A phase II study of gemcitabine/nab-paclitaxel/S-1 combination neoadjuvant chemotherapy for patients with borderline resectable pancreatic cancer with arterial contact. (December 2021)

• Record Type: Journal Article
• Authors: Kondo, Naru; Uemura, Kenichiro; Sudo, Takeshi; Hashimoto, Yasushi; Sumiyoshi, Tatsuaki; Okada, Kenjiro; Seo, Shingo; Otsuka, Hiroyuki; Murakami, Yoshiaki; Takahashi, Shinya
• Is Part Of: European journal of cancer. Volume 159(2021)
• Page Start: 215
• Page End: 223
• Publication Date: 2021-12
• Subjects: Borderline resectable pancreatic cancer -- Gemcitabine -- Nab-paclitaxel -- S-1 -- Neoadjuvant chemotherapy -- Arterial resection; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2021.10.012
• Languages: English
• ISSNs: 0959-8049

Abstract

Abstract: Background: The prognosis of patients with borderline resectable pancreatic cancer with arterial contact (BRPC-A) is extremely poor, and effective preoperative treatment is indispensable. We evaluated the clinical efficacy and safety of neoadjuvant chemotherapy, including gemcitabine, nab-paclitaxel and S-1 (GAS), for patients with BRPC-A. Material and methods: A multicentre, single-arm, phase II study was performed. Patients were administered 1000 mg/m 2 gemcitabine on day 1, 125 mg/m 2 nab-paclitaxel on day 1 and 60–100 mg/day S-1 on days 1–7 during a 14-day cycle. Patients were then assessed for resectability and response to treatment after six cycles. The primary end-points were 2-year overall survival (OS) rate and median OS time (trial registration: jRCTs061180045, UMIN000016630). Results: Forty-seven patients with BRPC-A were eligible for the present study. Six courses of neoadjuvant GAS regimen were completed in all eligible patients. The rate of grade III/IV toxicities occurred in 14 (30%) patients during the neoadjuvant GAS regimen. The response and disease control rates were 43% and 96%, respectively. Forty-five (96%) patients received potentially curative pancreatectomy, whereas two did not owing to disease progression. R0 resection was performed in 40 (86%) of 47 eligible patients. Eleven (24%) patients experienced postoperative major complications (>grade III), including one mortality. The 2-year OS rate and median OS time among 47 eligible patients were 70.1% and 41.0 months, respectively. Conclusions: The neoadjuvant GAS chemotherapy regimen for BRPC-A showed good efficacy with mild toxicity, resulting in a high R0 resection rate and prolonged survival in patients with BRPC-A. Graphical abstract: Image 1 Highlights: This was a phase II study of gemcitabine/nab-paclitaxel/S-1 (GAS) neoadjuvant chemotherapy. The patients with borderline resectable pancreatic cancer with arterial contact were eligible. The response rates were 43%, and forty-five (96%) patients received pancreatectomy. The 2-year overall survival (OS) rate and median OS time were 70.1% and 41.0 months, respectively. The neoadjuvant GAS chemotherapy regimen contributed to prolonged survival.