ArticleCancer science2019
Safety and effectiveness of alectinib in a real-world surveillance study in patients with ALK-positive non-small-cell lung cancer in Japan.
Article in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Management of Patients with Non-Small Cell Lung Cancer, Brain Metastases, and Actionable Genomic Alterations: A Systematic Literature Review.Advances in therapy · 2024Pooled it
- Comparative Treatment Outcomes Across Actionable Genomic Alterations in NSCLC: A Large Multicenter Real-World Study.JTO clinical and research reports · 2026Article
- International Consensus on Severe Lung Cancer-The Second Edition.Translational lung cancer research · 2026Review
- Global regulatory variability in small-molecule inhibitor approvals: Differences in timelines, dosing, and pediatric indications across FDA, EMA, and PMDA.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Multi-tyrosine kinase inhibitors: exploring immunomodulatory effects on various immune cell types in cancer.Cancer cell international · 2026Review
- Real-world first-line outcomes of alectinib and brigatinib in anaplastic lymphoma kinase-positive non-small cell lung cancer: a nationwide South Korean cohort study using the health insurance review and assessment data.Translational lung cancer research · 2025Article
- [Research Progress of Anti-lung Cancer Drug-related Interstitial Lung Disease].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025Review
- Article
- Progression patterns, resistant mechanisms and subsequent therapy for ALK-positive NSCLC in the era of second-generation ALK-TKIs.Journal of translational medicine · 2024Article
- Real-World Data Presenting the Descriptive Analysis of the Use of Tyrosine Kinase Inhibitors (TKIs) Among Metastatic Non-Small-Cell Lung Cancer (mNSCLC) Patients in Qatar: A Nationwide Retrospective Cohort Study.Clinical Medicine Insights. Oncology · 2024Article
- Review
- Real-world therapeutic effectiveness of lorlatinib after alectinib in Japanese patients with ALK-positive non-small-cell lung cancer.Cancer science · 2023Observational
- Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring.Current oncology (Toronto, Ont.) · 2023Article
- First-Line Anaplastic Lymphoma Kinase (ALK) Inhibitors for ALK-Positive Lung Cancer in Asian Populations: Systematic Review and Network Meta-Analysis.Journal of clinical medicine · 2021Review
- International consensus on severe lung cancer-the first edition.Translational lung cancer research · 2021Review
- Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Prior Therapies Work Group.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Article
- Treatment of Brain Metastases of Non-Small Cell Lung Carcinoma.International journal of molecular sciences · 2021Review
- Treatment Sequencing for Anaplastic Lymphoma Kinase-Rearranged Non-Small-Cell Lung Cancer.Drugs · 2021Review
- Clinical efficacy and safety of crizotinib and alectinib in ALK-positive non-small cell lung cancer treatment and predictive value of CEA and CA125 for treatment efficacy.American journal of translational research · 2021Article
- Patients with high-grade alectinib-induced skin rash: How do we desensitize these patients? A case report and review of literature.SAGE open medical case reports · 2020Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
We conducted a large-scale surveillance study as a post-marketing commitment to investigate the safety and effectiveness of alectinib in patients with ALK-positive non-small-cell lung cancer (NSCLC) in Japan. Patients receiving 300 mg twice-daily alectinib (September 2014 to June 2015) were monitored until termination of alectinib or completion of 18 months of treatment at 519 Japanese study sites. The primary endpoint was the incidence of adverse drug reactions (ADR), which are important identified risks for alectinib in Japanese patients. Overall survival (OS), a key secondary endpoint, was assessed according to information on outcome. Overall, 1251 patients were enrolled. The median patient age was 62.0 years; 12.9% of patients were aged ≥75 years. At baseline, 63.0% of patients had received crizotinib and 40.6% had brain metastases. Altogether, 1512 ADR occurred in 654 patients (53.6%), with 164 grade ≥3 ADR in 123 patients (10.1%). Commonly occurring ADR were hepatic disorders (all grades, 19.8%; grade ≥3, 2.0%), decreased neutrophil and/or white blood cell count (all grades, 7.6%; grade ≥3, 1.1%), and interstitial lung disease (all grades, 3.8%; grade ≥3, .7%). Median OS was not estimable. The 18-month cumulative OS rate was longer in patients with ECOG performance status ≤1 (vs 2 or ≥3; 83.7% vs 44.5% or 27.2%), without prior crizotinib (vs with; 81.1% vs 73.4%), receiving first-line alectinib (vs second and third or later line; 83.0% vs 79.2% or 71.9%), without brain metastases (vs with; 79.5% vs 71.5%). These data confirm the favorable safety and effectiveness of alectinib in patients with ALK-positive NSCLC in Japan.
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