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

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. A multicentre, single-arm, phase II study was performed. Patients were administered 1000 mg/m2 gemcitabine on day 1, 125 mg/m2 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). 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. 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.

Kondo N ，Uemura K ，Sudo T ，Hashimoto Y ，Sumiyoshi T ，Okada K ，Seo S ，Otsuka H ，Murakami Y ，Takahashi S ... -  《-》

Long-term outcomes of neoadjuvant gemcitabine, nab-paclitaxel, and S1 (GAS) in borderline resectable pancreatic cancer with arterial contact: Results from a phase II trial.

Uemura K ，Kondo N ，Sudo T ，Sumiyoshi T ，Shintakuya R ，Okada K ，Baba K ，Harada T ，Murakami Y ，Takahashi S ... -  《-》

A phase 1 study of gemcitabine/nab-paclitaxel/S-1 (GAS) combination neoadjuvant chemotherapy for patients with locally advanced pancreatic adenocarcinoma.

Kondo N ，Murakami Y ，Uemura K ，Sudo T ，Hashimoto Y ，Nakagawa N ，Takahashi S ，Ohge H ，Sueda T ... -  《-》

Comparisons of different neoadjuvant chemotherapy regimens with or without stereotactic body radiation therapy for borderline resectable pancreatic cancer: study protocol of a prospective, randomized phase II trial (BRPCNCC-1).

Gao S ，Zhu X ，Shi X ，Cao K ，Bian Y ，Jiang H ，Wang K ，Guo S ，Zhang H ，Jin G ... -  《Radiation Oncology》

Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group.

Ettrich TJ ，Berger AW ，Perkhofer L ，Daum S ，König A ，Dickhut A ，Wittel U ，Wille K ，Geissler M ，Algül H ，Gallmeier E ，Atzpodien J ，Kornmann M ，Muche R ，Prasnikar N ，Tannapfel A ，Reinacher-Schick A ，Uhl W ，Seufferlein T ... -  《BMC CANCER》