Department of Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Cancer Lett. 2011 Nov 28;310(2):134-9. doi: 10.1016/j.canlet.2011.06.026. Epub 2011 Jul 5.
PURPOSE: This study evaluated the efficacy and safety of neoadjuvant chemoradiotherapy with the XELOX regimen in rectal cancer patients. PATIENTS AND METHODS: Twenty-five patients with histopathologically confirmed and locally advanced rectal cancer (T3/T4 or N+) were enrolled in the study. Radiotherapy of 5000 cGy was delivered in 25 fractions of 200 cGy five times per week for a total of 5 weeks. During the first, second, fourth and fifth weeks of radiotherapy, the patients also received the following chemotherapy: 50 mg/m2 oxaliplatin on day one and 850 mg/m2 capecitabine bid for 5 days. Surgery was scheduled 5-6 weeks after the completion of the preoperative chemoradiotherapy. Four weeks after the surgery, four more cycles of chemotherapy were administered every 3 weeks. The postoperative chemotherapy consisted of 130 mg/m2 oxaliplatin on day 1 and 1000 mg/m2 capecitabine bid from day 1 to day 14. The end points were the downstage rate, R0 resection rate, and sphincter preservation rate. RESULTS: Twenty-five patients received the neoadjuvant chemoradiotherapy. The overall regression rate was 85%, with a Grade 3/4 regression rate of 30% and a pathological complete response rate of 12%. Among the 17 patients with lower rectal cancer, thirteen (76%) were originally indicated for abdominal-perineal resection (APR). However, after the neoadjuvant chemoradiotherapy, the anus could be preserved in nine patients (53%). The most frequent toxicities of the chemoradiotherapy were diarrhea (64%) and hematological toxicity (60%), followed by nausea and vomiting (48%), urinary tract irritation (28%), and anal pain (24%). Grade 3 or 4 adverse events were relatively infrequent and presented as diarrhea (12%), myelosuppression (8%), and elevated transaminase (4%). Six cases also experienced long-term anal exudates after surgery. CONCLUSIONS: Neoadjuvant chemoradiotherapy using the XELOX regimen in rectal cancer patients obviously reduced the TNM staging and improved the pathological complete response rate. The therapy was well-tolerated and had mild adverse events and no serious perioperational complications.
目的：本研究评估了新辅助放化疗联合 XELOX 方案治疗局部进展期直肠癌的疗效和安全性。
方法：本研究共纳入 25 例经组织病理学证实的局部进展期直肠癌（T3/T4 或 N+）患者。放疗采用 5000cGy，每周 5 次，每次 200cGy，共 5 周。在放疗的第 1、2、4 和 5 周，患者还接受以下化疗：奥沙利铂 50mg/m2，第 1 天；卡培他滨 850mg/m2，bid，连用 5 天。放化疗结束后 5-6 周行手术治疗。术后 4 周，每 3 周行 4 个周期的化疗，化疗方案为奥沙利铂 130mg/m2，第 1 天；卡培他滨 1000mg/m2，bid，第 1-14 天。术后化疗方案为奥沙利铂 100mg/m2，第 1 天；卡培他滨 1000mg/m2，bid，第 1-14 天。研究终点为降期率、R0 切除率和保肛率。
结果：25 例患者接受了新辅助放化疗。总体缓解率为 85%，其中 3/4 级缓解率为 30%，病理完全缓解率为 12%。17 例低位直肠癌患者中，13 例（76%）最初拟行腹会阴联合切除术（APR）。但新辅助放化疗后，9 例（53%）可保肛。放化疗最常见的毒性反应为腹泻（64%）和血液学毒性（60%），其次为恶心呕吐（48%）、尿路刺激（28%）和肛门疼痛（24%）。3/4 级不良事件相对少见，表现为腹泻（12%）、骨髓抑制（8%）和转氨酶升高（4%）。6 例患者术后还出现长期肛门渗液。
结论：XELOX 方案新辅助放化疗可明显降低直肠癌的 TNM 分期，提高病理完全缓解率。该方案耐受性良好，不良反应轻微，无严重围手术期并发症。
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