A Phase II Study of Biweekly Cisplatin, Fixed-Dose-Rate Gemcitabine and Infusional 5-Fluorouracil in Patients With Metastatic Pancreatic and Biliary Cancers
| Autor: | Edward J. Kim, Elizabeth J. Davis, Mark M. Zalupski, Kevin McDonnell, Kent A. Griffith, Joshua M. Ruch |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Cancer Research medicine.medical_treatment Phases of clinical research Gastroenterology Deoxycytidine 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols 030212 general & internal medicine Neoplasm Metastasis Infusions Intravenous Cancer Middle Aged Prognosis Biliary Tract Neoplasms Treatment Outcome Oncology Fluorouracil 6.1 Pharmaceuticals 030220 oncology & carcinogenesis Female Drug Intravenous medicine.drug Adult Infusions medicine.medical_specialty Clinical Trials and Supportive Activities Neutropenia Adenocarcinoma Risk Assessment Disease-Free Survival Drug Administration Schedule Article Dose-Response Relationship Pancreatic Cancer 03 medical and health sciences Rare Diseases Clinical Research Internal medicine Pancreatic cancer medicine Humans Neoplasm Invasiveness Oncology & Carcinogenesis Aged Neoplasm Staging Chemotherapy Dose-Response Relationship Drug business.industry Patient Selection Evaluation of treatments and therapeutic interventions medicine.disease Survival Analysis Gemcitabine Pancreatic Neoplasms Regimen Orphan Drug Dentistry Cisplatin Digestive Diseases business Progressive disease |
| Zdroj: | American journal of clinical oncology, vol 41, iss 2 |
| ISSN: | 1537-453X |
| Popis: | Objectives Combinations of gemcitabine, 5-fluorouracil (5-FU), and platinum have demonstrated improved outcomes compared with singlet chemotherapy in pancreatic and biliary cancers. This phase II study examined efficacy and safety of a novel schedule of cisplatin, fixed-dose-rate gemcitabine and infusional 5-FU. Materials and methods Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received 1 cytotoxic regimen for advanced disease, were treated with gemcitabine 1000 mg/m intravenously (IV) over 100 minutes, cisplatin 35 mg/m IV over 30 minutes, and 5-FU 2400 mg/m IV over 48 hours on day 1 of a 14-day cycle. Patients were treated until disease progression or for 12 cycles. After 12 cycles, patients with stable or responding disease could continue gemcitabine and 5-FU. The primary endpoint was objective response. Results Thirty-nine patients were treated: 8 with biliary cancer (all untreated) and 31 with pancreatic cancer (17 untreated, 14 previously treated). Best response in 25 untreated patients was partial response in 40%, stable disease in 40%, and progressive disease in 20%. In 14 previously treated pancreatic patients, best response was partial response in 7%, stable disease in 50%, and progressive disease in 43%. Median overall survival in untreated patients was 10.3 versus 4.9 months in previously treated patients. Adverse events were primarily uncomplicated hematologic toxicity, ≥grade 3 neutropenia (54%), anemia (21%), and thrombocytopenia (13%). Conclusion Biweekly cisplatin, fixed-dose-rate gemcitabine, and infusional 5-FU demonstrated a high response rate and were well tolerated, encouraging further investigation of this regimen in metastatic pancreatic and biliary cancers. |
| Databáze: | OpenAIRE |
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