Cancer Research and Treatment

Review Article

Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design: Hyerim Ha, Hee Yeon Lee, Jee Hyun Kim, Do Yeun Kim, Ho Jung An, SeungJin Bae, Hye-sung Park, Jin Hyoung Kang; Cancer Res Treat. 2024;56(4):991-1013. Published online May 7, 2024; DOI: https://doi.org/10.4143/crt.2024.128

Abstract PDF Supplementary Material PubReader ePub: Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.

2,578 View
144 Download

Original Articles

Breast cancer

Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions: Jieun Lee, Hyung Soon Park, Hye Sung Won, Ji Hyun Yang, Hee Yeon Lee, In Sook Woo, Kabsoo Shin, Ji Hyung Hong, Young Joon Yang, Sang Hoon Chun, Jae Ho Byun; Cancer Res Treat. 2021;53(2):409-423. Published online October 28, 2020; DOI: https://doi.org/10.4143/crt.2020.451

Abstract PDF Supplementary Material PubReader ePub

Purpose
Use of cyclin-dependent kinase 4/6 inhibitors improved survival outcome of hormone receptor (HR) positive metastatic breast cancer (MBC) patients, including Asian population. However, Asian real-world data of palbociclib is limited. We analyzed the real-world clinical practice patterns and outcome in HR-positive, MBC Asian patients treated with palbociclib.
Materials and Methods
Between April 2017 to November 2019, 169 HR-positive, human epidermal growth factor-2–negative MBC patients treated with letrozole or fulvestrant plus palbocilib were enrolled from eight institutions. Survival outcome (progression-free survival [PFS]), treatment response and toxicity profiles were analyzed.
Results
Median age of letrozole plus palbociclib (145 patients, 85.8%) and fulvestrant plus palbociclib (24 patients, 14.2%) was 58 and 53.5 years, with median follow-up duration of 14.63 months (range 0.2 to 33.9 months). Median PFS (mPFS) of letrozole plus palbociclib and fulvestrant plus palbociclib was 25.6 (95% confidence interval [CI], 19.1 to not reached) and 6.37 months (95% CI, 5.33 to not reached), comparable to previous phase 3 trials. In letrozole plus palbociclib arm, luminal A (hazard ratio, 2.86; 95% CI, 1.20 to 6.80; p=0.017) and patients with good performance (Eastern Cooperative Oncology Group 0-1 [hazard ratio, 3.68; 95% CI, 1.70 to 7.96]) showed better mPFS. In fulvestrant plus palbociclib group, chemotherapy naïve patients showed better mPFS (hazard ratio, 12.51, 95% CI, 1.59 to 99.17; p=0.017). The most common grade 3 or 4 adverse event was neutropenia (letrozole 86.3%, fulvestrant 88.3%).
Conclusion
To our knowledge, this is the first real-world data of palbociclib reported in Asia. Palbociclib showed comparable benefit to previous phase 3 trials in Asian patients during daily clinical practice.

Citations

Citations to this article as recorded by

Efficacy and Safety of Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Real-World Studies
Hui-Chen Su, Ho-Wei Lin, Ka-Wai Tam
Targeted Oncology.2025; 20(1): 71. CrossRef
Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review
Etienne Brain, Connie Chen, Sofia Simon, Vinay Pasupuleti, Kathleen Vieira Pfitzer, Karen A. Gelmon
Targeted Oncology.2024; 19(3): 303. CrossRef
Real-world progression-free survival and overall survival of palbociclib plus endocrine therapy (ET) in Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in the first-line or second-l
Tetsuhiro Yoshinami, Shigenori E. Nagai, Masaya Hattori, Takuho Okamura, Kenichi Watanabe, Takahiro Nakayama, Hiroko Masuda, Michiko Tsuneizumi, Daisuke Takabatake, Michiko Harao, Hiroshi Yoshino, Natsuko Mori, Hiroyuki Yasojima, Chiya Oshiro, Madoka Iwas
Breast Cancer.2024; 31(4): 621. CrossRef
The Effect of C-Reactive Protein/Lymphocyte Ratio (CLR) on PFS in Metastatic Breast Cancer Patients Treated with CDK4/6 Inhibitors: A Novel Biomarker
Mehmet Buyukbayram, Zekeriya Hannarici, Yakup Duzkopru, Aykut Turhan, Alperen Caglar, Pınar Coban Esdur, Mehmet Bilici, Salim Tekin, Doğan Yazılıtaş
Breast Cancer: Targets and Therapy.2024; Volume 16: 329. CrossRef
The treatment pattern of advanced HR-positive and HER2-negative breast cancer in central southern China: a hospital-based cross-sectional study
Zhe-Yu Hu, Binliang Liu, Ning Xie, Xiaohong Yang, Liping Liu, Huawu Xiao, Jing Li, Hui Wu, Jianxiang Gao, Jun Lu, Xuming Hu, Min Cao, Zhengrong Shui, Can Tian, Quchang Ouyang
BMC Cancer.2024;[Epub] CrossRef
Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials
Amit Rauthan, Ankita Jain, Manmohan Singh, Mehmet A. N. Sendur
Oncology and Therapy.2024; 12(3): 395. CrossRef
Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2−metastatic breast cancer patients: a multicenter study (YOUNGBC-28)
Yifan Chen, Yizhao Xie, Die Sang, Ning Xie, Xinhua Han, Yanxia Zhao, Juanjuan Li, Jian Yue, Peng Yuan, Biyun Wang
Therapeutic Advances in Medical Oncology.2024;[Epub] CrossRef
Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China
Jiao Yang, Bing Zhao, Xiaoling Ling, Donghui Li, Jiuda Zhao, Yonggang Lv, Guangxi Wang, Xinlan Liu, Nanlin Li, Jin Yang
BMC Cancer.2023;[Epub] CrossRef
A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance® Patient Program
Carlo Palmieri, Alison Musson, Catherine Harper-Wynne, Duncan Wheatley, Gianfilippo Bertelli, Iain R. Macpherson, Mark Nathan, Ellie McDowall, Ajay Bhojwani, Mark Verrill, Joe Eva, Colm Doody, Ruhe Chowdhury
British Journal of Cancer.2023; 129(5): 852. CrossRef
Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study
Fábio Cardoso Borges, Filipa Alves da Costa, Adriana Ramos, Catarina Ramos, Catarina Bernardo, Cláudia Brito, Alexandra Mayer-da-Silva, Cláudia Furtado, Arlindo R. Ferreira, Diogo Martins-Branco, Ana Miranda, António Lourenço
The Breast.2022; 62: 135. CrossRef
The Impact of Real-World Alternative Dosing Strategies of Palbociclib on Progression-Free Survival in Patients with Metastatic Breast Cancer
Fulbert Fu, Jessica Kano, Julia Ma, Mera Guindy
Current Oncology.2022; 29(3): 1761. CrossRef
Treatment patterns, effectiveness, and patient‐reported outcomes of palbociclib therapy in Chinese patients with advanced breast cancer: A multicenter ambispective real‐world study
Lesang Shen, Jun Zhou, Yiding Chen, Jinhua Ding, Haiyan Wei, Jian Liu, Wenjie Xia, Bojian Xie, Xiaohong Xie, Xujun Li, Yuechu Dai, Guobing Zhang, Xia Qiu, Chao Li, Shanshan Sun, Wuzhen Chen, Dihe Gong, Hengyu Li, Jian Huang, Xia Jiang, Chao Ni
Cancer Medicine.2022; 11(22): 4157. CrossRef
Starting dose selection of palbociclib in Chinese patients with breast cancer based on population kinetic–pharmacodynamic model of neutropenia
Weizhe Jian, Junsheng Xue, Qingyu Yao, Rong Chen, Ye Yao, Mopei Wang, Tianyan Zhou
Cancer Chemotherapy and Pharmacology.2022; 90(6): 489. CrossRef
Early Application of Palbociclib Plus Endocrine Therapy in HR+/HER2− Metastatic Breast Cancer: A Better Choice Based on Data From the Chinese Population
Yusi Zhang, Wenlin Chen, Shuanglong Chen, Qingmo Yang, Zhong Ouyang
Technology in Cancer Research & Treatment.2022;[Epub] CrossRef
Real-world Treatment Patterns and Clinical Outcomes Associated With Palbociclib Combination Therapy: A Multinational, Pooled Analysis From the Ibrance Real World Insights Study
Katie Mycock, Kent A. Hanson, Gavin Taylor-Stokes, Gary Milligan, Christian Atkinson, Debanjali Mitra, Salena Preciado, Ernest H. Law
Clinical Therapeutics.2022; 44(12): 1588. CrossRef
Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
Chaturbhuj Agrawal, Pankaj Goyal, Amit Agarwal, Rupal Tripathi, Chandragouda Dodagoudar, Saphalta Baghmar, Archana Sharma, Ullas Batra, Vineet Talwar, Sumit Goyal, Rajeev Kumar, Dinesh Chandra Doval
Scientific Reports.2021;[Epub] CrossRef
Which Clinicopathologic Parameters Suggest Primary Resistance to Palbociclib in Combination With Letrozole as the First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer?
Ji-Yeon Kim, Jung Min Oh, Yeon Hee Park, Jin Seok Ahn, Young-Hyuck Im
Frontiers in Oncology.2021;[Epub] CrossRef

10,124 View
386 Download
18 Web of Science
17 Crossref

Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea: Hee Yeon Lee, Ji Hyung Hong, Jae Ho Byun, Hee-Jun Kim, Sun Kyung Baek, Jin Young Kim, Ki Hyang Kim, Jina Yun, Jung A Kim, Kwonoh Park, Hyo Jin Lee, Jung Lim Lee, Young-Woong Won, Il Hwan Kim, Woo Kyun Bae, Kyong Hwa Park, Der-Sheng Sun, Suee Lee, Min-Young Lee, Guk Jin Lee, Sook Hee Hong, Yun Hwa Jung, Ho Jung An; Cancer Res Treat. 2020;52(1):277-283. Published online July 12, 2019; DOI: https://doi.org/10.4143/crt.2019.292

Abstract PDF PubReader ePub

Purpose
The purpose of this study was to evaluate clinical characteristics and treatment pattern of ovarian clear cell carcinoma (OCCC) in Korea and the role of adjuvant chemotherapy in early stage.
Materials and Methods
Medical records of 308 cases of from 21 institutions were reviewed and data including age, performance status, endometriosis, thromboembolism, stage, cancer antigen 125, treatment, recurrence, and death were collected.
Results
Regarding stage of OCCC, it was stage I in 194 (63.6%), stage II in 34 (11.1%), stage III in 66 (21.6%), and stage IV in 11 (3.6%) patients. All patients underwent surgery. Optimal surgery (residual disease ≤ 1 cm) was achieved in 89.3%. Majority of patients (80.5%) received postoperative chemotherapy. The most common regimen was taxane-platinum combination (96%). Median relapse-free survival (RFS) was 138.5 months for stage I, 33.4 for stage II, 19.3 for stage III, and 9.7 for stage IV. Median overall survival (OS) were not reached, 112.4, 48.7, and 18.3 months for stage I, II, III, and IV, respectively. Early-stage (stage I), endometriosis, and optimal debulking were identified as favorable prognostic factors for RFS. Early-stage and optimal debulking were also favorable prognostic factors for OS. Majority of patients with early-stage received adjuvant chemotherapy. However, additional survival benefit was not found in terms of recurrence.
Conclusion
Majority of patients had early-stage and received postoperative chemotherapy regardless of stage. Early-stage and optimal debulking were identified as favorable prognostic factors. In stage IA or IB, adding adjuvant chemotherapy did not show difference in survival. Further study focusing on OCCC is required.

Citations

Citations to this article as recorded by

Ovarian clear cell carcinoma: open questions on the management and treatment algorithm
Roberta Rosso, Margherita Turinetto, Fulvio Borella, Nicolas Chopin, Pierre Meeus, Alexandra Lainè, Isabelle Ray-Coquard, Olivia Le Saux, Domenico Ferraioli
The Oncologist.2025;[Epub] CrossRef
From clinical management to personalized medicine: novel therapeutic approaches for ovarian clear cell cancer
Zesi Liu, Chunli Jing, Fandou Kong
Journal of Ovarian Research.2024;[Epub] CrossRef
SOX17 expression in ovarian clear cell carcinoma
Daichi Kodama, Motoki Takenaka, Chiemi Saigo, Masako Azuma, Yuki Hanamatsu, Masanori Isobe, Tamotsu Takeuchi
Journal of Ovarian Research.2024;[Epub] CrossRef
Construction of a Prediction Model of Cancer-Specific Survival after Ovarian Clear Cell Carcinoma Surgery
Mengqi Huang, Li Ling, Yanbo Liu, Yujuan Li
Clinical and Experimental Obstetrics & Gynecology.2024;[Epub] CrossRef
Patients with stage IA ovarian clear cell carcinoma do not require chemotherapy following surgery
Li Shuqing, Zhu Zhiling
Cancer Medicine.2023; 12(6): 6668. CrossRef
Clear cell carcinoma of the ovary and venous thromboembolism: a systematic review and meta-analysis
Hamidreza Didar, Farah Farzaneh, Hanieh Najafiarab, Kosar Namakin, Kimiya Gohari, Ali Sheidaei, Sepehr Ramezani
Current Medical Research and Opinion.2023; 39(6): 901. CrossRef
The Significance of Radiotherapy in Ovarian Clear Cell Carcinoma: A Systematic Review and Meta-Analysis
Yuan Zhuang, Hua Yang
Cancer Control.2023;[Epub] CrossRef
Clinical perspectives of rare ovarian tumors: clear cell ovarian cancer
Satoe Fujiwara
Japanese Journal of Clinical Oncology.2023; 53(8): 664. CrossRef
Application of precision medicine based on next-generation sequencing and immunohistochemistry in ovarian cancer: a real-world experience
Yoo-Na Kim, Yun Soo Chung, Ji Hyun Lee, Eunhyang Park, Seung-Tae Lee, Sunghoon Kim, Jung-Yun Lee
Journal of Gynecologic Oncology.2023;[Epub] CrossRef
Characteristics and Prognosis of Ovarian Pure Clear Cell Carcinoma: A Retrospective Experience of 136 Patients
Yang Gao, Wei Ding, Pengpeng Qu
Clinical and Experimental Obstetrics & Gynecology.2023;[Epub] CrossRef
A clearer view on ovarian clear cell carcinoma
Aglaja De Pauw, Eline Naert, Koen Van de Vijver, Tummers Philippe, Katrien Vandecasteele, Hannelore Denys
Acta Clinica Belgica.2022; 77(4): 792. CrossRef
Friend or foe? The prognostic role of endometriosis in women with clear cell ovarian carcinoma. A UK population-based cohort study
Anastasios Tranoulis, Felicia Helena Buruiana, Bindiya Gupta, Audrey Kwong, Aarti Lakhiani, Jason Yap, Janos Balega, Kavita Singh
Archives of Gynecology and Obstetrics.2022; 305(5): 1279. CrossRef
Association Between Endometriosis and Prognosis of Ovarian Cancer: An Updated Meta-Analysis
Peng Chen, Chi-Yuan Zhang
Frontiers in Oncology.2022;[Epub] CrossRef
Clinical analysis and literature review of a case of ovarian clear cell carcinoma with PIK3CA gene mutation: A case report
Abdulkarim Mohamed Farah, Shiyu Gu, Yan Jia
Medicine.2022; 101(37): e30666. CrossRef
Clear cell carcinoma of the ovary: a clinical and molecular perspective
Yasushi Iida, Aikou Okamoto, Robert L Hollis, Charlie Gourley, C Simon Herrington
International Journal of Gynecological Cancer.2021; 31(4): 605. CrossRef
Clinical characteristics and prognosis of ovarian clear cell carcinoma: a 10-year retrospective study
Chenchen Zhu, Jing Zhu, Lili Qian, Hanyuan Liu, Zhen Shen, Dabao Wu, Weidong Zhao, Weihua Xiao, Ying Zhou
BMC Cancer.2021;[Epub] CrossRef
The oncological outcome of the patients with ovarian clear cell cancer: Platinum-based adjuvant chemotherapy is not suitable
Caner ÇAKIR, Fatih KILIÇ, Çiğdem KILIÇ, Dilek YÜKSEL, Vakkas KORKMAZ, Günsu KİMYON CÖMERT, Osman TÜRKMEN, Taner TURAN
Journal of Surgery and Medicine.2021; 5(8): 1. CrossRef
Development and validation of Nomograms for predicting overall survival and Cancer-specific survival in patients with ovarian clear cell carcinoma
Qian Chen, Shu Wang, Jing-He Lang
Journal of Ovarian Research.2020;[Epub] CrossRef

9,172 View
422 Download
23 Web of Science
18 Crossref

GRP78 Protein Expression as Prognostic Values in Neoadjuvant Chemoradiotherapy and Laparoscopic Surgery for Locally Advanced Rectal Cancer: Hee Yeon Lee, Ji-Han Jung, Hyun-Min Cho, Sung Hwan Kim, Kang-Moon Lee, Hyung-Jin Kim, Jong Hoon Lee, Byoung Yong Shim; Cancer Res Treat. 2015;47(4):804-812. Published online January 30, 2015; DOI: https://doi.org/10.4143/crt.2014.121

Abstract PDF PubReader ePub

Purpose
We investigated the relationships between biomarkers related to endoplasmic reticulum stress proteins (glucose-regulated protein of molecular mass 78 [GRP78] and Cripto-1 [teratocarcinoma-derived growth factor 1 protein]), pathologic response, and prognosis in locally advanced rectal cancer. Materials and Methods All clinical stage II and III rectal cancer patients received 50.4 Gy over 5.5 weeks, plus 5- fluorouracil (400 mg/m2/day) and leucovorin (20 mg/m2/day) bolus on days 1 to 5 and 29 to 33, and surgery was performed at 7 to 10 weeks after completion of all therapies. Expression of GRP78 and Cripto-1 proteins was determined by immunohistochemistry and was assessed in 101 patients with rectal cancer treated with neoadjuvant chemoradiotherapy (CRT).
Results
High expression of GRP78 and Cripto-1 proteins was observed in 86 patients (85.1%) and 49 patients (48.5%), respectively. Low expression of GRP78 protein was associated with a significantly high rate of down staging (80.0% vs. 52.3%, respectively; p=0.046) and a significantly low rate of recurrence (0% vs. 33.7%, respectively; p=0.008) compared with high expression of GRP78 protein. Mean recurrence-free survival according to GRP78 expression could not be estimated because the low expression group did not develop recurrence events but showed a significant correlation with time to recurrence, based on the log rank method (p=0.007). GRP78 also showed correlation with overall survival, based on the log rank method (p=0.045). Conclusion GRP78 expression is a predictive and prognostic factor for down staging, recurrence, and survival in rectal cancer patients treated with 5-fluorouracil and leucovorin neoadjuvant CRT.

Citations

Citations to this article as recorded by

Is GRP78 (Glucose-regulated protein 78) a prognostic biomarker in differents types of cancer? A systematic review and meta-analysis
Natália Souza dos Santos, Douglas Rodrigues Gonçalves, Bianca Balbinot, Fernanda Visioli
Pathology - Research and Practice.2023; 242: 154301. CrossRef
GRP78 is Overexpressed in Non-small Cell Lung Cancer Tissues and is Associated with High VEGF Expression in Squamous Cell Carcinoma: A Pilot Study
Maha Al-Keilani, Mohammad A. Alqudah, Basima Almomani, Moath M. Alrjoub, Batool A. Shhabat, Karem Alzoubi
Current Cancer Drug Targets.2023; 23(10): 805. CrossRef
GRP78 expression and prognostic significance in patients with pancreatic ductal adenocarcinoma treated with neoadjuvant therapy versus surgery first
Yi Tat Tong, Hua Wang, Dongguang Wei, Laura R. Prakash, Michael Kim, Ching-Wei D. Tzeng, Jeffrey E. Lee, Asif Rashid, Eugene J. Koay, Robert A. Wolff, Anirban Maitra, Matthew HG. Katz, Huamin Wang
Pancreatology.2021; 21(7): 1378. CrossRef
Exosomal ERp44 derived from ER-stressed cells strengthens cisplatin resistance of nasopharyngeal carcinoma
Tian Xia, Hui Tian, Kaiwen Zhang, Siyu Zhang, Wenhui Chen, Si Shi, Yiwen You
BMC Cancer.2021;[Epub] CrossRef
BCAP31, a cancer/testis antigen-like protein, can act as a probe for non-small-cell lung cancer metastasis
Jing Wang, Dongbo Jiang, Zichao Li, Shuya Yang, Jiayi Zhou, Guanwen Zhang, Zixin Zhang, Yuanjie Sun, Zhipei Zhang, Xiaofei Li, Liang Tao, Jingqi Shi, Yuchen Lu, Lianhe Zheng, Chaojun Song, Kun Yang
Scientific Reports.2020;[Epub] CrossRef
Prognostic Value of Cripto-1 Expression in Non-Small-Cell Lung Cancer Patients: A Systematic Review and Meta-Analysis
Yuanfeng Wei, Jinfang Jiang, Chengyan Wang, Hong Zou, Xihua Shen, Wei Jia, Shan Jin, Lu Zhang, Jianming Hu, Lan Yang, Lijuan Pang
Biomarkers in Medicine.2020; 14(4): 317. CrossRef
Interplay between endoplasmic reticulum stress and non-coding RNAs in cancer
Tianming Zhao, Juan Du, Hui Zeng
Journal of Hematology & Oncology.2020;[Epub] CrossRef
Dual role of Endoplasmic Reticulum Stress-Mediated Unfolded Protein Response Signaling Pathway in Carcinogenesis
Natalia Siwecka, Wioletta Rozpędek, Dariusz Pytel, Adam Wawrzynkiewicz, Adam Dziki, Łukasz Dziki, J. Alan Diehl, Ireneusz Majsterek
International Journal of Molecular Sciences.2019; 20(18): 4354. CrossRef
Clinical and Pathological Significance of ER Stress Marker (BiP/GRP78 and PERK) Expression in Malignant Melanoma
Akira Shimizu, Kyoichi Kaira, Masahito Yasuda, Takayuki Asao, Osamu Ishikawa
Pathology & Oncology Research.2017; 23(1): 111. CrossRef
Effects of gene polymorphisms in the endoplasmic reticulum stress pathway on clinical outcomes of chemoradiotherapy in Chinese patients with nasopharyngeal carcinoma
Xiao-bin Guo, Wan-le Ma, Li-juan Liu, Yu-ling Huang, Jing Wang, Li-hua Huang, Xiang-dong Peng, Ji-ye Yin, Jin-gao Li, Shao-jun Chen, Guo-ping Yang, Hui Wang, Cheng-xian Guo
Acta Pharmacologica Sinica.2017; 38(4): 571. CrossRef
The meta and bioinformatics analysis of GRP78 expression in gastric cancer
Hua-Chuan Zheng, Bao-Cheng Gong, Shuang Zhao
Oncotarget.2017; 8(42): 73017. CrossRef
Endoplasmic reticulum ribosome-binding protein 1, RRBP1, promotes progression of colorectal cancer and predicts an unfavourable prognosis
Y Pan, F Cao, A Guo, W Chang, X Chen, W Ma, X Gao, S Guo, C Fu, J Zhu
British Journal of Cancer.2015; 113(5): 763. CrossRef

13,008 View
76 Download
15 Web of Science
12 Crossref

A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy: Hee Yeon Lee, Hoon-Kyo Kim, Kyung Hee Lee, Bong-Seog Kim, Hong Suk Song, Sung Hyun Yang, Joon Hee Kim, Yeul Hong Kim, Jong Gwang Kim, Sang-We Kim, Dong-Wan Kim, Si-Young Kim, Hee Sook Park; Cancer Res Treat. 2014;46(1):19-26. Published online January 15, 2014; DOI: https://doi.org/10.4143/crt.2014.46.1.19

Abstract PDF PubReader ePub

PURPOSE
This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting.
MATERIALS AND METHODS
This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6.
RESULTS
Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events.
CONCLUSION
In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups.

Citations

Citations to this article as recorded by

Influence of ABCB1 genetic polymorphisms on the antiemetic response to ondansetron-based medication for cisplatin-based chemotherapy in South Indian cancer patients in a tertiary care hospital
Ayyar Porkodi, Deepak Gopal Shewade, Goud Alladi Charanraj
Current Issues in Pharmacy and Medical Sciences.2023; 36(3): 129. CrossRef
Hiccups in Cancer Patients Receiving Chemotherapy: A Cross-Sectional Study
Mevlüde Ergen, Fatma Arikan, Rüya Fırat Çetin
Journal of Pain and Symptom Management.2021; 62(3): e85. CrossRef
A Fast and Validated HPLC Method for the Simultaneous Analysis of Five 5-HT3 Receptor Antagonists via the Quantitative Analysis of Multicomponents by a Single Marker
Fuchao Chen, Baoxia Fang, Peng Li, Sicen Wang, Amr M. Mahmoud
International Journal of Analytical Chemistry.2021; 2021: 1. CrossRef
Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis
Vanessa Piechotta, Anne Adams, Madhuri Haque, Benjamin Scheckel, Nina Kreuzberger, Ina Monsef, Karin Jordan, Kathrin Kuhr, Nicole Skoetz
Cochrane Database of Systematic Reviews.2021;[Epub] CrossRef
Effectiveness of Steroid Rotation in a Japanese Patient with Hiccups Caused by Dexamethasone: a Case Report
Hiroki Hosokawa, Hideaki Shimoda, Takayuki Ishii
YAKUGAKU ZASSHI.2019; 139(4): 647. CrossRef
Stability of azasetron-dexamethasone mixture for chemotherapy-induced nausea and vomiting administration
Bao-Xia Fang, Fu-Chao Chen, Dan Zhu, Jun Guo, Lin-Hai Wang
Oncotarget.2017; 8(63): 106249. CrossRef
Gender Differences in Hiccup Patients: Analysis of Published Case Reports and Case-Control Studies
Gyeong-Won Lee, Rock Bum Kim, Se Il Go, Hyun Seop Cho, Seung Jun Lee, David Hui, Eduardo Bruera, Jung Hun Kang
Journal of Pain and Symptom Management.2016; 51(2): 278. CrossRef
Cheaper Options in the Prevention of Chemotherapy-Induced Nausea and Vomiting
Bishal Gyawali, Bishesh Sharma Poudyal, Mahesh Iddawela
Journal of Global Oncology.2016; 2(3): 145. CrossRef
Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review
K. Jordan, F. Jahn, M. Aapro
Annals of Oncology.2015; 26(6): 1081. CrossRef

12,154 View
70 Download
8 Web of Science
9 Crossref

First
Prev
Page of 1
Next
Last

Search