title: A phase II study of pemetrexed in patients with previously heavily treated non-squamous non-small cell lung cancer (HANSHIN Oncology Group 001).
abstract: OBJECTIVE
  Pemetrexed has shown substantial activity in non-squamous non-small cell lung cancer (NSCLC) and is one of the current standard agents in second-line settings due to its efficacy and favorable tolerability profile. We conducted phase II study to evaluate the safety and efficacy of pemetrexed in Japanese patients with previously heavily treated, advanced non-squamous NSCLC.
  
  
  METHODS
  Patients with stage IIIB or IV non-squamous NSCLC, performance status (PS) 0-2, previous two to five regimens of chemotherapy were enrolled and received pemetrexed (500 mg/m(2)) on day 1 every 21 days until disease progression. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.
  
  
  RESULTS
  From August 2009 to May 2010, 46 patients were enrolled: median age 65 years; 52 % women; PS 0/1/2 26/67/7 %; previous treatment regimen 2/3/4/5 48/28/20/4 %; epidermal growth factor receptor activating mutation positive/wild/unknown 30/48/22 %. The median follow-up period was 13.5 months. The median number of treatment cycles was 4 (range 1-18 cycles). The median PFS was 5.2 months (95 % CI 3.0-5.8 months). The median OS was 14.4 months (95 % CI 9.4-21.3 months). The ORR was 8.7 % and DCR was 63.0 %. The grade 3/4 hematological adverse events include 8 patients with leukopenia, 11 with neutropenia, 5 with anemia, and 2 with thrombocytopenia. There were no reports of febrile neutropenia and no treatment-related death was observed.
  
  
  CONCLUSIONS
  Treatment with pemetrexed in previously heavily treated Japanese non-squamous NSCLC patients is feasible and shows encouraging activity.
authors.affiliation: Department of Thoracic Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi-shi, Hyogo, 673-8558, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Hattori
authors.forename: Miyako
authors.initials: M
authors.lastname: Satouchi
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Shiro
authors.initials: S
authors.lastname: Fujita
authors.forename: Reiko
authors.initials: R
authors.lastname: Kaji
authors.forename: Akito
authors.initials: A
authors.lastname: Hata
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Urata
authors.forename: Temiko
authors.initials: T
authors.lastname: Shimada
authors.forename: Junji
authors.initials: J
authors.lastname: Uchida
authors.forename: Keisuke
authors.initials: K
authors.lastname: Tomii
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D005971:Glutamates / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed
chemical_list: D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine