完成六个周期一线蒽环类药物治疗后软组织肉瘤患者的生存:EORTC-STBSG数据库研究

Clinical Sarcoma Research Pub Date : 2020-09-09 eCollection Date: 2020-01-01 DOI:10.1186/s13569-020-00137-5
Arie Jan Verschoor, Saskia Litière, Sandrine Marréaud, Ian Judson, Maud Toulmonde, Eva Wardelmann, Axel LeCesne, Hans Gelderblom
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引用次数: 8

摘要

背景:以阿霉素为基础的化疗是软组织肉瘤患者的标准一线治疗。目前正在研究几种提高以阿霉素为基础的化疗后生存率的方案。本研究报告了完成6个周期含阿霉素一线治疗后的生存,这在设计试图改善一线治疗结果的研究时很重要。方法:回顾性分析来自12个EORTC肉瘤试验(纳入期1980-2012)的2045例接受一线阿霉素化疗的晚期软组织肉瘤患者,以确定完成6个周期的一线阿霉素化疗后的无进展生存期和总生存期。终点是总生存和无进展生存。研究的因素有组织学亚型和阿霉素化疗的类型。结果:2045例中有748例(36.6%)接受了至少6个周期的化疗,并且在化疗期间或结束时没有进展。2045名患者中有475名(23.2%)接受了6个周期的化疗,并且在化疗期间或结束时没有进展。以阿霉素为基础的化疗6个周期后,中位无进展生存期为4.2个月(95%可信区间3.7-4.8),中位总生存期为15.7个月(14.0-17.8)。随机化/注册的中位无进展生存期和总生存期分别为8.7个月(95%可信区间8.2-9.1)和20.1个月(95%可信区间18.3-22.3)。化疗方案之间的无进展生存期有显著差异,但总生存期无显著差异。这些数据也适用于接受7个或更多化疗周期的患者和接受3个或更多化疗周期的患者。结论:这项大型回顾性研究首次报道了一线含阿霉素化疗完成6个周期后的无进展生存期和总生存期。这些结果在设计新的研究探索时很重要,例如在以阿霉素为基础的化疗后维持治疗。
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Survival of soft tissue sarcoma patients after completing six cycles of first-line anthracycline containing treatment: an EORTC-STBSG database study.

Background: Doxorubicin based chemotherapy is standard first line treatment for patients with soft tissue sarcoma. Currently several options to improve survival after doxorubicin based chemotherapy are being studied. This study reports on survival after completing 6 cycles of doxorubicin containing first line treatment, which is important when designing studies trying to improve outcomes of first line treatment.

Methods: A retrospective database analysis was performed on 2045 patients from 12 EORTC sarcoma trials (inclusion period 1980-2012) receiving first line doxorubicin based chemotherapy for advanced soft tissue sarcoma in order to establish progression free survival and overall survival after completing 6 cycles of first line doxorubicin based chemotherapy. Endpoints were overall survival and progression free survival. Factors studied were histologic subtype and type of doxorubicin chemotherapy.

Results: 748 of 2045 (36.6%) received at least 6 cycles and did not progress during or at the end of chemotherapy. 475 of 2045 (23.2%) of patients received exactly 6 cycles and did not progress during or at the end of chemotherapy. Median progression free survival after 6 cycles of doxorubicin based chemotherapy was 4.2 months (95% confidence interval 3.7-4.8) and median overall survival 15.7 months (14.0-17.8). Median progression free survival and overall survival from randomisation/registration were 8.7 months (95% confidence interval 8.2-9.1) and 20.1 months (95% confidence interval 18.3-22.3) respectively. Significant differences in progression free survival were found between chemotherapy regimens, but not for overall survival. These data are also reported for patients receiving 7 or more cycles of chemotherapy and for patients with 3 or more cycles of chemotherapy.

Conclusion: This large retrospective study is the first to report progression free survival and overall survival after completion of 6 cycles of first line doxorubicin containing chemotherapy. These results are important when designing new studies exploring for example maintenance therapy after doxorubicin based chemotherapy.

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期刊介绍: Clinical Sarcoma Research considers for publication articles related to research on sarcomas, including both soft tissue and bone. The journal publishes original articles and review articles on the diagnosis and treatment of sarcomas along with new insights in sarcoma research, which may be of immediate or future interest for diagnosis and treatment. The journal also considers negative results, especially those from studies on new agents, as it is vital for the medical community to learn whether new agents have been proven effective or ineffective within subtypes of sarcomas. The journal also aims to offer a forum for active discussion on topics of major interest for the sarcoma community, which may be related to both research results and methodological topics.
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