title: A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer.
abstract: OBJECTIVE
  To compare the efficacy and toxicity of single-agent gemcitabine with gemcitabine plus cisplatin (G + C) in patients with metastatic pancreatic cancer
  
  
  METHODS
  Forty-six patients with metastatic pancreatic cancer were randomized to receive gemcitabine alone (n = 25; 1,000 mg m(-2)) or G + C (n = 21; 1,000 mg m(-2) gemcitabine and 25 mg m(-2) cisplatin). Treatments were administered once a week for 3 weeks and repeated every 4 weeks.
  
  
  RESULTS
  Patient characteristics were comparable between the gemcitabine alone and G + C groups. The gemcitabine dose intensity was similar between the gemcitabine alone and G + C groups (684 ± 32  vs. 617 ± 31 mg m(-2) week(-1)). The cisplatin dose intensity was 15.1 ± 0.9 mg m(-2) week(-1) × 9.9 ± 1.8 weeks. Partial response rates were 8 % (2/25) for gemcitabine alone and 4.8 % (1/21) for G + C (p = 1). The median survival and median time to progression were 7.7 and 4.6 months for gemcitabine alone and 7.9 and 3.6 months for G + C, respectively (p = 0.752 and p = 0.857, respectively). Clinical benefit was 36 % for gemcitabine alone and 29 % for G + C (p = 0.592). Quality-adjusted life months were 5.6 ± 0.3 for the gemcitabine alone group and 3.8 ± 0.2 for the G + C group (p < 0.001). The frequency of grade 3/4 neutropenia (8 vs. 19 %) and anemia (8 vs. 10 %) and the number of hospitalization days per month of survival (4.7 ± 1.3 vs. 6.3 ± 1.6 days; p = 0.431) were not significantly different between patients who received gemcitabine alone and those who received G + C. However, patients in the G + C group had a higher rate of thrombocytopenia than did patients in the gemcitabine alone group (62 vs. 24 %; p = 0.009).
  
  
  CONCLUSIONS
  Gemcitabine alone and G + C had comparable and modest response rates in metastatic pancreatic cancer, but gemcitabine alone produced less toxicities than did G + C.
authors.affiliation: Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Yee
authors.initials: Y
authors.lastname: Chao
authors.forename: Chen-Yi
authors.initials: CY
authors.lastname: Wu
authors.forename: Jack P
authors.initials: JP
authors.lastname: Wang
authors.forename: Rheun-Chuan
authors.initials: RC
authors.lastname: Lee
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Lee
authors.forename: Chung-Pin
authors.initials: CP
authors.lastname: Li
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine