Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Department of Radiation Oncology, Huashan Hospital, Fudan University, Shanghai, China; Department of Cyberknife Center, Huashan Hospital, Fudan University, Shanghai, China.
Clin Colorectal Cancer. 2020 Jun;19(2):e58-e69. doi: 10.1016/j.clcc.2020.01.004. Epub 2020 Feb 4.
This study explored the impact of chemotherapy completion on irinotecan efficacy in preoperative chemoradiotherapy in patients with locally advanced rectal cancer.
Patients with locally advanced rectal cancer (T3/4 and/or LN+) receiving neoadjuvant chemoradiotherapy were enrolled. All received preoperative pelvic radiotherapy concurrently with capecitabine and irinotecan, followed by a course of XELIRI and surgery. Patients were divided into low- and high-completion groups based on their cycles of concurrent irinotecan (1-3 or 4-5). Tumor response was compared. Significant risk factors for low completion were investigated by logistic regression modeling then a predictive nomogram was built.
Overall, 371 patients were enrolled, with 102 patients from CinClare phase III trial (NCT02605265). Proportions of patients with low and high completion were 38.8% and 61.2%, respectively. In the general population, the complete tumor response rates (combining sustained clinical complete response and pathologic complete response) were 21.5% and 33.6% in the low- and high-completion groups, respectively (P = .02), which were 24.2% versus 43.5% in the CinClare group (P = .08). The pathologic complete response rates were 19.4% and 26.1%, respectively (P = .19). A predictive nomogram was established and 3 different risk groups (low, intermediate, and high risk) were identified, with high completion rates of 29.2%, 50.0%, and 68.9%, respectively (P < .0001).
Our analysis suggested higher completion of concurrent irinotecan was associated with better tumor response for patients with locally advanced rectal cancer with UGT1A1∗1∗1 or UGT1A1∗1∗28 phenotypes in the neoadjuvant setting, and at least 4 cycles was recommended.
本研究旨在探讨局部晚期直肠癌患者新辅助放化疗中完成化疗对伊立替康疗效的影响。
纳入局部晚期直肠癌（T3/4 和/或 LN+）患者，接受新辅助放化疗。所有患者均接受盆腔放疗同步卡培他滨和伊立替康治疗，随后接受 XELIRI 治疗和手术。根据同步伊立替康（1-3 或 4-5 个周期）的周期数，将患者分为低完成组和高完成组。比较肿瘤反应。通过逻辑回归模型对低完成的显著危险因素进行调查，然后构建预测列线图。
共纳入 371 例患者，其中 102 例来自 CinClare III 期试验（NCT02605265）。低完成组和高完成组的患者比例分别为 38.8%和 61.2%。在一般人群中，低完成组和高完成组的完全肿瘤缓解率（包括持续临床完全缓解和病理完全缓解）分别为 21.5%和 33.6%（P=0.02），CinClare 组分别为 24.2%和 43.5%（P=0.08）。病理完全缓解率分别为 19.4%和 26.1%（P=0.19）。建立了一个预测列线图，并确定了 3 个不同的风险组（低、中、高风险），高完成率分别为 29.2%、50.0%和 68.9%（P<0.0001）。
我们的分析表明，对于 UGT1A1∗1∗1 或 UGT1A1∗1∗28 表型的局部晚期直肠癌患者，新辅助治疗中完成同步伊立替康化疗与更好的肿瘤反应相关，建议至少完成 4 个周期。
