title: Continuous administration of daily low-dose temozolomide in pretreated patients with advanced non-small cell lung cancer: a phase II study.
abstract: OBJECTIVE
  Temozolomide, a novel triazene derivative, has shown activity in vitro against lung cancer as well as against brain metastases from a variety of solid tumors including non-small cell lung cancer (NSCLC). The aim of the study was to evaluate the efficacy and safety of temozolomide in pretreated patients with NSCLC.
  
  
  METHODS
  Thirty-one pretreated patients (median age 60 years) with histologically confirmed NSCLC were enrolled. Sixteen (52%) patients had a performance status (ECOG) of 0-1, 12 (39%) had pretreated brain metastases and 28 (90.3%) had received >2 lines of treatment. Temozolomide was administered at a dose of 75 mg/m(2) daily for 21 days every 28 days. A total of 73 chemotherapy cycles were administered.
  
  
  RESULTS
  In an intention-to-treat analysis, 2 patients (6.5%; 95% CI: -2.2 to 15.1%) achieved a partial response and 3 (10%) stable disease. The median time to progression was 2.4 months, the median survival time 3.3 months and the 1-year survival rate 22.5%. There was a toxic death due to grade 4 neutropenia. Grade 3 and 4 lymphopenia occurred in 4 (13%) and 2 (6%) patients, respectively. Nonhematological toxicity was mild, consisting of grade 2-3 asthenia (n = 14 patients) and grade 3 diarrhea (n = 1 patient).
  
  
  CONCLUSIONS
  Prolonged low daily doses of temozolomide demonstrate minimal activity as salvage therapy in patients with advanced NSCLC. The combination of low daily doses of temozolomide with other anticancer drugs probably merits further evaluation.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Greece.
authors.forename: Charalambos
authors.initials: C
authors.lastname: Kouroussis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Antonia
authors.initials: A
authors.lastname: Kalykaki
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Zacharenia
authors.initials: Z
authors.lastname: Saridaki
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: Stelios
authors.initials: S
authors.lastname: Giassas
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy; D000077204:Temozolomide; D013997:Time Factors; D016896:Treatment Outcome; D014227:Triazines / Q000737:chemistry
chemical_list: D000970:Antineoplastic Agents; D014227:Triazines; D003606:Dacarbazine; D000077204:Temozolomide