Liu Fangqi, Yang Li, Wu Yuchen, Li Cong, Zhao Jiang, Keranmu Adili, Zheng Hongtu, Huang Dan, Wang Lei, Tong Tong, Xu Junyan, Zhu Ji, Cai Sanjun, Xu Ye
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Chin J Cancer Res. 2016 Dec;28(6):589-597. doi: 10.21147/j.issn.1000-9604.2016.06.05.
The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy (NAC) using oxaliplatin plus capecitabine (CapOX) for patients with operable locally advanced colon cancer (CC).
Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m oxaliplatin on d 1, plus 1,000 mg/m capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade (TRG) score. The primary endpoint was pathologic tumor response. This trial is registered in ClinicalTrials.gov (No: NCT02415829).
Forty-seven patients were enrolled in the study. Forty-two patients completed the planned treatments. The total radiological response rate was 68% (32/47), including complete and partial response rates of 2% (1/47) and 66% (31/47), respectively. Stable disease was observed in 32% (15/47) and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1 (2%), 2 (4%), and 29 (62%) patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation (1/47, 2%). There was no treatment-related death.
Our results suggest that NAC with CapOX is an effective and safe treatment option for patients with locally advanced CCs.
这项前瞻性单臂II期试验的目的是确认使用奥沙利铂联合卡培他滨（CapOX）进行新辅助化疗（NAC）对可手术切除的局部晚期结肠癌（CC）患者的安全性和有效性。
纳入计算机断层扫描定义为T4或淋巴结阳性的CC患者。在进行放射学分期后，患者接受至少2个周期的NAC治疗，具体方案为第1天给予130mg/m²奥沙利铂，加用卡培他滨1000mg/m²，每日2次，每3周服用14天，随后进行手术，然后进行辅助化疗的其余周期。在2个周期的NAC治疗后评估放射学反应。记录肿瘤反应、治疗毒性和手术并发症。根据肿瘤消退分级（TRG）评分评估对治疗的病理反应。主要终点是病理肿瘤反应。本试验已在ClinicalTrials.gov注册（编号：NCT02415829）。
47例患者纳入本研究。42例患者完成了计划的治疗。总放射学反应率为68%（32/47），其中完全缓解率和部分缓解率分别为2%（1/47）和66%（31/47）。疾病稳定率为32%（15/47），未观察到疾病进展。分别有1例（2%）、2例（4%）和29例（62%）患者达到完全病理缓解、主要消退和至少中度消退。4例患者出现3级治疗毒性。1例患者术后发生伤口感染（1/47，2%）。无治疗相关死亡。
我们的结果表明，CapOX方案的NAC对局部晚期CC患者是一种有效且安全的治疗选择。
