title: Pemetrexed versus erlotinib in pretreated patients with advanced non-small cell lung cancer: a Hellenic Oncology Research Group (HORG) randomized phase 3 study.
abstract: BACKGROUND
  In this superiority study, pemetrexed was compared with erlotinib in pre-treated patients with metastatic non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with stage IIIB/IV NSCLC who progressed after first-line or second-line treatment were randomized to receive either pemetrexed or erlotinib. In total, 21.7% of patients in the pemetrexed arm and 23.5% of patients in the erlotinib arm had squamous cell histology, and treatment was third line in 39.2% and 46.4% of patients, respectively. The primary study endpoint was time to tumor progression (TTP). Epidermal growth factor receptor/v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (EGFR/KRAS) mutation status also was investigated.
  
  
  RESULTS
  There was no difference in terms of the TTP (P = .195), the objective response rate (P = .469), or overall survival (P = .986) between the 2 treatment arms. In patients who had squamous cell histology, erlotinib resulted in a superior TTP compared with pemetrexed (4.1 months vs 2.5 months, respectively; P = .006). The incidence of grade 3 and 4 neutropenia, thrombocytopenia, and asthenia was significantly higher in the pemetrexed arm, whereas the incidence of grade 3 and 4 skin rash was higher in the erlotinib arm.
  
  
  CONCLUSIONS
  Both pemetrexed and erlotinib had comparable efficacy in pre-treated patients with metastatic NSCLC, and the current results indicated that genotyping of tumor cells may have an important effect on treatment efficacy.
authors: Medical Oncology Unit, 417 NIMTS Veterans Hospital, Athens, Greece.
authors: Athanasios
authors: A
authors: Karampeazis
authors: Alexandra
authors: A
authors: Voutsina
authors: John
authors: J
authors: Souglakos
authors: Nikos
authors: N
authors: Kentepozidis
authors: Stelios
authors: S
authors: Giassas
authors: Charalambos
authors: C
authors: Christofillakis
authors: Athanasios
authors: A
authors: Kotsakis
authors: Pavlos
authors: P
authors: Papakotoulas
authors: Ageliki
authors: A
authors: Rapti
authors: Maria
authors: M
authors: Agelidou
authors: Sofia
authors: S
authors: Agelaki
authors: Lambros
authors: L
authors: Vamvakas
authors: George
authors: G
authors: Samonis
authors: Dimitris
authors: D
authors: Mavroudis
authors: Vassilis
authors: V
authors: Georgoulias
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride; D005260:Female; D005493:Folic Acid Antagonists / Q000627:therapeutic use; D005971:Glutamates / Q000627:therapeutic use*; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D005493:Folic Acid Antagonists; D005971:Glutamates; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000068437:Pemetrexed; D006147:Guanine; D000069347:Erlotinib Hydrochloride
keywords: EGFR mutation; KRAS mutation; erlotinib; non-small cell lung cancer; pemetrexed; pretreated patients