Gebra Cuyun Carter, Anna Kaltenboeck, Jasmina Ivanova, Astra M. Liepa, Alexandra San Roman, Maria Koh, Narayan Rajan, Rebecca Cheng, Howard G. Birnbaum, Jong Seok Kim, Yung-Jue Bang
Cancer Res Treat. 2017;49(3):578-587. Published online September 12, 2016
Purpose
The purpose of this study was to understand patient treatment patterns, outcomes, and healthcare resource use in cases of metastatic and/orlocally recurrent, unresectable gastric cancer (MGC) in South Korea.
Materials and Methods
Thirty physicians reviewed charts of eligible patients to collect de-identified data. Patients must have received platinum/fluoropyrimidine first-line therapy followed by second-line therapy or best supportive care, had no other primary cancer, and not participated in a clinical trial following MGC diagnosis. Data were summarized using descriptive statistics. Kaplan-Meier analysis was used to describe survival.
Results
Of 198 patients, 73.7% were male, 78.3% were diagnosed with MGC after age 55 (mean, 61.3 years), and 47.0% were current orformer smokers. The majority of tumorswere located in the antrum/pylorus (51.5%). Metastatic sites most often occurred in the peritoneum (53.5%), lymph nodes (47.5%), and liver (38.9%). At diagnosis, the mean Charlson comorbidity indexwas 0.4 (standard deviation, 0.6). The most common comorbiditieswere chronic gastritis (22.7%) and cardiovascular disease (18.7%). Most patients (80.3%) received second-line treatment. Single-agent fluoropyrimidine was reported for 22.0% of patients, while 19.5% were treated with irinotecan and a fluoropyrimidine or platinum agent. The most common physician-reported symptoms during second-line treatment were nausea/vomiting (44.7%) and pain (11.3%), with antiemetics (44.7%), analgesics (36.5%), and nutritional support (11.3%) most often used as supportive care. Two-thirds of inpatient hospitalizations were for chemotherapy infusion. Outpatient hospitalization (31.6%) and visits to the oncologist (58.8%) were common among second-line patients.
Conclusion
Most patients received second-line treatment, although regimens varied. Understanding MGC patient characteristics and treatment patterns in South Korea will help address unmet needs.
Citations
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Purpose
We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexed-cisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status.
Materials and Methods
Patients, who were ≥ 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment-emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials. gov, NCT01017874.
Results
Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ≥ 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFRmutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients.
Conclusion
Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients,
regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit
from gefitinib monotherapy.
Citations
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Gefitinib for advanced non-small cell lung cancer Esther HA Sim, Ian A Yang, Richard Wood-Baker, Rayleen V Bowman, Kwun M Fong Cochrane Database of Systematic Reviews.2018;[Epub] CrossRef
Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC). We conducted a systematic review in order to collate this evidence and assess whether gemcitabine-cisplatin efficacy is influenced by primary tumor site, disease stage, or geographic region, and whether associated toxicities are related to regimen. MEDLINE (1946-search date), EMBASE (1966-search date), ClinicalTrials. gov (2008-search date), and abstracts from major oncology conferences (2009- search date) were searched (5 Dec 2013) using terms for BTC, gemcitabine, and cisplatin. All study types reporting efficacy (survival, response rates) or safety (toxicities) outcomes of gemcitabine-cisplatin in BTC were eligible for inclusion; efficacy data were extracted from prospective studies only. Evidence retrieved from one meta-analysis (abstract), four randomized controlled trials, 12 nonrandomized prospective studies, and three retrospective studies supported the efficacy and safety of gemcitabine-cisplatin for BTC. Median overall survival ranged from 4.6 to 11.7 months, and response rate ranged from 17.1% to 36.6%. Toxicities were generally acceptable and manageable. Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other). Incidence of grade 3/4 toxicities was not related to gemcitabine dose or cisplatin frequency. Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics. No substantial differences in toxicity were observed among the different dosing schedules of gemcitabine and cisplatin.
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NUC-1031 in biliary tract cancer: from bench to bedside and back? Lenka N. C. Boyd, Godefridus J. Peters, Geert Kazemier, Elisa Giovannetti Cancer Chemotherapy and Pharmacology.2020; 85(6): 1011. CrossRef
Targeting cancer stem cells in cholangiocarcinoma (Review) Nicole Mcgrath, Jianyang Fu, Sophie Gu, Changqing Xie International Journal of Oncology.2020; 57(2): 397. CrossRef
Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results Makoto Ueno, Masafumi Ikeda, Takashi Sasaki, Fumio Nagashima, Nobumasa Mizuno, Satoshi Shimizu, Hiroki Ikezawa, Nozomi Hayata, Ryo Nakajima, Chigusa Morizane BMC Cancer.2020;[Epub] CrossRef
Combined treatment for locally advanced cholangiocellular liver cancer - the case report A. N. Polyakov, Yu. I. Patyutko, A. Yu. Syskova, K. A. Romanova, I. S. Bazin, O. N. Sergeeva, E. R. Virshke, E. S. Makarov, E. Yu. Antonova, A. A. Kirshin, D. V. Podluzhnyi Research and Practical Medicine Journal.2019; 6(4): 158. CrossRef
Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin J. Dierks, M. P. Gaspersz, A. Belkouz, J. L. A. van Vugt, R. J. S. Coelen, J. W. B. de Groot, A. J. ten Tije, W. G. Meijer, J. F. M. Pruijt, T. van Voorthuizen, D. J. van Spronsen, M. Rentinck, D. ten Oever, J. M. Smit, H. M. Otten, T. M. van Gulik, J. W. Acta Oncologica.2018; 57(6): 807. CrossRef
Tumor Marker Kinetics as Prognosticators in Patients with Unresectable Gallbladder Adenocarcinoma Undergoing Palliative Chemotherapy Jae Woo Lee, Yong-Tae Kim, Sang Hyub Lee, Jun Hyuk Son, Jin Woo Kang, Ji Kon Ryu, Dong Kee Jang, Woo Hyun Paik, Ban Seok Lee Gut and Liver.2018; 12(1): 102. CrossRef
Tumor-infiltrating mast cells predict prognosis and gemcitabine-based adjuvant chemotherapeutic benefit in biliary tract cancer patients Xiaobo Bo, Jie Wang, Tao Suo, Xiaoling Ni, Han Liu, Sheng Shen, Min Li, Yueqi Wang, Houbao Liu, Jiejie Xu BMC Cancer.2018;[Epub] CrossRef
Revision of bilateral self-expandable metallic stents placed using the stent-in-stent technique for malignant hilar biliary obstruction Jun Hyuk Son, Hee Seung Lee, Sang Hyub Lee, Seungmin Bang, Jinwoo Kang, Woo Hyun Paik, Ji Kon Ryu, Yong-Tae Kim Hepatobiliary & Pancreatic Diseases International.2018; 17(5): 437. CrossRef
Aktueller Therapiealgorithmus des intrahepatischen cholangiozellulären Karzinoms G. Lurje, J. Bednarsch, C. Roderburg, C. Trautwein, U. P. Neumann Der Chirurg.2018; 89(11): 858. CrossRef
Defining the Chance of Statistical Cure Among Patients with Extrahepatic Biliary Tract Cancer Gaya Spolverato, Fabio Bagante, Cecilia G. Ethun, George Poultsides, Thuy Tran, Kamran Idrees, Chelsea A. Isom, Ryan C. Fields, Bradley Krasnick, Emily Winslow, Clifford Cho, Robert C. G. Martin, Charles R. Scoggins, Perry Shen, Harveshp D. Mogal, Carl Sc World Journal of Surgery.2017; 41(1): 224. CrossRef
Comparison of FOLFIRINOX Chemotherapy with Other Regimens in Patients with Biliary Tract Cancers: a Retrospective Study Tulay Kus, Gokmen Aktas, Mehmet Emin Kalender, Alper Sevinc, Celaletdin Camci Journal of Gastrointestinal Cancer.2017; 48(2): 170. CrossRef
SVCT-2 determines the sensitivity to ascorbate-induced cell death in cholangiocarcinoma cell lines and patient derived xenografts Changzheng Wang, Hongwei Lv, Wen Yang, Ting Li, Tian Fang, Guishuai Lv, Qin Han, Liwei Dong, Tianyi Jiang, Beige Jiang, Guangshun Yang, Hongyang Wang Cancer Letters.2017; 398: 1. CrossRef
Prospective multicenter phase II study of gemcitabine plus cisplatin in patients with unresectable gallbladder cancer Yoshiki Hirooka, Takuya Ishikawa, Hiroki Kawashima, Eizaburo Ohno, Koji Nonogaki, Akira Kanamori, Takanori Hirai, Hiroki Uchida, Osamu Shirai, Hideki Ishikawa, Hidemi Goto Cancer Chemotherapy and Pharmacology.2017; 80(1): 119. CrossRef
CA19-9 or CEA Decline after the First Cycle of Treatment Predicts Survival in Advanced Biliary Tract Cancer Patients Treated with S-1 and Cisplatin Chemotherapy Dae-Won Lee, Seock-Ah Im, Yu Jung Kim, Yaewon Yang, Jiyoung Rhee, Im Il Na, Kyung-Hun Lee, Tae-Yong Kim, Sae-Won Han, In Sil Choi, Do-Youn Oh, Jee Hyun Kim, Tae-You Kim, Yung-Jue Bang Cancer Research and Treatment.2017; 49(3): 807. CrossRef
Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients Bum Jun Kim, Jaewon Hyung, Changhoon Yoo, Kyu-pyo Kim, Seong-Joon Park, Sang Soo Lee, Do Hyun Park, Tae Jun Song, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim, Jin-hong Park, Hyungwoo Cho, Baek-Yeol Ryoo, Heung-Moon Chang Cancer Chemotherapy and Pharmacology.2017; 80(1): 209. CrossRef
Cholangiocarcinoma and its mimickers in primary sclerosing cholangitis Jonghun John Lee, Sebastian T Schindera, Hyun-Jung Jang, Scott Fung, Tae Kyoung Kim Abdominal Radiology.2017; 42(12): 2898. CrossRef
Impact of radiation dose in postoperative radiotherapy after R1 resection for extrahepatic bile duct cancer: long term results from a single institution Byoung Hyuck Kim, Eui Kyu Chie, Kyubo Kim, Jin-Young Jang, Sun Whe Kim, Do-Youn Oh, Yung-Jue Bang, Sung W. Ha Oncotarget.2017; 8(44): 78076. CrossRef
The efficacy and safety of different pharmacological interventions for patients with advanced biliary tract cancer: A network meta-analysis Xin-Fang Sun, Zhi-Kuan He, Jin-Ping Sun, Quan-Xing Ge, Er-Dong Shen Oncotarget.2017; 8(59): 100657. CrossRef
Gemcitabine and cisplatin in inoperable, loco-regionally advanced and metastatic gallbladder cancer: A study from Northern India cancer institute Vineet Talwar, Shubhra Raina, Varun Goel, Dinesh C. Doval International Journal of Hepatobiliary and Pancreatic Diseases.2017; 7(2): 1. CrossRef
Expression levels of ROS1/ALK/c-MET and therapeutic efficacy of cetuximab plus chemotherapy in advanced biliary tract cancer Nai-Jung Chiang, Chiun Hsu, Jen-Shi Chen, Hsiao-Hui Tsou, Ying-Ying Shen, Yee Chao, Ming-Huang Chen, Ta-Sen Yeh, Yan-Shen Shan, Shiu-Feng Huang, Li-Tzong Chen Scientific Reports.2016;[Epub] CrossRef
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The role of microRNAs in gallbladder cancer GANGHUA YANG, LEI ZHANG, RUIXIANG LI, LIN WANG Molecular and Clinical Oncology.2016; 5(1): 7. CrossRef