based on these results, it was concluded that combination treatment with 254-S and VDS is a safe and useful regimen for treatment of NSCLC, generating antitumor effects equivalent to the CDDP/VDS regimen.
II期研究表明，新型抗癌铂络合物254-S对多种癌症的治疗有效。为了更客观地评估该化合物的临床实用性，对晚期非小细胞肺癌患者进行了254-S加长春地辛与顺铂加长春地辛的随机对照研究。254-S或顺铂以90mg/m²静脉给药，至少每4周给药2次。在254-S或顺铂每次治疗的第1天和第8天，长春地辛以3mg/m²静脉给药。在登记的136例患者中，121例（254-S/长春地辛组64例，顺铂/长春地辛组57例）可评估肿瘤反应（完整病例）。肿瘤反应率在组间无显著差异（254-S/长春地辛组：12.5%[8/64]，顺铂/长春地辛组：15.8%[9/57]），按癌症分期、组织学类型或生存率划分也无显著差异。至于毒性作用，254-S/长春地辛组白细胞减少的发生率显著较低，而顺铂/长春地辛组血小板减少的发生率显著较低。尽管补液量较少，但254-S/长春地辛组中血尿素氮升高和血清肌酐降低等肾毒性的发生率显著较低。此外，尽管抗呕吐治疗频率较低，但254-S/长春地辛组恶心、呕吐以及食欲不振的发生率显著较低。基于这些结果，得出结论：254-S与长春地辛联合治疗是一种安全有效的非小细胞肺癌治疗方案，产生的抗肿瘤效果与顺铂/长春地辛方案相当。
