晚期软组织肉瘤（ASTS）中基于大剂量异环磷酰胺（HDIF）方案后的挽救性手术切除：一种潜在的阳性选择偏倚——西班牙肉瘤研究小组（GEIS）的一项研究

Salvage surgical resection after high-dose ifosfamide (HDIF) based regimens in advanced soft tissue sarcoma (ASTS): a potential positive selection bias--a study of the Spanish group for research on sarcomas (GEIS).

作者信息

Maurel Joan, Buesa José, López-Pousa Antonio, del Muro Xavier García, Quintana María Jesús, Martín Javier, Casado Antonio, Martínez-Trufero Javier, de Las Peñas Ramón, Balañá Carmen

机构信息

Department of Medical Oncology, Hospital Clínic, Barcelona, Spain.

出版信息

J Surg Oncol. 2004 Oct 1;88(1):44-9. doi: 10.1002/jso.20131.

DOI:10.1002/jso.20131

PMID:15384088

Abstract

PURPOSE

To assess the impact of different factors on response rate (RR), time to tumor progression (TTP), and overall survival time (OS) in patients with locally advanced or metastatic soft tissue sarcoma (ASTS), included in three protocols with high-dose ifosfamide (HDIF).

PATIENTS AND METHODS

One hundred fifty six ASTS patients included in three consecutive phase II trials with HDIF (>10 g/m(2)), alone or in combination with doxorubicin (DX), were analyzed. Cofactors were institution, trial, gender, age, performance status, histologic type, grade of malignancy, prior radiotherapy, presence of locoregional disease, metastatic site, salvage surgery, number of organs involved, and disease-free interval.

RESULTS

By multivariate analysis performance status >0 and lack of salvage surgery correlated with a poorer survival. A good-risk and a poor-risk group were identified, with median survival time (OS) of 29, 5, and 10 months, respectively (P = 0.00001). The 1-, 2-, and 3-year OS for 83 good-risk patients (either with PS = 0 or receiving salvage surgery) was 83, 44, and 29%, respectively, those figures being 37, 7, and 3% for 73 poor-risk patients.

CONCLUSION

The design of randomized trials in ASTS including HDIF should consider those prognostic factors as stratification variables.

摘要

目的

评估不同因素对局部晚期或转移性软组织肉瘤（ASTS）患者的缓解率（RR）、肿瘤进展时间（TTP）和总生存时间（OS）的影响，这些患者纳入了三项使用高剂量异环磷酰胺（HDIF）的方案。

患者与方法

分析了156例ASTS患者，这些患者纳入了三项连续的II期试验，使用HDIF（>10 g/m²），单独使用或与多柔比星（DX）联合使用。辅助因素包括机构、试验、性别、年龄、体能状态、组织学类型、恶性程度分级、既往放疗、局部区域疾病的存在、转移部位、挽救性手术、受累器官数量和无病间期。

结果

通过多因素分析，体能状态>0和缺乏挽救性手术与较差的生存率相关。确定了一个低风险组和一个高风险组，中位生存时间（OS）分别为29、5和10个月（P = 0.00001）。83例低风险患者（PS = 0或接受挽救性手术）的1年、2年和3年OS分别为83%、44%和29%，73例高风险患者的这些数字分别为37%、7%和3%。