晚期胃癌患者的早期肿瘤退缩和深度缓解：一线 S-1 加奥沙利铂与 S-1 加顺铂的随机 III 期研究的回顾性分析。
Early tumor shrinkage and depth of response in patients with advanced gastric cancer: a retrospective analysis of a randomized phase III study of first-line S-1 plus oxaliplatin vs. S-1 plus cisplatin.
机构信息
Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemotomachi, Matsuyama, 791-0280, Japan.
Department of Gastroenterology, Kitasato University East Hospital, 2-1-1 Asamizodai, Minami-ku, Sagamihara, 252-0380, Japan.
出版信息
Gastric Cancer. 2019 Jan;22(1):138-146. doi: 10.1007/s10120-018-0845-7. Epub 2018 Jun 9.
BACKGROUND
We investigated early tumor shrinkage (ETS) and depth of response (DpR) using data from the G-SOX study comparing S-1 plus oxaliplatin with S-1 plus cisplatin as the first-line treatment for advanced gastric cancer (AGC).
METHODS
ETS was determined as % decrease in the sum of the longest diameters of the target lesions at the first evaluation of week 6 compared to baseline. DpR was the maximum % shrinkage during the study treatment. The impact of ETS (cutoff value 20%) and DpR (continuous value) on progression-free survival (PFS) and overall survival (OS) were assessed by the log-rank test and Cox regression analysis including prognostic factors obtained in the G-SOX study; ECOG performance status, baseline sum of tumor diameters, disease status (recurrent/unresectable), and histology (diffuse/intestinal).
RESULTS
Among 685 patients enrolled in the G-SOX study, 632 patients who had the first tumor evaluation were analyzed. Patients with ETS ≥ 20% had longer PFS (median 4.5 vs. 2.8 months, p < 0.0001) and OS (median 14.8 vs. 10.5 months, p < 0.0001) than those with ETS < 20%. Adjusted hazard ratios of ETS < 20 vs. ≥ 20% were 0.606 (95% confidence interval (CI) 0.506-0.725) for PFS and 0.589 (95% CI 0.492-0.704) for OS. DpR was also significantly associated with PFS and OS (both p < 0.0001). These results were similar between the SOX and CS groups.
CONCLUSIONS
In AGC patients receiving the first-line therapy, ETS and DpR might be predictors for PFS and OS.
背景
我们利用 G-SOX 研究的数据，调查了早期肿瘤退缩（ETS）和深度应答（DpR），该研究比较了 S-1 加奥沙利铂与 S-1 加顺铂作为晚期胃癌（AGC）一线治疗。
方法
ETS 是指与基线相比，第 6 周首次评估时目标病变最长直径总和的%下降。DpR 是研究治疗期间的最大收缩%。通过对数秩检验和包括 G-SOX 研究中获得的预后因素的 Cox 回归分析评估 ETS（截断值 20%）和 DpR（连续值）对无进展生存期（PFS）和总生存期（OS）的影响；ECOG 表现状态、基线肿瘤直径总和、疾病状态（复发/不可切除）和组织学（弥漫/肠型）。
结果
在 G-SOX 研究中纳入的 685 名患者中，对 632 名进行了首次肿瘤评估的患者进行了分析。ETS≥20%的患者具有更长的 PFS（中位 4.5 个月 vs. 2.8 个月，p<0.0001）和 OS（中位 14.8 个月 vs. 10.5 个月，p<0.0001）比 ETS<20%的患者。ETS<20%与 ETS≥20%的调整风险比为 0.606（95%置信区间 0.506-0.725），PFS 和 0.589（95%置信区间 0.492-0.704）OS。DpR 也与 PFS 和 OS 显著相关（均 p<0.0001）。这些结果在 SOX 和 CS 组之间相似。
结论
在接受一线治疗的 AGC 患者中，ETS 和 DpR 可能是 PFS 和 OS 的预测因素。
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