Navelbine治疗晚期肺癌的Ⅱ期临床研究报告

1992年7月至1993年2月,用NAVELBINE治疗35例Ⅲ—Ⅳ期的非小细胞肺癌患者,所有病例均经病理组织学证实,包括鳞癌12例,腺癌18例、肺泡癌3例、腺样囊腺瘤和大细胞癌各1例。实际可评价的病人34例,其中Navelbine单药治疗16例(25mg/m~2/周×4),5例PR,有效率为31.3％。联合治疗(Navelbine+CDDP)18例,CR1例(5.6％)PR8例(44.4％),总有效率为50％。主要毒性为骨髓抑制,白细胞减少Ⅲ—Ⅳ级发生率为32.4％,其中一例高龄者白细胞严重减少,合并败血症而死亡。该研究提示,Navelbine对非小细胞肺癌的治疗价值是肯定的,主要剂量限制毒性为骨髓抑制,应在肿瘤学专家的指导下使用。

NAVELBINE TREATMENT OF ADVANCED NSCLC-A PILOT PHASEII STUDY IN CHINA

I 35 Cases of advanced, stage III-IV NSCLC cases, previously untreated, were treated with NAVELBINE(NVB). All cases were histological approved, Epidermoid 12 cases, Adenocarcinoma 18 cases, aveolar cell carcinoma 3 cases and Cystadenocarcinoma 1 case, Large Cell care 1 case. 16 cases were treated with single drug weekly NAVELBI-NE 25mg/m 2 for at least 4 weeks, 5 cases (31.3%) achiveved PR. 18 cases were treated with weekly NAVELBINE for 3 weeks and DDP 80mg/m 2 single inj every 4 weeks, CR 1 case and PR 8 cases, overall response rate 50% . Myelosuppresskm was the main dose-limiting toxicity, Grade III-IV leucopenia occured in 32.4%, 1 elderly case developed severe leucopenia and died of sepsis. This study showed that NAVELBINE is effective in advanced NSCLC and should be used under dose supervision of oncologist.