A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial
A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial
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DOI：
10.1245/s10434-011-1933-7
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发表时间：
2012-02-01
影响因子：
3.7
通讯作者：
Posner, Mitchell C.
中科院分区：
文献类型：
--
作者：
Garcia-Aguilar, Julio;Shi, Qian;Posner, Mitchell C.
我们设计了美国外科医师学会肿瘤学小组(ACOSOG)Z6041，这是一项前瞻性、多中心、单臂、II期试验，以评估新辅助放化疗(CRT)和局部切除(LE)治疗T2 N0直肠癌的疗效和安全性。在这里，我们报告了肿瘤反应、CRT相关毒性和围手术期并发症(PC)。临床分期为T2N0的直肠癌患者在放疗期间接受卡培他滨和奥沙利铂联合LE治疗。由于毒性，卡培他滨和辐射剂量都减少了。CRT后6周行LE。对患者的临床和病理反应进行评估。记录与CRT相关的并发症和PCS，90例患者，6例接受非方案治疗。其余84名患者中男性占65%；中位年龄63岁；83%的东部合作肿瘤组表现为0分；92%为白人；平均肿瘤大小为2.9厘米；与肛缘的平均距离为5.1厘米。5名患者被认为不符合条件。79名患者按方案完成了治疗，但2名患者没有接受LE。77例LE患者中，病理完全缓解34例(44%)，肿瘤降级49例(%)，但4例(5%)肿瘤为PYT3。5例LE标本有淋巴结；1例T3肿瘤有阳性结节。除一名患者外，所有患者的利润率均为负值。84例患者中33例(39%)出现了CRT相关的千分之三并发症。直肠疼痛是最常见的PPC，T2N0肿瘤行LE前CRT的病理完全缓解率高，切缘阴性。但CRT术中及LE术后并发症较多。这种方法的真正疗效最终将通过长期的肿瘤学结果进行评估。
We designed American College of Surgeons Oncology Group (ACOSOG) Z6041, a prospective, multicenter, single-arm, phase II trial to assess the efficacy and safety of neoadjuvant chemoradiation (CRT) and local excision (LE) for T2N0 rectal cancer. Here, we report tumor response, CRT-related toxicity, and perioperative complications (PCs).Clinically staged T2N0 rectal cancer patients were treated with capecitabine and oxaliplatin during radiation followed by LE. Because of toxicity, capecitabine and radiation doses were reduced. LE was performed 6 weeks after CRT. Patients were evaluated for clinical and pathologic response. CRT-related complications and PCs were recorded.Ninety patients were accrued; 6 received nonprotocol treatment. The remaining 84 were 65% male; median age 63 years; 83% Eastern Cooperative Oncology Group performance score 0; 92% white; mean tumor size 2.9 cm; and average distance from anal verge 5.1 cm. Five patients were considered ineligible. Therapy was completed per protocol in 79 patients, but two patients did not undergo LE. Among 77 eligible patients who underwent LE, 34 patients achieved a pathologic complete response (44%) and 49 (64%) tumors were downstaged (ypT0-1), but 4 patients (5%) had ypT3 tumors. Five LE specimens contained lymph nodes; one T3 tumor had a positive node. All but one patient had negative margins. Thirty-three (39%) of 84 patients developed CRT-related grade a parts per thousand yen3 complications. Rectal pain was the most common PC.CRT before LE for T2N0 tumors results in a high pathologic complete response rate and negative resection margins. However, complications during CRT and after LE are high. The true efficacy of this approach will ultimately be assessed by the long-term oncologic outcomes.