Neoadjuvant Chemotherapy Without Routine Use of Radiation Therapy for Patients With Locally Advanced Rectal Cancer: A Pilot Trial
Neoadjuvant Chemotherapy Without Routine Use of Radiation Therapy for Patients With Locally Advanced Rectal Cancer: A Pilot Trial
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DOI：
10.1200/jco.2013.51.7904
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发表时间：
2014-02-20
影响因子：
45.3
通讯作者：
Saltz, Leonard B.
中科院分区：
文献类型：
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作者：
Schrag, Deborah;Weiser, Martin R.;Saltz, Leonard B.
目的 尽管新辅助放化疗在临床 II 期至 III 期直肠癌中实现了较低的局部复发率，但它延迟了最佳化疗的实施。我们评估了术前输注氟尿嘧啶、亚叶酸和奥沙利铂 (FOLFOX)/贝伐珠单抗以及选择性而非持续使用放化疗的情况。 患者和方法 32 名临床 II 期至 III 期直肠癌患者参加了这项单中心 II 期试验。所有患者均适合接受低位前切除加全直肠系膜切除术（TME）。患者将接受六个周期的 FOLFOX，其中第 1 至第 4 个周期包含贝伐珠单抗。疾病稳定/进展的患者将在 TME 之前接受放疗，而有反应者将立即接受 TME。如果未实现 R0 切除，则计划进行术后放射治疗。建议术后 FOLFOX x 6，但辅助治疗方案由临床医生自行决定。主要结果是 R0 切除率。结果 2007 年 4 月至 2008 年 12 月期间，32 名研究参与者中有 32 名（100%）进行了 R0 切除。两人因心血管毒性而未能完成术前化疗。两人均接受了术前放化疗，然后进行了 R0 切除。完成术前化疗的 30 名患者均在未进行术前放化疗的情况下实现了肿瘤消退和 TME。单纯化疗的病理完全缓解率为 32 例中的 8 例（25%；95% CI，11% 至 43%）。 4年局部复发率为0%（95% CI，0%～11%）； 4 年无病生存率为 84%（95% CI，67% 至 94%）。 结论 对于选定的临床 II 期至 III 期直肠癌患者，新辅助化疗和选择性放疗似乎不会影响预后。术前放疗或化疗和 TME 之前的选择性术前放疗和评估 (PROSPECT) 是一项验证这一经验的随机 III 期试验，现已在美国合作组网络中开放。 (C) 2014 年美国临床肿瘤学会
Purpose Although neoadjuvant chemoradiotherapy achieves low local recurrence rates in clinical stages II to III rectal cancer, it delays administration of optimal chemotherapy. We evaluated preoperative infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX)/bevacizumab with selective rather than consistent use of chemoradiotherapy.Patients and Methods Thirty-two patients with clinical stages II to III rectal cancer participated in this single-center phase II trial. All were candidates for low anterior resection with total mesorectal excision (TME). Patients were to receive six cycles of FOLFOX, with bevacizumab included for cycles 1 to 4. Patients with stable/progressive disease were to have radiation before TME, whereas responders were to have immediate TME. Postoperative radiation was planned if R0 resection was not achieved. Postoperative FOLFOX x 6 was recommended, but adjuvant regimens were left to clinician discretion. The primary outcome was R0 resection rate.Results Between April 2007 and December 2008, 32 (100%) of 32 study participants had R0 resections. Two did not complete preoperative chemotherapy secondary to cardiovascular toxicity. Both had preoperative chemoradiotherapy and then R0 resections. Of 30 patients completing preoperative chemotherapy, all had tumor regression and TME without preoperative chemoradiotherapy. The pathologic complete response rate to chemotherapy alone was 8 of 32 (25%; 95% CI, 11% to 43%). The 4-year local recurrence rate was 0% (95% CI, 0% to 11%); the 4-year disease-free survival was 84% (95% CI, 67% to 94%).Conclusion For selected patients with clinical stages II to III rectal cancer, neoadjuvant chemotherapy and selective radiation does not seem to compromise outcomes. Preoperative Radiation or Selective Preoperative Radiation and Evaluation Before Chemotherapy and TME (PROSPECT), a randomized phase III trial to validate this experience, is now open in the US cooperative group network. (C) 2014 by American Society of Clinical Oncology