Osimertinib in poor performance status patients with T790M-positive advanced non-small-cell lung cancer after progression of first- and second-generation EGFR-TKI treatments (NEJ032B)
| العنوان: | Osimertinib in poor performance status patients with T790M-positive advanced non-small-cell lung cancer after progression of first- and second-generation EGFR-TKI treatments (NEJ032B) |
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| المؤلفون: | Kiyotaka Miura, Ryota Saito, Kensuke Nakazawa, Takeshi Isobe, Ryoichi Honda, Yuki Akazawa, Nobuhiro Kanaji, Susumu Takeuchi, Yukari Tsubata, Kana Watanabe, Satoshi Morita, Kunihiko Kobayashi, Taku Nakagawa, Atsushi Nakamura, Naoki Furuya, Daisuke Jingu, Eiki Ichihara, Atsuto Mouri, Satoshi Ohizumi, Makoto Maemondo, Mami Morita, Hiroshige Yoshioka |
| المصدر: | International Journal of Clinical Oncology |
| بيانات النشر: | Springer Singapore, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, medicine.medical_specialty, Afatinib, Phases of clinical research, EGFR T790M, T790M, Gefitinib, Internal medicine, medicine, Clinical endpoint, Osimertinib, Lung cancer, Poor performance status, business.industry, Hematology, General Medicine, medicine.disease, Phase II, respiratory tract diseases, Surgery, Original Article, Erlotinib, business, Non-small-cell lung cancer, medicine.drug |
| الوصف: | Background Osimertinib is effective in patients with T790M mutation-positive advanced non-small-cell lung cancer (NSCLC) resistant to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). However, its effectiveness and safety in patients with poor performance status (PS) are unknown. Methods Enrolled patients showed disease progression after treatment with gefitinib, erlotinib, or afatinib; T790M mutation; stage IIIB, IV, or recurrent disease; and PS of 2–4. Osimertinib was orally administered at a dose of 80 mg/day. The primary endpoint of this phase II study (registration, jRCTs061180018) was response rate and the secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate, and safety. Results Thirty-three patients were enrolled, of which 69.7% and 24.2% had PS of 2 and 3, respectively. One patient was excluded due to protocol violation; in the remaining 32 patients, the response rate was 53.1%; disease control rate was 75.0%; PFS was 5.1 months; and OS was 10.0 months. The most frequent adverse event of grade 3 or higher severity was lymphopenia (12.1%). Interstitial lung disease (ILD) was observed at all grades and at grades 3–5 in 15.2% (5/33) and 6.1% (2/33) of patients, respectively. Treatment-related death due to ILD occurred in one patient. Patients negative for activating EGFR mutations after osimertinib administration had longer median PFS than those positive for these mutations. Conclusion Osimertinib was sufficiently effective in EGFR-TKI-resistant, poor PS patients with T790M mutation-positive advanced NSCLC. Plasma EGFR mutation clearance after TKI treatment could predict the response to EGFR-TKIs. |
| اللغة: | English |
| تدمد: | 1437-7772 1341-9625 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::83096e34e31b1e0f189ad2972dcda7c1Test http://europepmc.org/articles/PMC8732858Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....83096e34e31b1e0f189ad2972dcda7c1 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14377772 13419625 |
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