Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer
| Autor: | Jin Ho Baek, Yee Soo Chae, Byung Woog Kang, Jin Young Kim, Min Kyoung Kim, Kyung Hee Lee, Hong Suk Song, Keon-Uk Park, Sung Hwa Bae, Yoon Young Cho, Jong Gwang Kim, Young Rok Do, Hun Mo Ryoo |
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| Rok vydání: | 2016 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Paclitaxel medicine.medical_treatment 02 engineering and technology Kaplan-Meier Estimate Neutropenia Gastroenterology Deoxycytidine Disease-Free Survival 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Aged Febrile Neutropenia Chemotherapy Biliary tract cancer business.industry Combination chemotherapy General Medicine Middle Aged 021001 nanoscience & nanotechnology medicine.disease Gemcitabine Clinical trial Biliary Tract Neoplasms Treatment Outcome chemistry 030220 oncology & carcinogenesis Disease Progression Female 0210 nano-technology business Febrile neutropenia medicine.drug |
| Zdroj: | Anticancer research. 37(3) |
| ISSN: | 1791-7530 |
| Popis: | This multicenter phase II clinical trial was designed to evaluate the efficacy and safety of weekly Genexol-PM® and gemcitabine combination chemotherapy in patients with unresectable or metastatic biliary tract cancer. Patients and methods Patients received 100 mg/m2 Genexol-PM® and 1,000 mg/m2 gemcitabine intravenously on days 1 and 8 every 21 days. Results Out of 39 patients, there were 10 partial responses (25.6%) and 18 with stable diseases (46.2%) were confirmed with median response duration 4.1 months. The median progression-free survival was 5.9±1.6 months and overall survival 11.9±1.4 months. The median number of cycles administered was 4.0 (range=1-10). Grade 3 or more neutropenia occurred in 12 patients (26.7%). The most common grade 3/4 non-hematological toxicities were febrile neutropenia (13.4%) and elevation of liver enzymes (6.7%). Conclusion Weekly Genexol-PM® combined with gemcitabine demonstrated sufficient antitumor activity to warrant further development when used as first-line chemotherapy for advanced biliary tract cancer. |
| Databáze: | OpenAIRE |
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