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
Final results of JASPAC05: Phase II trial of neoadjuvant S-1 and concurrent radiotherapy followed by surgery in borderline resectable pancreatic cancer.
Gastrointestinal (Noncolorectal) Cancer
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #232)
J Clin Oncol 37, 2019 (suppl; abstr 4127)
Author(s): Shinichiro Takahashi, Izumi Ohno, Masafumi Ikeda, Masaru Konishi, Tatsushi Kobayashi, Tetsuo Akimoto, Motohiro Kojima, Soichiro Morinaga, Hirochika Toyama, Yasuhiro Shimizu, Atsushi Miyamoto, Shoichi Hishinuma, Norihisa Takakura, Wataru Takayama, Satoshi Hirano, Takehito Otsubo, Masato Nagino, Wataru Kimura, Keishi Sugimachi, Katsuhiko Uesaka, JASPAC Group; Department of Hepato-Biliary Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan; National Cancer Center Hospital East- Hepatobiliary and Pancreatic Oncology, Kashiwa, Japan; National Cancer Center Hospital East, Chiba, Japan; Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Division of Pathology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Kashiwa, Japan; Division of Hepatobiliary and Pancreatic Surgery, Kanagawa Cancer Center, Yokohama, Japan; Kobe University Hospital, Dept. of Hepato-Biliary Pancreatic Surgery, Kobe, Japan; Aichi Cancer Center Hospital, Aichi, Japan; Department of Hepato-Biliary and Pancreatic Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan; Tochigi Cancer Center, Utsunomiya, Japan; Fukuyama City Hospital, Fukuyama, Japan; Chiba Cancer Center, Dept. of Hepato-Biliary Pancreatic Surgery, Chiba, Japan; Department of Gastroenterological Surgery II, Hokkaido University Hospital, Sapporo, Japan; St. Marianna University School of Medicine Hospital, Kawasaki, Japan; Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan; Yamagata University Hospital, Yamagata, Japan; Kyushu University Beppu Hospital, Beppu, Japan; Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan
Background: Borderline resectable pancreatic cancer (BRPC) is frequently associated with positive surgical margins and a poor prognosis when treated with upfront surgery. This study was designed to assess whether neoadjuvant chemoradiotherapy (CRT) with S-1 increases the R0 resection rate. Methods: This was a multicenter, single-arm, phase II study. Patients with BRPC received S-1 (40 mg/m2 bid) and concurrent radiotherapy (50.4 Gy in 28 fractions) before surgery if they fulfilled any of the following: (1) bilateral impingement of the superior mesenteric vein or portal vein; and (2) tumor contact ≤180° with the superior mesenteric artery, common hepatic artery, or celiac axis. The primary endpoint was the R0 resection rate in BRPC confirmed by central review. Secondary endpoints were overall survival (OS), progression-free survival (PFS), response rate (RECISTv1.1), pathological response rate, surgical morbidity (Clavien–Dindo classification), and toxicity (CTCAEv4.0). At least 40 patients were required, with one-sided α = 0.05 and β = 0.05, with an expected and threshold value for the primary endpoint of 30% and 10%. Results: Fifty-two patients were eligible, of whom 41 had BRPC by central review. CRT was completed in 50 (96%) patients and was well tolerated. The rate of grade 3/4 toxicity with CRT was 43%. The R0 resection rate was 52% (95% CI, 37.6%–66.0%) in 52 eligible patients and 63% (95% CI, 46.9%–77.9%) in 41 patients with BRPC. The radiological response rate was 5.8%, while destruction of > 50% of tumor cells was shown microscopically in 32% of patients. Postoperative grade III/IV adverse events were observed in 7.5% of operated patients. Among the 52 eligible patients, the 2-year OS rate, median OS, and median PFS were 51%, 25.8 mo, and 6.7 mo. Of the 41 patients with BRPC, the 2-year OS rate, median OS, and median PFS were 58%, 30.8 mo, and 10.4 mo. Conclusions: S-1 and concurrent radiotherapy appear to be feasible and effective at increasing the R0 resection rate with encouraging survival rates in BRPC. A phase II/III trial evaluating this treatment is ongoing. Clinical trial information: NCT02459652