title: Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer.
abstract: BACKGROUND
  This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer.
  
  
  METHODS
  Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 (80/100/120 mg day(-1) based on body surface area (BSA), orally, days 1-28, every 6 weeks) or SOX (S-1 80/100/120 mg day(-1) based on BSA, orally, days 1-14, plus oxaliplatin 100 mg m(-2), intravenously, day 1, every 3 weeks). The primary end point was PFS.
  
  
  RESULTS
  Between January 2009 and July 2010, 271 patients were randomly allocated to either S-1 (n=135) or SOX (n=136). Median PFS for S-1 and SOX were 2.8 and 3.0 months, respectively (hazard ratio (HR)=0.84; 95% confidence interval (CI), 0.65-1.08; stratified log-rank test P=0.18). Median overall survival (OS) was 6.9 vs 7.4 months (HR=1.03; 95% CI, 0.79-1.34; stratified log-rank test P=0.82). The response rate (RR) was 11.5% vs 20.9% (P=0.04). The major grade 3/4 toxicities (S-1 and SOX) were neutropenia (11.4% and 8.1%), thrombocytopenia (4.5% and 10.3%) and anorexia (12.9% and 14.7%).
  
  
  CONCLUSIONS
  Although SOX showed an advantage in RR, it provided no significant improvement in PFS or OS compared with S-1 alone.
authors.affiliation: Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Ohkawa
authors.affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Okusaka
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, University of Tokyo Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Isayama
authors.affiliation: Department of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007, Shimonagakubo, Nagaizumi-cho Sunto-gun, Shizuoka 411-8777, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Fukutomi
authors.affiliation: Department of Gastroenterology, Saitama Cancer Center, 780, Komuro, Inamachi, Kitaadachi-gun, Saitama 362-0806, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Yamaguchi
authors.affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Ikeda
authors.affiliation: Department of Gastroenterology, National Hospital Organization Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Funakoshi
authors.affiliation: Department of Chemotherapy, Japanese Red Cross Nagoya Daiichi Hospital, 15-1, Michishita-cho, Nakamura-ku, Nagoya, Aichi 453-8511, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Nagase
authors.affiliation: Department of Internal Medicine, Keio University Hospital, 35, Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Hamamoto
authors.affiliation: Department of Hepatobiliary-Pancreatic Surgery, Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka 540-0006, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Nakamori
authors.affiliation: Department of Surgery, Niigata Cancer Center, 2-15-3, Kawagishi-cho, Chuo-ku, Niigata 951-8566, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Tsuchiya
authors.affiliation: Department of Digestive Surgery, Kumamoto University Hospital, 1-1-1, Honjo, Chuo-ku, Kumamoto 860-8556, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Baba
authors.affiliation: Department of Gastroenterology, Cancer Institute Hospital of JFCR, 3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Ishii
authors.affiliation: Department of Chemotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22, Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Omuro
authors.affiliation: Department of Surgery, Nara Medical University Hospital, 840, Shijo-cho, Kashihara, Nara 634-8522, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Sho
authors.affiliation: Department of Clinical Oncology, Kyoto University Hospital, 54, Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Matsumoto
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Yamada
authors.affiliation: Department of Surgery, Kansai Medical University Hirakata Hospital, 2-3-1, Shinmachi, Hirakata, Osaka 573-1191, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Yanagimoto
authors.affiliation: Department of Hepatobiliary-Pancreatic Surgery, Tohoku University Hospital, 1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Unno
authors.affiliation: Department of Gastroenterological Surgery, Yokohama City University Hospital, 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ichikawa
authors.affiliation: Department of Clinical Oncology, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: Department of Digestive Surgery, Toranomon Hospital, 2-2-2, Toranomon, Minato-ku, Tokyo 105-8470, Japan.
authors.forename: G
authors.initials: G
authors.lastname: Watanabe
authors.affiliation: Department of Surgery, Iwate Medical University Hospital, 19-1, Uchimaru, Morioka, Iwate 020-8505, Japan.
authors.forename: G
authors.initials: G
authors.lastname: Wakabayashi
authors.affiliation: Department of Internal Medicine, Tokyo Metropolitan Matsuzawa Hospital, 2-1-1, Kamikitazawa, Setagaya-ku, Tokyo 156-0057, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Egawa
authors.affiliation: Department of Gastroenterological Oncology, Hyogo Cancer Center, 13-70, Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Tsuda
authors.affiliation: Department of Surgery, Kobe City Medical Center General Hospital, 2-1-1, Minatojimanakamachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan.
authors.forename: R
authors.initials: R
authors.lastname: Hosotani
authors.affiliation: Department of Management Science, Tokyo University of Science, 1-3, Kagurazaka, Shinjuku-ku, Tokyo, 162-8601, Japan.
authors.forename: C
authors.initials: C
authors.lastname: Hamada
authors.affiliation: Department of Gastroenterology, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, Ibaraki 305-8577, Japan.
authors.forename: I
authors.initials: I
authors.lastname: Hyodo
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine