Beppu Naohito, Yoshie Hidenori, Kimura Fumihiko, Aihara Tsukasa, Doi Hiroshi, Kamikonya Norihiko, Matsubara Nagahide, Tomita Naohiro, Yanagi Hidenori, Yamanaka Naoki
Department of Surgery, Meiwa Hospital, 4-31 Agenaruo-cho, Nishinomiya, Hyogo, 663-8186, Japan.
Department of Radiology, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.
Surg Today. 2016 Oct;46(10):1123-31. doi: 10.1007/s00595-015-1284-2. Epub 2015 Dec 24.
To evaluate the safety and efficacy of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy and surgery in patients with poor-risk locally advanced rectal cancer.
We enrolled eligible patients with poor-risk rectal cancer defined as T3 lower rectal cancer with mesorectal fascia involvement, T4a or T4b tumors or cases with lateral lymph node swelling. The primary endpoint was a pathological complete response (pCR), and the secondary endpoints were the objective response rate (ORR) and the pathological high response rate (Grade 2 plus 3).
Twenty eligible patients were enrolled. The majority (75.0 %, 15/20) of the patients completed four cycles of induction chemotherapy, and all patients completed the radiotherapy (25 Gy/10 fractions/5 days). The global rate of Grade 3-4 toxicities was 30.0 % (6/20 patients). The ORRs were 85.0 % (17/20) and 95.0 % (19/20) in the patients who underwent R0 and R1 resection, respectively. The pathological high response rate was 70.0 % (14/20) and the pCR was 10.0 % (2/20).
The regimen of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy is safe and is associated with good tumor regression in patients with poor-risk locally advanced rectal cancer.
评估诱导化疗方案SOX(S-1+奥沙利铂)±西妥昔单抗化疗,序贯短程放化疗及手术治疗高危局部晚期直肠癌患者的安全性和疗效。
纳入符合条件的高危直肠癌患者,定义为侵犯直肠系膜筋膜的T3低位直肠癌、T4a或T4b肿瘤或伴有侧方淋巴结肿大的病例。主要终点为病理完全缓解(pCR),次要终点为客观缓解率(ORR)和病理高缓解率(2级加3级)。
共纳入20例符合条件的患者。大多数患者(75.0%,15/20)完成了4周期诱导化疗,所有患者均完成了放疗(25Gy/10次/5天)。3-4级毒性反应的总体发生率为30.0%(6/20例患者)。接受R0和R1切除患者的ORR分别为85.0%(17/20)和95.0%(19/20)。病理高缓解率为70.0%(14/20),pCR为10.0%(2/20)。
诱导化疗方案SOX(S-1+奥沙利铂)±西妥昔单抗化疗序贯短程放化疗对高危局部晚期直肠癌患者安全,且与良好的肿瘤退缩相关。