title: Biweekly Carboplatin Plus Gemcitabine as First-Line Treatment of Elderly Patients With Advanced Squamous Non-Small-cell Lung Cancer: A Multicenter Phase I-II Trial by the Hellenic Oncology Research Group.
abstract: The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities of the biweekly carboplatin/gemcitabine combination and evaluate its safety and efficacy in patients aged ≥ 70 years with advanced squamous non-small-cell lung cancer (NSCLC).
  
  
  
  Patients aged ≥ 70 years with advanced or metastatic squamous NSCLC received escalated doses of carboplatin (area under the curve [AUC] 2-2.5 intravenously) and gemcitabine (800-1100 mg/m2intravenously) every 2 weeks (phase I). In the phase II, the drugs were administered at their previously defined MTDs (carboplatin, AUC 2.5; gemcitabine, 1100 mg/m2). The primary endpoint was the overall response rate.
  
  
  
  A total of 69 patients were enrolled (phase I, n = 15). The median age was 76 years (range, 70-84 years); 52 patients had stage IV disease, and 61 and 8 patients had Eastern Cooperative Oncology Group performance status of 0 to 1 and 2, respectively. The MTDs could not be reached at the predefined last dose levels. The dose-limiting toxicities were grade 5 renal toxicity and grade 3 thrombocytopenia. In the phase II study, the overall response rate was 35.8% (95% confidence interval [CI], 23.0%-48.8%). In the intention-to-treat analysis, the median progression-free survival was 6.7 months (95% CI, 4.2-8.8 months), and the median overall survival was 13.3 months (95% CI, 7.1-19.6 months). Grade 3 or 4 neutropenia was observed in 7 patients (12.3%), grade 3 or 4 thrombocytopenia in 4 patients (7.1%), and grade 2 or 3 fatigue in 10 patients (17.5%). One toxic death occurred in the phase I of the study.
  
  
  
  The biweekly regimen of gemcitabine and carboplatin showed satisfactory efficacy and a favorable toxicity profile in elderly patients with advanced or metastatic squamous cell NSCLC.
authors.affiliation: 401 Army General Hospital, Athens, Greece; Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karampeazis
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece.
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Medical Oncology Department, 251 General Air Force Hospital, Athens, Greece.
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; 1st Department of Medicine, Medical School, University of Athens, Laikon General Hospital, Athens, Greece.
authors.forename: Aris
authors.initials: A
authors.lastname: Polyzos
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; 1st Department of Pulmonary Disease, Sismanoglion Hospital, Athens, Greece.
authors.forename: Vassilis
authors.initials: V
authors.lastname: Chandrinos
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Unit of Medical Technology and Intelligent Information Systems, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.
authors.forename: Georgios
authors.initials: G
authors.lastname: Rigas
authors.affiliation: 401 Army General Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christofyllakis
authors.affiliation: Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: Dora
authors.initials: D
authors.lastname: Hatzidaki
authors.affiliation: Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: Athanasios G
authors.initials: AG
authors.lastname: Pallis
authors.affiliation: Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece. Electronic address: georgoul@med.uoc.gr.
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine
keywords: Geriatric assessment; NSCLC; Older; Phase I and II study; Platinum