The clinical efficacy of Afatinib 30 mg daily as starting dose may not be inferior to Afatinib 40 mg daily in patients with stage IV lung Adenocarcinoma harboring exon 19 or exon 21 mutations

Yang, Chih‐Jen; Tsai, Ming‐Ju; Hung, Jen‐Yu; Lee, Hsuan-Shu; Tsai, Ying‐Ming; Tsai, Yu-Chen; Hsu, Jen‐Fu; Liu, Ta-Chih; Huang, Ming‐Shyan; Chong, Inn‐Wen

doi:10.1186/s40360-017-0190-1

Cited by 38 publications

(79 citation statements)

References 22 publications

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“…These outcomes may lead to a tendency in clinical practice to prescribe afatinib to patients with 19del mutations. Several real‐world studies have also demonstrated this tendency and reported longer median PFS in common EGFR mutation groups . Kim et al revealed that in a subgroup of patients with 19del mutations, the median PFS of afatinib was significantly superior to gefitinib or erlotinib (19.1 vs. 15.0 and 16.3 months, respectively; P = 0.01).…”

Section: Discussionmentioning

confidence: 89%

“…Several real-world studies have also demonstrated this tendency and reported longer median PFS in common EGFR mutation groups. [19][20][21] Kim et al revealed that in a subgroup of patients with 19del mutations, the median PFS of afatinib was significantly superior to gefitinib or erlotinib (19.1 vs. 15.0 and 16.3 months, respectively; P = 0.01). However, there was no such significant difference in the L858R subgroup (P = 0.46).…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of afatinib in a Chinese population with advanced lung adenocarcinoma with sensitive EGFR mutations

et al. 2019

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Background Afatinib is an irreversible ErbB family blocker that improves progression‐free survival (PFS) of advanced EGFR ‐mutant lung adenocarcinoma compared to chemotherapy. However, afatinib leads to more adverse events than first‐generation EGFR inhibitors. Hence, exploration of the optimal afatinib initial dose and its efficacy and safety in Asian patients has drawn extensive attention. Methods We retrospectively evaluated demographic and clinical information, survival data, and adverse events in advanced non‐small cell lung cancer patients treated with afatinib from 27 February 2017 to 30 October 2018. Results A total of 60 patients were included in the study. Thirty‐nine (65%) patients received afatinib as first‐line treatment. The median PFS was 12.3 months (95% confidence internal 7.6–17.0). Multivariate Cox regression analysis revealed that age, gender, smoking history, baseline brain metastasis status, afatinib starting dose, and mutation type did not significantly influence PFS. No significant difference in median PFS between patients treated with an initial dose of afatinib of 40 mg or 30 mg, either in the first‐line (14.5 vs. 5.2 months; P = 0.101) or in a second or later‐line setting (3.0 vs. 5.0 months; P = 0.375) was observed. The incidence of all grades of rash/acne (92.5% vs. 61.1%; P = 0.011) and paronychia (82.5% vs. 50.0%; P = 0.010) in the 40 mg group was significantly higher than in the 30 mg group. Conclusion First‐line afatinib treatment is beneficial for advanced lung adenocarcinoma patients with sensitive EGFR mutations. Initial dose and baseline brain metastasis status do not significantly impact PFS.

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Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of afatinib in a Chinese population with advanced lung adenocarcinoma with sensitive EGFR mutations

et al. 2019

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“…An important clinical problem is that afatinib has high rates of severe AEs including grade 3–4 diarrhea, skin rash, and paronychia that led to treatment discontinuation . Recently, a dose reduction of afatinib to <40 mg was found to have no effect on its efficacy in EGFR 19del and L858R mutation‐positive NSCLC . Afatinib plasma concentrations were not significantly different between patients with a dose reduction to 30 mg/day and with 40 mg/day.…”

Section: Discussionmentioning

confidence: 99%

Successful treatment of an elderly patient with an uncommon L861Q epidermal growth factor receptor mutation with low‐dose afatinib: A case report

et al. 2019

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There are limited data on the clinical efficiency of afatinib in non-small cell lung cancer (NSCLC) patients with uncommon epidermal growth factor receptor (EGFR) mutations. Moreover, the efficacy and safety of afatinib in elderly patients with these mutations has not been established. Here, we describe a case of successful treatment of a patient aged >80 years with lung adenocarcinoma positive for the uncommon EGFR L861Q mutation with low-dose afatinib. An 83-year-old woman presented with cough and dyspnea. A chest computed tomography (CT) scan revealed tumors in the left upper lobe, left pleural effusion, and multiple lung metastases in both lungs. The patient was diagnosed with lung adenocarcinoma with an EGFR L861Q mutation based on cytological findings. The patient received 30 mg/day of afatinib and experienced no severe adverse events. Two weeks later, partial response was observed based on a CT scan. The results of the present case support the effectiveness and safety of lowdose afatinib in elderly patients with EGFR L861Q mutation-positive NSCLC.

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“…Our preliminary report, a very small-scale study that only enrolled 48 patients with different starting doses, showed that patients who received 30 mg afatinib as the starting dose had non-inferior PFS with fewer severe ADRs [23]. We believe that fewer adverse events, especially fewer severe ADRs will result in good drug compliance and a better quality of life during lung cancer treatment [24].…”

Section: Introductionmentioning

confidence: 90%

Lower Starting Dose of Afatinib for the Treatment of Metastatic Lung Adenocarcinoma Harboring Exon 21 and Exon 19 Mutations

Chen

Tsai

Lee

et al. 2020

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BackgroundAfatinib has shown favorable response rates (RRs) and longer progression free survival (PFS) in lung cancer patients harboring EGFR mutations compared with standard platinum-based chemotherapy. However, serious adverse drug reactions (ADRs) limit the clinical application of afatinib. MethodsWe designed a retrospective study, enrolled all patients with metastatic lung adenocarcinoma who were diagnosed and treated with 30 or 40 mg afatinib as their starting dose in three Kaohsiung Medical University-affiliated hospitals in TaiwanResultsA total of 179 patients were enrolled in the study, of which 102 (57%) and 77 (43%) received 30 mg and 40 mg afatinib daily as their initial treatment, respectively. The patients initially using 30 mg afatinib daily had a similar RR (74% vs. 82%, p = 0.1661), median PFS (14.5 months vs. 14.80 months, log-rank p = 0.465) and median OS (34 months vs 25.2 months, log-rank p = 0.5982) compared with those initially using 40 mg afatinib daily. Patients with the lower starting dose had fewer ADRs compared with patients receiving 40 mg as their starting dose. The overall incidence of moderate (49% vs 77%, p=0.002) or severe (7% vs 24%, p<0.0001) ADRs was significantly lower in patients receiving 30 mg afatinib compared with those receiving 40 mg. ConclusionPatients receiving 30 mg afatinib as their starting dose had non-inferior RRs, PFS, OS and significantly fewer serious ADRs compared with those patients who received standard 40 mg afatinib as their starting dose.

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The clinical efficacy of Afatinib 30 mg daily as starting dose may not be inferior to Afatinib 40 mg daily in patients with stage IV lung Adenocarcinoma harboring exon 19 or exon 21 mutations

Cited by 38 publications

References 22 publications

Efficacy and safety of afatinib in a Chinese population with advanced lung adenocarcinoma with sensitive EGFR mutations

Efficacy and safety of afatinib in a Chinese population with advanced lung adenocarcinoma with sensitive EGFR mutations

Successful treatment of an elderly patient with an uncommon L861Q epidermal growth factor receptor mutation with low‐dose afatinib: A case report

Lower Starting Dose of Afatinib for the Treatment of Metastatic Lung Adenocarcinoma Harboring Exon 21 and Exon 19 Mutations

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