title: Phase II study of gefitinib readministration in patients with advanced non-small cell lung cancer and previous response to gefitinib.
abstract: OBJECTIVE
  Salvage treatment for acquired resistance to gefitinib has yet to be developed. We conducted the first prospective phase II study of gefitinib readministration in previous gefitinib responders.
  
  
  METHODS
  Gefitinib (250 mg/day) was readministered to patients with advanced/metastatic non-small cell lung cancer who had achieved objective response to initial gefitinib and subsequently received cytotoxic chemotherapy after disease progression with initial gefitinib. The primary endpoint was the objective response rate with gefitinib readministration. Secondary endpoints were disease control rate, progression-free survival (PFS), overall survival (OS), quality of life, and toxicity. Changes in lung cancer-related symptoms were evaluated using the seven-item lung cancer subscale of the questionnaire.
  
  
  RESULTS
  Sixteen patients were enrolled between February 2005 and January 2008. Most had received ≥3 regimens of chemotherapy. Response and disease-control rates for all patients were 0 and 44%. Median PFS and OS were 2.5 and 14.7 months, respectively. Four of 7 patients with stable disease experienced a long duration (≥6 months) of disease control without severe toxicity. Symptom improvement was observed in 2 of 12 patients (17%) for whom quality of life was evaluable.
  
  
  CONCLUSIONS
  Gefitinib represents a useful therapeutic option for selected previous gefitinib responders.
authors.affiliation: First Department of Medicine, Hokkaido University School of Medicine, Kita-ku, Sapporo, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Asahina
authors.forename: Satoshi
authors.initials: S
authors.lastname: Oizumi
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kinoshita
authors.forename: Takashi
authors.initials: T
authors.lastname: Ishida
authors.forename: Yuka
authors.initials: Y
authors.lastname: Fujita
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sukoh
authors.forename: Masao
authors.initials: M
authors.lastname: Harada
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Saijo
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Dosaka-Akita
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Isobe
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
authors.forename: Masaharu
authors.initials: M
authors.lastname: Nishimura
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib