title: BAYPAN study: a double-blind phase III randomized trial comparing gemcitabine plus sorafenib and gemcitabine plus placebo in patients with advanced pancreatic cancer.
abstract: BACKGROUND
  Sorafenib is an oral anticancer agent targeting Ras-dependent signaling and angiogenic pathways. A phase I trial demonstrated that the combination of gemcitabine and sorafenib was well tolerated and had activity in advanced pancreatic cancer (APC) patients. The BAYPAN study was a multicentric, placebo-controlled, double-blind, randomized phase III trial comparing gemcitabine/sorafenib and gemcitabine/placebo in the treatment of APC.
  
  
  METHODS
  The patient eligibility criteria were locally advanced or metastatic pancreatic adenocarcinoma, no prior therapy for advanced disease and a performance status of zero to two. The primary end point was progression-free survival (PFS). The patients received gemcitabine 1000 mg/m(2) i.v., weekly seven times followed by 1 rest week, then weekly three times every 4 weeks plus sorafenib 200 mg or placebo, two tablets p.o., twice daily continuously.
  
  
  RESULTS
  Between December 2006 and September 2009, 104 patients were enrolled on the study (52 pts in each arm) and 102 patients were treated. The median and the 6-month PFS were 5.7 months and 48% for gemcitabine/placebo and 3.8 months and 33% for gemcitabine/sorafenib (P = 0.902, stratified log-rank test), respectively. The median overall survivals were 9.2 and 8 months, respectively (P = 0.231, log-rank test). The overall response rates were similar (19 and 23%, respectively).
  
  
  CONCLUSIONS
  The addition of sorafenib to gemcitabine does not improve PFS in APC patients.
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille. Electronic address: goncalvesa@marseille.fnclcc.fr.
authors: A
authors: A
authors: Gonçalves
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.
authors: M
authors: M
authors: Gilabert
authors: Department of Medical Oncology, Centre Antoine Lacassagne, Nice.
authors: E
authors: E
authors: François
authors: Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille; Department of Digestive Oncology, Hôpital de le Timone, Assistance Publique-Hôpitaux de Marseille, Marseille.
authors: L
authors: L
authors: Dahan
authors: Digestive Oncology Unit, Hôpital Saint-Joseph, Marseille.
authors: H
authors: H
authors: Perrier
authors: Department of Oncology, Centre Hospitalier Bretagne Sud (Lorient), Lorient.
authors: R
authors: R
authors: Lamy
authors: Medicine Unit, Centre Hospitalier Antibes Juan-les-Pins, Antibes.
authors: D
authors: D
authors: Re
authors: Department of Oncology, Centre azuréen de cancérologie, Mougins.
authors: R
authors: R
authors: Largillier
authors: Department of Gastro-enterology, Hôpital Nord APHM, Marseille.
authors: M
authors: M
authors: Gasmi
authors: Department of Medical Oncology, Centre Hospitalier Toulon, Toulon, France.
authors: X
authors: X
authors: Tchiknavorian
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Clinical Investigation Center 9502, Marseille.
authors: B
authors: B
authors: Esterni
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Clinical Investigation Center 9502, Marseille.
authors: D
authors: D
authors: Genre
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.
authors: L
authors: L
authors: Moureau-Zabotto
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.
authors: M
authors: M
authors: Giovannini
authors: Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille; Department of Digestive Oncology, Hôpital de le Timone, Assistance Publique-Hôpitaux de Marseille, Marseille.
authors: J-F
authors: JF
authors: Seitz
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille.
authors: J-R
authors: JR
authors: Delpero
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille.
authors: O
authors: O
authors: Turrini
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille.
authors: P
authors: P
authors: Viens
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258.
authors: J-L
authors: JL
authors: Raoul
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D000077157:Sorafenib; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D010919:Placebos; D047428:Protein Kinase Inhibitors; D003841:Deoxycytidine; D009536:Niacinamide; D000077157:Sorafenib; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine