title: Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial.
abstract: BACKGROUND
  Paclitaxel embedded in cationic liposomes (EndoTAG™-1; ET) is an innovative agent targeting tumor endothelial cells. This randomized controlled phase II trial evaluated the safety and efficacy of ET in combination with gemcitabine (GEM) in advanced pancreatic cancer (PDAC).
  
  
  METHODS
  Chemotherapy-naive patients with locally advanced or metastatic disease were randomly assigned to receive weekly GEM 1000 mg/m(2) or GEM plus twice-weekly ET 11, 22 or 44 mg/m(2) for 7 weeks. After a safety run-in of 100 patients, a second cohort continued treatment. End points included overall survival (OS), progression-free survival (PFS), tumor response and safety.
  
  
  RESULTS
  Two hundred and twelve patients were randomly allocated to the study and 200 were treated (80% metastatic, 20% locally advanced). Adverse events were manageable and reversible. Transient thrombocytopenia and infusion reactions with chills and pyrexia mostly grade 1 or 2 occurred in the ET groups. Disease control rate after the first treatment cycle was 43% with GEM and 60%, 65% and 52% in the GEM + ET cohorts. Median PFS reached 2.7 compared with 4.1, 4.6 and 4.4 months, respectively. Median OS was 6.8 compared with 8.1, 8.7 and 9.3 months, respectively.
  
  
  CONCLUSIONS
  Treatment of advanced PDAC with GEM + ET was generally well tolerated. GEM + ET showed beneficial survival and efficacy. A randomized phase III trial should confirm this positive trend.
authors: Department of Medicine II, University Hospital Mannheim, Mannheim, Germany; Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden. Electronic address: matthias.lohr@ki.se.
authors: J M
authors: JM
authors: Löhr
authors: Department of Medicine II, University Hospital Mannheim, Mannheim, Germany; Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden.
authors: S L
authors: SL
authors: Haas
authors: Department of General and Visceral Surgery, University Hospital Frankfurt, Frankfurt/Main, Germany.
authors: W-O
authors: WO
authors: Bechstein
authors: Department of Oncology, Szent Laszlo Hospital, Budapest, Hungary.
authors: G
authors: G
authors: Bodoky
authors: Department of Oncology, University Hospital Olomouc, Olomouc, Czech Republic.
authors: K
authors: K
authors: Cwiertka
authors: Department of Medicine II, Klinikum Aschaffenburg, Aschaffenburg.
authors: W
authors: W
authors: Fischbach
authors: Department of General Internal Medicine, University Hospital Schleswig-Holstein, Kiel.
authors: U R
authors: UR
authors: Fölsch
authors: Department of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.
authors: D
authors: D
authors: Jäger
authors: Institute of Oncology AMS of Ukraine, Kiev, Ukraine.
authors: D
authors: D
authors: Osinsky
authors: Department of Oncological Radiotherapy, University Hospital Prague, Prague, Czech Republic.
authors: J
authors: J
authors: Prausova
authors: Department of Medicine I, St. Josef-Hospital, Ruhr-University, Bochum.
authors: W E
authors: WE
authors: Schmidt
authors: Department of Medicine, Caritasklinik St. Theresia, Saarbrücken, Germany.
authors: M P
authors: MP
authors: Lutz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002412:Cations; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D002412:Cations; D004304:Dosage Forms; D008081:Liposomes; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine