P1.01-11 Named Patient Use Program for Afatinib in Advanced NSCLC with Progression on Prior Therapy: Experience from Asian Centers

Chang, Gee‐Chen; Lam, Clk; Tsai, Chun‐Ming; Chen, Y.; Shih, Jin‐Yuan; Aggarwal, Shyam; Wang, S.; Kim, S.; Kim, Y.; Wahid, I.; Li, R.; Lim, Wan-Teck; Sriuranpong, Virote; Chan, TK; Lorence, Robert M.; Carrière, Philippe; Raabe, Christina; Cseh, A.; Park, K.

doi:10.1016/j.jtho.2018.08.567

Cited by 3 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…No comparative studies were identified, but rather, nine single-arm phase I/II trials (range 11–115 patients) [ 40 , 42 , 43 , 45 – 47 , 49 , 52 , 53 ] two prospective cohort studies (29 and 35 patients) [ 23 , 29 , 39 ], two pooled analyses of clinical trials (21 and 23 patients) [ 21 , 48 ], and 22 retrospective observational studies (range 15–165 patients). Half of the studies (n = 16) reported on subgroups or select cohorts of patients with Exon 20ins from studies with broader study populations, and half were conducted in Asia (n = 14), followed by the US (n = 8).…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Epidemiological and clinical burden of EGFR Exon 20 insertion in advanced non-small cell lung cancer: A systematic literature review

Burnett¹,

Emich

Carroll

et al. 2021

PLoS ONE

View full text Add to dashboard Cite

Objectives The burden of epidermal growth factor receptor (EGFR) exon 20 insertion mutation (Exon 20ins) in non-small cell lung cancer is not well understood. A systematic review was conducted to identify evidence on mutation frequency, prognostic impact, clinical, patient-reported, and economic outcomes associated with Exon 20ins. Materials and methods Searches were conducted in Embase and Medline and supplemented with recent conference proceedings. Included studies were not limited by intervention, geography, or publication year. Results Seventy-eight unique studies were included; 53 reporting mutation frequency, 13 prognostic impact, 36 clinical outcomes, and one humanistic burden. No economic burden data were identified. The frequency of Exon 20ins mutation ranged from 0.1% to 4% of all NSCLC cases and 1% to 12% of all EGFR mutations. Data on the prognostic impact of Exon 20ins were heterogeneous but highlighted poorer outcomes in patients with Exon 20ins mutation compared with patients with other EGFR mutations and EGFR wildtype across a wide range of therapies and treatment lines. Comparative evidence on the clinical efficacy and safety of currently available therapies were limited, as were sample sizes of studies reporting on real-world effectiveness. Nine single-arm trials and 27 observational studies reported clinical outcomes for patients with Exon 20ins. Trends towards better survival and response were observed for chemotherapy compared with TKIs as first-line treatments. For subsequent treatment lines, novel targeted therapies provided encouraging preliminary responses while results for chemotherapy were less favorable. Limited safety data were reported. One conference abstract described the symptom burden for Exon 20ins patients with fatigue and pain being most common. Conclusion Findings of the systematic review show a high unmet need for safe and efficacious treatments for patients with Exon 20ins as well and need for further evidence generation to better understand the patient-level and economic impact for these patients.

show abstract

Section: Resultsmentioning

confidence: 99%

“…Sixteen studies (reported across 21 publications) reported the clinical efficacy/effectiveness and safety of various subsequent-line treatment regimens in patients with Exon 20ins, but based on very limited sample sizes (range 11–165 patients) [ 10 , 23 , 24 , 29 , 30 , 37 , 39 – 44 , 45 – 53 ].…”

Section: Resultsmentioning

confidence: 99%

Epidemiological and clinical burden of EGFR Exon 20 insertion in advanced non-small cell lung cancer: A systematic literature review

Burnett¹,

Emich

Carroll

et al. 2021

PLoS ONE

View full text Add to dashboard Cite

show abstract

Experience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung cancer who had progressed following prior therapies, including patients with uncommon EGFR mutations

et al. 2021

View full text Add to dashboard Cite

Background This study evaluated outcomes among patients with advanced/metastatic non-small-cell lung cancer (NSCLC) treated at Asian centers participating in the global named-patient-use (NPU) program for afatinib. Methods Patients had progressed after initial benefit with erlotinib or gefitinib, and/or had an EGFR or HER2 mutation, had no other treatment options, and were ineligible for afatinib trials. The recommended starting dose of afatinib was 50 mg/day. Dose modifications were allowed, and afatinib was continued as long as deemed beneficial. Response and survival information was provided voluntarily. Safety reporting was mandatory. Results 2242 patients (26% aged ≥ 70 years, 96% with adenocarcinoma) received afatinib at centers in 10 Asian countries. Most were heavily pre-treated, including prior treatment with erlotinib or gefitinib. Of 1281 patients tested, 1240 had EGFR mutations (common: 1034/1101; uncommon: 117/1101). There were no new safety signals, the most common adverse events being rash and diarrhea. Objective response rate (ORR) was 24% overall (n = 431 with data available), 27% for patients with common EGFR mutations (n = 230) and 28% for those with uncommon mutations (n = 32); median time to treatment failure (TTF) in these groups was 7.6 months (n = 1550), 6.4 months (n = 692) and 8.4 months (n = 83), respectively. In patients with EGFR exon 20 insertions (n = 23) and HER2 mutations (n = 12), median TTF exceeded 12 months. Conclusions Patient outcomes in this study were similar to those reported in the analysis of the global NPU. Afatinib achieved clinical benefits in patients with refractory NSCLC. ORR and TTF were similar between patients with tumors harboring uncommon and common EGFR mutations.

show abstract

Uncommon EGFR mutations in non-small-cell lung cancer: A systematic literature review of prevalence and clinical outcomes

John¹,

Taylor²,

Wang³

et al. 2022

Cancer Epidemiology

View full text Add to dashboard Cite

P1.01-11 Named Patient Use Program for Afatinib in Advanced NSCLC with Progression on Prior Therapy: Experience from Asian Centers

Cited by 3 publications

References 0 publications

Epidemiological and clinical burden of EGFR Exon 20 insertion in advanced non-small cell lung cancer: A systematic literature review

Epidemiological and clinical burden of EGFR Exon 20 insertion in advanced non-small cell lung cancer: A systematic literature review

Experience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung cancer who had progressed following prior therapies, including patients with uncommon EGFR mutations

Uncommon EGFR mutations in non-small-cell lung cancer: A systematic literature review of prevalence and clinical outcomes

Contact Info

Product

Resources

About