التفاصيل البيبلوغرافية
| العنوان: |
Afatinib in EGFR TKI-naïve patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer: Interim analysis of a Phase 3b study. |
| المؤلفون: |
de Marinis, Filippo1 (AUTHOR) Filippo.DeMarinis@ieo.it, Laktionov, Konstantin K.2 (AUTHOR), Poltoratskiy, Artem3 (AUTHOR), Egorova, Inna4 (AUTHOR), Hochmair, Maximilian5 (AUTHOR), Passaro, Antonio1 (AUTHOR), Migliorino, Maria Rita6 (AUTHOR), Metro, Giulio7 (AUTHOR), Gottfried, Maya8 (AUTHOR), Tsoi, Daphne9 (AUTHOR), Ostoros, Gyula10 (AUTHOR), Rizzato, Simona11 (AUTHOR), Mukhametshina, Guzel Z.12 (AUTHOR), Schumacher, Michael13 (AUTHOR), Novello, Silvia14 (AUTHOR), Dziadziuszko, Rafal15 (AUTHOR), Tang, Wenbo16 (AUTHOR), Clementi, Laura17 (AUTHOR), Cseh, Agnieszka18 (AUTHOR), Kowalski, Dariusz19 (AUTHOR) |
| المصدر: |
Lung Cancer (01695002). Feb2021, Vol. 152, p127-134. 8p. |
| مصطلحات موضوعية: |
*NON-small-cell lung carcinoma, *EPIDERMAL growth factor receptors, *PROTEIN-tyrosine kinases |
| مستخلص: |
• Interim data from a Phase 3b trial investigating afatinib in a real-world setting. • TKI-naïve patients with EGFR m + NSCLC received afatinib 40 mg orally, once-daily. • Included patients aged ≥65 years, with comorbidities, poor ECOG PS and/or brain mets. • Overall, 99.8 % patients had an AE; grade ≥ 3 AEs were reported in 65.8 % patients. • This real-world study supports findings from RCTs of afatinib in EGFR m + NSCLC. Randomized controlled trials have demonstrated that afatinib is a suitable treatment option for patients with epidermal growth factor receptor mutation-positive (EGFR m +) non-small cell lung cancer (NSCLC). However, such studies often exclude patients treated in routine clinical practice. We report interim results from a Phase 3b, open-label, multicenter, single-arm, exploratory trial, in which afatinib was investigated in a real-world setting. Patients with EGFR m + tyrosine kinase inhibitor (TKI)-naïve NSCLC received afatinib 40 mg orally, once-daily, until disease progression, or voluntary withdrawal. Primary objective was safety. Overall, 479 patients received afatinib: median age 65 years, 8 % of patients had an ECOG performance status ≥ 2, 17 % had brain metastases, and 13 % had tumors containing uncommon mutations only. All but one patient (99.8 %) had an adverse event (AE). Treatment-related AEs (TRAEs; any/grade ≥ 3) occurred in 97 %/44 % of patients; most common were diarrhea (87 %/16 %) and rash (51 %/11 %). AEs leading to afatinib dose-reduction were reported in 258 patients (54 %), and 37 patients (8 %) discontinued treatment due to a TRAE. Objective response rate was 45.5 %, median duration of response was 14.1 months (95 % CI: 12.2–16.4). Overall median time to symptomatic progression and progression-free survival were 14.9 months (95 % CI: 13.8–17.6) and 13.4 months (95 % CI: 11.8–14.5), respectively, in the overall population and 19.3 months (95 % CI: 15.6–21.8) and 15.9 months (95 % CI: 13.9–19.1) in patients with EGFR exon 19 deletions. Afatinib administration in routine clinical practice was well tolerated with no new safety signals and demonstrated promising efficacy in patients with EGFR m + NSCLC. TRAEs were generally manageable with tolerability-guided dose reductions. Overall, these data independently support findings from randomized controlled trials of afatinib in EGFR m + NSCLC. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
