Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials
Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials
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DOI：
10.1093/annonc/mdu460
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发表时间：
2014-12-01
影响因子：
50.5
通讯作者：
Van der Graaf, W. T. A.
中科院分区：
文献类型：
--
作者：
Le Cesne, A.;Ouali, M.;Van der Graaf, W. T. A.
背景：EORTC-STBSG协调了两项局部高级别软组织肉瘤（STS）辅助化疗（CT）的大型试验。两项研究均未能证明对总生存期（OS）的任何益处。这两项试验的分析的目的是确定亚组的患者谁可能受益于辅助CT.Patients和方法：从两个EORTC试验比较阿霉素为基础的CT观察只有在完全切除STS（大切除，R 0/边缘切除，R1）的个别患者的数据进行了汇总。单因素和多因素分析评估预后因素。随后根据每个分析factor.Results：共819例患者已入组，中位随访时间为8.2年的两组患者之间的患者结果进行了比较。肿瘤大小、高组织学分级和R1切除术是无复发生存期（RFS）和OS的独立不良预后因素。辅助CT是RFS的独立有利预后因素，但不是OS的独立有利预后因素。观察到辅助CT的益处与年龄、性别和R1切除术对RFS和OS的显著相互作用。治疗组中男性和>40岁的患者的RFS显著更好，而辅助CT与女性和患者的OS略微恶化相关，
Background: The EORTC-STBSG coordinated two large trials of adjuvant chemotherapy (CT) in localized high-grade soft tissue sarcoma (STS). Both studies failed to demonstrate any benefit on overall survival (OS). The aim of the analysis of these two trials was to identify subgroups of patients who may benefit from adjuvant CT.Patients and methods: Individual patient data from two EORTC trials comparing doxorubicin-based CT to observation only in completely resected STS (large resection, R0/marginal resection, R1) were pooled. Prognostic factors were assessed by univariate and multivariate analyses. Patient outcomes were subsequently compared between the two groups of patients according to each analyzed factor.Results: A total of 819 patients had been enrolled with a median follow-up of 8.2 years. Tumor size, high histological grade and R1 resection emerged as independent adverse prognostic factors for relapse-free survival (RFS) and OS. Adjuvant CT is an independent favorable prognostic factor for RFS but not for OS. A significant interaction between benefit of adjuvant CT and age, gender and R1 resection was observed for RFS and OS. Males and patients >40 years had a significantly better RFS in the treatment arms, while adjuvant CT was associated with a marginally worse OS in females and patients