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  • Title: [Analysis on efficacy and safety of total neoadjuvant therapy in patients with locally advanced rectal cancer with high risk factors].
    Author: Ouyang GL, Meng WJ, Shu P, Deng XB, Wu B, Jiang D, Zhuang H, Shen YL, Zhou ZG, Wang ZQ, Wang X.
    Journal: Zhonghua Wei Chang Wai Ke Za Zhi; 2019 Apr 25; 22(4):349-356. PubMed ID: 31054549.
    Abstract:
    Objective: To evaluate the safety and preliminary efficacy of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer (LARC) with high risk factors. Methods: Data of 101 patients who were diagnosed with stage II-III rectal cancer with high risk factors and received TNT between March 2015 and January 2018 at West China Hospital of Sichuan University were analyzed retrospectively. Inclusion criteria: (1) patients were diagnosed with stage II-III rectal cancer by high-resolution MRI combined with CT and endorectal ultrasound; (2) at least one high risk factor: cT4a, cT4b, cN2, EMVI+, CRM+ and lateral lymph node+; (3) distance from tumor to anal verge was within 15 cm; (4) Eastern Collaborative Oncology Group (ECOG) performance status score was 0-1; bone marrow function, liver function and kidney function were suitable for chemoradiotherapy; (5) patients were treated with TNT strategy; (6) the follow-up data and postoperative pathological data were complete. Patients with previous rectal cancer surgery (except prophylactic colostomy), pelvic radiotherapy, and systemic chemotherapy, those with distant metastases, those without neoadjuvant radiotherapy, those receiving less than 4 cycles of neoadjuvant chemotherapy were excluded. The regimen of TNT: 3 cycles of induction CAPOX (oxaliplatin plus capecitabine) were followed by pelvic radiotherapy and concurrent CAPOX, then 3 cycles of consolidation CAPOX were delivered after radiotherapy. Total mesorectal resection (TME) or watch-and-wait strategy was selected according to the therapeutic effect and patients' wishes. Short-term efficacy, including tumor regression grade (TRG), pathological complete response (pCR), clinical complete response (cCR), postoperative complications within 30 days of surgery, and adverse events (AE) to radiotherapy and chemotherapy (measured using CTCAE 4.0) was analyzed. Results: The 101 patients included 68 males (67.3%) and 33 females (32.7%) with a median age of 54 years. The proportion of patients with cT4a, cT4b, cN2 and enlarged lateral lymph node was 13.9%, 29.7%, 56.4% and 43.6%, respectively. The mean cycle of neoadjuvant chemotherapy was 6.0±1.3. Seventy-five patients (74.3%) received at least 6 cycles of neoadjuvant chemotherapy and 100 (99.0%) completed radiotherapy. The mean cycle of induction and consolidation chemotherapy was 2.0±0.9 and 2.8±1.0 respectively. Most common grade 3 AE was leucopenia (n=13, 12.9%) and thrombocytopenia (n=7, 6.9%). Grade 3 diarrhea and radiation dermatitis were observed in 5 cases (5.0%) respectively. Grade 3 anemia and rectal pain were observed in 4 cases (4.0%) respectively. And rectal mucositis was observed in 2 cases (2.0%). Most of the AE was observed during concurrent chemoradiotherapy. No grade 4 or higher AE was observed. After TNT, 32 patients (31.7%) achieved pCR or cCR, and 62 patients (60.4%) achieved partial response (PR). Only 2 patients (2.0%) developed distant metastasis after chemoradiotherapy, while the other patients did not show disease progression. Seven patients (6.9%) with cCR refused surgery and selected watch-and-wait, while 7 patients without cCR still refused surgery. The other 87 patients (86.1%) underwent TME successfully. The mean interval from the completion of chemoradiotherapy to surgery was (20.1±8.5) weeks. The R0 resection rate was 97.7% (85/87).The morbidity of surgical complication was 16.1% (14/87), including pelvic infection or abscess in 6 cases (6.9%), anastomotic leakage in 3 (3.4%), hemorrhage in 2 (2.3%), and gastrointestinal dysfunction in 3 (3.4%). Pathological findings revealed that 24 cases (27.6%) had TRG 0, 20 (23.0%) had TRG 1, 30 (34.5%) TRG 2, and 13 (14.9%) TRG 3. Conclusion: TNT is safe and has good short-term efficacy for locally advanced rectal cancer patients with high risk factors. 目的： 探讨全程新辅助治疗（TNT）在高危局部晚期直肠癌患者中的疗效和安全性。 方法： 回顾性分析2015年3月至2018年1月期间，在四川大学华西医院接受TNT治疗的101例局部晚期直肠癌患者的临床资料。病例纳入标准：（1）通过直肠高分辨MRI结合胸腹部增强CT以及直肠超声诊断，临床分期为Ⅱ~Ⅲ期的直肠癌；（2）至少具有以下高危因素之一：cT4a、cT4b、cN2、壁外血管侵犯阳性、环周切缘阳性、侧方淋巴结阳性；（3）肿瘤距离肛缘≤15 cm；（4）美国东部肿瘤协作组（ECOG）体力状况评分0~1分，骨髓造血功能、肝功能、肾功能均符合放化疗标准；（5）采用TNT方案治疗；（6）临床随访资料及术后病理资料完整者。排除既往接受过直肠癌手术（预防性结肠造瘘术除外）、盆腔放疗、系统化疗者；基线发现有远处转移者；未接受新辅助放疗者；新辅助化疗<4周期者。具体治疗方案为：3周期CAPOX方案（奥沙利铂+卡培他滨）诱导化疗后，行盆腔调强放疗联合CAPOX方案同步化疗，之后再行3周期CAPOX方案巩固化疗。根据治疗效果和患者意愿选择行全直肠系膜切除术（TME）或采取等待-观察策略。观察评价本组患者的近期疗效，包括肿瘤退缩分级（TRG）、病理完全缓解率（pCR）或临床完全缓解率（cCR）、术后并发症（术后30 d）及放化疗不良反应[根据常见不良反应事件评价标准（CTCAE）4.0版进行分级]。 结果： 全组101例患者，男68例（67.3%），女33例（32.7%），中位年龄54岁，临床T4a期者14例（13.9%），临床T4b期者30例（29.7%），临床N2期者57例（56.4%），侧方淋巴结肿大者44例（43.6%）。本组患者新辅助化疗周期为（6.0±1.3）个。75例（74.3%）接受了至少6周期新辅助化疗。完成足量新辅助放疗的患者为100例（99.0%）诱导化疗和巩固化疗的周期分别为（2.0±0.9）个和（2.8±1.0）个。TNT过程中发生的3级急性不良反应最常见的是白细胞减少[13例（12.9%）]和血小板减少[7例（6.9%）]；其次依次为腹泻5例（5.0%）、放射性皮炎5例（5.0%）、贫血4例（4.0%）、直肠疼痛4例（4.0%）和直肠炎2例（2.0%）。3级急性不良反应以发生在同步放化疗过程中为主，包括白细胞减少6例，血小板减少、腹泻以及放射性皮炎各5例，直肠炎2例和直肠疼痛4例，无4级不良反应发生。TNT后，共32例（31.7%）获得pCR或cCR者，61例（60.4%）部分缓解，有2例（2.0%）放化疗后出现远处转移，其余患者放化疗期间未出现疾病进展。除14例（13.9%）患者拒绝手术（其中7例为cCR患者选择等待-观察，另7例未达cCR）外，有87例（86.1%）患者成功行TME手术，放化疗完成至TME手术的时间间隔为（20.1±8.5）周，手术R0切除率97.7%（85/87），手术并发症发生率为16.1%（14/87），其中盆腔感染或脓肿6例（6.9%），吻合口漏3例（3.4%），出血2例（2.3%）以及胃肠功能障碍3例（3.4%）。术后病理提示：TRG 0级为24例（27.6%）、TRG 1级20例（23.0%）、TRG 2级为30例（34.5%）、TRG 3级为13例（14.9%）。 结论： TNT对于具有高危因素的局部晚期直肠癌患者具有良好的近期疗效和安全性。.
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