title: Granulocyte colony-stimulating factor improves survival of patients with decompensated cirrhosis: a randomized-controlled trial.
abstract: BACKGROUND
  Liver transplantation is the only curative option for patients with decompensated cirrhosis; however, many patients die while awaiting transplantation. Granulocyte colony-stimulating factor (GCSF) has shown promising results in improving outcomes in patients with advanced liver disease. We evaluated the efficacy of GCSF in patients with decompensated cirrhosis in an open-labeled randomized-controlled trial.
  
  
  METHODS
  Consecutive patients with decompensated cirrhosis were randomized to receive either GCSF 300 μg twice daily for 5 days plus standard medical therapy (SMT) (GCSF+SMT group) or SMT alone (SMT alone group). Outcomes were assessed at 6 months from randomization.
  
  
  RESULTS
  A total of 126 patients [median age: 53 (range: 31-76) years, 85% men] received GCSF+SMT and 127 patients received SMT alone. Baseline characteristics were similar in both the groups. The 5-day GCSF therapy did not lead to any significant adverse effects. At 6 months, in the GCSF+SMT group, 17 patients had died and nine were lost to follow-up, whereas in the SMT-alone group, 30 patients had died and 11 were lost to follow-up. By intention-to-treat analysis, cumulative survival was significantly higher in the GCSF+SMT group (79 vs. 68%; P=0.025). Also, significantly more patients (66%) showed improvement or stability in the Child-Turcotte-Pugh score at 6 months in the GCSF+SMT group compared with the SMT-alone group (51%, P=0.021).
  
  
  CONCLUSIONS
  GCSF therapy improves survival and clinical outcome in patients with decompensated cirrhosis. It may be useful in patients awaiting transplantation to prevent worsening during the waiting period. Further studies are needed to explore whether repeated periodic GCSF courses can further increase the survival and decrease the need for liver transplantation.Clinical trial registered at https://clinicaltrials.gov vide NCT02642003.
authors.affiliation: Institute of Liver, Gastroenterology, and Panceaticobiliary Sciences, Sir Ganga Ram Hospital, New Delhi, India.
authors.forename: Ritesh
authors.initials: R
authors.lastname: Prajapati
authors.forename: Anil
authors.initials: A
authors.lastname: Arora
authors.forename: Praveen
authors.initials: P
authors.lastname: Sharma
authors.forename: Naresh
authors.initials: N
authors.lastname: Bansal
authors.forename: Vikas
authors.initials: V
authors.lastname: Singla
authors.forename: Ashish
authors.initials: A
authors.lastname: Kumar
mesh_terms: D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor