title: S-1 plus gemcitabine chemotherapy followed by concurrent radiotherapy and maintenance therapy with S-1 for unresectable pancreatic cancer.
abstract: OBJECTIVE
  To investigate the feasibility and efficacy of the combination of S-1 with gemcitabine followed by oral S-1 with concurrent radiotherapy (intensity modulated radiotherapy, IMRT) and maintenance therapy with S-1 for locally advanced pancreatic cancer.
  
  
  METHODS
  Subjects selected in the study were patients who had unresectable and locally advanced pancreatic cancer without distant metastases, adequate organ and marrow functions, an Eastern Cooperative Oncology Group performance status of 0-1 and no prior anticancer therapy. Initially the subjects received two cycles of chemotherapy, oral administration of S-1 40 mg/m(2) twice daily from day 1 to day 14 of a 21-d cycle, with 30-min intravenous infusions of gemcitabine 1000 mg/m(2) on day 1 and day 8. Two weeks after the completion of chemotherapy, S-1 was administered orally with concurrent IMRT. Oral S-1 was administered at a dose of 80 mg/m(2) per day twice daily from day 1 to day 14 and from day 22 to day 35. Radiation was concurrently delivered at a dose of 50.4 Gy (1.8 Gy/d, 5 times per week, 28 fractions). One month after the completion of chemotherapy and radiotherapy, S-1 was administered orally at a dose of 80 mg/m(2) per day twice daily for 14 d, followed by a 14-d rest period. This cycle was repeated as maintenance therapy, until unacceptable toxicity occurred or the disease worsened. Thirty-two patients were involved in this study. The median follow-up was 15.6 mo (range: 8.6-32.3 mo).
  
  
  RESULTS
  Thirty-two patients completed the scheduled course of chemotherapy, while 30 patients (93.8%) received chemoradiotherapy with two patients ceasing to continue with radiotherapy. The major toxic effects were nausea and leukopenia. There was no grade 4 toxicity or treatment-related death. According to the Response Evaluation Criteria in Solid Tumors criteria, the objective tumor response was partial response in 17 (53.1%) patients, stable disease in 9 (28.1%), and progressive disease in 6 (18.8%). The median overall survival and median progression-free survival were 15.2 mo and 9.3 mo, respectively. The survival rates at 1 year and 2 years were 75% and 34.4%, respectively.
  
  
  CONCLUSIONS
  The combination of S-1 with gemcitabine followed by oral S-1 with IMRT and maintenance therapy with S-1 alone in patients with locally advanced pancreatic cancer may be considered a well-tolerated, promising treatment regimen.
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Qing-Hua
authors.initials: QH
authors.lastname: Ke
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Shi-Qiong
authors.initials: SQ
authors.lastname: Zhou
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Ji-Yuan
authors.initials: JY
authors.lastname: Yang
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Du
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Gai
authors.initials: G
authors.lastname: Liang
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Lei
authors.affiliation: Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Luo
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D002681:China; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016634:Radiosurgery / Q000009:adverse effects; D020266:Radiotherapy, Conformal / Q000009:adverse effects; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine
keywords: CA19-9; Chemoradiotherapy; Pancreatic cancer; Radiosensitizer; S-1