title: S-1 and gemcitabine as an outpatient-based regimen in patients with advanced or metastatic pancreatic cancer.
abstract: OBJECTIVE
  The standard beneficial chemotherapy proved for patients with pancreatic cancer is a regimen containing gemcitabine. Novel oral fluoropyrimidine, S-1, can be added to gemcitabine to improve the efficacy of chemotherapy and to provide better convenience for patients. We aimed to evaluate the efficacy and safety of S-1 plus gemcitabine combination chemotherapy as a first-line treatment in patients with locally advanced or metastatic pancreatic cancer.
  
  
  METHODS
  Patients with histologically confirmed, bidimensionally measurable advanced/metastatic pancreatic cancer were eligible for the study. Chemotherapy consisted of S-1 (30 mg/m(2) p.o. bid from Day 1 to 14) and gemcitabine (1000 mg/m(2) on Days 8 and 15) every 3 weeks based on the results of a previously reported Phase I trial. Treatment was repeated until disease progression or unacceptable toxicity occurred.
  
  
  RESULTS
  From January 2005 to August 2007, 22 patients were enrolled. Median age was 62 years (range, 50-73). Nineteen patients (86.3%) had metastases and of these, 11 patients (57.9%) had multiple liver metastases. The overall response rate was 27.3% (95% CI, 8.7-45.9), with a partial response in six patients, stable disease in nine (40.9%) and progressive disease in seven (31.8%). With a median follow-up of 25.4 months, the median time to progression and overall survival were 4.6 (95% CI, 2-7.2 months) and 8.5 months (95% CI, 6.8-10.1 months), respectively, and 1-year survival rate was 27.3%. S-1 plus gemcitabine was well tolerated. Grade 3/4 hematological adverse events were neutropenia (9.1/9.1%) and anemia (4.5/0%). Non-hematological adverse events were mainly gastrointestinal events. Twenty patients (91%) received chemotherapy on an outpatient basis.
  
  
  CONCLUSIONS
  Combination chemotherapy of S-1 plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.
authors.affiliation: Division of Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Gyeongju, Republic of Korea.
authors.forename: Min Kyoung
authors.initials: MK
authors.lastname: Kim
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Byung Ik
authors.initials: BI
authors.lastname: Jang
authors.forename: Tae Nyeun
authors.initials: TN
authors.lastname: Kim
authors.forename: Jong Ryul
authors.initials: JR
authors.lastname: Eun
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.forename: Hun Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Sun Ah
authors.initials: SA
authors.lastname: Lee
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000284:Administration, Oral; D000368:Aged; D000553:Ambulatory Care; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D012189:Retrospective Studies; D005641:Tegafur / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine