title: Gemcitabine versus gemcitabine-carboplatin for patients with advanced non-small cell lung cancer and a performance status of 2: a prospective randomized phase II study of the Hellenic Cooperative Oncology Group.
abstract: BACKGROUND
  The purpose of this study was to evaluate gemcitabine-carboplatin (GCb) versus single-agent gemcitabine (G) in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2. The primary endpoint was clinical benefit.
  
  
  METHODS
  Patients were randomly assigned to either 1250 mg/m of G (arm A) or 1250 mg/m of G plus carboplatin area under the curve of 3 (arm B). Both treatments were given on days 1 and 14 and were repeated every 28 days for up to four cycles.
  
  
  RESULTS
  Among the 90 eligible patients (47 in arm A and 43 in arm B), in arm A, two (4%) had partial responses (95% CI, 0.52%-14.5%) and 10 (21%) had stable disease (95% CI, 10.7%-35.7%). In arm B, six (14%) had partial responses (95% CI, 5.3%-27.9%) and nine (21%) had stable disease (95% CI, 10%-36%) (p = 0.14). No significant difference was found in terms of clinical benefit between the two treatment groups after two cycles of treatment or at the end of chemotherapy. Furthermore, no association was found between clinical benefit and response to treatment (p > 0.05). Median survival was 4.8 months (95% CI, 2.45-7.25) for arm A and 6.7 months (95% CI, 2.47-10.8) for arm B (p = 0.49). Neutropenia (p = 0.007) and thrombocytopenia (p < 0.001) were more common in group B. Nevertheless, no significant differences were found in terms of severe toxicities (p > 0.05 in all cases).
  
  
  CONCLUSIONS
  No significant difference was found in terms of clinical benefit in patients with NSCLC and PS 2 who received single-agent G or GCb. Nevertheless, GCb caused more toxicity, particularly neutropenia and thrombocytopenia.
authors.affiliation: Hygeia Hospital, Athens, Greece. parkosmi@otenet.gr
authors.forename: Paris A
authors.initials: PA
authors.lastname: Kosmidis
authors.forename: Meletios-Athanasios
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Syrigos
authors.forename: Costas
authors.initials: C
authors.lastname: Nicolaides
authors.forename: Gerasimos
authors.initials: G
authors.lastname: Aravantinos
authors.forename: Ioannis
authors.initials: I
authors.lastname: Boukovinas
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Pectasides
authors.forename: George
authors.initials: G
authors.lastname: Fountzilas
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Bafaloukos
authors.forename: Charalampos
authors.initials: C
authors.lastname: Bacoyiannis
authors.forename: Haralampos P
authors.initials: HP
authors.lastname: Kalofonos
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine