Docetaxel plus gemcitabine in combination with capecitabine as treatment for inoperable pancreatic cancer: a phase II study

• Published in: Cancer chemotherapy and pharmacology Vol. 69; no. 2; pp. 477 - 484
• Main Authors: Xenidis, N., Chelis, L., Amarantidis, K., Chamalidou, E., Dimopoulos, P., Courcoutsakis, N., Tentes, A., Chiotis, A., Prassopoulos, P., Kakolyris, S.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.02.2012; Springer; Springer Nature B.V
• Subjects: Administration, Oral; Adult; Aged; Anorexia - chemically induced; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Cancer Research; Capecitabine; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; Gastroenterology. Liver. Pancreas. Abdomen; Hand-Foot Syndrome - etiology; Humans; Kaplan-Meier Estimate; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Neutropenia - chemically induced; Oncology; Original Article; Pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pancreatic Neoplasms - pathology; Pharmacology. Drug treatments; Pharmacology/Toxicology; Prospective Studies; Treatment Outcome; Tumors; Phase II; Gemcitabine; Capecitabine; Pancreatic cancer; Docetaxel; Antineoplastic agent; Human; Drug combination; Fluoropyrimidine derivatives; Malignant tumor; Prodrug; Treatment; Antimetabolic; Taxane derivatives; Pancreas cancer; Phase II trial; Pyrimidine derivatives; Digestive diseases; Fluorine Organic compounds; Antimitotic; Pyrimidine nucleoside; Cancer; Pancreatic disease
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-011-1717-6

Purpose To evaluate the activity and tolerance of gemcitabine in combination with docetaxel and capecitabine in previously untreated patients with advanced pancreatic cancer. Patients and methods Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were treated with gemcitabine (1,500 mg/m 2 on days 1 and 15), docetaxel (50 mg/m 2 on days 1 and 15) and capecitabine (2,250 mg/m 2 , orally in two daily divided doses, on days 1–7 and 15–21). All three drugs were administered in 4-week cycles, in an initial prospective plan of six cycles. The primary end-point was response rate. Results Forty patients were enrolled in the study. At the time of enrollment, 40% of patients had locally advanced and 60% metastatic disease. All patients were evaluable for response and toxicity. On an intent-to-treat analysis, the overall response and disease control rates were 40 and 80%, respectively. The median progression-free survival was 6.0 months, and the median overall survival was 9.0 months. Major grade 3/4 toxicities were neutropenia (17.5%), diarrhea (10%) and hand-foot syndrome (7.5%). There was no treatment-related death. Conclusion The combination of gemcitabine with docetaxel and capecitabine is feasible and exhibits satisfactory degree of activity in patients with advanced pancreatic cancer, deserving further exploration.