title: Metformin Addition to Chemotherapy in Stage IV Non-Small Cell Lung Cancer: an Open Label Randomized Controlled Study.
abstract: OBJECTIVE
  To evaluate effects of metformin on clinical outcome of non-diabetic patients with stage IV NSCLC.
  
  
  METHODS
  A prospective, randomized, open-label, controlled pilot study was conducted on patients with stage IV NSCLC with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2, excluding patients with diabetes and lactic acidosis. Thirty chemo-naive, non-diabetic patients with stage IV NSCLC were enrolled. Fifteen patients received intravenous gemcitabine/cisplatin regimen alone (arm B) while fifteen patients received the same regimen plus daily oral metformin 500 mg (arm A). The effect of metformin on chemotherapy-response rates, survival, and adverse events in these patients was evaluated.
  
  
  RESULTS
  Objective response rate (ORR) and median overall survival (OS) in arms A and B were 46.7% versus 13.3% respectively, p=0.109 and 12 months versus 6.5 months, respectively, p=0.119. Median progression free survival (PFS) in arms A and B was 5.5 months versus 5 months, p=0.062. No significant increase in toxicity was observed in arm A versus arm B. Percentage of patients who experienced nausea was significantly lower in arm A versus arm B, at 26.7% versus 66.7% respectively, p=0.028.
  
  
  CONCLUSIONS
  Metformin administration reduced occurrence of chemotherapy induced-nausea. Non-statistically significant improvements in the ORR or OS were observed. Metformin had no effect on PFS.
authors.affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt E-mail : lamywak@yahoo.com.
authors.forename: Rana
authors.initials: R
authors.lastname: Sayed
authors.forename: Amr S
authors.initials: AS
authors.lastname: Saad
authors.forename: Lamia
authors.initials: L
authors.lastname: El Wakeel
authors.forename: Engi
authors.initials: E
authors.lastname: Elkholy
authors.forename: Osama
authors.initials: O
authors.lastname: Badary
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D009367:Neoplasm Staging; D010865:Pilot Projects; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D008687:Metformin; D002945:Cisplatin; D000093542:Gemcitabine