2019 ASCO Annual Meeting!
Session: Gastrointestinal (Noncolorectal) Cancer
Type: Poster Session
Time: Monday June 3, 8:00 AM to 11:00 AM
Location: Hall A
The effect of neoadjuvant chemotherapy with gemcitabine and S-1 for resectable pancreatic cancer (randomized phase II/III trial; Prep-02/JSAP-05).
Gastrointestinal (Noncolorectal) Cancer
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #231)
J Clin Oncol 37, 2019 (suppl; abstr 4126)
Author(s): Sohei Satoi, Michiaki Unno, Fuyuhiko Motoi, Yutaka Matsuyama, Ippei Matsumoto, Suefumi Aosasa, Hirofumi Shirakawa, Keita Wada, Tsutomu Fujii, Hideyuki Yoshitomi, Shinichiro Takahashi, Masayuki Sho, Hideki Ueno, Tomohisa Yamamoto, Tomoo Kosuge; Department of Surgery, Kansai Medical University, Hirakata, Japan; Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan; Department of Surgery, Kindai University, Osaka, Japan; Department of Surgery, National Defense Medical College, Tokorozawa, Japan; Department of Hepato-Biliary-Pancreatic Surgery, Tochigi Cancer Center, Utsunomiya, Japan; Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan; Nagoya University, Nagoya, Japan; Department of General Surgery, Chiba University Graduate School of Medicine, Chiba, Japan; Department of Hepato-Biliary Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan; Nara Medical University, Kashihara, Japan; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Tokyo, Japan; Dept of Surgery, Kansai Medical University, Hirakata, Japan; National Cancer Center Hospital East, Tokyo, Japan
Background: Despite recent progress of adjuvant chemotherapy for resected pancreatic ductal adenocarcinoma (PDAC), its survival remains limited. We conducted a randomized controlled trial to compare neoadjuvant chemotherapy (NAC) with upfront surgery (UP-S) for patients with resectable PDAC. Methods: Patients with resectable PDAC, all confirmed cytologically or histologically were enrolled. Patients received 2 cycles of gemcitabine and S-1 regimen (GS) followed by surgery (NAC) or UP-S after randomization (1:1). Patients in both arms received adjuvant chemotherapy using S-1 for 6 months after surgical resection. The primary endpoint was overall survival (OS); secondary endpoints included adverse events, resection rate, recurrence-free survival, residual tumor status, nodal metastases, and tumor marker kinetics. Results: A total 362 patients were randomly assigned to NAC-GS (n=182) or UP-S (n=180) for 3 years (2013-16). The median OS was 36.7 months in NAC-GS and 26.6 months in UP-S; HR 0.72 (p=0.015, stratified log-rank test) at 2.5 year after final enrollment. Crude resection rate for NAC and UP-S were 77%, 72% respectively. There was no operative mortality in both groups. Although G3/4 adverse events were observed frequently (73%) during NAC, no significant difference for both groups was observed for perioperative outcomes including blood loss, operation time, R0 resection rate and post-operative morbidity. Significant decrease of pathological nodal metastases in NAC was noted compared to those in UP-S by pathological evaluation for resected patients(p<0.01). Although significant decrease of viable tumor cells was observed in primary tumor after NAC compared to UP-S (p<0.01), Evans IIb or more was found in only 14 % of resected patients in NAC. Hepatic recurrence after surgery was significantly reduced in NAC (30.0%) compared to UP-S (47.5%) in observed period. Conclusions: The strategy of NAC showed significant longer survival compared to that of UP-S with acceptable feasibility. The effect of NAC might imply the control of subdiagnostic liver metastases before surgery for resectable PDAC. Clinical trial information: UMIN000009634.