title: Do recurrent and metastatic pancreatic cancer patients have the same outcomes with gemcitabine treatment?
abstract: BACKGROUND
  Whether recurrence after surgery and primary metastatic pancreatic cancer should be included in the same category when conducting gemcitabine-based clinical trials remains controversial.
  
  
  OBJECTIVE
  To clarify the outcomes of recurrent and metastatic pancreatic cancers.
  
  
  METHODS
  326 patients who received gemcitabine monotherapy as a first-line treatment for advanced pancreatic cancer between 2001 and 2007 were reviewed. Multivariate analysis was performed to determine the prognostic relevance of recurrence or metastasis in relation to other factors possibly influencing treatment outcomes with respect to overall survival. Differences in response to chemotherapy, drug delivery and adverse events were also analyzed.
  
  
  RESULTS
  There were 65 recurrent and 261 metastatic cancer patients. Recurrent cancer patients had a significantly longer time to treatment failure and survival (respective medians 138 and 77 days, p = 0.017) than the metastatic patients (respective medians 270 and 185 days, p = 0.0003). Multivariate analysis revealed poor Karnofsky performance status (<80), presence of liver or peritoneal metastasis, elevated lactate dehydrogenase (>220 U/l), elevated alkaline phosphatase (>330 U/l) and elevated C-reactive protein (>1.0 mg/dl) to be significantly correlated with short survival, while neither recurrent nor metastatic status were related to survival (hazard ratio 0.76, 95% CI 0.53-1.09, p = 0.14). The response rates and dose intensities of gemcitabine were similar in these groups, although leukopenia was more frequently observed in the recurrence group (p = 0.008).
  
  
  CONCLUSIONS
  When conducting clinical trials, it appears to be acceptable to treat recurrent pancreatic cancer after surgery and pancreatic cancer with primary metastasis under the same category.
authors.affiliation: National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hashimoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Ueno
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ikeda
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Kojima
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hagihara
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Kondo
authors.forename: Chigusa
authors.initials: C
authors.lastname: Morizane
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000032:analysis; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D002097:C-Reactive Protein; D000093542:Gemcitabine