Bum Jun Kim1,2, Jaewon Hyung1, Changhoon Yoo3, Kyu-Pyo Kim1, Seong-Joon Park1, Sang Soo Lee4, Do Hyun Park4, Tae Jun Song4, Dong Wan Seo4, Sung Koo Lee4, Myung-Hwan Kim4, Jin-Hong Park5, Hyungwoo Cho1, Baek-Yeol Ryoo1, Heung-Moon Chang6. 1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. 2. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Seoul, Republic of Korea. 3. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. yooc@amc.seoul.kr. 4. Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 5. Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 6. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. changhm@amc.seoul.kr.
Abstract
PURPOSE: Biliary tract cancer (BTC) is a heterogeneous group of diseases comprising intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer. Although gemcitabine plus cisplatin (GEMCIS) was established as the standard first-line chemotherapy based on the ABC-02 trial, more data are needed to define the clinical course of BTC and its prognostic factors with the standard GEMCIS treatment. METHODS: Between April 2010 and June 2016, 740 patients with histologically documented cholangiocarcinoma and gallbladder cancer were treated with first-line GEMCIS in Asan Medical Center, Seoul, Korea. RESULTS: In 389 patients with measurable disease (53%), the objective response rate was 13% (n = 50) and there was no significant difference between primary tumor sites (p = 0.45). With a median follow-up duration of 27.3 months (95% CI 24.2-30.5), the median PFS and OS were 5.2 months (95% CI 4.7-5.6) and 10.4 months (95% CI 9.6-11.2), respectively. In multivariate analysis, male gender (female versus male, hazard ratio [HR] 0.83), baseline CA 19-9 level (elevated versus normal, HR 1.31), initially metastatic disease (versus locally advanced disease, HR 1.92), poor performance status (2 versus 0-1, HR 1.45), and measurable disease by RECIST criteria (versus non-measurable, HR 1.40) were significantly associated with a poorer OS (all p < 0.05). CONCLUSIONS: Our retrospective analysis of a large number of patients in a real-world setting found comparable efficacy outcomes to the ABC-02 trial. The prognostic factors identified here may help to predict clinical outcomes and design future clinical trials for advanced BTC.
PURPOSE:Biliary tract cancer (BTC) is a heterogeneous group of diseases comprising intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer. Although gemcitabine plus cisplatin (GEMCIS) was established as the standard first-line chemotherapy based on the ABC-02 trial, more data are needed to define the clinical course of BTC and its prognostic factors with the standard GEMCIS treatment. METHODS: Between April 2010 and June 2016, 740 patients with histologically documented cholangiocarcinoma and gallbladder cancer were treated with first-line GEMCIS in Asan Medical Center, Seoul, Korea. RESULTS: In 389 patients with measurable disease (53%), the objective response rate was 13% (n = 50) and there was no significant difference between primary tumor sites (p = 0.45). With a median follow-up duration of 27.3 months (95% CI 24.2-30.5), the median PFS and OS were 5.2 months (95% CI 4.7-5.6) and 10.4 months (95% CI 9.6-11.2), respectively. In multivariate analysis, male gender (female versus male, hazard ratio [HR] 0.83), baseline CA 19-9 level (elevated versus normal, HR 1.31), initially metastatic disease (versus locally advanced disease, HR 1.92), poor performance status (2 versus 0-1, HR 1.45), and measurable disease by RECIST criteria (versus non-measurable, HR 1.40) were significantly associated with a poorer OS (all p < 0.05). CONCLUSIONS: Our retrospective analysis of a large number of patients in a real-world setting found comparable efficacy outcomes to the ABC-02 trial. The prognostic factors identified here may help to predict clinical outcomes and design future clinical trials for advanced BTC.
Authors: Pedro Luiz Serrano Uson Junior; Umair Majeed; Jun Yin; Gehan Botrus; Mohamad Bassam Sonbol; Daniel H Ahn; Jason S Starr; Jeremy C Jones; Hani Babiker; Samantha R Inabinett; Natasha Wylie; Ashton W R Boyle; Tanios S Bekaii-Saab; Gregory J Gores; Rory Smoot; Michael Barrett; Bolni Nagalo; Nathalie Meurice; Natalie Elliott; Joachim Petit; Yumei Zhou; Mansi Arora; Chelsae Dumbauld; Oumar Barro; Alexander Baker; James Bogenberger; Kenneth Buetow; Aaron Mansfield; Kabir Mody; Mitesh J Borad Journal: JCO Precis Oncol Date: 2022-06
Authors: Rachna T Shroff; Milind M Javle; Lianchun Xiao; Ahmed O Kaseb; Gauri R Varadhachary; Robert A Wolff; Kanwal P S Raghav; Michiko Iwasaki; Peter Masci; Ramesh K Ramanathan; Daniel H Ahn; Tanios S Bekaii-Saab; Mitesh J Borad Journal: JAMA Oncol Date: 2019-06-01 Impact factor: 31.777
Authors: Julia S Johansen; Jesper B Andersen; Dan Høgdall; Colm J O'Rourke; Christian Dehlendorff; Ole F Larsen; Lars H Jensen; Astrid Z Johansen; Hien Dang; Valentina M Factor; Mie Grunnet; Morten Mau-Sørensen; Douglas V N P Oliveira; Dorte Linnemann; Mogens K Boisen; Xin W Wang Journal: Clin Cancer Res Date: 2020-09-15 Impact factor: 13.801