CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase II trial.
OBJECTIVE
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).


METHODS
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/m2oxaliplatin on d 1, plus 1,000 mg/m2capecitabine 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).


RESULTS
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.


CONCLUSIONS
Our results suggest that NAC with CapOX is an effective and safe treatment option for patients with locally advanced CCs.
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Fangqi
F
Liu
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Li
L
Yang
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Yuchen
Y
Wu
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Cong
C
Li
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Jiang
J
Zhao
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Adili
A
Keranmu
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Hongtu
H
Zheng
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Dan
D
Huang
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Lei
L
Wang
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Tong
T
Tong
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Junyan
J
Xu
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Ji
J
Zhu
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Sanjun
S
Cai
Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Ye
Y
Xu
Colon cancer; neoadjuvant chemotherapy; phase II trial; surgery