Wolmark N, Fisher B
Ann Surg. 1986 Oct;204(4):480-9. doi: 10.1097/00000658-198610000-00016.
Abdominoperineal resections for rectal carcinoma are being performed with decreasing frequency in favor of sphincter-saving resections. It remains, however, to be unequivocally demonstrated that sphincter preservation has not resulted in compromised local disease control, disease-free survival, and survival. Accordingly, it is the specific aim of this endeavor to compare local recurrence, disease-free survival, and survival in patients with Dukes' B and C rectal cancer undergoing curative abdominoperineal resection or sphincter-saving resection. For the purpose of this study, 232 patients undergoing abdominoperineal resection and 181 subjected to sphincter-saving resections were available for analysis from an NSABP randomized prospective clinical trial designed to ascertain the efficacy of adjuvant therapy in rectal carcinoma (protocol R-01). The mean time on study was 48 months. Analyses were carried out comparing the two operations according to Dukes' class, the number of positive nodes, and tumor size. The only significant differences in disease-free survival and survival were observed for the cohort characterized by greater than 4 positive nodes and were in favor of patients treated with sphincter-saving resections. A patient undergoing sphincter-saving resection was 0.62 times as likely to sustain a treatment failure as a similar patient undergoing abdominoperineal resection (p = 0.07) and 0.49 times as likely to die (p = 0.02). The inability to demonstrate an attenuated disease-free survival and survival for patients treated with sphincter-saving resection was in spite of an increased incidence of local recurrence (anastomotic and pelvic) observed for the latter operation when compared to abdominoperineal resection (13% vs. 5%). A similar analysis evaluating the length of margins of resection in patients undergoing sphincter-preserving operations indicated that treatment failure and survival were not significantly different in patients whose distal resection margins were less than 2 cm, 2-2.9 cm, or greater than or equal to 3 cm. If any trend was observed, it appeared that patients with smaller resection margins had a slightly prolonged survival (p = 0.10). This observation was present in spite of the fact that local recurrence as a first site of treatment failure was greater in the group with less than 2 cm that it was in the greater than or equal to 3 cm category, 22% versus 12%. This increased local recurrence rate in the population with smaller margins was not translated into an in crease in overall treatment failure and had absolutely no influence on survival. It is suggested that local recurrence serves as a marker of distant disease.(ABSTRACT TRUNCATED AT 400 WORDS)
由于保肛手术更受青睐,直肠癌腹会阴联合切除术的实施频率正在降低。然而,仍需明确证明保肛手术不会导致局部疾病控制、无病生存期和总生存期受到影响。因此,本研究的具体目的是比较接受根治性腹会阴联合切除术或保肛手术的 Dukes' B 期和 C 期直肠癌患者的局部复发率、无病生存期和总生存期。在一项旨在确定辅助治疗对直肠癌疗效的 NSABP 随机前瞻性临床试验(方案 R - 01)中,有 232 例接受腹会阴联合切除术的患者和 181 例接受保肛手术的患者可供分析。研究的平均时间为 48 个月。根据 Dukes' 分期、阳性淋巴结数量和肿瘤大小对这两种手术进行了比较分析。在无病生存期和总生存期方面,唯一显著的差异出现在阳性淋巴结大于 4 个的队列中,且保肛手术治疗的患者更具优势。接受保肛手术的患者发生治疗失败的可能性是接受类似腹会阴联合切除术患者的 0.62 倍(p = 0.07),死亡可能性是其 0.49 倍(p = 0.02)。尽管与腹会阴联合切除术相比,保肛手术观察到局部复发(吻合口和盆腔)发生率增加(13% 对 5%),但仍未能证明保肛手术治疗的患者无病生存期和总生存期缩短。一项评估保肛手术患者切缘长度的类似分析表明,远端切缘小于 2 cm、2 - 2.9 cm 或大于或等于 3 cm 的患者,治疗失败率和总生存期无显著差异。如果观察到任何趋势,似乎切缘较小的患者生存期略有延长(p = 0.10)。尽管切缘小于 2 cm 的组中局部复发作为首次治疗失败部位的发生率高于切缘大于或等于 3 cm 的组(22% 对 12%),但仍有此观察结果。切缘较小人群中局部复发率的增加并未转化为总体治疗失败率的增加,且对生存期绝对没有影响。提示局部复发可作为远处疾病的一个标志。(摘要截断于 400 字)