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吡柔比星用于晚期非小细胞肺癌。德国癌症协会医学肿瘤学协会I/II期研究组的一项试验。

Pirarubicin in advanced non-small cell lung cancer. A trial of the Phase I/II Study Group of the Association for Medical Oncology of the German Cancer Society.

作者信息

Drings P, Günther I U, Gatzemeier U, Berdel W, Stahl M, Salewski E, Edler L

机构信息

Abteilung Innere Medizin-Onkologie, Thoraxklinik Heidelberg-Rohrbach, FRG.

出版信息

Onkologie. 1990 Jun;13(3):180-4. doi: 10.1159/000216754.

DOI:10.1159/000216754
PMID:2168533
Abstract

Forty-seven patients with advanced non-small cell lung cancer (NSCLC) were treated in a multicentre phase II study with pirarubicin (THP), 4'-O-tetrahydropyranyl-doxorubicin using a dosage of 70 mg/m2 every 3 weeks. The median age of the patients was 59 years (range 45-70) and the performance status grade 0-2 (WHO). Thirty-eight patients had stage IV and 9 stage III (UICC). Twenty-six patients had an adenocarcinoma. 19 a squamous cell carcinoma, and 2 a polymorphocellular carcinoma. Six out of 45 evaluable patients achieved a partial remission leading to an overall response rate of 13%. Eighteen patients showed no change (NC), 12 were progressive (PD), 2 patients had early progression (EP), and 7 patients died during the first course with clinical signs of tumor progression (early death). The median survival time was 4.6 months. Leukocytopenia and thrombocytopenia (WHO grade 4) was experienced in 8.5% and 2.1%, nausea and vomiting (grade 2 and 3) by 32% of the patients. There was no cardiotoxicity or other severe side effects. Pirarubicin has only a moderate antineoplastic activity in patients with advanced NSCLC. Observed response rates are similar to those reported for doxorubicin, but the toxic side effects are milder.

摘要

47例晚期非小细胞肺癌(NSCLC)患者参与了一项多中心II期研究,接受吡柔比星(THP),即4'-O-四氢吡喃基阿霉素治疗,剂量为每3周70mg/m²。患者的中位年龄为59岁(范围45 - 70岁),体能状态为0 - 2级(WHO标准)。38例患者为IV期,9例为III期(UICC标准)。26例患者为腺癌,19例为鳞状细胞癌,2例为多形细胞癌。45例可评估患者中,6例达到部分缓解,总缓解率为13%。18例患者病情无变化(NC),12例进展(PD),2例早期进展(EP),7例患者在第一个疗程中因肿瘤进展的临床症状死亡(早期死亡)。中位生存时间为4.6个月。8.5%的患者出现白细胞减少和血小板减少(WHO 4级),32%的患者出现恶心和呕吐(2级和3级)。未观察到心脏毒性或其他严重副作用。吡柔比星在晚期NSCLC患者中仅具有中等抗肿瘤活性。观察到的缓解率与阿霉素报道的相似,但毒副作用较轻。

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