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A PHASE 1 STUDY OF GEMCITABINE / NAB-PACLITAXEL / S-1 (GAS) COMBINATION NEOADJUVANT CHEMOTHERAPY FOR PATIENTS WITH LOCALLY-ADVANCED PANCREATIC ADENOCARCINOMA
Naru Kondo*1, Yoshiaki Murakami1, Kenichiro Uemura1, Takeshi Sudo2, Yasushi Hashimoto3, Naoya Nakagawa1, Taijiro Sueda1
1Surgery, Institute of Biomedical and Health Sciences Applied Life Sciences , Hiroshima, Japan; 2Surgery, Kure Medical Center and Chugoku Cancer Center, Kure, Japan; 3Surgery, Hiroshima Memorial Hospital, Hiroshima, Japan
Background: To increase the number of patients with locally advanced pancreatic cancer (LAPC) who can be offered a chance for cure after radical pancreatectomy, efforts are being made to develop a more effective preoperative therapeutic strategy including chemo- and chemoradiotherapy for LAPC.
Objective: The aim of this study was to determine the recommended dose of a biweekly combination neoadjuvant chemotherapy including gemcitabine, nab-paclitaxel and S-1 (GAS) for patients with LAPC.
Methods: Patients with borderline resectable or unresectable LA-PDAC without distant metastasis were eligible for this study. The planned dosage of gemcitabine (mg/m2, day1), nab-paclitaxel (mg/m2, day1) and S-1 (mg/day, day1-7) were 800 / 100 / 60-100 at level 1, and 1000 / 125 / 60-100 at level 2. The treatment cycle was repeated every 2 weeks, and patients were assessed resectability and response to the treatment after 6 cycles.
Results: Sixteen patients with LAPC enrolled this study. According to the resectability status of NCCN 2016 version 2, 14 (88%) patients was diagnosed as borderline resectable pancreas cancer, whereas 2 (12%) was diagnosed as unresectable LAPC. Of the 2 patients with unresectable LAPC, one had a tumor contacted with common hepatic artery with extension to hepatic artery bifurcation, and the other had a tumor contacted with superior mesenteric artery more than 180 degree. At dose level 1, one of 8 patients experienced dose limiting toxicity (DLT). Next, one of the following 8 patients also experienced DLT at dose level 2. Based on these results level 2 was confirmed as the recommended dose in this regimen. Two (13%) patients experienced grade 3 of leukopenia (level 1: n = 1, level 2: n = 1) and 3 (19%) experienced grade 3/4 neutropenia (level 1: n = 1, level 2: n = 2). With regard to overall non-hematological toxicity, grade 3 cholangitis was observed in only 1 (6%) patient at the dose of level 1. Pancreatectomy with curative intent could be performed in 13 (81%) of 16 patients. R0 resection was performed in 12 (92%) of 13 patients underwent surgical resection.
Conclusion: In conclusion, the recommended dose of biweekly GAS chemotherapy regimen was determined as nab-paclitaxel: 125 mg/m2, gemcitabine: 1000 mg/m2 on day 1, S-1: < 1.25 m2, 60 mg; 1.25 - 1.5 m2, 80 mg; > 1.5 m2, 100 mg twice a day on days 1 - 7. GAS chemotherapy in this study showed good preliminary efficacy with mild toxicity, which warrant further phase 2 trial to investigate the efficacy of GAS regimen for LAPC.
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