title: A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The number of elderly patients with advanced non-small cell lung cancer (NSCLC) is increasing. Although several studies have suggested the benefit of chemotherapy with a platinum doublet for elderly patients with advanced NSCLC, this treatment is still controversial in this age group. To evaluate the efficacy and tolerability of combination chemotherapy with biweekly paclitaxel and carboplatin for elderly patients with advanced NSCLC, we conducted a multicenter, non-randomized, open label, phase II trial.
  
  
  METHODS
  We recruited patients aged ≥70 years with clinical stage IIIB and IV NSCLC and ECOG performance status (PS) of 0-2. Patients received paclitaxel (90 mg/m(2)) and carboplatin (AUC = 2.5) on day 1 and 15, every 4 weeks. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.
  
  
  RESULTS
  Sixty-five patients (median age 79 years; range 70-87 years) were enrolled. Forty-nine patients were men, and 48 were stage IV. The PS was 0, 1, and 2 in 28, 33, and 4 patients, respectively. The histological type of NSCLC was non-squamous in 69.3 % and squamous cell carcinoma in 30.7 % of patients. The median number of treatment cycles was 3 (range 1-6). The response rate was 29.4 % (95 % CI 18.7-43.0), and the disease control rate was 78.0 % (95 % CI 64.8-87.2). Median PFS and OS were 3.8 months (95 % CI 1.9-5.3) and 17.3 months (95 % CI 10.4-25.1), respectively. The most common grade 3 or 4 toxicities were neutropenia (27 %), leukopenia (15 %), infection (10 %), and anemia (8 %).
  
  
  CONCLUSIONS
  The combination of biweekly paclitaxel and carboplatin was effective and well tolerated in elderly patients with advanced NSCLC.
authors.affiliation: Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan, ksoejima@cpnet.med.keio.ac.jp.
authors.forename: Kenzo
authors.initials: K
authors.lastname: Soejima
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Naoki
authors.forename: Kota
authors.initials: K
authors.lastname: Ishioka
authors.forename: Morio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Michie
authors.initials: M
authors.lastname: Nakatani
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kawada
authors.forename: Hideo
authors.initials: H
authors.lastname: Watanabe
authors.forename: Ichiro
authors.initials: I
authors.lastname: Nakachi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yasuda
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Satomi
authors.forename: Sohei
authors.initials: S
authors.lastname: Nakayama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yoda
authors.forename: Sinnosuke
authors.initials: S
authors.lastname: Ikemura
authors.forename: Hideki
authors.initials: H
authors.lastname: Terai
authors.forename: Takashi
authors.initials: T
authors.lastname: Sato
authors.forename: Keiko
authors.initials: K
authors.lastname: Ohgino
authors.forename: Daisuke
authors.initials: D
authors.lastname: Arai
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Tani
authors.forename: Aoi
authors.initials: A
authors.lastname: Kuroda
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishino
authors.forename: Tomoko
authors.initials: T
authors.lastname: Betsuyaku
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / 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; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel