Ceddia S, Onesti C E, Vari S, Torchia A, Cosimati A, Riva F, Maccallini M T, Cerro M, Benvenuti G, Russillo M, Anelli V, Sperduti I, Biagini R, Ferraresi V
UOSD Sarcomas and Rare Tumors, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Scienze Radiologiche, Oncologiche e Anatomo-Patologiche, Sapienza Università di Roma, Rome, Italy.
Front Pharmacol. 2024 Aug 20;15:1411707. doi: 10.3389/fphar.2024.1411707. eCollection 2024.
Trabectedin is an antineoplastic drug approved for patients (pts) with advanced soft tissue sarcomas (STS). Interestingly, the radiological evaluation of response during trabectedin therapy is peculiar. The aim of this single-center retrospective study is to analyze the concordance of response assessment according to RECIST compared with Choi criteria in patients with STS treated with trabectedin between 2009 and 2020 at Regina Elena National Cancer Institute in Rome. We present the preliminary data collected in the last 2 months (mos) on 37 pts who received the diagnosis between 2015 and 2020, with a median age of 52.5 years (range 32-78). The median number of trabectedin cycles administered was four (range 2-50) for a median follow up of 5.83 months (range 1-60). Histological subtypes of STS were five (13.5%) leiomyosarcoma, 14 (37.8%) liposarcoma, nine (24.3%) undifferentiated pleomorphic sarcoma, three (8.1%) synovial sarcoma, and six (16.2%) other rare histological subtypes. Eight pts (21.6%) received trabectedin in the first line setting, 21 (56.8%) in the second line, and seven (18.9%) received it in subsequent lines. One pt received trabectedin as neoadjuvant therapy in a clinical trial (ISG-STS 1001). Median progression-free survival was 3.6 months (CI95% 2.7-4.6); median overall survival was 34.3 months (CI95% 0-75.4). The radiological responses were evaluated with both RECIST and Choi criteria; responses matched in 33 pts (89.2%) but not in four (10.8%). The best responses obtained according to RECIST criteria were two (5.4%) partial response (PR), 13 (35.1%) stable disease (SD), and 22 (59.5%) progressive disease (PD). Instead, two (5.4%), 13 (35.1%), and 22 (59.5%) pts obtained PR, SD, and PD respectively, according to Choi criteria. Cohen's kappa coefficient of concordance was 0.792 (-value <0.002). A specialized radiologist performed all imaging examinations using a dedicated workstation in the same center. In this first analysis, the concordance between RECIST and Choi assessments demonstrates no statistically significant difference. Responses did not match for four pts. We are expanding the analysis to all pts included in the original cohort to confirm or deny these initial results.
曲贝替定是一种已被批准用于晚期软组织肉瘤（STS）患者的抗肿瘤药物。有趣的是，曲贝替定治疗期间反应的放射学评估很特殊。本单中心回顾性研究的目的是分析2009年至2020年在罗马的雷吉娜·埃琳娜国家癌症研究所接受曲贝替定治疗的STS患者中，根据实体瘤疗效评价标准（RECIST）与Choi标准进行反应评估的一致性。我们展示了过去2个月收集的关于37例患者的初步数据，这些患者在2015年至2020年期间确诊，中位年龄为52.5岁（范围32 - 78岁）。给予曲贝替定的中位周期数为4个（范围2 - 50个），中位随访时间为5.83个月（范围1 - 60个月）。STS的组织学亚型有5例（13.5%）平滑肌肉瘤、14例（37.8%）脂肪肉瘤、9例（24.3%）未分化多形性肉瘤、3例（8.1%）滑膜肉瘤和6例（16.2%）其他罕见组织学亚型。8例（21.6%）患者一线接受曲贝替定治疗，21例（56.8%）二线治疗，7例（18.9%）在后续线次接受治疗。1例患者在一项临床试验（ISG - STS 1001）中接受曲贝替定作为新辅助治疗。中位无进展生存期为3.6个月（95%置信区间2.7 - 4.6）；中位总生存期为34.3个月（95%置信区间0 - 75.4）。采用RECIST和Choi标准评估放射学反应；33例（89.2%）患者的反应一致，4例（10.8%）患者不一致。根据RECIST标准获得的最佳反应为2例（5.4%）部分缓解（PR）、13例（35.1%）疾病稳定（SD）和22例（59.5%）疾病进展（PD）。相反，根据Choi标准，分别有2例（5.4%）、13例（35.1%）和22例（59.5%）患者获得PR、SD和PD。Cohen一致性kappa系数为0.792（P值<0.002）。一名专业放射科医生在同一中心使用专用工作站进行了所有影像学检查。在这首次分析中，RECIST和Choi评估之间的一致性未显示出统计学上的显著差异。4例患者的反应不匹配。我们正在将分析扩展至原始队列中的所有患者，以确认或否定这些初步结果。
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