Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study

Abstract

Background Preoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency. Adjuvant oxaliplatin plus capecitabine (XELOX) is a recommended regimen for patients with curatively resected colon cancer. However, the efficacy of postoperative adjuvant therapy for rectal cancer patients who have not undergone preoperative chemoradiation remains unknown. We aimed to evaluate the efficacy of surgery and postoperative XELOX without preoperative chemoradiation for treating rectal cancer. Methods We performed a prospective, multicenter, open-label, single arm phase II study. Patients with curatively resected high-risk stage II and stage III rectal cancer who had not undergone preoperative therapy were treated with a 120 min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and capecitabine (2000 mg/m2/day) in 2 divided doses for 14 days of a 3-week cycle, for a total of 8 cycles (24 weeks). The primary endpoint was 3-year disease-free survival (DFS). Results Between August 2012 and June 2015, 60 men and 47 women with a median age was 63 years (range: 29–77 years) were enrolled. Ninety-three patients had Eastern Cooperative Oncology Group performance status scores of ‘0’ and 14 had scores of ‘1’. Tumors were located in the upper and lower rectums in 54 and 48 patients, respectively; 8 patients had stage II disease and 99 had stage III. The 3-year DFS was 70.1% (95% confidence interval, 60.8–78.0%) and 33 patients (31%) experienced recurrence, most commonly in the lung (16 patients) followed by local recurrence (9) and hepatic recurrence (7). Conclusions Postoperative XELOX without preoperative chemoradiation is effective for rectal cancer and provides adequate 3-year DFS prospects. Trial registration This clinical trial was registered in the University Hospital Medical Information Network registry system as UMIN000008634 at Aug 06, 2012.

Randomized Phase II Study Comparing the Efficacy and Safety of SOX versus mFOLFOX6 as Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer (KSCC1301)

“…In Japan, D3 dissection with lateral lymph nodes, which preserves pelvic autonomic nerve function without preoperative CRT, and subsequent adjuvant chemotherapy are widely used to improve the outcomes of patients with LARC. [31] Mizushima et al reported that the 3-year DFS rate was 70.1% in a phase II study of 107 patients with high-risk stage II and stage III rectal cancer without preoperative treatment who had received capecitabine + oxaliplatin therapy as postoperative adjuvant chemotherapy, [32] similar to the ndings of our study. There is controversy surrounding whether chemotherapy for LARC should be performed before or after TME in Japan; this issue needs to be resolved in a future phase III study.…”

[Retracted] Efficacy of Aidi Injection and Brucea javanica Oil Emulsion Injection in Rectal Cancer during CapeOX Adjuvant Chemotherapy

“…Unfortunately, quite a few patients are undergoing complications from sphincter excision and chemotherapeutic toxicity. CapeOX (XELOX) is a first-line adjuvant regimen that brings convenient use and lowers toxicity to rectal cancer patients [ 6 ]. However, adverse reactions (ADRs) are unavoidable after long-range chemotherapy.…”

Randomized phase II study comparing the efficacy and safety of SOX versus mFOLFOX6 as neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer (KSCC1301)

“…In Japan, D3 dissection with lateral lymph nodes, which preserves pelvic autonomic nerve function without preoperative CRT, and subsequent adjuvant chemotherapy are widely used to improve the outcomes of patients with LARC [31]. Mizushima et al reported that the 3-year DFS rate was 70.1% in a phase II study of 107 patients with high-risk stage II and stage III rectal cancer without preoperative treatment who had received capecitabine + oxaliplatin therapy as postoperative adjuvant chemotherapy, [32] similar to the findings of our study. There is controversy surrounding whether chemotherapy for LARC should be performed before or after TME in Japan; this issue needs to be resolved in a future phase III study.…”