Trial reportBMC cancer2016
Efficacy and safety of afatinib in Chinese patients with EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) previously responsive to first-generation tyrosine-kinase inhibitors (TKI) and chemotherapy: comparison with historical cohort using erlotinib.
Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02625168 (Efficacy and Safety of Afatinib in Patients With EGFR-mutated Metastatic Non-small-cell Lung Cancer Previously Responsive to First-generation Tyrosine-kinase Inhibitors and Chemotherapy), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Efficacy and Safety of Afatinib in Patients With EGFR-mutated Metastatic Non-small-cell Lung Cancer Previously Responsive to First-generation Tyrosine-kinase Inhibitors and Chemotherapy
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Association of Hypokalemia Incidence and Better Treatment Response in NSCLC Patients: A Meta-Analysis and Systematic Review on Anti-EGFR Targeted Therapy Clinical Trials.Frontiers in oncology · 2021Pooled it
- Matching-adjusted indirect comparison of selpercatinib and pralsetinib inFuture oncology (London, England) · 2025Article
- Effectiveness of afatinib after long-term gefitinib treatment forRespiratory medicine case reports · 2025Article
- Rechallenge of afatinib forTranslational lung cancer research · 2023Article
- Clinical efficacy of dacomitinib in rechallenge setting for patients with epidermal growth factor receptor mutant non-small cell lung cancer: A multicenter retrospective analysis (TOPGAN2020-02).Thoracic cancer · 2022Article
- Survival analysis of afatinib versus erlotinib for individuals with advanced del19 lung adenocarcinoma with asymptomatic brain metastasis after pemetrexed-cisplatin chemotherapy: a retrospective study.The Journal of international medical research · 2020Article
- Real-world study of afatinib in first-line or re-challenge settings for patients with EGFR mutant non-small cell lung cancer.Medical oncology (Northwood, London, England) · 2019Article
- Osimertinib for Previously Treated Patients With Advanced EGFR T790M Mutation-Positive NSCLC: Tolerability and Diagnostic Methods From an Expanded Access Program.Oncology and therapy · 2018Article
- Clinical efficacy and safety of afatinib in the treatment of non-small-cell lung cancer in Chinese patients.OncoTargets and therapy · 2018Review
- Survival difference betweenChinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2017Article
- The efficacy and toxicity of afatinib in advanced EGFR-positive non-small-cell lung cancer patients after failure of first-generation tyrosine kinase inhibitors: a systematic review and meta-analysis.Journal of thoracic disease · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAfaitnib has shown anti-tumor activity against metastatic EGFR-mutated NSCLC after prior failure to first generation EGFR-TKI and chemotherapy. We prospectively evaluated the efficacy and safety of afatinib in Chinese patients who previously failed first-generation TKI and chemotherapy under a compassionate use program (CUP) and compared to the erlotinib cohort.
methodsPatients who suffered from metastatic EGFR-mutated NSCLC previously responsive to first-generation TKI and chemotherapy received afatinib until progression, loss of clinical benefits or intolerable toxicity. Treatment response, survival and safety were evaluated and compared to the erlotinib cohort.
resultsTwenty-five and 28 patients received afatinib and erlotinib respectively. More patients in the afatinib group had worse performance status (ECOG 2) than the erlotinib group (p = 0.008). After a median follow-up of 12.1 months, afatinib demonstrated comparable objective response rate (ORR) (20.0% vs. 7.1%, p = 0.17) but significantly higher disease control rate (DCR) (68.0% vs. 39.3%, p = 0.04) compared to erlotinib. Median progression-free survival (PFS) (4.1 months [95% CI, 2.7-5.5 months] vs. 3.3 months [95% CI, 2.2-4.3 months], p = 0.97) and overall survival (OS) were not different between the two groups (10.3 months [95% CI, 7.5-13.0 months] vs. 10.8 months [95% CI, 7.4-14.2 months], p = 0.51). Multivariate analyses revealed that age ≤ 70 years and time to progression (TTP) ≥ 18 months for the 1st TKI therapy were prognostic of PFS (p = 0.006 and p = 0.008 respectively). Afatinib caused less rash (60.0% vs. 67.9%, p = 0.04) but more diarrhea (60.0% vs. 10.7%, p = 0.002) compared to erlotinib.
conclusionAfatinib produced encouraging clinical efficacy as 2nd TKI therapy with manageable safety profiles in our Chinese patients after failure to another TKI and systemic chemotherapy. This study was registered at ClinicalTrials.gov (NCT02625168) on 3rd December 2015.
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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.