Kuebler J Philip, Colangelo Linda, O'Connell Michael J, Smith Roy E, Yothers Greg, Begovic Mirsada, Robinson Bridget, Seay Thomas E, Wolmark Norman
National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, Pennsylvania 15212, USA.
Cancer. 2007 Nov 1;110(9):1945-50. doi: 10.1002/cncr.23013.
Cases of severe gastrointestinal toxicity were monitored prospectively during NSABP C-07, a randomized clinical trial of adjuvant therapy for patients with stage II/III colon cancer.
Patients were treated with weekly bolus 5-fluorouracil (5-FU) and leucovorin (FL; "Roswell Park Regimen") or the same regimen plus oxaliplatin (FLOX).
Of 1857 patients, 79 (4.3%) developed a syndrome of bowel wall injury (BWI, small or large) characterized by hospitalization for the management of severe diarrhea or dehydration and radiographic or endoscopic evidence of bowel wall thickening or ulceration. Fifty-one (64.6%) of these adverse events occurred in patients treated with FLOX and 28 (35.4%) in those treated with FL (P < .01). Enteric sepsis (ES), characterized by grade 3 or greater diarrhea and grade 4 neutropenia with or without proven bacteremia occurred in 22 patients treated with FLOX, versus 8 in those treated with FL (P = .01). Patients >60 years were at higher risk for BWI after treatment with FLOX (6.7%) versus treatment with FL (2.9%, P < .01). Female patients had a higher incidence of BWI with FLOX (9.1%) than with FL (3.9%, P < .01). Severe gastrointestinal toxicity usually occurred during the third or fourth week on the first cycle of therapy, required hospitalization, and was managed with fluids, antidiarrheals, and antibiotics. There were 5 deaths (0.3%) due to enteropathy, 2 related to ES and 3 related to both BWI and ES. Seventy-one percent of patients resumed treatment with FL after recovery.
Patients treated with adjuvant FL should be closely monitored for diarrhea and aggressively managed, especially if oxaliplatin has been added to the regimen. Society.
在NSABP C - 07（一项针对II/III期结肠癌患者的辅助治疗随机临床试验）中，对严重胃肠道毒性病例进行了前瞻性监测。
患者接受每周一次的5 - 氟尿嘧啶（5 - FU）推注和亚叶酸（FL；“罗斯韦尔帕克方案”）治疗，或相同方案加奥沙利铂（FLOX）治疗。
1857例患者中，79例（4.3%）出现肠壁损伤综合征（BWI，小肠或大肠），其特征为因严重腹泻或脱水的治疗而住院，并有肠壁增厚或溃疡的影像学或内镜证据。这些不良事件中有51例（64.6%）发生在接受FLOX治疗的患者中，28例（35.4%）发生在接受FL治疗的患者中（P <.01）。以3级或更高级别腹泻和4级中性粒细胞减少伴或不伴有确诊菌血症为特征的肠道败血症（ES），在接受FLOX治疗的22例患者中出现，而在接受FL治疗的患者中有8例出现（P =.01）。60岁以上患者接受FLOX治疗后发生BWI的风险高于接受FL治疗（6.7%对2.9%，P <.01）。女性患者接受FLOX治疗时BWI的发生率高于接受FL治疗（9.1%对3.9%，P <.01）。严重胃肠道毒性通常发生在治疗第一周期的第三或第四周，需要住院治疗，并通过补液、止泻药和抗生素进行处理。有5例（0.3%）因肠病死亡，2例与ES相关，3例与BWI和ES均相关。71%的患者康复后恢复接受FL治疗。
接受辅助FL治疗的患者应密切监测腹泻情况并积极处理，尤其是在方案中加入奥沙利铂的情况下。学会。
