title: Tolerability and efficacy of afatinib at a low starting dosage in 10 elderly or low performance status patients with advanced refractory non-small-cell lung cancer.
abstract: BACKGROUND
  Whether a full dosage of afatinib is tolerable and effective for elderly or low performance status (PS) patients with advanced refractory non-small-cell lung cancer (NSCLC) is unclear.
  
  
  METHODS
  We retrospectively evaluated the tolerability and efficacy of afatinib in 10 patients (the majority elderly) with a low PS score (2 or 3), who had advanced refractory adenocarcinoma and were carrying active epidermal growth factor receptor mutations. Afatinib was administered at a starting dosage of 20 or 30mg/day, followed by 10mg increases in dose up to a maximum dosage of 40mg/day.
  
  
  RESULTS
  The median patient age was 76 years and 50% of the patients had a PS of 3. The patients had previously been treated with gefitinib and/or erlotinib, with a median number of three chemotherapy regimens. All the patients received at least 30mg/day of afatinib. Eight patients did not receive the 40mg/day dosage because of patient refusal due to grade 2 diarrhea (n=6) or the judgment of the doctor (n=2). One patient discontinued the treatment because of drug-induced interstitial lung disease. The most frequent adverse event was grade 2 diarrhea. The objective response rate was 11% and the PS score of five cases improved after afatinib therapy. The median progression-free survival and overall survival periods were 3.6 months and 5.8 months, respectively.
  
  
  CONCLUSIONS
  A low starting dosage of afatinib might enable elderly or low PS patients with advanced refractory NSCLC to receive this drug as salvage therapy.
authors.affiliation: Department of Respiratory Medicine, Kumamoto Regional Medical Center, 5-16-10 hon-jo, Kumamoto, 860-0811, Japan. Electronic address: kskkswbr@krmc.or.jp.
authors.forename: Kosuke
authors.initials: K
authors.lastname: Kashiwabara
authors.affiliation: Department of Respiratory Medicine, Kumamoto Regional Medical Center, 5-16-10 hon-jo, Kumamoto, 860-0811, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Semba
authors.affiliation: Department of Respiratory Medicine, Kumamoto Regional Medical Center, 5-16-10 hon-jo, Kumamoto, 860-0811, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Fujii
authors.affiliation: Department of Respiratory Medicine, Kumamoto Regional Medical Center, 5-16-10 hon-jo, Kumamoto, 860-0811, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Tsumura
mesh_terms: D000077716:Afatinib; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D006801:Humans; D050152:Intra-Abdominal Fat; D017563:Lung Diseases, Interstitial / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D011799:Quinazolines; D011838:Radiation-Sensitizing Agents; D000077716:Afatinib; D066246:ErbB Receptors
keywords: Diarrhea; Elderly; Low performance status; Low starting dosage