Matsui Y, Oshima S, Kado M, Nakayama M, Shimokata K, Sakai S, Ito F, Chikata E, Hara K, Kanda T
Second Department of Internal Medicine, Kyoto University, Japan.
Cancer. 1987 Dec 15;60(12):2882-5. doi: 10.1002/1097-0142(19871215)60:12<2882::aid-cncr2820601205>3.0.co;2-a.
The soft, gelatin capsule of VP-16-213 (etoposide) was given orally and evaluated in a Phase II study of 56 patients with histologically confirmed small cell lung cancer. The drug was given in a dose of 200 mg/body/day orally for 5 consecutive days, and the courses were repeated every 3 to 4 weeks depending upon the individual patient recovery from myelosuppression. An overall objective response was obtained in 17 patients (30%), five previously treated (23%) and 12 untreated (35%). The median days for response after the start of treatment was 14 d (range, 5 to 64), and the median duration of response was 62 days (range, 28 to 278). The dose-limiting factor was leukopenia, while thrombocytopenia was also experienced. Gastrointestinal reactions to toxicity and alopecia were also observed, but they were not overwhelming. The study demonstrated that the VP-16-213 soft gelatin capsule given orally is effective against small cell lung cancer without clinical cross-resistance to other cytotoxic agents. Its usefulness in combination chemotherapy is thus suggested.
口服VP - 16 - 213（依托泊苷）软胶囊，并在一项针对56例经组织学确诊的小细胞肺癌患者的II期研究中进行评估。药物剂量为200mg/体/天，口服，连续5天，疗程根据个体患者骨髓抑制恢复情况每3至4周重复一次。17例患者（30%）获得总体客观缓解，其中5例曾接受过治疗（23%），12例未接受过治疗（35%）。治疗开始后达到缓解的中位天数为14天（范围5至64天），中位缓解持续时间为62天（范围28至278天）。剂量限制因素为白细胞减少，同时也出现了血小板减少。还观察到胃肠道毒性反应和脱发，但并不严重。该研究表明，口服VP - 16 - 213软胶囊对小细胞肺癌有效，且与其他细胞毒性药物无临床交叉耐药性。因此提示其在联合化疗中具有应用价值。
