Kleisbauer J P, Vergeret J, Balmes P, Arnaud A, Taytard A, Targhetta R, Thomas P, Bonnaud F, Poirier R, Touron D
Hôpital Sainte Marguerite, Marseille, France.
Am J Clin Oncol. 1990;13 Suppl 1:S20-3. doi: 10.1097/00000421-199012001-00006.
Pirarubicin (THP) (Roger Bellon Laboratory, France) is a new anthracycline under clinical development. In order to assess the efficacy and toxicity of the drug in small-cell lung carcinoma (SCLC), we have undertaken this trial in front-line therapy in patients with metastatic disease, PS less than 3 and at least one evaluable lesion. Responses were assessed after two cycles of THP (60 mg/m2 i.v. bolus every 3-4 weeks) and a further cross over to VP16 + CDDP (three cycles) was systematic whatever the response to THP. This crossover was performed after only one cycle in case of obvious progression. From June 1988 to April 1990, 32 patients were enrolled: 6 were ineligible (4 non-SCLC, 2 M0), 26 patients were fully evaluable for THP and 18 patients for VP16-CDDP. The characteristics of the patients were as follows: mean age 57.4 years (38-71); T4: 54%; T3: 27%; T2: 19%; N3: 62%; N2: 35%; No: 4%. The efficacy was as follows 1 complete response and 2 partial responses (confirmed by endoscopy); 12 patients received only one cycle because of obvious progression; the overall response rate is 12% (95% confidence interval 0-24%). The patient who had complete response after pirarubicin remained in CR after VP16-CDDP, whereas the 2 patients who had partial response achieved CR for one and PR for the other; among the 15 who did not respond 1 CR and 7 PR were observed. The only significant toxicity of THP was granulopenia without infection. THP seems to be an effective anthracycline in SCLC, and the study is continuing. A response could be reached in 50% of the nonresponders with standard therapy and 10 of 24 patients (42%) finally responded. Therefore, this schedule for testing new drugs in metastatic SCLC appears ethically acceptable.
吡柔比星（THP）（法国罗杰·贝隆实验室）是一种正在临床开发中的新型蒽环类药物。为了评估该药物在小细胞肺癌（SCLC）中的疗效和毒性，我们对转移性疾病、体能状态（PS）小于3且至少有一个可评估病灶的患者进行了一线治疗试验。在给予两个周期的THP（60mg/m²静脉推注，每3 - 4周一次）后评估疗效，无论对THP的反应如何，都会系统性地进一步交叉使用VP16 + CDDP（三个周期）。如果出现明显进展，仅在一个周期后就进行这种交叉治疗。从1988年6月至1990年4月，共纳入32例患者：6例不符合入选标准（4例非小细胞肺癌，2例M0），26例患者可对THP进行全面评估，18例患者可对VP16 - CDDP进行评估。患者的特征如下：平均年龄57.4岁（38 - 71岁）；T4：54%；T3：27%；T2：19%；N3：62%；N2：35%；N0：4%。疗效如下：1例完全缓解和2例部分缓解（经内镜确认）；12例患者因明显进展仅接受了一个周期的治疗；总体缓解率为12%（95%置信区间0 - 24%）。接受吡柔比星治疗后达到完全缓解的患者在接受VP16 - CDDP治疗后仍保持完全缓解，而2例部分缓解的患者中，1例达到完全缓解，另1例达到部分缓解；在15例无反应的患者中，观察到1例完全缓解和7例部分缓解。THP唯一显著的毒性是粒细胞减少但无感染。THP似乎是一种对小细胞肺癌有效的蒽环类药物，研究仍在继续。50%的无反应者采用标准治疗后可能会出现反应，24例患者中有10例（42%）最终出现反应。因此，这种在转移性小细胞肺癌中测试新药的方案在伦理上似乎是可以接受的。
