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Combination of gemcitabine and docetaxel: a regimen overestimated in refractory metastatic osteosarcoma?

机译:吉西他滨和多西他赛的组合:难治性转移性骨肉瘤的高估方案?

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摘要

The combination of gemcitabine and docetaxel (GT) has been demonstrated to be effective against various types of solid tumors, including sarcoma. However, the regimen has not been confirmed in large, well-designed clinical trials in refractory metastatic osteosarcoma. We retrospectively reviewed the records of patients with refractory metastatic osteosarcoma at Peking University People’s Hospital who were treated with gemcitabine (1000?mg/m2) intravenously (IV) on Day 1 and Day 8, and docetaxel (75?mg/m2) IV on Day 8, repeated every 21?days. A total of 52 patients with a median age of 18.4?years were treated with GT at the Peking University People’s Hospital from August 2012 to August 2017. A total of 174 courses were administered. Only five patients with pulmonary metastasis achieved a best response of stable disease (SD), while all other patients had progressive disease. The result was disappointing with an ORR of 0%, a DCR of 9.6%, and a median DOR of 3.5?months. Grade 3 or 4 toxicities were observed in 69 (39.7%) courses and in 28 (53.8%) patients, most of which were myelosuppression, especially thrombocytopenia. No fatal adverse effect (AE) was found. The combination of gemcitabine and docetaxel (GT) as a salvage regimen is well-tolerated but not as effective as expected in refractory metastatic osteosarcoma. This report highlights the need for the development of new approaches with higher activity in these patients.
机译:吉西他滨和多西他赛(GT)的组合已被证明可有效抵抗各种类型的实体瘤,包括肉瘤。但是,该方案尚未在大规模设计良好的难治性转移性骨肉瘤临床试验中得到证实。我们回顾性回顾了北京大学人民医院难治性转移性骨肉瘤患者的记录,这些患者在第1天和第8天接受了吉西他滨(1000?mg / m2)静脉内(IV)的治疗,并在第1天和第3天接受了多西他赛(75?mg / m2)的治疗。第8天,每21天重复一次。 2012年8月至2017年8月,共有52例中位年龄为18.4岁的患者在北京大学人民医院接受了GT治疗。共治疗174个疗程。只有5例肺转移患者对稳定疾病(SD)的反应最佳,而其他所有患者均患有进行性疾病。结果令人失望,ORR为0%,DCR为9.6%,中位DOR为3.5个月。在69(39.7%)个疗程和28(53.8%)个患者中观察到3级或4级毒性,其中大多数是骨髓抑制,尤其是血小板减少症。没有发现致命的不良反应(AE)。吉西他滨和多西他赛(GT)的联合治疗方案耐受性良好,但在难治性转移性骨肉瘤中疗效不如预期。该报告强调了在这些患者中需要开发具有更高活性的新方法的需求。

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