title: A phase II study of pemetrexed in chemotherapy-naive elderly patients aged ≥ 75 years with advanced non-squamous non-small-cell lung cancer (HANSHIN Oncology Group 003).
abstract: OBJECTIVE
  Pemetrexed has relatively mild toxicity and possibly can be administered long term to patients with non-small-cell lung cancer. We conducted a Phase II trial to evaluate the efficacy and safety of pemetrexed in chemotherapy-naïve elderly patients with advanced non-squamous non-small-cell lung cancer.
  
  
  METHODS
  In this multicenter Phase II trial, we recruited elderly patients with non-squamous non-small-cell lung cancer. Patients with previously untreated Stage IIIB or IV non-squamous non-small-cell lung cancer, ≥75 years, Eastern Cooperative Oncology Group performance status 0-1 and adequate organ functions were eligible. Patients received pemetrexed (500 mg/m(2)) intravenously on Day 1 every 3 weeks until disease progression. The primary endpoint was objective response rate.
  
  
  RESULTS
  Forty-seven patients were enrolled from August 2009 to July 2011, and 46 patients were eligible. The median age was 79 years (range 75-91 years), 57% were males, 37% had never smoked, 87% had adenocarcinoma, 74% had Stage IV and 33% had epidermal growth factor receptor tyrosine kinase-activating mutation. The median number of cycles was 4 (1-20). The objective response rate was 13.3% (95% confidence interval; 5.1-26.8%), the disease control rate was 66.7% (95% confidence interval 51.0-80.0%), the median progression-free survival was 4.9 months (95% confidence interval 3.0-6.1 months) and the median overall survival was 18.2 months (95% confidence interval 13.2-23.5 months). One Grade 5 infection (pneumonia) was observed.
  
  
  CONCLUSIONS
  This study did not meet the primary endpoint. Pemetrexed monotherapy is not recommended in chemotherapy-naïve elderly patients aged ≥75 years with advanced non-squamous non-small-cell lung cancer.
authors.affiliation: *Department of Thoracic Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi-shi, Hyogo 673-8558, Japan. satouchi@hp.pref.hyogo.jp.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Hattori
authors.forename: Masahiro
authors.initials: M
authors.lastname: Iwasaku
authors.forename: Miyako
authors.initials: M
authors.lastname: Satouchi
authors.forename: Akihiro
authors.initials: A
authors.lastname: Nishiyama
authors.forename: Yohei
authors.initials: Y
authors.lastname: Korogi
authors.forename: Kojiro
authors.initials: K
authors.lastname: Otsuka
authors.forename: Shiro
authors.initials: S
authors.lastname: Fujita
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Masahide
authors.initials: M
authors.lastname: Mori
authors.forename: Kazumi
authors.initials: K
authors.lastname: Nishino
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D066246:ErbB Receptors / Q000378:metabolism; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009154:Mutation; D009367:Neoplasm Staging; D000068437:Pemetrexed; D011505:Protein-Tyrosine Kinases / Q000235:genetics; D013921:Thrombocytopenia / Q000139:chemically induced; D017211:Treatment Failure
chemical_list: D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D066246:ErbB Receptors; D011505:Protein-Tyrosine Kinases
keywords: Phase II study; chemotherapy-naïve; elderly; non-small-cell lung cancer; pemetrexed