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

Abstract

BackgroundPreoperative chemoradiotherapy (CRT), the current standard of care for locally advanced rectal cancer (LARC), is associated with many radiotherapy (RT)-related side effects. We aimed to evaluate whether S-1 and oxaliplatin (SOX) or folinic acid, 5-FU, and oxaliplatin (mFOLFOX6) can be as effective as neoadjuvant chemotherapy (NAC) regimens for LARC without RT. MethodsPatients with untreated resectable LARC were randomly assigned to receive SOX or mFOLFOX6. The NAC protocol period was 3 months. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints included pathological effects, surgical completion rate, 3-year survival, and safety.ResultsFrom September 2013 to October 2015, 56 and 54 patients were enrolled in the SOX and mFOLFOX6 arms, respectively. The 3-year DFS rates were 69.4% (95% confidence interval [CI] 54.9–83.6) and 73.4% (95% CI 58.7–83.6) in the SOX and mFOLFOX6 arms, respectively; no significant differences were found between the arms (log-rank test; P = 0.5315, hazard ratio: 0.808, 95% CI 0.414–1.578). The 3-year survival rates were 92.3% and 91.8% in the SOX and mFOLFOX6 arms, respectively. The surgical completion rate was 98.1% overall, 100% in the SOX arm, and 96.0% in the mFOLFOX6 arm. The incidences of pathological response rates ≥grade 1b were 41.5% and 43.8% in the SOX and mFOLFOX6 arms, respectively. Both treatments were manageable and tolerable. ConclusionWe demonstrated the effectiveness and safety of SOX and mFOLFOX6, both of which may be new neoadjuvant treatment candidates in previously untreated LARC cases.Trial registrationThis study was registered in the UMIN clinical trials registry on Aug 14th, 2013. (UMIN-CTR number UMIN000011486). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&recptno=R000013441&language=J

Application of Circulating Tumor Cells and Circulating Free DNA from Peripheral Blood in the Prognosis of Advanced Gastric Cancer

“…Perioperative chemotherapy is an effective treatment for advanced gastric cancer [24,25]. However, there is no uniform standard for the evaluation of the efficacy of preoperative chemotherapy [26,27]. Traditional methods for evaluating the efficacy of gastric cancer treatment or chemotherapy include the following: tumor marker levels, imaging examinations, endoscopic ultrasound before and after treatment, or pathological regression after surgery.…”

Short-term outcomes of neoadjuvant chemotherapy with capecitabine plus oxaliplatin for patients with locally advanced rectal cancer followed by total or tumor-specific mesorectal excision with or without lateral pelvic lymph node dissection

“…Since CAPOX is the one of the main regimens for adjuvant and unresectable/recurrent RC in the NCCN 15) , ESMO 16) and Japanese guidelines, the selection of a CAPOX regimen for NAC is reasonable 17) . There are a few prospective studies reporting promising results of NAC using oxaliplatin 18,19) . Okuyama et al reported an 85.2% 3 -year RFS rate and a 96.3% 4 -year OS of cT3/4 and N+RC patients treated with NAC using CAPOX 16) .…”