Department of Medical Oncology, Eugene Marquis Center, Rennes, France.
Cancer. 2012 Jan 1;118(1):147-56. doi: 10.1002/cncr.26255. Epub 2011 Jun 28.
A significant improvement in overall survival (OS) was demonstrated in patients with advanced hepatocellular carcinoma (HCC) who received sorafenib (Sor) in the Sorafenib HCC Assessment Randomized Protocol (SHARP) study, in contrast to a response rate (RR) of 2% assessed according to Response Evaluation Criteria in Solid Tumors (RECIST). Modified RECIST (mRECIST) were developed to assess the response in patients with HCC, based on measurement of viable tumor with arterial enhancement on a computed tomography (CT) scan. In the current study, mRECIST were evaluated and were compared with RECIST in patients who received Sor for advanced HCC.
The authors retrospectively analyzed 53 patients who received Sor for advanced HCC. Patients must to have undergone a 4-phase CT scan before treatment and repeatedly thereafter. CT scans were analyzed using RECIST 1.1 and mRECIST.
The rates of objective response (OR), stable disease (SD), and progressive disease (PD) were 2%, 79%, and 19%, respectively, according to RECIST and 23%, 57%, and 21%, respectively, according to mRECIST (P < .001). Patients who achieved an OR according to mRECIST had a longer OS than nonresponding patients with SD or PD (median OS, 18 months and 8 months, respectively; P = .013). In the 42 patients who achieved SD according to RECIST, OS differed depending on tumor response according to mRECIST, with a median OS of 17 months, 10 months, and 4 months for patients who achieved an OR (n = 11), SD (n = 29), and PD (n = 2), respectively (P = .016).
The current series validated mRECIST in patients who received Sor for advanced HCC. The majority of patients who had SD according to RECIST had a different prognosis according to mRECIST. The results indicated that, for patients with HCC, mRECIST should be used for the standard assessment of treatment efficacy, particularly in patients who are receiving antiangiogenic drugs.
在索拉非尼 HCC 评估随机协议（SHARP）研究中，接受索拉非尼（Sor）治疗的晚期肝细胞癌（HCC）患者的总生存期（OS）显著改善，而根据实体瘤反应评估标准（RECIST）评估的缓解率（RR）为 2%。改良 RECIST（mRECIST）是为了评估接受 HCC 治疗的患者的反应而开发的，其依据是在 CT 扫描上测量动脉增强的存活肿瘤。在本研究中，评估了 mRECIST，并将其与接受 Sor 治疗的晚期 HCC 患者的 RECIST 进行了比较。
作者回顾性分析了 53 例接受 Sor 治疗的晚期 HCC 患者。患者必须在治疗前和随后的治疗过程中进行 4 期 CT 扫描。使用 RECIST 1.1 和 mRECIST 分析 CT 扫描。
根据 RECIST，客观缓解（OR）、疾病稳定（SD）和疾病进展（PD）的发生率分别为 2%、79%和 19%，根据 mRECIST，分别为 23%、57%和 21%（P<0.001）。根据 mRECIST 达到 OR 的患者的 OS 长于 SD 或 PD 的非应答患者（中位 OS，分别为 18 个月和 8 个月；P=0.013）。在根据 RECIST 达到 SD 的 42 例患者中，OS 因 mRECIST 肿瘤反应而异，OR（n=11）、SD（n=29）和 PD（n=2）患者的中位 OS 分别为 17 个月、10 个月和 4 个月（P=0.016）。
本系列研究验证了 mRECIST 在接受 Sor 治疗的晚期 HCC 患者中的应用。根据 RECIST 达到 SD 的大多数患者根据 mRECIST 具有不同的预后。结果表明，对于 HCC 患者，mRECIST 应作为治疗疗效的标准评估方法，特别是在接受抗血管生成药物治疗的患者中。
