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Article

A Prospective Cohort Study Assessing the Relationship between Plasma Levels of Osimertinib and Treatment Efficacy and Safety

by
Tatsuro Fukuhara
1,
Kazuhiro Imai
2,
Taku Nakagawa
3,
Ryotaro Igusa
4,
Hayato Yokota
5,
Kana Watanabe
1,
Aya Suzuki
1,
Mami Morita
1,
Ren Onodera
6,
Akira Inoue
7,
Masatomo Miura
8,
Yoshihiro Minamiya
2 and
Makoto Maemondo
9,*
1
Department of Respiratory Medicine, Miyagi Cancer Center, Natori 981-1239, Japan
2
Department of Thoracic Surgery, Akita University Graduate School of Medicine, Akita 010-8543, Japan
3
Department of Thoracic Surgery, Omagari Kosei Medical Center, Daisen 014-0027, Japan
4
Department of Respiratory Medicine, Osaki Citizen Hospital, Osaki 989-6136, Japan
5
Department of Pharmacy, Akita University Hospital, Akita 010-8543, Japan
6
Division of Pulmonary Medicine, Department of Internal Medicine, Iwate Medical University School of Medicine, Yahaba 028-3694, Japan
7
Department of Palliative Medicine, Tohoku University Graduate School of Medicine, Sendai 980-8575, Japan
8
Department of Pharmacokinetics, Akita University Graduate School of Medicine, Akita 010-8543, Japan
9
Division of Pulmonary Medicine, Department of Medicine, Jichi Medial University, Shimotsuke 329-0498, Japan
*
Author to whom correspondence should be addressed.
Biomedicines 2023, 11(9), 2501; https://doi.org/10.3390/biomedicines11092501
Submission received: 10 August 2023 / Revised: 7 September 2023 / Accepted: 8 September 2023 / Published: 10 September 2023
(This article belongs to the Section Cancer Biology and Oncology)
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Abstract

Osimertinib is a standard treatment for patients with EGFR-mutated non-small cell lung carcinoma (NSCLC). We evaluated the relationship between plasma osimertinib concentrations and treatment outcome in patients with NSCLC for this cohort study. The plasma levels of osimertinib and its metabolite AZ5104 were measured a week after the start of treatment (P1). The primary endpoint was to evaluate the correlation between plasma concentration and adverse events (AEs). The correlation with treatment efficacy was one of the secondary endpoints. In patients with CNS metastases, the concentration in the cerebrospinal fluid was also measured. Forty-one patients were enrolled. The frequency of AEs was highest for rash, followed by anorexia and thrombocytopenia. Thirty-eight cases provided measurements for P1. The median plasma concentration of osimertinib was 227 ng/mL, and that of AZ5104 was 16.5 ng/mL. The mean CNS penetration rate of two cases was 3.8%. The P1 in the group with anorexia was significantly higher than that in the group without anorexia (385.0 ng/mL vs. 231.5 ng/mL, p = 0.009). Divided into quartiles by P1 trough level, Q2 + Q3 (164–338 ng/mL) had longer PFS, while Q1 and Q4 had shorter PFS. An appropriate plasma level of osimertinib may avoid some adverse events and induce long PFS. Further large-scale trials are warranted.
Keywords: osimertinib; EGFR; trough level; non-small cell lung cancer osimertinib; EGFR; trough level; non-small cell lung cancer

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MDPI and ACS Style

Fukuhara, T.; Imai, K.; Nakagawa, T.; Igusa, R.; Yokota, H.; Watanabe, K.; Suzuki, A.; Morita, M.; Onodera, R.; Inoue, A.; et al. A Prospective Cohort Study Assessing the Relationship between Plasma Levels of Osimertinib and Treatment Efficacy and Safety. Biomedicines 2023, 11, 2501. https://doi.org/10.3390/biomedicines11092501

AMA Style

Fukuhara T, Imai K, Nakagawa T, Igusa R, Yokota H, Watanabe K, Suzuki A, Morita M, Onodera R, Inoue A, et al. A Prospective Cohort Study Assessing the Relationship between Plasma Levels of Osimertinib and Treatment Efficacy and Safety. Biomedicines. 2023; 11(9):2501. https://doi.org/10.3390/biomedicines11092501

Chicago/Turabian Style

Fukuhara, Tatsuro, Kazuhiro Imai, Taku Nakagawa, Ryotaro Igusa, Hayato Yokota, Kana Watanabe, Aya Suzuki, Mami Morita, Ren Onodera, Akira Inoue, and et al. 2023. "A Prospective Cohort Study Assessing the Relationship between Plasma Levels of Osimertinib and Treatment Efficacy and Safety" Biomedicines 11, no. 9: 2501. https://doi.org/10.3390/biomedicines11092501

APA Style

Fukuhara, T., Imai, K., Nakagawa, T., Igusa, R., Yokota, H., Watanabe, K., Suzuki, A., Morita, M., Onodera, R., Inoue, A., Miura, M., Minamiya, Y., & Maemondo, M. (2023). A Prospective Cohort Study Assessing the Relationship between Plasma Levels of Osimertinib and Treatment Efficacy and Safety. Biomedicines, 11(9), 2501. https://doi.org/10.3390/biomedicines11092501

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