title: Phase II study of nedaplatin and irinotecan followed by gefitinib for elderly patients with unresectable non-small cell lung cancer.
abstract: OBJECTIVE
  We conducted a phase II study of combination chemotherapy with nedaplatin (NP) and irinotecan (CPT) followed by gefitinib to determine the effects and toxicities in patients 70 years or older with unresectable non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients were entered to receive 3 courses of 50 mg/m(2) NP and 60 mg/m(2) CPT on days 1 and 8 every 4 weeks and sequential gefitinib 250 mg po once a day was followed until tumor progression.
  
  
  RESULTS
  Twenty-eight patients received NP and CPT combination chemotherapy. One patient achieved CR, 10 PR, 14 SD and 3 PD, and the response rate was 39.3%. Twenty-one patients received gefitinib 250 mg per day until tumor progression after completion of the NP and CPT chemotherapy. Two patients with SD after NP and CPT chemotherapy achieved PR. For the 3-drug combination, there were 13 responders and the overall response rate was 42.9%. Of the toxicities associated with NP and CPT chemotherapy, grade 4 neutropenia, and grade 3 febrile neutropenia were observed in 24 (33.8%) and 3 (4.2%) courses, respectively. Of the toxicities associated with gefitinib treatment, grade 3 anemia, and SGOT and SGPT elevation were observed in one patient (4.8%) each, respectively. The median survival time was 8.7 months, and the 1- and 2-year survival rates were 42.9 and 32.1%, respectively.
  
  
  CONCLUSIONS
  NP and CPT followed by gefitinib is feasible for elderly patients with unresectable NSCLC.
authors.affiliation: Department of Thoracic Oncology, Kanagawa Cancer Center, Nakao 1-1-2, Asahi-ku, Yokohama, Japan. foshita@kcch.jp
authors.forename: Fumihiro
authors.initials: F
authors.lastname: Oshita
authors.forename: Kouzo
authors.initials: K
authors.lastname: Yamada
authors.forename: Haruhiro
authors.initials: H
authors.lastname: Saito
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Noda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D000077156:Gefitinib; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D009944:Organoplatinum Compounds; D011799:Quinazolines; D000077146:Irinotecan; C053989:nedaplatin; D000077156:Gefitinib; D002166:Camptothecin