Jin Young Kim1,2, Young Rok Do1, Hong Suk Song1, Yoon Young Cho3, Hun Mo Ryoo3, Sung Hwa Bae3, Jong Gwang Kim4, Yee Soo Chae4, Byung Woog Kang4, Jin Ho Baek5, Min Kyoung Kim6, Kyung Hee Lee6, Keonuk Park7. 1. Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea. 2. Pain Research Center, School of Medicine, Keimyung University, Daegu, Republic of Korea. 3. Division of Hematology/Oncology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Republic of Korea. 4. Division of Hematology/Oncology, Department of Internal Medicine, Kyungpook National University Medical Center, Daegu, Republic of Korea. 5. Division of Hematology/Oncology, Department of Internal Medicine, Ulsan University Hospital, Ulsan, Republic of Korea. 6. Division of Hematology/Oncology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea. 7. Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea keonukpark@gmail.com.
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. Copyright
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. Copyright
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