TY - JOUR T1 - Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer JF - Anticancer Research JO - Anticancer Res SP - 1467 LP - 1473 VL - 37 IS - 3 AU - JIN YOUNG KIM AU - YOUNG ROK DO AU - HONG SUK SONG AU - YOON YOUNG CHO AU - HUN MO RYOO AU - SUNG HWA BAE AU - JONG GWANG KIM AU - YEE SOO CHAE AU - BYUNG WOOG KANG AU - JIN HO BAEK AU - MIN KYOUNG KIM AU - KYUNG HEE LEE AU - KEONUK PARK Y1 - 2017/03/01 UR - http://ar.iiarjournals.org/content/37/3/1467.abstract N2 - 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. ER -