Furuse K, Fukuoka M, Yamamoto M, Kawahara M, Tsuruta M, Kodama N, Arai R, Hayashi S, Kiyota M, Kubota K
Gan To Kagaku Ryoho. 1986 Sep;13(9):2835-40.
A phase II study of epirubicin (EPI) was performed on 65 eligible lung cancer patients. EPI was administered intravenously at the dosage of 60 mg/m2 for non-small cell lung cancer (NSCLC) and 75 mg/m2 for small cell lung cancer (SCLC) at the interval of three to four weeks. The response rate of 57 measurable patients was 7.0% (predicted true response rate was 1.9-17.0%). In SCLC, the overall response rate was as low as 8.3% (2/24), but a better response rate, 20% (2/10), was observed in patients given no prior therapy. In NSCLC, the response rate was 6.1% (2/33) as a whole and 12.5% (2/16) in patients given no prior therapy. We were able to conclude that EPI was a moderately active agent in SCLC and marginally effective in NSCLC. Although the dose limiting factor was leukopenia, its incidence and degree seemed low as compared with adriamycin (ADM). As for alopecia or GI tract side effects, those associated with EPI appeared less acute than those produced by ADM. No cardiac toxicities were observed, partly because of the low cumulative maximum dose of 311 mg/m2 used in our study.
对65例符合条件的肺癌患者进行了表柔比星(EPI)的II期研究。非小细胞肺癌(NSCLC)患者静脉注射EPI的剂量为60mg/m²,小细胞肺癌(SCLC)患者为75mg/m²,给药间隔为三到四周。57例可测量患者的缓解率为7.0%(预测真实缓解率为1.9 - 17.0%)。在SCLC中,总体缓解率低至8.3%(2/24),但在未接受过先前治疗的患者中观察到较好的缓解率,为20%(2/10)。在NSCLC中,总体缓解率为6.1%(2/33),未接受过先前治疗的患者为12.5%(2/16)。我们能够得出结论,EPI在SCLC中是一种中等活性的药物,在NSCLC中疗效微乎其微。尽管剂量限制因素是白细胞减少,但与阿霉素(ADM)相比,其发生率和程度似乎较低。至于脱发或胃肠道副作用,与EPI相关的副作用似乎不如ADM产生的副作用那么严重。未观察到心脏毒性,部分原因是我们研究中使用的累积最大剂量较低,为311mg/m²。