Cancer Research and Treatment

Kazuhiko Nakagawa

2 Articles

Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer: Makoto Nishio, Dong-Wan Kim, Yi-Long Wu, Kazuhiko Nakagawa, Benjamin J. Solomon, Alice T. Shaw, Satoshi Hashigaki, Emiko Ohki, Tiziana Usari, Jolanda Paolini, Anna Polli, Keith D. Wilner, Tony Mok; Cancer Res Treat. 2018;50(3):691-700. Published online July 6, 2017; DOI: https://doi.org/10.4143/crt.2017.280

Abstract PDF Supplementary Material PubReader ePub

Purpose
Crizotinib has demonstrated superior progression-free survival (PFS) and objective response rates (ORRs) versus chemotherapy in previously treated and untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). We report the safety and efficacy of crizotinib in Asian subpopulations of two global phase III trials.
Materials and Methods
This analysis evaluated previously treated and untreated patients in two randomized, openlabel phase III trials of crizotinib versus chemotherapy in ALK-positive advanced NSCLC in second-line (PROFILE 1007) and first-line settings (PROFILE 1014). Efficacy and safety were analyzed by race in the intention-to-treat and “as-treated” populations for efficacy and safety endpoints, respectively.
Results
In previously treated (n=157) and untreated (n=157) Asian patients, PFS was statistically significantly longer with crizotinib versus chemotherapy (hazard ratio for PFS, 0.526; 95% confidence interval, 0.363 to 0.762; p < 0.001 and hazard ratio, 0.442; 95% confidence interval, 0.302 to 0.648; p < 0.001, respectively). Similar antitumor activity was seen in the non-Asian and overall populations. ORRs were statistically significantly higher with crizotinib versus chemotherapy in both Asian and non-Asian previously treated and untreated patients (p < 0.05). The most common treatment-emergent adverse events (any grade)with crizotinib were vision disorder, diarrhea, and nausea, which were observed at a comparable incidence across Asian and non-Asian populations, irrespective of previous treatment status. Most adverse events were mild to moderate in severity.
Conclusion
These data, currently the only analysis showing Asian and non-Asian populations in the same study, support the efficacy and safety of crizotinib in Asian patients with previously treated or untreated ALK-positive advanced NSCLC.

Citations

Citations to this article as recorded by

Inhalable iron redox cycling powered nanoreactor for amplified ferroptosis-apoptosis synergetic therapy of lung cancer
Linjing Wu, Wenhao Wang, Mengqin Guo, Fangqin Fu, Wenhua Wang, Tszching Sung, Meihong Zhang, Ziqiao Zhong, Chuanbin Wu, Xin Pan, Zhengwei Huang
Nano Research.2024; 17(6): 5435. CrossRef
Long-Term Outcomes of Crizotinib Treated ALK-Positive Lung Cancer Patients: A Retrospective Audit of Prospective Data from Resource-Constrained Settings
Akhil Kapoor, Vanita Noronha, Vijay Patil, Nandini Menon, Ravindra Nandhana, Amit Kumar, Abhishek Mahajan, Amit Janu, Rajiv Kumar, Kumar Prabhash
South Asian Journal of Cancer.2023; 12(02): 179. CrossRef
Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
Byoung Chul Cho, Dong-Wan Kim, Ullas Batra, Keunchil Park, Sang-We Kim, Cheng-Ta Yang, Pei-Jye Voon, Virote Sriuranpong, K. Govind Babu, Khalid Amin, Yingbo Wang, Paramita Sen, Khemaies Slimane, Sarayut Geater
Cancer Research and Treatment.2023; 55(1): 83. CrossRef
Successful Retreatment with Crizotinib After Crizotinib-Induced Liver Failure in ALK-Positive Advanced Lung Adenocarcinoma: A Case Report
Xiangming Zhang, Kai Ni, Huijun Chen
OncoTargets and Therapy.2023; Volume 16: 87. CrossRef
A Bayesian network meta‐analysis of ALK inhibitor treatments in patients with ALK‐positive non‐small cell lung cancer
Bei Zheng, Hong Jiang, Wenjuan Yang, Ying Li, Bingqing Liang, Jun Zhu, Nanmei Chen, Miao Chen, Meiling Zhang
Cancer Medicine.2023; 12(15): 15983. CrossRef
Anaplastic Lymphoma Kinase Inhibitor-Induced Neutropenia: A Systematic Review
Fabien Moinard-Butot, Simon Nannini, Cathie Fischbach, Safa Abdallahoui, Martin Demarchi, Thierry Petit, Laura Bender, Roland Schott
Cancers.2023; 15(20): 4940. CrossRef
Dual peptides-modified cationic liposomes for enhanced Lung cancer gene therapy by a gap junction regulating strategy
Ziyu Zhao, Wenhao Wang, Guanlin Wang, Zhengwei Huang, Liping Zhou, Li Lin, Yueling Ou, Wanzhen Huang, Xuejuan Zhang, Chuanbin Wu, Liang Tao, Qin Wang
Journal of Nanobiotechnology.2023;[Epub] CrossRef
Performance of Japanese patients in registrational studies
Yasushi Goto, Sayaka Arakawa, Masayuki Shirasawa, Ryoko Higashiyama, Keisuke Baba, Ken Masuda, Yuki Shinno, Yuji Matsumoto, Yusuke Okuma, Tatsuya Yoshida, Hidehito Horinouchi, Noboru Yamamoto, Yuichiro Ohe
Japanese Journal of Clinical Oncology.2022; 52(1): 53. CrossRef
Targeted therapy for advanced anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer
Laird B Cameron, Nadia Hitchen, Elias Chandran, Tessa Morris, Renée Manser, Benjamin J Solomon, Vanessa Jordan
Cochrane Database of Systematic Reviews.2022;[Epub] CrossRef
Targeted Extracellular Vesicles Delivered Verrucarin A to Treat Glioblastoma
Kai Chen, Yingnan Si, Jia-Shiung Guan, Zhuoxin Zhou, Seulhee Kim, Taehyun Kim, Liang Shan, Christopher D. Willey, Lufang Zhou, Xiaoguang Liu
Biomedicines.2022; 10(1): 130. CrossRef
The application of radiomics in predicting gene mutations in cancer
Yana Qi, Tingting Zhao, Mingyong Han
European Radiology.2022; 32(6): 4014. CrossRef
Safety of MET Tyrosine Kinase Inhibitors in Patients With MET Exon 14 Skipping Non-small Cell Lung Cancer: A Clinical Review
Alexis Cortot, Xiuning Le, Egbert Smit, Santiago Viteri, Terufumi Kato, Hiroshi Sakai, Keunchil Park, D. Ross Camidge, Karin Berghoff, Soetkin Vlassak, Paul K. Paik
Clinical Lung Cancer.2022; 23(3): 195. CrossRef
Role ofSTK11inALK‑positive non‑small cell lung cancer (Review)
Wen Zhou, Lu-Da Yan, Zhi-Qiong Yu, Na Li, Yong-Hua Yang, Meng Wang, Yuan-Yuan Chen, Meng-Xia Mao, Xiao-Chun Peng, Jun Cai
Oncology Letters.2022;[Epub] CrossRef
Efficacy and Safety of Brigatinib Compared With Crizotinib in Asian vs. Non-Asian Patients With Locally Advanced or Metastatic ALK–Inhibitor-Naive ALK+ Non–Small Cell Lung Cancer: Final Results From the Phase III ALTA-1L Study
Myung J. Ahn, Hye R. Kim, James C.H. Yang, Ji-Yu Han, Jacky Yu-Chung. Li, Maximilian J. Hochmair, Gee-Chen Chang, Angelo Delmonte, Ki H. Lee, Rosario G. Campelo, Cesare Gridelli, Alexander I. Spira, Raffaele Califano, Frank Griesinger, Sharmistha Ghosh, E
Clinical Lung Cancer.2022; 23(8): 720. CrossRef
Secondary mutant ALK-I1171s in pituitary metastases from a patient with ALK fusion-positive advanced lung adenocarcinoma: A case report and literature review
Dan Han, Kewei Zhao, Qin Yang, Liling Zhang, Shihong Fei
Frontiers in Oncology.2022;[Epub] CrossRef
Combination of crizotinib and chemotherapy in patients with relapsed or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)
Mei-ting Chen, Xiao-hong Fu, He Huang, Zhao Wang, Xiao-jie Fang, Yu-Yi Yao, Quan-Guang Ren, Ze-geng Chen, Tong-yu Lin
Leukemia & Lymphoma.2021; 62(3): 571. CrossRef
Breakthrough in targeted therapy for non-small cell lung cancer
Zhencong Ye, Yongmei Huang, Jianhao Ke, Xiao Zhu, Shuilong Leng, Hui Luo
Biomedicine & Pharmacotherapy.2021; 133: 111079. CrossRef
Ceritinib Efficacy and Safety in Treatment-Naive Asian Patients With Advanced ALK-Rearranged NSCLC: An ASCEND-4 Subgroup Analysis
Daniel S.W. Tan, Sarayut Geater, Chong-Jen Yu, Chun-Ming Tsai, Te-Chun Hsia, Jun Chen, Meng-Chih Lin, You Lu, Virote Sriuranpong, Cheng-Ta Yang, Paramita Sen, Fabrice Branle, Michael Shi, Yi-Long Wu
JTO Clinical and Research Reports.2021; 2(3): 100131. CrossRef
Guidelines for clinical practice of ALK fusion detection in non-small-cell lung cancer: a proposal from the Chinese RATICAL study group
Wenbin Li, Jing Zhang, Zhijie Wang, Lin Li, Jie Ma, Xiaoyang Zhou, Jie Wang, Zhiyong Liang, Jianming Ying
Journal of the National Cancer Center.2021; 1(4): 123. CrossRef
Pathological cytomorphologic features and the percentage of ALK FISH-positive cells predict pulmonary adenocarcinoma prognosis: a prospective cohort study
Fenge Jiang, Congcong Wang, Ping Yang, Ping Sun, Jiannan Liu
World Journal of Surgical Oncology.2021;[Epub] CrossRef
Genetic Analysis of Pediatric Pancreatoblastoma
Zhengzheng Wang, Xiaoting Li, Qingjun Li, Jinxue Zhou
Pancreas.2021; 50(10): 1445. CrossRef
Treatment of advanced non-small-cell lung cancer
Kumar Prabhash, Amish Vora, Sewanti Limaye, Tarini Prasad Sahoo, Ullas Batra, Shekhar Patil, Vijay M. Patil, Vanita Noronha, Bharat Bhosale, Nirmal Vivek Raut, Narayanankutty Warrier, Bharat Vaswani, Govind Babu, Adwaita Gore, Nitesh Rohatgi, Shailesh Bon
Cancer Research, Statistics, and Treatment.2021; 4(2): 279. CrossRef
Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial
Yunpeng Yang, Jianya Zhou, Jianying Zhou, Jifeng Feng, Wu Zhuang, Jianhua Chen, Jun Zhao, Wei Zhong, Yanqiu Zhao, Yiping Zhang, Yong Song, Yi Hu, Zhuang Yu, Youling Gong, Yuan Chen, Feng Ye, Shucai Zhang, Lejie Cao, Yun Fan, Gang Wu, Yubiao Guo, Chengzhi
The Lancet Respiratory Medicine.2020; 8(1): 45. CrossRef
Clinical, Conventional CT and Radiomic Feature-Based Machine Learning Models for Predicting ALK Rearrangement Status in Lung Adenocarcinoma Patients
Lan Song, Zhenchen Zhu, Li Mao, Xiuli Li, Wei Han, Huayang Du, Huanwen Wu, Wei Song, Zhengyu Jin
Frontiers in Oncology.2020;[Epub] CrossRef
Renal complication of crizotinib: Crizotinib-associated complex renal cyst
Warissara Jutidamrongphan, Pimporn Puttawibul
The ASEAN Journal of Radiology.2020; : 44. CrossRef
A Unique Case of a High-Grade Neuroepithelial Tumor With EML4-ALK Fusion in a Five-Month-Old
Oliver D Mrowczynski, Russell Payne, Cunfeng Pu, Robert Greiner, Elias Rizk
Cureus.2020;[Epub] CrossRef
Histomorphologic features of lung adenocarcinomas exhibiting ALK gene rearrangement
Daniel S. Grosser, Haiying Zhang
Baylor University Medical Center Proceedings.2019; 32(2): 206. CrossRef
ALK-rearranged lung adenocarcinoma patient with development of severe sinus bradycardia after treatment with crizotinib
Ye Qiu, Bixun Li, Yihong Zhang, Xiaoyun Guo, Chunzhi Xiang, Congshui Wang, Yang Lu, Shuang Ren, Juan Zhao
Medicine.2019; 98(11): e14826. CrossRef
Emerging therapies for non-small cell lung cancer
Chao Zhang, Natasha B. Leighl, Yi-Long Wu, Wen-Zhao Zhong
Journal of Hematology & Oncology.2019;[Epub] CrossRef
De novo MET amplification promotes intrinsic resistance to first-generation EGFR tyrosine kinase inhibitors
Jing-Wen Li, Shu-Hui Cao, Jian-Lin Xu, Hua Zhong
Cancer Biology & Therapy.2019; 20(9): 1183. CrossRef
Incidence and risk of fatigue in cancer patients treated with MET inhibitors
Hongxuan Tong, Yutian Zhu, Yihua Liu
Medicine.2019; 98(22): e15522. CrossRef
Metastasis manners and the underlying mechanisms of ALK and ROS1 rearrangement lung cancer and current possible therapeutic strategies
Xing Chang, Zi Liu, Shuai Man, Annie Roys, Zengqiang Li, Daiying Zuo, Yingliang Wu
RSC Advances.2019; 9(31): 17921. CrossRef
Front‐line treatment of ceritinib improves efficacy over crizotinib for Asian patients with anaplastic lymphoma kinase fusion NSCLC: The role of systemic progression control
Shih‐Hao Huang, Allen Chung‐Cheng Huang, Chin‐Chou Wang, Wen‐Chen Chang, Chien‐Ying Liu, Stelios Pavlidis, Ho‐Wen Ko, Fu‐Tsai Chung, Ping‐Chih Hsu, Yi‐Ke Guo, Chih‐Hsi Scott Kuo, Cheng‐Ta Yang
Thoracic Cancer.2019; 10(12): 2274. CrossRef
Erastin/sorafenib induces cisplatin‑resistant non‑small cell lung cancer cell ferroptosis through inhibition of the Nrf2/xCT pathway
Yu Li, Hengyi Yan, Xiaoman Xu, Hongbo Liu, Cen Wu, Li Zhao
Oncology Letters.2019;[Epub] CrossRef
Silencing of LncRNA-HOTAIR decreases drug resistance of Non-Small Cell Lung Cancer cells by inactivating autophagy via suppressing the phosphorylation of ULK1
Yan Yang, Caiyu Jiang, Yang Yang, Lu Guo, Jiang Huang, Xingren Liu, Chi Wu, Jun Zou
Biochemical and Biophysical Research Communications.2018; 497(4): 1003. CrossRef
Real-World Treatment Patterns, Survival, and Prediction of CNS Progression in ALK-Positive Non-Small-Cell Lung Cancer Patients Treated with First-Line Crizotinib in Latin America Oncology Practices
Claudio Martín, Andrés F. Cardona, Zyanya Lucia Zatarain-Barrón, Alejandro Ruiz-Patiño, Omar Castillo, George Oblitas, Luis Corrales, Lorena Lupinacci, María Angelina Pérez, Leonardo Rojas, Lisde González, Luis Chirinos, Carlos Ortíz, Mauricio Lema, Carlo
Oncology.2018; 94(5): 297. CrossRef
CRISPR therapeutic tools for complex genetic disorders and cancer (Review)
Stella Baliou, Maria Adamaki, Anthony Kyriakopoulos, Demetrios Spandidos, Michalis Panagiotidis, Ioannis Christodoulou, Vassilis Zoumpourlis
International Journal of Oncology.2018;[Epub] CrossRef

15,794 View
704 Download
42 Web of Science
37 Crossref

Pemetrexed Continuation Maintenance in Patients with Nonsquamous Non-small Cell Lung Cancer: Review of Two East Asian Trials in Reference to PARAMOUNT: James Chin-Hsin Yang, Myung-Ju Ahn, Kazuhiko Nakagawa, Tomohide Tamura, Helen Barraclough, Sotaro Enatsu, Rebecca Cheng, Mauro Orlando; Cancer Res Treat. 2015;47(3):424-435. Published online September 15, 2014; DOI: https://doi.org/10.4143/crt.2013.266

Abstract PDF PubReader ePub

Purpose
A recent phase III study (PARAMOUNT) demonstrated that pemetrexed continuation maintenance therapy is a new treatment paradigm for advanced nonsquamous non-small cell lung cancer (NSCLC). The majority of patients enrolled in PARAMOUNT were Caucasian (94%). We reviewed efficacy and safety data from two clinical trials, which enrolled East Asian (EA) patients, to supplement data from PARAMOUNT on pemetrexed continuation maintenance therapy in patients with nonsquamous NSCLC. Materials and Methods Study S110 was a phase II, multicenter, randomized, controlled, open-label trial in never-smoker, chemonaïve, EA patients (n=31) with locally advanced or metastatic nonsquamous NSCLC (n=27). Study JMII was a multicenter, open-label, single-arm, postmarketing, clinical trial in Japanese patients (n=109) with advanced nonsquamous NSCLC. PARAMOUNT was a multicenter, randomized, double-blind, placebo-controlled trial in patients with advanced nonsquamous NSCLC. Results In EA patients with nonsquamous NSCLC, the median progression-free survival (PFS) for pemetrexed continuation maintenance therapy was 4.04 months (95% confidence interval [CI], 3.22 to 5.29 months) in study S110 and 3.9 months (95% CI, 3.2 to 5.2 months) in study JMII. The median PFS for pemetrexed continuation maintenance therapy in PARAMOUNT was 4.1 months (95% CI, 3.2 to 4.6 months). Pemetrexed continuation maintenance therapy in EA patients in studies S110 and JMII did not lead to any unexpected safety events, and was consistent with PARAMOUNT’s safety profile. Conclusion The efficacy and safety data in the EA trials were similar to those in PARAMOUNT despite differences in patient populations and study designs. These data represent consistent evidence for pemetrexed continuation maintenance therapy in EA patients with advanced nonsquamous NSCLC.

Citations

Citations to this article as recorded by

Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial
Caicun Zhou, Gongyan Chen, Yunchao Huang, Jianying Zhou, LiZhu Lin, Jifeng Feng, Zhehai Wang, Yongqian Shu, Jianhua Shi, Yi Hu, QiMing Wang, Ying Cheng, Fengying Wu, Jianhua Chen, Xiaoyan Lin, Yongsheng Wang, Jianan Huang, Jiuwei Cui, Lejie Cao, Yunpeng L
The Lancet Respiratory Medicine.2021; 9(3): 305. CrossRef
Survival Benefit and Genetic Profile of Pemetrexed as Initial Chemotherapy in Selected Chinese Patients With Advanced Lung Adenocarcinoma
Long-Hua Guo, Ming-Feng Zhang, He-Long Zhang, Jian-Ying Zhou, Xiao-Hong Cai, Yu Long, Qi-Sen Guo, Nong Yang, Jun Zhao, Zhan-Hong Xie, Bo Jiang, Ying Zhu, Yun Fan, Cong-Ying Xie, Yi Hu, Yu Yao, Jun Jia, Xiao-Ling Li, Jiu-Wei Cui, Xi-Zhao Sui, Wen Lin, Ying
Frontiers in Oncology.2020;[Epub] CrossRef
Effect of pemetrexed on brain metastases from nonsmall cell lung cancer with wild-type and unknown EGFR status
Xiaoqing Yu, Yun Fan
Medicine.2019; 98(3): e14110. CrossRef
Best Practices in Treatment Selection for Patients with Advanced NSCLC
Mark A. Socinski, Nathan A. Pennell
Cancer Control.2016; 23(4_suppl): 2. CrossRef

13,858 View
103 Download
4 Web of Science
4 Crossref

Author index