State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, PR China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, PR China.
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, PR China; Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, PR China.
Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1153-60. doi: 10.1016/j.ijrobp.2014.07.021. Epub 2014 Oct 13.
PURPOSE: Systemic failure remains the major challenge in management of locally advanced rectal cancer (LARC). To optimize the timing of neoadjuvant treatment and enhance systemic control, we initiated a phase 2 trial to evaluate a new strategy of neoadjuvant sandwich treatment, integrating induction chemotherapy, concurrent chemoradiation therapy, and consolidation chemotherapy. Here, we present preliminary results of this trial, reporting the tumor response, toxicities, and surgical complications. METHODS AND MATERIALS: Fifty-one patients with LARC were enrolled, among which were two patients who were ineligible because of distant metastases before treatment. Patients were treated first with one cycle of induction chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by chemoradiation therapy, 50 Gy over 5 weeks, with the modified XELOX regimen (oxaliplatin 100 mg/m²), and then with another cycle of consolidation chemotherapy with the XELOX regimen. Surgery was performed 6 to 8 weeks after completion of radiation therapy. Tumor responses, toxicities, and surgical complications were recorded. RESULTS: All but one patent completed the planned schedule of neoadjuvant sandwich treatment. Neither life-threatening blood count decrease nor febrile neutropenia were observed. Forty-five patents underwent optimal surgery with total mesorectal excision (TME). Four patients refused surgery because of clinically complete response. There was no perioperative mortality in this cohort. Five patients (11.1%) developed postoperative complications. Among the 45 patients who underwent TME, pathologic complete response (pCR), pCR or major regression, and at least moderate regression were achieved in 19 (42.2%), 37 (82.2%), and 44 patients (97.8%), respectively. CONCLUSIONS: Preliminary results suggest that the strategy of neoadjuvant sandwich treatment using XELOX regimen as induction, concomitant, and consolidation chemotherapy to the conventional radiation is well tolerated. The strategy is highly effective in terms of pCR and major regression, which warrants further investigation.
目的：局部晚期直肠癌（LARC）的治疗仍面临全身性失败这一主要挑战。为了优化新辅助治疗的时机并增强全身性控制，我们启动了一项 2 期试验，以评估一种新的新辅助夹心治疗策略，该策略整合了诱导化疗、同期放化疗和巩固化疗。在此，我们报告该试验的初步结果，包括肿瘤反应、毒性和手术并发症。
方法和材料：共纳入 51 例 LARC 患者，其中 2 例患者因治疗前发生远处转移而不符合入组条件。患者首先接受一个周期的诱导化疗，方案为奥沙利铂 130mg/m²，第 1 天，卡培他滨 1000mg/m²，每日 2 次，每 3 周为 1 个周期（XELOX 方案），然后进行放化疗，50Gy，5 周，采用改良的 XELOX 方案（奥沙利铂 100mg/m²），然后再进行一个周期的 XELOX 方案巩固化疗。放疗结束后 6-8 周进行手术。记录肿瘤反应、毒性和手术并发症。
结果：除 1 例患者外，所有患者均完成了新辅助夹心治疗的计划方案。无危及生命的血细胞减少或发热性中性粒细胞减少。45 例患者接受了全直肠系膜切除术（TME）。4 例患者因临床完全缓解而拒绝手术。该队列中无围手术期死亡。5 例（11.1%）患者发生术后并发症。在接受 TME 的 45 例患者中，19 例（42.2%）、37 例（82.2%）和 44 例（97.8%）患者分别达到了病理完全缓解（pCR）、pCR 或主要退缩以及至少中度退缩。
结论：初步结果表明，XELOX 方案作为诱导、同期和巩固化疗的新辅助夹心治疗策略联合常规放疗具有良好的耐受性。该策略在 pCR 和主要退缩方面非常有效，值得进一步研究。
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