评价舒尼替尼治疗胰腺神经内分泌肿瘤的影像学反应：Choi 标准与 RECIST 标准的比较（CRIPNET_GETNE1504 研究）。

Evaluating radiological response in pancreatic neuroendocrine tumours treated with sunitinib: comparison of Choi versus RECIST criteria (CRIPNET_ GETNE1504 study).

机构信息

Medical Oncology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.

Radiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.

出版信息

Br J Cancer. 2019 Oct;121(7):537-544. doi: 10.1038/s41416-019-0558-7. Epub 2019 Sep 3.

BACKGROUND

The purpose of our study was to analyse the usefulness of Choi criteria versus RECIST in patients with pancreatic neuroendocrine tumours (PanNETs) treated with sunitinib.

METHOD

A multicentre, prospective study was conducted in 10 Spanish centres. Computed tomographies, at least every 6 months, were centrally evaluated until tumour progression.

RESULTS

One hundred and seven patients were included. Median progression-free survival (PFS) by RECIST and Choi were 11.42 (95% confidence interval [CI], 9.7-15.9) and 15.8 months (95% CI, 13.9-25.7). PFS by Choi (Kendall's τ = 0.72) exhibited greater correlation with overall survival (OS) than PFS by RECIST (Kendall's τ = 0.43). RECIST incorrectly estimated prognosis in 49.6%. Partial response rate increased from 12.8% to 47.4% with Choi criteria. Twenty-four percent of patients with progressive disease according to Choi had stable disease as per RECIST, overestimating treatment effect. Choi criteria predicted PFS/OS. Changes in attenuation occurred early and accounted for 21% of the variations in tumour volume. Attenuation and tumour growth rate (TGR) were associated with improved survival.

CONCLUSION

Choi criteria were able to capture sunitinib's activity in a clinically significant manner better than RECIST; their implementation in standard clinical practice shall be strongly considered in PanNET patients treated with this drug.

背景

我们研究的目的是分析 Choi 标准与 RECIST 在接受舒尼替尼治疗的胰腺神经内分泌肿瘤（PanNETs）患者中的作用。

方法

在 10 家西班牙中心进行了一项多中心前瞻性研究。通过中央评估计算机断层扫描，至少每 6 个月评估一次，直至肿瘤进展。

结果

共纳入 107 例患者。根据 RECIST 和 Choi 标准，无进展生存期（PFS）分别为 11.42（95%置信区间[CI]，9.7-15.9）和 15.8 个月（95%CI，13.9-25.7）。Choi（Kendall's τ=0.72）标准的 PFS 与总生存期（OS）的相关性大于 RECIST（Kendall's τ=0.43）。RECIST 标准错误地估计了 49.6%的患者预后。Choi 标准将部分缓解率从 12.8%提高到了 47.4%。根据 Choi 标准，24%的疾病进展患者根据 RECIST 标准表现为稳定疾病，高估了治疗效果。Choi 标准预测了 PFS/OS。衰减变化发生较早，占肿瘤体积变化的 21%。衰减和肿瘤生长率（TGR）与生存改善相关。