Department of Surgery, Kitasato University School of Medicine, Kanagawa, Japan.
Department of Surgery, Kitasato University School of Medicine, Kanagawa, Japan.
Int J Radiat Oncol Biol Phys. 2014 Jul 1;89(3):547-55. doi: 10.1016/j.ijrobp.2014.03.007.
To assess the long-term outcomes of patients with rectal cancer who received neoadjuvant chemoradiation therapy (NCRT) with concurrent S-1 and irinotecan (S-1/irinotecan) therapy.
The study group consisted of 115 patients with clinical stage T3 or T4 rectal cancer. Patients received pelvic radiation therapy (45 Gy) plus concurrent oral S-1/irinotecan. The median follow-up was 60 months.
Grade 3 adverse effects occurred in 7 patients (6%), and the completion rate of NCRT was 87%. All 115 patients (100%) were able to undergo R0 surgical resection. Twenty-eight patients (24%) had a pathological complete response (ypCR). At 60 months, the local recurrence-free survival was 93%, disease-free survival (DFS) was 79%, and overall survival (OS) was 80%. On multivariate analysis with a proportional hazards model, ypN2 was the only independent prognostic factor for DFS (P=.0019) and OS (P=.0064) in the study group as a whole. Multivariate analysis was additionally performed for the subgroup of 106 patients with ypN0/1 disease, who had a DFS rate of 85.3%. Both ypT (P=.0065) and tumor location (P=.003) were independent predictors of DFS. A combination of these factors was very strongly related to high risk of recurrence (P<.0001), which occurred most commonly in the lung.
NCRT with concurrent S-1/irinotecan produced high response rates and excellent long-term survival, with acceptable adverse effects in patients with rectal cancer. ypN2 is a strong predictor of dismal outcomes, and a combination of ypT and tumor location can identify high-risk patients among those with ypN0/1 disease.
评估接受新辅助放化疗（NCRT）联合 S-1 和伊立替康（S-1/伊立替康）治疗的直肠癌患者的长期疗效。
研究组包括 115 例临床 T3 或 T4 期直肠癌患者。患者接受盆腔放疗（45Gy）加同期口服 S-1/伊立替康。中位随访时间为 60 个月。
7 例（6%）发生 3 级不良反应，NCRT 完成率为 87%。115 例患者（100%）均能行 R0 手术切除。28 例（24%）患者获得病理完全缓解（ypCR）。60 个月时，局部无复发生存率为 93%，无病生存率（DFS）为 79%，总生存率（OS）为 80%。多因素分析采用比例风险模型，ypN2 是研究组 DFS（P=.0019）和 OS（P=.0064）的唯一独立预后因素。对 ypN0/1 疾病的 106 例患者亚组进行了多因素分析，DFS 率为 85.3%。ypT（P=.0065）和肿瘤位置（P=.003）是 DFS 的独立预测因素。这些因素的组合与高复发风险密切相关（P<.0001），最常见于肺部。
NCRT 联合 S-1/伊立替康治疗直肠癌患者可获得较高的缓解率和长期生存，不良反应可接受。ypN2 是预后不良的强烈预测因素，ypT 和肿瘤位置的组合可在 ypN0/1 疾病患者中识别出高危患者。
