116237-132

JASPAC 01: Randomized phase III trial of adjuvant chemotherapy with gemcitabine versus S-1 for patients with resected pancreatic cancer.

Subcategory: 
Category: 
Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 

4008

Citation: 

J Clin Oncol 31, 2013 (suppl; abstr 4008)

Author(s): 

Akira Fukutomi, Katsuhiko Uesaka, Narikazu Boku, Hideyuki Kanemoto, Masaru Konishi, Ippei Matsumoto, Yuji Kaneoka, Yasuhiro Shimizu, Shoji Nakamori, Hirohiko Sakamoto, Soichiro Morinaga, Osamu Kainuma, Koji Imai, Naohiro Sata, Shoichi Hishinuma, Takayuki Nakamura, Michio Kanai, Satoshi Hirano, Yukinobu Yoshikawa, Yasuo Ohashi; Shizuoka Cancer Center, Shizuoka, Japan; St. Marianna University School of Medicine, Kawasaki, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Kobe University Graduate School of Medicine, Kobe, Japan; Ogaki Municipal Hospital, Ogaki, Japan; Aichi Cancer Center Hospital, Nagoya, Japan; Osaka National Hospital, Osaka, Japan; Saitama Medical University International Medical Center, Saitama, Japan; Kanagawa Cancer Center, Yokohama, Japan; Chiba Cancer Center, Chiba, Japan; Asahikawa Medical University, Asahikawa, Japan; Jichi Medical University, Shimotsuke, Japan; Tochigi Cancer Center, Utsunomiya, Japan; Gunma Prefectural Cancer Center, Gunma, Japan; Kasugai Municipal Hospital, Kasugai, Japan; Hokkaido University Graduate School of Medicine, Sapporo, Japan; National Hospital Organization Kure Medical Center, Kure, Japan; The University of Tokyo, Tokyo, Japan


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: Adjuvant chemotherapy with gemcitabine (G) has been standard treatment for resected pancreatic cancer (PC). In the GEST study, S-1 (S) had shown non-inferiority to G in overall survival (OS) for unresectable PC. The aim of this phase III study is to investigate non-inferiority of S to G on OS as adjuvant chemotherapy for resected PC. Methods: Patients (pts) after macroscopically curative resection of PC with an ECOG PS of 0-1 and adequate organ functions were randomly assigned to G (1000 mg/m2, iv, d1, 8 and 15, q4w, for 6 courses) or S (80/100/120 mg/day based on BSA, po, d1-28, q6w, for 4 courses) with balancing by surgical margins (R), nodal status (N) and institution. Primary endpoint was OS. With 180 pts per arm, the study had 80% power to prove non-inferiority with a margin of hazard ratio (HR) 1.25 on the basis of expected HR 0.87, with 0.05 two-sided alpha. Secondary endpoints were relapse-free survival (RFS), safety, and quality of life (EQ-5D). One interim analysis was planned after 180 deaths. Results: From 4/2007 to 6/2010, 385 pts were enrolled from 33 hospitals in Japan. 378 pts (G/S: 191/187) were included in the full analysis set. Pts characteristics (G/S) were well balanced (PS0: 67%/70%, R0: 86%/88%, N0: 38%/36%). Based on the interim analysis with 205 OS events, IDMC recommended to publish the results. OS at 2-years were 53% for G and 70% for S. HR for S to G was 0.56 (95% CI, 0.42-0.74, p<0.0001 for non-inferiority, p<0.0001 for superiority). On subgroup analysis, HRs for R0/R1, N0/N1 pts were 0.57 (95% CI, 0.42-0.78)/0.53 (0.27-1.05), 0.48 (0.28-0.83)/0.58 (0.41-0.80), respectively. RFS at 2-years were 29% for G and 49% for S. HR of relapse for S to G was 0.56 (95% CI, 0.43-0.71, log-rank p<0.0001). Incidences of grade 3/4 toxicities in G/S were leukopenia 39%/9%, hemoglobin decrease 17%/13%, thrombocytopenia 9%/4%, elevated AST 5%/1%, fatigue 5%/5%, and anorexia 6%/8%. Relative dose intensity of G/S was 84%/97%. EQ-5D QOL score in S was significantly better than that in G (p<0.0001). Conclusions: S-1 adjuvant chemotherapy is shown non-inferior, and furthermore, even superior to GEM. S-1 is considered as the new standard treatment for resected PC pts. Clinical trial information: UMIN000000655.