Background
The optimal stent type in patients receiving preoperative neoadjuvant chemoradiotherapy (NACRT) is uncertain. The present study aimed to compare the clinical effectiveness of biliary metallic stent (MS) and plastic stent (PS) in patients undergoing preoperative NACRT for resectable pancreatic cancer.
Methods
This retrospective study included 43 patients who required either biliary MS or PS before initiating NACRT for resectable or borderline resectable pancreatic head cancer. Seventeen patients had MS (MS group), while 23 patients had PS (PS group). All patients received preoperative NACRT, including gemcitabine and concomitant three‐dimensional radiation of 54 Gy, and underwent pancreatectomy. Stent patency, surgery postponement, postoperative outcomes, and cost‐effectiveness were compared between these groups.
Results
There were no significant differences in baseline demographic or tumor characteristics between the groups. Stent patency was significantly longer in the MS group than in the PS group (p = 0.042). There were no differences in time to surgery, intraoperative characteristics, surgical complications, margin positivity, and pathological response between the groups. Furthermore, the medical cost of maintenance of biliary drainage during NACRT was similar between the groups.
Conclusions
MS placement compared to PS in patients receiving preoperative NACRT provided no significant benefits during the postoperative course of pancreatectomy. However, MS placement was associated with long stent patency while showing no economic disadvantage. Therefore, MS placement may be recommended in patients receiving preoperative NACRT for resectable pancreatic cancer.
Lessons Learned.
The triple combination chemotherapy of SOXIRI (S‐1/oxaliplatin/irinotecan) in patients with unresectable pancreatic ductal adenocarcinoma was an effective treatment that appeared to be better tolerated than the widely used FOLFIRINOX regimen.
SOXIRI regimen may provide an alternative approach for advanced pancreatic cancer.
Background.
In our previous phase I study, we determined the recommended dose of a biweekly S‐1, oxaliplatin, and irinotecan (SOXIRI) regimen in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). This phase II study was conducted to assess the safety and clinical efficacy in patients with unresectable PDAC.
Methods.
Patients with previously untreated metastatic and locally advanced PDAC were enrolled. The primary endpoint was response rate (RR). Secondary endpoints were adverse events (AEs), progression‐free survival (PFS), and overall survival (OS). Patients received 80 mg/m
2
of S‐1 twice a day for 2 weeks in alternate‐day administration, 150 mg/m
2
of irinotecan on day 1, and 85 mg/m
2
of oxaliplatin on day 1 of a 2‐week cycle.
Results.
Thirty‐five enrolled patients received a median of six (range: 2–15) treatment cycles. The RR was 22.8% (95% confidence interval [CI]: 10.4–40.1); median OS, 17.7 months (95% CI: 9.8–22.0); and median PFS, 7.4 months (95% CI: 4.2–8.4). Furthermore, the median OS in patients with distant metastasis was 10.1 months, whereas that in patients with locally advanced PDAC was 22.6 months. Major grade 3 or 4 toxicity included neutropenia (54%), anemia (17%), febrile neutropenia (11%), anorexia (9%), diarrhea (9%), and nausea (9%). There were no treatment‐related deaths.
Conclusion.
SOXIRI is considered a promising and well‐tolerated regimen in patients with unresectable PDAC.
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