title: Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer.
abstract: BACKGROUND
  This study prospectively evaluated the efficacy and safety of pemetrexed and carboplatin followed by maintenance pemetrexed in chemo-naïve patients with advanced nonsquamous non-small cell lung cancer (NSCLC).
  
  
  METHODS
  A total of 109 patients received pemetrexed (500 mg/m(2)) and carboplatin (area under the curve = 6 mg/mL·min) every 21 days. For patients without disease progression after 4 cycles, pemetrexed was continued until disease progression or unacceptable toxicity. Pre-planned subgroup analysis results based on the presence of epidermal growth factor receptor (EGFR) mutations are also presented.
  
  
  RESULTS
  The median number of treatment cycles was 5 (range: 1-30) in the entire study period. Most of the grade ≥ 3 toxicities observed were hematologic in nature, with no increase in the relative incidence associated with continuation maintenance therapy with pemetrexed. Among the 106 total patients assessable for efficacy, the objective response rate was 35.8 %, median progression free survival (PFS) 5.7 months, and median overall survival (OS) 20.2 months. Sixty patients received maintenance pemetrexed (median: 4 cycles, range: 1-26 cycles); median PFS from the beginning of induction treatment was 7.5 months. From the subgroup analysis for EGFR mutation status, the median OS of EGFR wild-type patients (n=61) was 20.2 months.
  
  
  CONCLUSIONS
  Pemetrexed/carboplatin followed by pemetrexed was well tolerated and active for front-line treatment of advanced nonsquamous NSCLC. Encouraging survival outcomes were observed even in EGFR-wild type patients.
authors.affiliation: Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan, chi-okamoto@dotd.med.kindai.ac.jp.
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Keisuke
authors.initials: K
authors.lastname: Aoe
authors.forename: Terufumi
authors.initials: T
authors.lastname: Kato
authors.forename: Yukio
authors.initials: Y
authors.lastname: Hosomi
authors.forename: Akira
authors.initials: A
authors.lastname: Yokoyama
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.forename: Hideo
authors.initials: H
authors.lastname: Saka
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Naoto
authors.initials: N
authors.lastname: Yoshizuka
authors.forename: Risa
authors.initials: R
authors.lastname: Sekiguchi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kiyosawa
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068437:Pemetrexed; D016896:Treatment Outcome
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D016190:Carboplatin