Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.
Klinikum Esslingen, Cancer Center Esslingen, Esslingen am Neckar, Germany.
Clin Colorectal Cancer. 2019 Dec;18(4):245-256.e5. doi: 10.1016/j.clcc.2019.07.009. Epub 2019 Jul 29.
There is no standardized assessment of symptomatic events in metastatic colorectal cancer (mCRC) despite disease symptoms that affect treatment decisions. Data from 3 first-line panitumumab in mCRC trials were retrospectively analyzed to assess whether early tumor shrinkage (ETS) and depth of response (DpR) were associated with time to occurrence of tumor-related symptoms.
Patients with RAS wild-type mCRC from PRIME, PEAK, and Study 314 were included. ETS was defined as a reduction of ≥ 30% in the sum of the longest diameters of lesions at 8 weeks. DpR was calculated as maximum percentage change in tumor size from baseline to nadir. The proportion of patients who developed symptoms (including a composite symptomatic endpoint) during study treatment was calculated. This study was registered at ClinicalTrials.gov as PRIME (NCT00364013), PEAK (NCT00819780), and Study 314 (NCT00508404).
Overall, data of 659 patients were analyzed. Onset of symptoms was delayed in patients with ETS ≥ 30% versus ETS < 30% and in patients with greater DpR. In patients with symptoms at baseline who experienced ETS ≥ 30%, overall survival was similar to that seen for patients without symptoms at baseline.
Both ETS and DpR were associated with delayed onset of symptoms in RAS wild-type mCRC patients. Treatments with high cytoreductive potential may delay symptom development.
转移性结直肠癌（mCRC）存在影响治疗决策的症状，但目前缺乏对症状性事件的标准化评估。本研究对 3 项帕尼单抗一线治疗 mCRC 临床试验的数据进行回顾性分析，旨在评估早期肿瘤退缩（ETS）和深度缓解（DpR）与肿瘤相关症状发生时间的相关性。
纳入 RAS 野生型 mCRC 患者，这些患者来自 PRIME、PEAK 和 Study 314 研究。ETS 定义为 8 周时最长径总和较基线下降≥30%。DpR 计算为从基线至最低点肿瘤大小的最大百分比变化。计算研究治疗期间出现症状（包括复合症状终点）的患者比例。该研究在 ClinicalTrials.gov 登记为 PRIME（NCT00364013）、PEAK（NCT00819780）和 Study 314（NCT00508404）。
共分析了 659 例患者的数据。与 ETS<30%的患者相比，ETS≥30%的患者症状出现时间延迟，DpR 较大的患者症状出现时间也延迟。在基线时出现症状但发生 ETS≥30%的患者中，总生存期与基线时无症状的患者相似。
在 RAS 野生型 mCRC 患者中，ETS 和 DpR 均与症状出现时间延迟相关。细胞减灭潜力高的治疗可能会延迟症状的发生。
