Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial
| Autor: | Löhr, J. M., Haas, S. L., Bechstein, W. O., Bodoky, G., Cwiertka, K., Fischbach, W., Fölsch, U. R., Jäger, Dieter, Osinsky, D., Prausova, J., Schmidt, W. E., Lutz, M. P., CT4001 Study Group |
|---|---|
| Přispěvatelé: | Gauler, Thomas (Beitragende*r) |
| Rok vydání: | 2011 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty endocrine system diseases Paclitaxel Medizin Phases of clinical research Deoxycytidine Models Biological law.invention chemistry.chemical_compound Randomized controlled trial law Internal medicine Pancreatic cancer Cations Antineoplastic Combined Chemotherapy Protocols medicine Humans Progression-free survival Elektrotechnik Aged Neoplasm Staging Aged 80 and over Dosage Forms business.industry Carcinoma Hematology Middle Aged medicine.disease Chemotherapy regimen Survival Analysis Gemcitabine Pancreatic Neoplasms chemistry Liposomes Disease Progression Chills Female medicine.symptom business medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 23(5) |
| ISSN: | 1569-8041 |
| Popis: | 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). Patients and methods Chemotherapy-naive patients with locally advanced or metastatic disease were randomly assigned to receive weekly GEM 1000 mg/m2 or GEM plus twice-weekly ET 11, 22 or 44 mg/m2 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|