Giotrif

Thirty-one Japanese patients with EGFR mutation-positive NSCLC (15 women and 16 men) who were hospitalized from October 2014 through December 2020 were consecutively enrolled in this study. The grade for diarrhea was determined based on CTCAE version 4.0. Three patients (2 women and 1 man) were excluded because of withdrawal due to CTCAE grade 3 diarrhea just after beginning and before blood sampling for afatinib pharmacokinetics. Patient characteristics at the start of afatinib therapy are listed in Table 1. The study protocol was approved by the Ethics Committee of Akita University School of Medicine (approval no. 790), and all patients gave written informed consent. This study was performed in accordance with the guidelines of the Declaration of Helsinki.
An initial dose of 30 or 40 mg afatinib (Giotrif; Boehringer Ingelheim, Tokyo, Japan) was orally administered once daily at a designated time (11:00 a.m.). On day 15 after beginning afatinib therapy, whole blood samples were collected just prior to (C₀, 24 h after the 14th administration) and at 1, 2, 4, 6, 8, 12, and 24 h after the 15th administration of afatinib. Plasma was isolated by centrifugation at 1900× g for 15 min and was stored at −80 °C until analysis. For the 15 days prior to plasma sampling, nurses managed the administration of afatinib for hospitalized patients.

Stage III NSCLCm+ received 2 to 4 cycles (each cycle lasted 4 weeks) administration of neoadjuvant Afatinib (Giotrif ®, Boehringer-Ingelheim Pharma GmbH, Ingelheim, Germany) therapy (NAT) (oral Afatinib 40 mg, once-daily). Chest CT was performed at the 8th and/or 16th weeks after Afatinib treatment. All CT scans of participants were assessed by the same radiologist and 3 experienced thoracic surgeons via Response Evaluation Criteria in Solid Tumors measurement criteria (RECIST, version 1.1). Radiologically PR or responder were defined as at least a 30% decrease in the sum of diameters of target lesions versus baseline^{62 (link)}. If PR or SD participants after NAT could be resected completely, surgery should be performed within 3 weeks after Afatinib discontinuation. However, if participants with PR or SD who were still unable to perform radical resection after 16 weeks NAT, or participants with PD during neoadjuvant phase, they should consider withdrawing from this study and treating them based on multi-disciplinary therapy (MDT).

An open-label, non-interventional, single-arm, multicenter prospective observational study was conducted across 7 medical centers and 5 regional hospitals in Taiwan. Patients who fulfilled all of the following criteria were eligible for the study: 1) provision of informed consent form, 2) aged 20 years and older, 3) diagnosed with locally advanced or metastatic (stage IIIb/IV) NSCLC and confirmed positive for EGFR mutation, 4) treatment-naïve and ready for the prescription of a EGFR-TKI as their first-line cancer treatment, 5) able to complete the questionnaires. Patients were excluded from the study if they were involved in the planning and/or the progress of the clinical trials. The study was reviewed and approved by all the Institutional Review Board of the participating institutes.
EGFR-TKI therapy of 250 mg gefitinib (Iressa^®, AstraZeneca, Cambridge, England), 150 mg erlotinib (Tarceva^®, Hoffmann-La Roche, Basel Switzerland) or 40 mg afatinib (Giotrif^®, Boehringer Ingelheim, Ingelheim, Germany) was prescribed to patients by physicians at baseline according to physicians' judgment under the real-world settings. Drugs were administrated daily by investigators and no patients changed medications during the course of the study.