Trial reportThe oncologist2022
A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study.
Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 9 papers.
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
9 citing papers in PubMed, 11 citations in OpenAlex.
- Efficacy and safety findings of the EXTRA study in older adult EGFR-mutant lung cancer patients receiving afatinib as first-line treatment.Scientific reports · 2026Article
- Two Cases of Epidermal Growth Factor Receptor L861R Mutation-Positive Lung Adenocarcinoma Treated With Osimertinib and Afatinib.Cancer reports (Hoboken, N.J.) · 2025Article
- [Research Status and Progress of Third-generation EGFR-TKIs in Elderly Patients with Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025Review
- Clinical Impact of Osimertinib Dose Reduction in the First-Line Setting on EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Retrospective Monocentric Study.OncoTargets and therapy · 2025Article
- Epidermal growth factor receptor-mutated lung carcinomas with insufficient response to epidermal growth factor receptor inhibitors.Future oncology (London, England) · 2024Review
- First-line osimertinib for patients with EGFR-mutated advanced non-small cell lung cancer: efficacy and safety during the COVID-19 pandemic.Translational lung cancer research · 2023Article
- Fatal ventricular arrhythmias after osimertinib treatment for lung adenocarcinoma: a case report.Journal of geriatric cardiology : JGC · 2023Article
- Development and internal validation of a nomogram for predicting survival of nonoperative EGFR-positive locally advanced elderly esophageal cancers.Frontiers in oncology · 2023Article
- Disproportionality Analysis of Osimertinib-related Adverse Events in Elderly Patients Using the Japanese Pharmacovigilance Database.Cancer diagnosis & prognosisArticle
Corrections and comments
- Erratum issued
Authors and funding
23 authors at 19 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOsimertinib is one of the standard first-line treatments for advanced non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations, because it achieves significantly longer progression-free survival (PFS) than conventional first-line treatments (hazard ratio: 0.46). However, the efficacy and safety of osimertinib as a first-line treatment for patients aged ≥75 years remain unclear.
methodsThis phase II study was performed to prospectively investigate the efficacy and safety of osimertinib for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. The primary endpoint was 1-year PFS rate; secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety.
resultsThirty-eight patients were included in the analysis. The 1-year PFS rate was 59.4% (95% confidence interval [CI], 46.1%-72.7%), which did not meet the primary endpoint (the threshold 1-year PFS rate of 50% predicted using data from the NEJ003 study). The most common grade 3/4 adverse events were rash/dermatitis acneiform/ALT increased/hypokalemia (2 patients, 5%). Seven patients developed pneumonitis (17.5%). There were no other cases of treatment discontinuation due to adverse events other than pneumonitis.
conclusionAlthough this study did not meet the primary endpoint, osimertinib was tolerable for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. (Japan Registry of Clinical Trials [JRCT] ID number: jRCTs071180007).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.