Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer
- Affiliated Author(s)
- 박건욱; 도영록; 송홍석; 김진영; 조윤경
- Alternative Author(s)
- Park, Keon Uk; Do, Young Rok; Song, Hong Suk; Kim, Jin Young; Cho, Yun Kyeong
- Journal Title
- Anticancer Research
- ISSN
- 0250-7005
- Issued Date
- 2017
- Keyword
- Biliary tract cancer; chemotherapy; gemcitabine; paclitaxel; polymeric micelle; clinical trial; phase II
- Abstract
- 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.
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