Real-World Data on Prognostic Factors for Overall Survival in EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer Patients Treated with First-Line Gefitinib

Yao, Zong‐Han; Liao, Wen-Chieh; Ho, Chao‐Chi; Chen, Kuan‐Yu; Shih, Jin‐Yuan; Chen, Jin‐Shing; Lin, Zhong‐Zhe; Lin, Chia‐Chi; Yang, James Chih‐Hsin

doi:10.1634/theoncologist.2016-0331

Cited by 30 publications

(26 citation statements)

References 40 publications

(45 reference statements)

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“…Our previous report found that in the era in which only gefitinib was reimbursed by the Taiwan NHI, 33.2% of gefitinib-treated patients had M1a disease and 27.9% had brain metastasis. The median PFS of firstline gefitinib-treated patients was 11.9 months in that report, 29 shorter than the PFS in this cohort, and this supported our hypothesis. The recent prospective CTONG 0901 trial has already revealed a long median erlotinib PFS of 13.0 months.…”

Section: Discussionsupporting

confidence: 89%

Clinical outcomes and secondary epidermal growth factor receptor (EGFR) T790M mutation among first‐line gefitinib, erlotinib and afatinib‐treated non‐small cell lung cancer patients with activating EGFR mutations

Lin

Chen

Liao

et al. 2019

Intl Journal of Cancer

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Gefitinib, erlotinib and afatinib are approved for first‐line treatment of advanced non‐small cell lung cancer (NSCLC) bearing an activating epidermal growth factor receptor (EGFR) mutation. However, the clinical outcomes among the three EGFR tyrosine kinase inhibitors (TKIs) are still controversial. We aimed to evaluate clinical outcomes and secondary EGFR T790M mutation among the three EGFR TKIs. From May 2014 to January 2016, a total of 301 patients received treatment with gefitinib, erlotinib or afatinib, for first‐line treatment of advanced NSCLC with an activating EGFR mutation, based on their clinicians’ choice. The median overall survival (OS) was 37.0 months. Although the baseline characteristics of patients were unequal, progression‐free survival and OS did not differ among the 3 groups. Multivariate analysis found that gefitinib (adjusted odds ratio [aOR] 3.29, 95% confidence interval [CI], 1.15–9.46, p = 0.027), EGFR TKI treatment duration more than 13 months (aOR 3.16, 95% CI, 1.20–8.33, p = 0.020), male (aOR 3.25, 95% CI, 1.10–9.66, p = 0.034), initial liver metastasis (aOR 4.97, 95% CI 1.18–20.96, p = 0.029) and uncommon EGFR mutation (aOR 0.14, 95% CI, 0.02–0.97, compared to EGFR deletion 19, p = 0.047) were independent factors for secondary T790M mutation. In real‐world practice, choosing first line EGFR TKI based on the patients’ clinical characteristics yielded good clinical outcomes. First‐line gefitinib, longer EGFR TKI treatment duration, male, initial liver metastasis and uncommon EGFR mutations may be independent factors for secondary EGFR T790M mutation.

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Section: Discussionsupporting

confidence: 89%

Clinical outcomes and secondary epidermal growth factor receptor (EGFR) T790M mutation among first‐line gefitinib, erlotinib and afatinib‐treated non‐small cell lung cancer patients with activating EGFR mutations

Lin

Chen

Liao

et al. 2019

Intl Journal of Cancer

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“…Among the different sites of extracranial metastases, concomitant liver metastases were also associated with shorter OS in our analysis. This finding was consistent with the fact that liver metastases have also been observed as a predictor of poorer prognosis in a few retrospective studies despite the patients in those studies receiving different first-line treatments [26, 27].…”

Section: Discussionsupporting

confidence: 88%

“…Thus, some physicians may prefer to use erlotinib to treat BM before the use of afatinib has been validated. Nevertheless, one retrospective study found that BM at initial diagnosis had no impact on OS in EGFR mutation-positive patients treated with first-line gefitinib [26]. A subgroup analysis of the LUX-Lung 3 and LUX-Lung 6 studies disclosed that afatinib significantly improved the PFS (8.2 versus 5.4 months; HR, 0.50; p = 0.0297) and objective response rate versus chemotherapy in patients with BM [33].…”

Section: Discussionmentioning

confidence: 99%

Clinical factors associated with treatment outcomes in EGFR mutant non-small cell lung cancer patients with brain metastases: a case-control observational study

Chen

Shih

et al. 2019

BMC Cancer

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BackgroundNon-small cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations often develop brain metastases. Treatment with EGFR-tyrosine kinase inhibitors (TKIs) has shown the effectiveness; however, knowledge of the clinical factors associated with outcomes in NSCLC patients with EGFR mutations remains limited.MethodsTreatment-naive patients diagnosed with advanced non-squamous NSCLC with brain metastases harboring EGFR mutations and treated with an EGFR-TKI as first-line therapy were enrolled with analysis of their medical records.ResultsA total of 134 advanced NSCLC patients with brain metastases harboring EGFR mutations received an EGFR-TKI (gefitinib: 62, erlotinib: 49, and afatinib: 23) as the first-line therapy. Sixty-nine had exon 19 deletions (51.5%), and 56 (41.8%) had L858R mutations. There was no statistically significant difference in progression-free survival (PFS) and overall survival (OS) among the EGFR-TKIs. Significantly shorter OS was noted in patients with multiple brain metastases (hazard ratio [HR]: 2.43, p = 0.007), uncommon EGFR mutations (HR: 3.75, p = 0.009), and liver metastases. Thirty-eight patients (29.1%) received brain radiotherapy for brain metastases before disease progression, and had a significantly longer time until intracranial progression. However, the brain radiotherapy had no statistically significant impact on PFS or OS.ConclusionsPatients with uncommon mutations, multiple brain metastases, and concomitant liver metastases tended to have shorter OS. Brain radiotherapy could delay the time to intracranial disease progression but had no impact on survival. The different first-line EGFR-TKIs achieved similar treatment responses in terms of PFS and OS in the EGFR-mutated NSCLC patients with brain metastases.

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“…5 In a real-life Taiwanese study, the observed PFS and OS were 11.9 and 26.9 months, respectively. 37 Comparable to our results, in a Californian study, TKIs had the most prominent effect on OS among all the studied treatments in stage IV nonsquamous NSCLC patients. 38 We observed certain discrepancies between IREs for OS and PFS in various studied regimens (IRE for PFS was <1 but IRE for OS was >1 for pemetrexed, bevacizumab and bevacizumab maintenance).…”

Section: Discussionsupporting

confidence: 74%

Real‐life effectiveness of first‐line anticancer treatments in stage IIIB/IV NSCLC patients: Data from the Czech TULUNG Registry

et al. 2020

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Background Data regarding real‐life effectiveness of any treatment may improve clinical decision‐making. The aim of this study was to evaluate real‐life effectiveness of tyrosin‐kinase inhibitors, bevacizumab and pemetrexed as first‐line treatments in patients with advanced/metastatic non‐small cell lung cancer (NSCLC). Methods We analyzed data of 2157 patients of the Czech TULUNG Registry of patients with advanced/metastatic NSCLC who received modern‐era treatments between 2011 and 2018. Patients treated with gefitinib, erlotinib, afatinib, bevacizumab (+ maintenance), pemetrexed (+ maintenance) as first‐line therapy were included in the study. A systematic literature search separately identified clinical trials suitable for calculation of comparator pooled OS and PFS for each regimen. For each subgroup, basic characteristics and survival data (Kaplan‐Meier estimates) are shown. We propose the “index of real‐life effectiveness” (IRE), a ratio of real‐life OS/PFS and comparator pooled OS/PFS. Univariate and multivariate logistic regression identified factors were associated with longer OS (ie, IRE>1.1). Results Survival analysis showed median OS of 23 months for erlotinib, 29.3 months for afatinib, 19.6 months for gefitinib, 12.2 months for pemetrexed, 17.5 months for pemetrexed maintenance, 15.8 months for bevacizumab and 15.8 months for bevacizumab maintenance. Calculated IREs for OS for the regimens were: erlotinib 1.013, afatinib 1.184, gefitinib 0.736, pemetrexed 1.188, pemetrexed maintenance 1.294, bevacizumab 1.178, and bevacizumab maintenance 1.189. Multivariate regression analysis showed that these factors were associated with longer OS: lower PS for afatinib; lower PS, absence of adverse events and female sex for bevacizumab; and lower PS and female sex for pemetrexed. Conclusions This study clearly demonstrated that real‐life effectiveness of certain treatment regimens may strongly differ in various populations/health care systems, and comparison between TULUNG data and pooled survival data from trials showed higher real‐life effectiveness for most of the studied first‐line regimens. Lower ECOG PS, younger age, female sex and adverse events were associated with longer survival in most regimens. Key points Significant findings of the study Comparison between TULUNG data and pooled survival data from trials showed higher real‐life effectiveness for most of the studied first‐line regimens; for most regimens, lower ECOG PS, younger age, female sex and adverse events were associated with longer survival. What this study adds Real‐life effectiveness of certain treatment regimens may strongly differ in various populations/health care systems.

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Real-World Data on Prognostic Factors for Overall Survival in EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer Patients Treated with First-Line Gefitinib

Cited by 30 publications

References 40 publications

Clinical outcomes and secondary epidermal growth factor receptor (EGFR) T790M mutation among first‐line gefitinib, erlotinib and afatinib‐treated non‐small cell lung cancer patients with activating EGFR mutations

Clinical outcomes and secondary epidermal growth factor receptor (EGFR) T790M mutation among first‐line gefitinib, erlotinib and afatinib‐treated non‐small cell lung cancer patients with activating EGFR mutations

Clinical factors associated with treatment outcomes in EGFR mutant non-small cell lung cancer patients with brain metastases: a case-control observational study

Real‐life effectiveness of first‐line anticancer treatments in stage IIIB/IV NSCLC patients: Data from the Czech TULUNG Registry

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