title: Frontline treatment with gemcitabine, oxaliplatin and erlotinib for the treatment of advanced or metastatic pancreatic cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG).
abstract: OBJECTIVE
  Intravenous gemcitabine is the standard of care for patients with metastatic cancer of the pancreas. Gemcitabine-based chemotherapy combinations, either doublets or triplets, have been tested in the past but have offered a small advantage (Brodoefel et al. in Eur J Radiol 73:594-600, 2010). In the present study, we present the results of the triplet gemcitabine-oxaliplatin-erlotinib combination as firstline treatment in this setting.
  
  
  METHODS
  Seventy-one eligible patients were included in this study. All patients received chemotherapy with gemcitabine (1,100 mg/m(2) on days 1 and 8) plus oxaliplatin (130 mg/m(2) on day 8) and erlotinib (100 mg p.o./day for 21 days). The treatment cycle was 21 days.
  
  
  RESULTS
  Partial response was achieved in 15 patients (21%; 95% CI 11.63-30.62) and stable disease in 15 patients (21%). Forty-one patients (57.8%) experienced disease progression. Median progression-free survival was 5.2 months (range 0.6-34.7; 95% CI 3.71-6.76). The median overall survival was 10.5 months (95% CI 7.39-13.61) and the 1-year survival estimate 47.3%. The main adverse events were grade 3/4 anemia occurring in three (4.2%) patients and grade 3 and 4 thrombocytopenia occurring in eight (11.3%) and three (4.2%) patients, respectively. Grade 4 neutropenia was rare (1.4%), and one patient presented febrile neutropenia.
  
  
  CONCLUSIONS
  This study demonstrated that the combination of gemcitabine, oxaliplatin and erlotinib is active, well tolerated and safe for patients with metastatic adenocarcinoma of the pancreas. However, the results do not seem to be better than those reported with chemotherapy alone.
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lombardou Str., 11470, Athens, Greece, okatopod@otenet.gr.
authors.forename: O
authors.initials: O
authors.lastname: Katopodis
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.forename: E
authors.initials: E
authors.lastname: Stathopoulos
authors.forename: A
authors.initials: A
authors.lastname: Christopoulou
authors.forename: E
authors.initials: E
authors.lastname: Kontopodis
authors.forename: A
authors.initials: A
authors.lastname: Kotsakis
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: N
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: A
authors.initials: A
authors.lastname: Polyzos
authors.forename: D
authors.initials: D
authors.lastname: Hatzidaki
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069347:Erlotinib Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011379:Prognosis; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D011799:Quinazolines; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine