Department Radiation Oncology, Hospital Clínico Universitario San Carlos, c/Profesor Martín Lagos, S/N, 28040 Madrid, Spain.
Clin Transl Oncol. 2013 Apr;15(4):294-9. doi: 10.1007/s12094-012-0915-y. Epub 2012 Aug 2.
To assess pathologic complete response, sphincter preservation rates and toxicity profile of preoperative chemoradiation with capecitabine in resectable locally advanced rectal cancer.
Fifty-eight patients from six Spanish centers were included (March 2004 to June 2005) with histological/cytological diagnosis of locally advanced rectal cancer, age between 18 and 80 years, ECOG 0-2, adequate bone marrow, renal and hepatic functions. Prior chemotherapy/radiotherapy was not allowed. Preoperative treatment was capecitabine 825 mg/m(2) bid concomitant to radiotherapy (45 + 5.4 Gy boost over 5.5 weeks). Surgery was performed 4-8 weeks after completion of chemoradiotherapy.
Fifty-eight patients were enrolled in this study: 60.3 % males, median age of 64.5 (30.9-78.7) years, 28.6 % with ECOG 0 and 71.4 % with ECOG 1. Median distance of tumor from the anal verge was 7 (1-12) cm. Fifty-two (89.6. %) patients completed preoperative chemoradiotherapy. Primary tumor and node downstaging occurred in 61.1 and 69.6 % of patients, respectively. Surgery was performed in 55 patients (94.8 %): 80 % had negative lymph nodes and 72.7 % underwent sphincter-preserving procedures. A pathologic complete response was observed in 10.5 % (95 % CI 2.5-18.5) of the patients. Main grade I-II toxicities were leucopenia (43.1 %), neutropenia (24.1 %), anemia (36.2 %), diarrhea (32.8 %) and skin disorders (5.1 %), from which diarrhea (6.9 %), leucopenia (1.7 %) and skin disorders (1.7 %) reached grade III. There were no grade IV toxicities.
Preoperative capecitabine-based chemoradiation is a well-tolerated and effective neoadjuvant treatment for locally advanced rectal cancer that achieves encouraging rates of tumor downstaging.
评估术前卡培他滨放化疗治疗可切除局部进展期直肠癌的病理完全缓解率、保肛率和毒性谱。
纳入了来自西班牙 6 家中心的 58 例患者（2004 年 3 月至 2005 年 6 月），组织学/细胞学诊断为局部进展期直肠癌，年龄在 18 至 80 岁之间，ECOG 0-2，骨髓、肾功能和肝功能良好。不允许进行先前的化疗/放疗。术前治疗为卡培他滨 825mg/m²bid 联合放疗（45+5.4Gy 5.5 周加量）。放化疗结束后 4-8 周行手术。
本研究共纳入 58 例患者：男性占 60.3%，中位年龄 64.5（30.9-78.7）岁，ECOG 0 占 28.6%，ECOG 1 占 71.4%。肿瘤距肛缘的平均距离为 7（1-12）cm。52 例（89.6%）患者完成术前放化疗。原发肿瘤和淋巴结降期分别发生在 61.1%和 69.6%的患者中。55 例（94.8%）患者行手术治疗：80%患者淋巴结阴性，72.7%患者行保肛手术。病理完全缓解率为 10.5%（95%CI 2.5-18.5）。主要为 I-II 级毒性反应，包括白细胞减少（43.1%）、中性粒细胞减少（24.1%）、贫血（36.2%）、腹泻（32.8%）和皮肤疾病（5.1%），其中腹泻（6.9%）、白细胞减少（1.7%）和皮肤疾病（1.7%）达到 III 级。无 IV 级毒性反应。
术前卡培他滨为基础的放化疗是一种耐受性良好且有效的局部进展期直肠癌新辅助治疗方法，可实现令人鼓舞的肿瘤降期效果。
