title: Phase II trial of adjuvant chemotherapy with S-1 for colorectal liver metastasis.
abstract: BACKGROUND
  This phase II trial was designed to evaluate the safety and efficacy of adjuvant chemotherapy with S-1 in patients with curatively resected liver metastasis from colorectal cancer. Results of an interim analysis of safety and short-term outcomes are reported.
  
  
  METHODS
  Patients who underwent curative resection of liver metastasis from colorectal cancer received S-1 monotherapy (on days 1-28, followed by 14 days' rest, 8 cycles) as adjuvant chemotherapy.
  
  
  RESULTS
  Among 62 patients enrolled between October 2008 and August 2010, a total of 60 patients were eligible for analysis. The most frequent grade 3 or higher hematologic toxicity involved neutropenia in three patients (5.0 %). Nonhematologic toxicities of grade 3 or higher were fatigue in 6.7 % of patients. Grade 4 enteritis occurred in one patient, but resolved promptly after withdrawal of S-1 therapy. The completion rate of the eight scheduled cycles of chemotherapy was 58.3 %. The most common reasons for withdrawal of treatment was the detection of early relapse in 16 patients (64 %). When the 16 patients who had recurrence during adjuvant treatment were excluded from analysis, 79.5 % of the remaining 44 patients completed the scheduled treatment. Early recurrence within 1 year after curative liver resection occurred in 21 patients (35 %). The most common site was the remnant liver in 14 patients.
  
  
  CONCLUSIONS
  Orally administered S-1 after curative liver resection has an acceptable toxicity profile and a high rate of completion of the therapy. S-1 can be safely used and might be a viable treatment option in an adjuvant setting.
authors.affiliation: Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. kuehara@med.nagoya-u.ac.jp
authors.forename: Keisuke
authors.initials: K
authors.lastname: Uehara
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Maeda
authors.forename: Eiji
authors.initials: E
authors.lastname: Sakamoto
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Hiramatsu
authors.forename: Eiji
authors.initials: E
authors.lastname: Takeuchi
authors.forename: Kenji
authors.initials: K
authors.lastname: Sakaguchi
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Tojima
authors.forename: Yu
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Tomoki
authors.initials: T
authors.lastname: Ebata
authors.forename: Masato
authors.initials: M
authors.lastname: Nagino
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000188:drug therapy; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D011379:Prognosis; D016879:Salvage Therapy; D005641:Tegafur / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid