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Real-world data: evidence of the efficacy and safety of afatinib in clinical practice
Real-world data from patients in Austria, Canada, Japan, South Korea and Taiwan provide evidence of the efficacy and safety of afatinib* in the treatment of non-small cell lung cancer (NSCLC) in clinical practice. Objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) data were comparable or better than in the LUX-Lung 3, LUX-Lung 6 and LUX-Lung 7 clinical trials, and there were no new safety signals. Efficacy data for patients with brain metastases and patients with uncommon epidermal growth factor receptor (EGFR) mutations have also been reported. Dose adjustments were necessary in many patients but did not affect efficacy.
Afatinib in Japanese patients with EGFR mutation-positive NSCLC
In a prospective, post-marketing observational study in 1,602 Japanese patients with inoperable or recurrent EGFR mutation-positive NSCLC (40.1%, 46.1% and 13.8% of patients had an Eastern Cooperative Oncology Group performance status of 0, 1 and ≥2, respectively), ORR with afatinib was higher in EGFR tyrosine kinase inhibitor (TKI)-naïve patients than in patients who had previously been treated with EGFR TKIs (68% vs 21%).1 In EGFR TKI-naïve patients who started on a daily afatinib dose of 40 mg, ORR was 71% in those aged ≥75 years (n=49) and 74% in those aged <75 years (n=362).1 Adverse drug reactions were predictable, generally manageable and consistent with the known safety profile of afatinib.1
In another Japanese study in 128 patients with advanced EGFR mutation-positive NSCLC, 76 patients received first-line afatinib and 52 received afatinib following a first generation TKI.2 In patients treated with first-line afatinib, median PFS was 17.8 months (95% confidence interval [CI]: 13.7–21.5), median OS was 39.5 months (95% CI: 34.4–not estimable) and the response rate was 64%.2 Although 76% of these patients required a dose reduction due to adverse events (AEs), this did not impair efficacy.2 In all patients, the most common AEs leading to dose modification or treatment discontinuation were diarrhoea, paronychia and oral mucositis.2
Afatinib compared with gefitinib or erlotinib in Korean patients with EGFR mutation-positive NSCLC
A retrospective study was carried out in 467 Korean patients with recurrent or metastatic EGFR mutation-positive NSCLC who received first-line afatinib (n=165), gefitinib (n =230) or erlotinib (n=72).3 Overall, median PFS was significantly longer with afatinib versus gefitinib or erlotinib (19.1 [95% CI: 12.3–25.9], 13.7 [95% CI: 12.3–15.1] and 14.0 months [95% CI: 11.3–16.8], respectively; p=0.001; median follow up: 17.7 months).3
In afatinib-treated patients with brain metastases at baseline who had not received radiotherapy for brain tumours, median PFS was 15.7 months (n=39).4 Of these patients, 29 had follow-up magnetic resonance imaging data and 55% of these patients were described as having significantly decreased brain metastases with afatinib treatment.4
In patients with exon 19 deletions, median PFS with afatinib, gefitinib and erlotinib was 19.1, 15.0 and 16.3 months, respectively (p=0.01).3 However, in patients with L858R mutations, there was no significant difference in median PFS between treatment groups (p=0.46).3 In patients with uncommon EGFR mutations, median PFS was also longer with afatinib (median PFS had not been reached at the data cut-off) versus gefitinib (5.0 months) or erlotinib (6.1 months), but the difference did not reach statistical significance in this small sample (p=0.06; n=31).3
Overall toxicity profiles were comparable in the different groups but Grade 3 or 4 AEs were more frequent with afatinib (7%) versus gefitinib (3%) or erlotinib (2%).3 Common Grade 3 or 4 AEs in the afatinib group included diarrhoea (3%), paronychia (2%) and skin rash (2%).3 Dose reductions due to AEs were more frequent with afatinib (68%) versus gefitinib (2%) or erlotinib (6%). However, afatinib dose reduction did not impair efficacy (median PFS in dose reduction vs no dose reduction groups, 23.5 vs 12.4 months).3
PFS with afatinib, gefitinib or erlotinib in Korean patients with EGFR mutation-positive NSCLC
PFS, progression-free survival; TKI, tyrosine kinase inhibitor.
PFS in Korean patients with and without brain metastases
GKS, Gamma Knife surgery; PFS, progression-free survival; WBRT, whole-brain radiotherapy.
Clinical efficacy in relation to dose and EGFR mutation type in Taiwanese patients with advanced EGFR mutation-positive lung adenocarcinoma
A retrospective, observational study evaluated whether afatinib dose adjustment and EGFR mutation type affected clinical efficacy in Taiwanese patients with advanced EGFR mutation-positive lung adenocarcinoma (30% of patients had brain metastases; 23% had complex or rare EGFR mutations).5 Fifty-nine of 140 patients received an afatinib dose of <40 mg in the first 6 months of treatment; there was no significant difference in median PFS between the 40 mg and <40 mg groups (12.0 vs 11.0 months; hazard ration [HR]=0.84; 95% CI: 0.53–1.31; p>0.05).5 After excluding patients with exon 20 insertions from the analysis, there was no significant difference in median PFS between patients who had common EGFR mutations (del19/L858R; n=108) and those who had uncommon EGFR mutations (n=22; median PFS, 12.2 vs 11.5 months; HR=0.85; 95% CI: 0.47–1.53; p>0.05).5
PFS in relation to afatinib dose in Taiwanese patients
CI, confidence interval; HR, hazard ratio; PFS, progression-free survival.
PFS in relation to EGFR mutation type in Taiwanese patients (excluding patients with exon 20 insertions)
CI, confidence interval; HR, hazard ratio; PFS, progression-free survival.
Clinical efficacy in relation to EGFR mutation type and the presence or absence of brain metastases in Taiwanese patients with advanced EGFR mutation-positive NSCLC
In a retrospective study in 422 Taiwanese patients with advanced EGFR mutation-positive NSCLC, 104 patients received afatinib as first-line treatment.4 Of these patients, 56% had exon 19 mutations, 22% had L858R mutations and 22% had uncommon EGFR mutations.6 In patients who received afatinib, median PFS was 12.2 months in the overall patient group, 12.2 months in patients with exon 19 mutations, 11.7 months in patients with L858R mutations and 19.7 months in patients with uncommon EGFR mutations.6 Median PFS in patients with and without brain metastases at baseline was 9.9 and 13.1 months, respectively.6
First- compared with second-generation EGFR TKIs in Canadian patients with advanced EGFR mutation-positive NSCLC
In a retrospective study of 500 Canadian patients with advanced EGFR mutation-positive NSCLC, treatment with a second-generation EGFR TKI was associated with a longer OS than treatment with a first-generation EGFR TKI (median OS: 43 [n=110] vs 23 months [n=390]; HR=0.6; 95% CI: 0.4–0.8; p<0.01).7 The survival benefit favouring second-generation TKIs was significant in the overall patient cohort and in the exon 19 deletion patient cohort, but not the cohort with exon 21 L858R mutations.7 Skin and gastrointestinal side effects were common in patients receiving second-generation TKIs, but were manageable with dose reductions and only one patient discontinued treatment.7
Efficacy of first- compared with second-generation EGFR TKIs in Canadian patients with advanced EGFR mutation-positive NSCLC
CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio; TKI, tyrosine kinase inhibitor.
Therapeutic sequencing: the GioTag study of afatinib followed by osimertinib
GioTag is a retrospective study on sequential therapy with afatinib followed by osimertinib in patients with EGFR mutation-positive advanced NSCLC in a real-world setting.8 The primary objective is to determine the time on treatment with first-line afatinib followed by second-line osimertinib for patients who developed a T790M resistance mutation.8 The secondary objective is to collect data on the acquired resistance mechanism to osimertinib.8 This study is based on existing data from medical records of approximately 190 pre-selected patients in 11 countries. Click here for more information about GioTag.
GioTag study design
EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; PD, progressive disease.
Afatinib in patients with advanced NSCLC who progressed following prior therapies: results of a global named patient use programme
This afatinib named patient use programme included 5,622 patients with advanced/metastatic NSCLC from 49 countries.9 Data from 3,966 patients in 41 countries were analysed. All patients had progressed after clinical benefit on erlotinib or gefitinib and/or had a mutation in EGFR or HER2 and had exhausted all other treatment options. Median time to treatment failure with afatinib was 4.4 months in 2,862 patients for which data were available. 9 Of these, response assessments were available in 1,141 patients; ORR was 23.4% (267/1,141).9 In patients with an EGFR mutation, the ORR was 25.0% (181/723); ORR was 19.0% (11/58) in T790M mutation-positive patients and 35.0% (7/20) in patients with insertions in exon 20.9 The safety profile of afatinib was as expected in this patient population. Overall, these data suggest that afatinib can provide clinical benefit in heavily pretreated patients with NSCLC, including those with uncommon EGFR mutations.
Yamamoto N, et al. Poster presented at WCLC 2017 (Poster P3.01-035).
Tanaka H, et al. J Clin Oncol 2018;36 (Abstract e21173).
Kim Y, et al. Cancer Res Treat 2018 Jun 13. doi: 10.4143/crt.2018.117. [Epub ahead of print].
Kim Y, et al. Poster presented at WCLC 2017 (Poster P3.01-023).
Liang S-K, et al. Oncotarget 2017;8(52):90430–43.
Tu C-Y, et al. Oncotarget 2018;9(36):24237–47.
Lau S, et al. Poster presented at WCLC 2017 (Poster P3.01-015).
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT03370770 (Accessed: August 2018).
Cappuzzo F, et al. Future Oncol 2018;14(15):1477–86.
*Afatinib is approved in more than 80 markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list, please click here. Registration conditions differ internationally; please refer to locally approved prescribing information.
© 2018 Boehringer Ingelheim International GmbH. All rights reserved.
Last updated: October 2018
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