title: Randomised phase II trial of irinotecan plus S-1 in patients with gemcitabine-refractory pancreatic cancer.
abstract: BACKGROUND
  We aimed to compare the efficacy and safety of irinotecan/S-1 (IRIS) therapy with S-1 monotherapy in patients with gemcitabine-refractory pancreatic cancer.
  
  
  METHODS
  Patients were treated with oral S-1 (80-120 mg for 14 days every 4 weeks) plus intravenous irinotecan (100 mg m-2on days 1 and 15 every 4 weeks; IRIS group) or oral S-1 group (80-120 mg daily for 28 days every 6 weeks). The primary endpoint was progression-free survival (PFS).
  
  
  RESULTS
  Of 137 patients enrolled, 127 were eligible for efficacy. The median PFS in the IRIS group and S-1 monotherapy group were 3.5 and 1.9 months, respectively (hazard ratio (HR)=0.77; 95% confidence interval (CI), 0.53-1.11; P=0.18), while the median overall survival (OS) were 6.8 and 5.8 months, respectively (HR=0.75; 95% CI, 0.51-1.09; P=0.13). Response rate was significantly higher in the IRIS group than in the S-1 monotherapy group (18.3% vs 6.0%, P=0.03). Grade 3 or higher neutropenia and anorexia occurred more frequently in the IRIS group.
  
  
  CONCLUSIONS
  There was a trend for better PFS and OS in the IRIS group that could be a treatment arm in the clinical trials for gemcitabine-refractory pancreatic cancer.
authors.affiliation: Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ioka
authors.affiliation: Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, 5-chome, Kita 14 Jou Nishi, Kita-ku, Sapporo 060-8648, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Komatsu
authors.affiliation: Department of Gastroenterology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Mizuno
authors.affiliation: Department of Medical Oncology, Kochi Health Sciences Center, 2125-1 Ike, Kochi 781-0111, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Tsuji
authors.affiliation: Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center Hospital, 2-3-2 Nakao, Asahi-ku, Yokohama 241-8515, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Ohkawa
authors.affiliation: Department of Surgery and Oncology, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Tanaka
authors.affiliation: Department of Gastroenterology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-chou, Matsuyama 791-0280, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Iguchi
authors.affiliation: Department of Medical Oncology, Hirosaki University, 53 Hon-cho, Hirosaki 036-8562, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Ishiguro
authors.affiliation: Department of Gastroenterology and Hepatology, Kinki University School of Medicine, 377-2 Onohigashi, Osakasayama 589-8511, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kitano
authors.affiliation: Faculty of Medicine, Department of Medical Oncology, Kinki University, 377-2 Onohigashi, Osakasayama 589-8511, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Division of Gastroenterology, Chiba Cancer Center Hospital, 666-2 Nitona-cho, Chuo-ku, Chiba 260-8717, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yamaguchi
authors.affiliation: Department of Clinical Oncology, Osaka City General Hospital, 2-13-22 Miyakojima-hondori, Miyakojia-ku, Osaka 534-0021, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Takeda
authors.affiliation: Department of Medicine, Kitasato University School of Medicine, 2-1-1 Asamizodai, Minami-ku, Sagamihara 252-0374, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kida
authors.affiliation: Department of Internal Medicine, Medical Oncology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-Ku, Tokyo 173-8605, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Eguchi
authors.affiliation: Department of Medicine and Bioregulatory Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ito
authors.affiliation: Department of Medical Oncology, Misawa City Hospital, 164-65 Oazamisawaazahoriuchi, Misawa 033-0022, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Munakata
authors.affiliation: Department of Gastroenterological Medicine, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 166-0023, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Itoi
authors.affiliation: Department of Medical Oncology, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, 181-8611, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Furuse
authors.affiliation: Faculty of Engineering, Tokyo University of Science, 6-3-1 Niijuku, Katsushika-ku, Tokyo 125-8585, Japan.
authors.forename: C
authors.initials: C
authors.lastname: Hamada
authors.affiliation: Department of Medical Oncology, Misawa City Hospital, 164-65 Oazamisawaazahoriuchi, Misawa 033-0022, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Sakata
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D061605:Administration, Intravenous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine