Randomised phase II trial of irinotecan plus S-1 in patients with gemcitabine-refractory pancreatic cancer View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-01-12

AUTHORS

T Ioka, Y Komatsu, N Mizuno, A Tsuji, S Ohkawa, M Tanaka, H Iguchi, A Ishiguro, M Kitano, T Satoh, T Yamaguchi, K Takeda, M Kida, K Eguchi, T Ito, M Munakata, T Itoi, J Furuse, C Hamada, Y Sakata

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−2 on 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. More... »

PAGES

464-471

Journal

TITLE

British Journal of Cancer

ISSUE

4

VOLUME

116

Author Affiliations

  • Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, 537-8511, Higashinari-ku, Osaka, Japan
  • Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, 5-chome, Kita 14 Jou Nishi, 060-8648, Kita-ku, Sapporo, Japan
  • Department of Gastroenterology, Aichi Cancer Center Hospital, 1-1 Kanokoden, 464-8681, Chikusa-kuNagoya, Japan
  • Department of Medical Oncology, Kochi Health Sciences Center, 2125-1 Ike, 781-0111, Kochi, Japan
  • Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center Hospital, 2-3-2 Nakao, 241-8515, Asahi-ku, Yokohama, Japan
  • Department of Surgery and Oncology, Kyushu University, 3-1-1 Maidashi, 812-8582, Higashi-ku, Fukuoka, Japan
  • Department of Gastroenterology, National Hospital Organization Shikoku Cancer Center, 160 Kou, 791-0280, Minamiumemoto-chou, Matsuyama, Japan
  • Department of Medical Oncology, Hirosaki University, 53 Hon-cho, 036-8562, Hirosaki, Japan
  • Department of Gastroenterology and Hepatology, Kinki University School of Medicine, 377-2 Onohigashi, 589-8511, Osakasayama, Japan
  • Department of Medical Oncology, Faculty of Medicine, Kinki University, 377-2 Onohigashi, 589-8511, Osakasayama, Japan
  • Division of Gastroenterology, Chiba Cancer Center Hospital, 666-2 Nitona-cho, 260-8717, Chuo-ku, Chiba, Japan
  • Department of Clinical Oncology, Osaka City General Hospital, 2-13-22 Miyakojima-hondori, 534-0021, Miyakojia-ku, Osaka, Japan
  • Department of Medicine, Kitasato University School of Medicine, 2-1-1 Asamizodai, 252-0374, Minami-ku, Sagamihara, Japan
  • Department of Internal Medicine, Medical Oncology, Teikyo University School of Medicine, 2-11-1 Kaga, 173-8605, Itabashi-Ku, Tokyo, Japan
  • Department of Medicine and Bioregulatory Science, Kyushu University, 3-1-1 Maidashi, 812-8582, Higashi-ku, Fukuoka, Japan
  • Department of Medical Oncology, Misawa City Hospital, 164-65 Oazamisawaazahoriuchi, 033-0022, Misawa, Japan
  • Department of Gastroenterological Medicine, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 166-0023, Japan
  • Department of Medical Oncology, Kyorin University School of Medicine, 6-20-2 Shinkawa, 181-8611, Mitaka, Japan
  • Faculty of Engineering, Tokyo University of Science, 6-3-1 Niijuku, 125-8585, Katsushika-ku, Tokyo, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/bjc.2016.436

    DOI

    http://dx.doi.org/10.1038/bjc.2016.436

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1036984838

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/28081543


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