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

Abstract

ObjectiveThe 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).MethodsPatients 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/m2 oxaliplatin on d 1, plus 1,000 mg/m2 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).ResultsForty-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.ConclusionsOur results suggest that NAC with CapOX is an effective and safe treatment option for patients with locally advanced CCs.

Efficacy and safety of self-expanding metallic stent placement followed by neoadjuvant chemotherapy and scheduled surgery for treatment of obstructing left-sided colonic cancer

“…Although neoadjuvant chemotherapy is not routinely administered in locally advanced colorectal cancer patients, several authors have demonstrated benefits with a neoadjuvant chemotherapy-alone approach [25,26]. Studies have shown that neoadjuvant chemotherapy with CAPOX or FOLFOX is effective and safe in patients with locally advanced colon cancers [25,26].…”

Efficacy and safety of self-expanding metallic stent placement followed by neoadjuvant chemotherapy and scheduled surgery for treatment of obstructing left-sided colonic cancer

“…An important concern with neoadjuvant chemotherapy, especially when administered after SEMS for obstructive colorectal cancer, is the toxicity of the drugs used. 20 In our series, only one (9.1%) patient had a grade 3 toxicity (diarrhea). Neoadjuvant chemotherapy was generally well tolerated, and all patients were able to undergo surgery after completion of chemotherapy.…”

“…Although neoadjuvant chemotherapy is not routinely administered in locally advanced colorectal cancer patients, several authors have demonstrated benefits with a neoadjuvant chemotherapy-alone approach. 20,[25][26][27] A single-center phase II study conducted at Memorial Sloan-Kettering Cancer Center evaluated neoadjuvant chemotherapy with six cycles of FOLFOX plus bevacizumab in locally advanced rectal cancer patients and showed that neoadjuvant chemotherapy was relatively safe and capable of inducing major tumor regression. 25 Four cycles of neoadjuvant mFOLFOX6 chemotherapyalone approach has also shown promising efficacy for locally advanced rectal cancer in the FOWARC study.…”

Efficacy and safety of self-expanding metallic stent placement followed by neoadjuvant chemotherapy and scheduled surgery for treatment of obstructing left-sided colonic cancer

“…Although neoadjuvant chemotherapy is not routinely administered in locally advanced colorectal cancer patients, several authors have demonstrated benefits with a neoadjuvant chemotherapy-alone approach. 25,26 Studies have shown that neoadjuvant chemotherapy with CAPOX or FOLFOX is effective and safe in patients with locally advanced colon cancers. 25,26 All patients in our study completed neoadjuvant chemotherapy without experiencing any major toxicities.…”

“…25,26 Studies have shown that neoadjuvant chemotherapy with CAPOX or FOLFOX is effective and safe in patients with locally advanced colon cancers. 25,26 All patients in our study completed neoadjuvant chemotherapy without experiencing any major toxicities. Although no patient achieved complete pathologic response in our study, tumor reduction was achieved in all patients.…”