title: Retrospective efficacy and safety analyses of erlotinib, pemetrexed, and docetaxel in EGFR-mutation-negative patients with previously treated advanced non-squamous non-small-cell lung cancer.
abstract: OBJECTIVE
  Several guidelines recommend erlotinib, pemetrexed, or docetaxel for second-line chemotherapy in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The aim of this study was to retrospectively evaluate the efficacy of erlotinib, pemetrexed, and docetaxel in epidermal growth factor receptor (EGFR) mutation-negative patients with previously treated advanced non-squamous NSCLC.
  
  
  METHODS
  We analyzed the efficacy of these agents in patients with previously treated advanced non-squamous NSCLC who had EGFR wild-type tumors, performance status (PS) of 0, 1, or 2 and received erlotinib, pemetrexed, or docetaxel between December 2007 and September 2011. Variability among patient backgrounds was evaluated using propensity scores to assess comparability. The efficacy of these agents was evaluated in patient subgroups with low variability.
  
  
  RESULTS
  The propensity scores showed that the backgrounds of the groups that received second-line therapy with each agent had low variability and were adequate for comparison. Patients were divided into the PS0/1 and PS2 groups for analysis. The median progression-free survival (PFS) in patients treated with erlotinib was 2.8 months in the PS0/1 group, as compared with 1.0 month in the PS0/1/2 group and 0.90 months in the PS2 group. PFS in PS0/1 patients who received erlotinib was comparable to that in PS0/1 patients who received pemetrexed (2.5 months) or docetaxel (1.9 months). Overall survival (OS) in erlotinib-, pemetrexed-, and docetaxel-treated PS0/1 patients was 16.1, 7.4 and 10.0 months, respectively. The study had limited power to detect differences in PFS and OS because of the small sample size.
  
  
  CONCLUSIONS
  Erlotinib appears to be a useful second-line option in PS0/1 patients with EGFR mutation-negative advanced non-squamous NSCLC given its mild adverse effects. The results should be carefully interpreted because of the small sample size, limited power, and retrospective nature of the study.
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Nishiyama
authors.affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Japan. Electronic address: kabu568459@yahoo.co.jp.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Japan.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Iwasaku
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Korogi
authors.affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Japan.
authors.forename: Akito
authors.initials: A
authors.lastname: Hata
authors.affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Japan.
authors.forename: Jumpei
authors.initials: J
authors.lastname: Takeshita
authors.affiliation: Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Japan.
authors.forename: Kojiro
authors.initials: K
authors.lastname: Otsuka
authors.affiliation: Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: Kazumi
authors.initials: K
authors.lastname: Nishino
authors.affiliation: Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Uchida
authors.affiliation: Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: Takako
authors.initials: T
authors.lastname: Okuyama
authors.affiliation: Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Namba
authors.affiliation: Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Japan.
authors.forename: Masahide
authors.initials: M
authors.lastname: Mori
authors.affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Fujita
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D000077143:Docetaxel; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D000068437:Pemetrexed / Q000008:administration & dosage; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000068437:Pemetrexed; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors
keywords: Docetaxel; EGFR mutation-negative; Erlotinib; Non-squamous non-small-cell lung cancer; Pemetrexed; Performance status; Second-line treatment