Trial reportCancer science2014
Final safety and efficacy of erlotinib in the phase 4 POLARSTAR surveillance study of 10 708 Japanese patients with non-small-cell lung cancer.
Trial report in Cancer science, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Interstitial lung disease epidemiology and etiology in patients with solid malignant tumors: a systematic literature review.Future oncology (London, England) · 2025Pooled it
- Pooled it
- Eye, hepatobiliary, and renal disorders of erlotinib in patients with non-small-cell lung cancer: A meta-analysis.PloS one · 2020Pooled it
- Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan.Japanese journal of clinical oncology · 2020Trial
- Osimertinib for Japanese patients with T790M-positive advanced non-small-cell lung cancer: A pooled subgroup analysis.Cancer science · 2019Trial
- Safety evaluation of afatinib in patients with a history of interstitial lung disease using data from an administrative claims database in Japan.International journal of clinical pharmacy · 2026Article
- Clinical features, diagnosis, and outcome of anaplastic lymphoma kinase tyrosine kinase inhibitors associated interstitial lung disease.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2026Article
- Real-world analysis of interstitial lung disease/pneumonitis in Japanese patients with breast cancer receiving trastuzumab deruxtecan.Breast cancer (Tokyo, Japan) · 2026Observational
- Observational
- Drug-induced interstitial lung disease caused by gefitinib in the treatment of non-small cell lung cancer: A case report.Molecular and clinical oncology · 2025Article
- Successful Switch to Afatinib and Osimertinib Rechallenge with Corticosteroids after Osimertinib-induced Interstitial Lung Disease: A Case Report and Literature Review.Internal medicine (Tokyo, Japan) · 2025Review
- Real-world incidence of and risk factors for abemaciclib-induced interstitial lung disease in Japan: a nested case-control study of abemaciclib-induced interstitial lung disease (NOSIDE).Breast cancer (Tokyo, Japan) · 2025Article
- Signals of interstitial lung disease with novel antineoplastic agents in ovarian cancer: a three-database disproportionality study.Frontiers in pharmacology · 2025Article
- The radiologist's role in detecting systemic anticancer therapy-related interstitial lung disease: an educational review.Insights into imaging · 2024Review
- Mesenchymal-epithelial Transition Exon 14-skipping Mutation-positive Invasive Mucinous Adenocarcinoma of the Lung: First Case Treated with Mesenchymal-epithelial Transition-tyrosine Kinase Inhibitors.Internal medicine (Tokyo, Japan) · 2024Article
- Real-World Data on Subsequent Therapy for First-Line Osimertinib-Induced Pneumonitis: Safety of EGFR-TKI Rechallenge (Osi-risk Study TORG-TG2101).Targeted oncology · 2024Article
- Successful osimertinib rechallenge without concomitant corticosteroids after osimertinib-induced pneumonitis.Respiratory medicine case reports · 2024Article
- Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021.Therapeutic advances in drug safety · 2024Article
- Managing the Risk of Lung Toxicity with Trastuzumab Deruxtecan (T-DXd): A Canadian Perspective.Current oncology (Toronto, Ont.) · 2023Review
- International expert consensus on diagnosis and treatment of lung cancer complicated by chronic obstructive pulmonary disease.Translational lung cancer research · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 14 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Interstitial lung disease (ILD) occurrence and risk factors were investigated in the Japanese non-small-cell lung cancer, post-marketing, large-scale surveillance study, POLARSTAR. All patients with unresectable, recurrent/advanced non-small-cell lung cancer who were treated with erlotinib in Japan between December 2007 and October 2009 were enrolled. Primary endpoints were patterns of ILD and risk factors for onset of ILD and ILD-related death. Overall survival, progression-free survival, and occurrence of adverse drug reactions were secondary endpoints. Interstitial lung disease was confirmed in 429 (4.3%) patients. Concurrent/previous ILD (hazard ratio, 3.19), emphysema or chronic obstructive pulmonary disease (hazard ratio, 1.86), lung infection (hazard ratio, 1.55), smoking history (hazard ratio, 2.23), and period from initial cancer diagnosis to the start of treatment (<360 days; hazard ratio, 0.58) were identified as significant risk factors for developing ILD by Cox multivariate analysis. Logistic regression analysis identified Eastern Cooperative Oncology Group performance status 2-4 (odds ratio, 2.45 [95% confidence interval, 1.41-4.27]; P = 0.0016), ≤50% remaining normal lung area (odds ratio, 3.12 [1.48-6.58]; P = 0.0029), and concomitant honeycombing with interstitial pneumonia (odds ratio, 6.67 [1.35-32.94]; P = 0.02) as poor prognostic factors for ILD death. Median overall survival was 277 days; median progression-free survival was 67 days. These data confirm the well-characterized safety profile of erlotinib. Interstitial lung disease is still an adverse drug reaction of interest in this population, and these results, including ILD risk factors, give helpful information for treatment selection and monitoring. Erlotinib efficacy was additionally confirmed in this population. (POLARSTAR trial ML21590.).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.