Although the efficacy of trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) against metastatic colorectal cancer (mCRC) has been demonstrated, little is known about its effectiveness upon disease stratification by RAS mutations. In this phase II study, we investigated the efficacy and safety profiles of FTD/TPI in mCRC according to RAS mutation status. Eligible patients were mCRC refractory or intolerant to all standard therapies other than FTD/TPI and regorafenib. Patients received 4-week cycles of treatment with FTD/TPI (35 mg/m2, twice daily, days 1-5 and 8-12) and bevacizumab (5 mg/kg, days 1 and 15). The primary endpoint was disease control rate (DCR). The null hypothesis of DCR in both RAS wild-type (WT) and mutant (MUT) cohorts was 44%, assuming a one-sided significance level of 5.0%. The necessary sample size was estimated to be 49 patients (target sample size: 50 patients) for each cohort. Between January and September 2018, 102 patients were enrolled, and 97 patients fulfilled the eligibility criteria (48 in the RAS WT cohort and 49 in the RAS MUT cohort). DCRs in the RAS WT and MUT cohort were 66.7% [90% confidence interval (CI), 53.9%-77.8%, P = 0.0013] and 55.1% (90% CI, 42.4%-67.3%, P = 0.0780), respectively. The median progression-free survival (PFS) and overall survival (OS) were 3.8 and 9.3 months, respectively, in the RAS WT cohort and 3.5 and 8.4 months, respectively, in the RAS MUT cohort. The most common grade 3 or higher adverse event in both cohorts was neutropenia (46% in the RAS WT cohort and 62% in the RAS MUT cohort), without unexpected safety signals. FTD/TPI plus bevacizumab showed promising activity with an acceptable safety profile for pretreated mCRC, regardless of RAS mutation status, although the efficacy outcomes tended to be better in RAS WT.
The clinical benefit of cetuximab combined with oxaliplatin-based chemotherapy remains under debate. The aim of the present multicenter open-label Phase II
Background: Between April 2005 and December 2012, we performed laparoscopic colorectal resection with regional lymph node dissection on 273 cases of colorectal cancer patients. However, Laparoscopic rectal cancer surgery requires a high degree of skill. Any surgeon who is going to embark on these difficult resections should have at a minimum laparoscopic suturing skills in order to be able to close the peritoneal defect. Methods: In laparoscopic surgery for rectal cancer, the intracorporeal suture technique required to close the pelvic cavity is very difficult. Barbed sutures have recently been proposed to facilitate laparoscopic suturing. Two patients with rectal cancer who underwent laparoscopic abdominoperineal resection (APR) with intracorporeal closure of the pelvic cavity from September to October 2012 were enrolled in this study. Results: We present our initial experience of two consecutive cases of intracorporeal closure of the pelvic cavity by totally laparoscopic APR. After clinical follow-up, the two patients have no complaints and have shown no signs of recurrence. Conclusions: We hypothesized that barbed sutures could potentially improve the efficiency of intracorporeal closure of the pelvic cavity after laparoscopic APR. Further, we expect that use of the V-Loc™ will reduce intra-operative stress on the endoscopic surgeon.