Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Unit of Medical Statistics, Biometry and Bioinformatics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Eur J Cancer. 2018 Apr;93:28-36. doi: 10.1016/j.ejca.2018.01.071. Epub 2018 Feb 21.
Patients with extremity and trunk wall soft tissue sarcoma (STS) with high malignancy grade and size >5 cm are at high-risk of death. This risk varies depending also on other patient and tumour features, including histologic subtype. This study investigated whether a prognostic nomogram can improve risk assessment of these patients.
Data from high-risk STS patients enrolled in a randomised controlled trial investigating different perioperative chemotherapy regimens were analysed. Ten-year probability of overall survival (OS) and incidence of distant metastasis (DM) were computed using the prognostic nomogram Sarculator (pr-OS and inc-DM, respectively). Tumour response according to RECIST and Choi criteria was also investigated.
Variation in pr-OS and inc-DM were observed and patients stratified in three prognostic groups. The 10-year OS in the low, intermediate, and high pr-OS categories were 0·42 (95%CI 0·32-0·52), 0·63 (95%CI 0·53-0·72), and 0·78 (95%CI 0·68-0·85), respectively. Patients in the intermediate (HR 0·51, P = 0·002) and high (HR 0·28, P < 0·001) pr-OS categories were at statistically significant lower risk of death compared with those in the low pr-OS category. Higher rate of Choi partial tumour responses were detected in intermediate pr-OS category. Tumour response according to Choi but not to RECIST criteria stratified patient survival of pr-OS categories, particularly for patients with intermediate to low pr-OS. Analyses conducted for 10-year inc-DM were consistent with results for pr-OS for prognostic value of Sarculator predictions and Choi tumour response.
Sarculator identifies variations in outcomes of high-risk STS treated with perioperative chemotherapy and improve prognostic classification, which is also associated with different patterns of tumour response, an outcome that further stratifies survival particularly for patients predicted at higher risk. Future trials investigating neoadjuvant chemotherapy should consider prognostic tool for selecting patients to be enrolled.
European Union Drug Regulating Authorities Clinical Trials No. 2004-003979-36.
肢体和躯干壁软组织肉瘤（STS）患者，恶性程度高且肿瘤尺寸＞5cm 者，死亡风险高。这种风险还取决于其他患者和肿瘤特征，包括组织学亚型。本研究旨在探究预后列线图是否能改善此类患者的风险评估。
分析纳入研究不同围手术期化疗方案的高危 STS 患者的随机对照试验数据。采用 Sarculator（总生存预后[pr-OS]和远处转移发生率[inc-DM]）计算 10 年总生存率（OS）和远处转移发生率。还研究了根据 RECIST 和 Choi 标准的肿瘤反应。
观察到 pr-OS 和 inc-DM 的变化，并将患者分为三个预后组。低、中、高 pr-OS 组的 10 年 OS 分别为 0.42（95%CI 0.32-0.52）、0.63（95%CI 0.53-0.72）和 0.78（95%CI 0.68-0.85）。与低 pr-OS 组相比，中（HR 0.51，P=0.002）和高（HR 0.28，P＜0.001）pr-OS 组患者死亡风险显著降低。在中间 pr-OS 组中检测到 Choi 部分肿瘤反应的比例较高。根据 Choi 而非 RECIST 标准进行的肿瘤反应对 pr-OS 分类患者的生存进行了分层，特别是对于中低 pr-OS 患者。对于 10 年 inc-DM 的分析结果与 pr-OS 一致，表明 Sarculator 预测的预后价值和 Choi 肿瘤反应可改善预后分类。
Sarculator 确定了接受围手术期化疗治疗的高危 STS 患者结局的变化，并改善了预后分类，该分类还与不同的肿瘤反应模式相关，特别是对于预测风险较高的患者，该模式进一步分层了生存。未来的新辅助化疗试验应考虑使用预后工具来选择入组患者。
欧洲药品管理局临床试验号 2004-003979-36。
