Eckhardt S, Kolaric K, Vukas D, Kánitz E, Schoket Z, Jassem J, Vuletic L, Jelic S, Mechl Z, Koza I
National Institute of Oncology, Budapest, Hungary.
Med Oncol Tumor Pharmacother. 1990;7(1):19-23.
The purpose of the study was to investigate the antitumour activity and toxicity of high dose (120 mg m-2) single agent epirubicin therapy in untreated extensive small cell lung cancer patients. Out of 80 patients entered, 71 were evaluable for both antitumour activity and toxicity, 4 only for toxicity and 5 were lost for follow-up. The drug possessed a high antitumour activity, the overall response rate was 47.9% (34/71) with 4 complete remissions (CR) and 30 partial remissions (PR). The median remission duration was 3.5 months. Particular drug activity was observed in the primary tumours, lymph nodes and pleural metastases. Toxicity (leukopenia, anaemia, vomiting, reversible rhythmic cardiac disorder, stomatitis) was mild, alopecia was registered less than in adriamycin medication. One fatal congestive heart failure occurred. The actual mean survival time calculated on the basis of the data gained from 64 patients was 7.0 months (range 2-22). The high antitumour activity and no increase in toxicity justify the incorporation of high dose epirubicin into combination therapy.
本研究旨在调查高剂量（120mg/m²）表柔比星单药治疗未经治疗的广泛期小细胞肺癌患者的抗肿瘤活性和毒性。入组的80例患者中，71例可评估抗肿瘤活性和毒性，4例仅可评估毒性，5例失访。该药物具有较高的抗肿瘤活性，总缓解率为47.9%（34/71），其中4例完全缓解（CR），30例部分缓解（PR）。中位缓解持续时间为3.5个月。在原发性肿瘤、淋巴结和胸膜转移灶中观察到了特殊的药物活性。毒性（白细胞减少、贫血、呕吐、可逆性心律失常、口腔炎）较轻，脱发发生率低于阿霉素治疗。发生了1例致命的充血性心力衰竭。根据64例患者的数据计算得出的实际平均生存时间为7.0个月（范围2-22个月）。高抗肿瘤活性且毒性未增加证明将高剂量表柔比星纳入联合治疗是合理的。
