Mehta V K, Poen J, Ford J, Edelstein P S, Vierra M, Bastidas A J, Young H, Fisher G
Department of Radiation Oncology, Stanford University Medical Center, Stanford, California 94305, USA.
Dis Colon Rectum. 2001 Jan;44(1):52-8. doi: 10.1007/BF02234821.
A prospective study was undertaken to evaluate the response and toxicity of neoadjuvant chemoradiotherapy for ultrasound-staged T3 or T4 rectal cancer.
Since 1995, 30 patients (18 males; median age, 56 (range, 25-83) years) have received preoperative chemoradiotherapy for ultrasound-staged T3 or T4 rectal cancer. All patients underwent an endorectal ultrasound, CT scan, and review in our multidisciplinary Gastrointestinal Tumor Board before treatment. All patients had pathology-demonstrated invasive adenocarcinoma of the rectum. Eleven patients were Stage T3N0, 14 were T3N1, and five were T4N1. Patients received radiotherapy to the primary tumor and draining lymph nodes (45 Gy) followed by a tumor boost (50.4-54 Gy). Protracted-venous-infusion 5-fluorouracil (225 mg/m2 per day, seven days per week) was administered throughout treatment. Surgical resection was performed six to ten weeks after completing chemoradiotherapy. Using endorectal ultrasound measurements, the primary tumor was a median of 4 (range, 0-12) cm from the anal verge, encompassed 50 (range, 20-90) percent of the rectal circumference, and was 6 (range, 3-12) cm in diameter.
No Grade 4 toxicity was observed during chemoradiotherapy. Three patients experienced Grade 3 toxicity (diarrhea), and four patients required a treatment interruption of greater than three days. All patients completed at least 90 percent of the prescribed radiotherapy dose. All patients underwent surgical resection. Ninety-four percent had clear surgical margins. All pathologic specimens had significant evidence of necrosis, hyalinization, and fibrosis. Thirty-three percent of the specimens had a complete pathologic response (defined as no evidence of viable tumor cells). Of the 19 patients with ultrasound-staged N1 disease, only five had pathologic evidence of nodal involvement after chemoradiotherapy. Of the 25 patients with ultrasound-staged T3 disease, pathologic staging revealed eight with T0, two with T1, five with T2, and ten with T3 disease. Of the five patients with ultrasound-staged T4 disease, pathologic staging revealed two with T0, one with T2, and two with T3 disease. No patient developed progressive disease while on treatment. Two patients have experienced local failure at 6 and 20 months, and one patient failed in the liver at seven months. Twenty-seven patients remain free of disease with a median follow-up of 20 (range, 3-53) months.
Our experience suggests that preoperative chemoradiotherapy is well tolerated, down-stages tumors, and sterilizes regional lymph nodes.
开展了一项前瞻性研究，以评估新辅助放化疗对超声分期为T3或T4期直肠癌的疗效及毒性。
自1995年以来，30例患者（18例男性；中位年龄56岁（范围25 - 83岁））接受了针对超声分期为T3或T4期直肠癌的术前放化疗。所有患者在治疗前均接受了直肠内超声、CT扫描，并在我们的多学科胃肠肿瘤委员会进行了评估。所有患者均经病理证实为直肠浸润性腺癌。11例患者为T3N0期，14例为T3N1期，5例为T4N1期。患者接受针对原发肿瘤及引流淋巴结的放疗（45 Gy），随后对肿瘤进行追加剂量放疗（50.4 - 54 Gy）。在整个治疗过程中持续静脉输注5-氟尿嘧啶（每天225 mg/m²，每周7天）。在完成放化疗后6至10周进行手术切除。根据直肠内超声测量，原发肿瘤距肛缘的中位距离为4 cm（范围0 - 12 cm），累及直肠周长的50%（范围20% - 90%），直径为6 cm（范围3 - 12 cm）。
放化疗期间未观察到4级毒性反应。3例患者出现3级毒性反应（腹泻），4例患者需要中断治疗超过3天。所有患者均完成了至少90%的规定放疗剂量。所有患者均接受了手术切除。94%的患者手术切缘清晰。所有病理标本均有明显的坏死、透明变性和纤维化证据。33%的标本有完全病理缓解（定义为无存活肿瘤细胞证据）。在19例超声分期为N1期疾病的患者中，放化疗后只有5例有淋巴结受累的病理证据。在25例超声分期为T3期疾病的患者中，病理分期显示8例为T0期，2例为T1期，5例为T2期，10例为T3期。在5例超声分期为T4期疾病的患者中，病理分期显示2例为T0期，1例为T2期，2例为T3期。没有患者在治疗期间出现疾病进展。2例患者分别在6个月和20个月时出现局部复发，1例患者在7个月时肝脏出现复发。27例患者疾病无进展，中位随访时间为20个月（范围3 - 53个月）。
我们的经验表明，术前放化疗耐受性良好，可使肿瘤降期，并使区域淋巴结失活。
