Feasibility study of postoperative adjuvant chemotherapy with S-1 in patients with biliary tract cancer View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-04-28

AUTHORS

Kohei Nakachi, Masaru Konishi, Masafumi Ikeda, Kazuaki Shimada, Takuji Okusaka, Akio Saiura, Hiroshi Ishii, Masanori Sugiyama, Junji Furuse, Hirohiko Sakamoto, Tomotaka Shimamura, Takehiro Ohta

ABSTRACT

BackgroundThe role of adjuvant chemotherapy has not yet been established for patients with resected biliary tract cancer. S-1 has been shown to exert activity against advanced biliary tract cancer. Therefore, we evaluated the feasibility of adjuvant chemotherapy with S-1 in patients with resected biliary tract cancer.MethodsPatients with complete macroscopic resection of intrahepatic/extrahepatic bile duct, gall bladder, or ampullary cancer were eligible. S-1 was administered orally twice daily for 4 weeks every 6 weeks, up to 4 cycles. The treatment was continued up to 24 weeks or until recurrence/appearance of unacceptable toxicity. The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who received a relative dose intensity of ≥ 75%. This trial was registered as UMIN000004051.ResultsThirty-three patients were enrolled between June 2010 and March 2011. The relative dose intensity was ≥ 75% in 27 patients representing a treatment completion rate of 81.8%. The most common grade 3/4 adverse event was neutropenia (18%). Grade 2 nausea or diarrhea was observed in 12%. The 3-year relapse-free survival rate was 39.4%. The 3-year survival rate was 54.5%.ConclusionAdjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC. More... »

PAGES

894-899

Journal

Author Affiliations

  • Otaru General Hospital, 1-1-1, Wakamatsu, 047-8550, Otaru, Hokkaido, Japan
  • Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, 277-8577, Kashiwa, Chiba, Japan
  • Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, 277-8577, Kashiwa, Chiba, Japan
  • Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, 104-0045, Tokyo, Japan
  • Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, 104-0045, Tokyo, Japan
  • Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, 135-8550, Tokyo, Japan
  • Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, 135-8550, Tokyo, Japan
  • Department of Surgery, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, 181-8611, Tokyo, Japan
  • Department of Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, 181-8611, Tokyo, Japan
  • Department of Gastroenterological Surgery, Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi-gun, 362-0806, Saitama, Japan
  • Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi-gun, 362-0806, Saitama, Japan
  • Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, 8-1, Kawada-cho, Shinjuku-ku, 162-8666, Tokyo, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10147-018-1283-6

    DOI

    http://dx.doi.org/10.1007/s10147-018-1283-6

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1103676663

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29705976


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    30 schema:description BackgroundThe role of adjuvant chemotherapy has not yet been established for patients with resected biliary tract cancer. S-1 has been shown to exert activity against advanced biliary tract cancer. Therefore, we evaluated the feasibility of adjuvant chemotherapy with S-1 in patients with resected biliary tract cancer.MethodsPatients with complete macroscopic resection of intrahepatic/extrahepatic bile duct, gall bladder, or ampullary cancer were eligible. S-1 was administered orally twice daily for 4 weeks every 6 weeks, up to 4 cycles. The treatment was continued up to 24 weeks or until recurrence/appearance of unacceptable toxicity. The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who received a relative dose intensity of ≥ 75%. This trial was registered as UMIN000004051.ResultsThirty-three patients were enrolled between June 2010 and March 2011. The relative dose intensity was ≥ 75% in 27 patients representing a treatment completion rate of 81.8%. The most common grade 3/4 adverse event was neutropenia (18%). Grade 2 nausea or diarrhea was observed in 12%. The 3-year relapse-free survival rate was 39.4%. The 3-year survival rate was 54.5%.ConclusionAdjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC.
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    37 ConclusionAdjuvant chemotherapy
    38 III study
    39 MethodsPatients
    40 activity
    41 adjuvant chemotherapy
    42 adjuvant therapy
    43 advanced biliary tract cancer
    44 adverse events
    45 ampullary cancer
    46 appearance
    47 bile duct
    48 biliary tract cancer
    49 bladder
    50 cancer
    51 chemotherapy
    52 common grade 3/4 adverse events
    53 complete macroscopic resection
    54 completion rates
    55 cycle
    56 diarrhea
    57 dose intensity
    58 duct
    59 efficacy
    60 endpoint
    61 events
    62 extrahepatic bile duct
    63 feasibility
    64 feasibility study
    65 feasible treatment
    66 gall bladder
    67 grade 2 nausea
    68 grade 3/4 adverse events
    69 intensity
    70 macroscopic resection
    71 nausea
    72 neutropenia
    73 patients
    74 percentage
    75 percentage of patients
    76 phase III study
    77 postoperative adjuvant chemotherapy
    78 primary endpoint
    79 rate
    80 relapse-free survival rate
    81 relative dose intensity
    82 resection
    83 role
    84 study
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    86 therapy
    87 toxicity
    88 tract cancer
    89 treatment
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