title: Gemcitabine in brief versus prolonged low-dose infusion, both combined with carboplatin for advanced non-small cell lung cancer.
abstract: OBJECTIVE
  Gemcitabine in low-dose prolonged infusion is a treatment with documented activity against a variety of tumors. The present study was conducted to evaluate the efficacy and safety of the combination of gemcitabine at a low-dose prolonged infusion in comparison with standard dose gemcitabine with carboplatin in chemonaive patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Sixty chemonaive patients with stage IIIB or IV NSCLC were included. Patients were randomly assigned 1:1 to receive 350 mg/m 2 gemcitabine in a 6-h infusion on days 1 and 8 and carboplatin area under the serum concentration time curve (AUC) 5 on day 1 versus gemcitabine 1,000 mg/m 2 on days 1 and 8 and carboplatin AUC 5 on day 1 (3-week cycle both). A total of 118 chemotherapy cycles, with a median of 4 cycles per patient (range 2-6), and 134 chemotherapy cycles, with a median of 4.47 cycles per patient (range 3-6) were administered in standard and low infusional dose arm, respectively.
  
  
  RESULTS
  Among patients in the standard arm, 40% had overall response rate (ORR), 33.3% had stable disease and 26.6% had progressive disease, while in low-dose infusional arm, 36.6% had ORR, 36.3% had stable disease and 26.6% had progressive disease (P = 0.992). Median progression-free survival was 5.5 months and 5.4 months, median overall survival was 9.7 months and 10.7 months, and 1-year survival was 33.7% and 36.6% in standard arm and low-dose infusion arm, respectively. Grade 3/4 toxicity was rare.
  
  
  CONCLUSIONS
  In NSCLC, gemcitabine low-dose prolonged infusion with carboplatin has low toxicity, especially thrombocytopenia, and has an activity comparable with gemcitabine given in higher dose in standard infusion.
authors.affiliation: Department of Medical Oncology, The Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India.
authors.forename: S K
authors.initials: SK
authors.lastname: Beniwal
authors.forename: K M
authors.initials: KM
authors.lastname: Patel
authors.forename: S
authors.initials: S
authors.lastname: Shukla
authors.forename: B J
authors.initials: BJ
authors.lastname: Parikh
authors.forename: S
authors.initials: S
authors.lastname: Shah
authors.forename: A
authors.initials: A
authors.lastname: Patel
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007263:Infusions, Parenteral; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine