High-Trough Plasma Concentration of Afatinib Is Associated with Dose Reduction
Afatinib is used to treat non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation as a second-generation EGFR-tyrosine kinase inhibitor (TKI). Early prediction of adverse effects based on the pharmacokinetics of afatinib enables support for quality of life (QOL)...
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creator | Takahashi, Takayuki Terazono, Hideyuki Suetsugu, Takayuki Sugawara, Hideki Arima, Junko Nitta, Mina Tanabe, Toru Okutsu, Kayu Ikeda, Ryuji Mizuno, Keiko Inoue, Hiromasa Takeda, Yasuo |
description | Afatinib is used to treat non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation as a second-generation EGFR-tyrosine kinase inhibitor (TKI). Early prediction of adverse effects based on the pharmacokinetics of afatinib enables support for quality of life (QOL) in patients with no change in efficacy. We examined the pharmacokinetic relationship between trough plasma concentration and adverse effects and evaluated the utility of measuring the trough plasma concentration of afatinib as the first EGFR-TKI treatment for NSCLC in a prospective multicenter study. Twenty-four patients treated with afatinib were enrolled in this study. All blood samples were collected at the trough point, and plasma concentrations were measured using high-performance liquid chromatography–tandem mass spectrometry. Logistic regression analysis for the dose reduction of afatinib was performed, and the receiver operating characteristic (ROC) curve was plotted. Although all patients started afatinib at 40 mg/day, plasma concentrations were variable, and mean and median trough plasma concentrations were 32.9 ng/mL and 32.5 ng/mL in this study, respectively. Minimum and maximum trough plasma concentrations were 10.4 ng/mL and 72.7 ng/mL, respectively. This variability was speculated to involve personal parameters such as laboratory data. However, no patient characteristics or laboratory data examined correlated with the trough plasma concentration of afatinib, except albumin. Albumin showed a weak correlation with plasma concentration (r = 0.60, p = 0.009). The trough plasma concentration of afatinib was significantly associated with the dose reduction of afatinib (p = 0.047). The area under the ROC curve (AUC) for the trough plasma concentration of afatinib was 0.81. The cut-off value was 21.4 ng/mL. The sensitivity and specificity of the cut-off as a risk factor were 0.80 and 0.75. In summary, the trough plasma concentration of afatinib was associated with continued or reduced dosage because of the onset of several adverse effects, and a threshold was seen. Adverse effects not only lower QOL but also hinder continued treatment. Measuring plasma concentrations of afatinib appears valuable to predict adverse effects and continue effective therapy. |
doi_str_mv | 10.3390/cancers13143425 |
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Early prediction of adverse effects based on the pharmacokinetics of afatinib enables support for quality of life (QOL) in patients with no change in efficacy. We examined the pharmacokinetic relationship between trough plasma concentration and adverse effects and evaluated the utility of measuring the trough plasma concentration of afatinib as the first EGFR-TKI treatment for NSCLC in a prospective multicenter study. Twenty-four patients treated with afatinib were enrolled in this study. All blood samples were collected at the trough point, and plasma concentrations were measured using high-performance liquid chromatography–tandem mass spectrometry. Logistic regression analysis for the dose reduction of afatinib was performed, and the receiver operating characteristic (ROC) curve was plotted. Although all patients started afatinib at 40 mg/day, plasma concentrations were variable, and mean and median trough plasma concentrations were 32.9 ng/mL and 32.5 ng/mL in this study, respectively. Minimum and maximum trough plasma concentrations were 10.4 ng/mL and 72.7 ng/mL, respectively. This variability was speculated to involve personal parameters such as laboratory data. However, no patient characteristics or laboratory data examined correlated with the trough plasma concentration of afatinib, except albumin. Albumin showed a weak correlation with plasma concentration (r = 0.60, p = 0.009). The trough plasma concentration of afatinib was significantly associated with the dose reduction of afatinib (p = 0.047). The area under the ROC curve (AUC) for the trough plasma concentration of afatinib was 0.81. The cut-off value was 21.4 ng/mL. The sensitivity and specificity of the cut-off as a risk factor were 0.80 and 0.75. In summary, the trough plasma concentration of afatinib was associated with continued or reduced dosage because of the onset of several adverse effects, and a threshold was seen. Adverse effects not only lower QOL but also hinder continued treatment. Measuring plasma concentrations of afatinib appears valuable to predict adverse effects and continue effective therapy.</description><identifier>ISSN: 2072-6694</identifier><identifier>EISSN: 2072-6694</identifier><identifier>DOI: 10.3390/cancers13143425</identifier><identifier>PMID: 34298637</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Albumin ; Creatinine ; Diarrhea ; Dosage ; Enzyme inhibitors ; Epidermal growth factor ; Epidermal growth factor receptors ; High-performance liquid chromatography ; Laboratories ; Mass spectroscopy ; Mucositis ; Mutation ; Non-small cell lung carcinoma ; Patients ; Pharmacokinetics ; Plasma ; Protein-tyrosine kinase ; Proteins ; Quality of life ; Regression analysis ; Risk factors ; Side effects ; Small cell lung carcinoma ; Stomatitis</subject><ispartof>Cancers, 2021-07, Vol.13 (14), p.3425</ispartof><rights>2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 by the authors. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c328t-4a1ab5038bcb076a97ed5cdae5b7fe300e65ea45005e8d97b81719b699b3fcc3</citedby><cites>FETCH-LOGICAL-c328t-4a1ab5038bcb076a97ed5cdae5b7fe300e65ea45005e8d97b81719b699b3fcc3</cites><orcidid>0000-0002-2657-4454 ; 0000-0001-8080-3812</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305619/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305619/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids></links><search><creatorcontrib>Takahashi, Takayuki</creatorcontrib><creatorcontrib>Terazono, Hideyuki</creatorcontrib><creatorcontrib>Suetsugu, Takayuki</creatorcontrib><creatorcontrib>Sugawara, Hideki</creatorcontrib><creatorcontrib>Arima, Junko</creatorcontrib><creatorcontrib>Nitta, Mina</creatorcontrib><creatorcontrib>Tanabe, Toru</creatorcontrib><creatorcontrib>Okutsu, Kayu</creatorcontrib><creatorcontrib>Ikeda, Ryuji</creatorcontrib><creatorcontrib>Mizuno, Keiko</creatorcontrib><creatorcontrib>Inoue, Hiromasa</creatorcontrib><creatorcontrib>Takeda, Yasuo</creatorcontrib><title>High-Trough Plasma Concentration of Afatinib Is Associated with Dose Reduction</title><title>Cancers</title><description>Afatinib is used to treat non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation as a second-generation EGFR-tyrosine kinase inhibitor (TKI). Early prediction of adverse effects based on the pharmacokinetics of afatinib enables support for quality of life (QOL) in patients with no change in efficacy. We examined the pharmacokinetic relationship between trough plasma concentration and adverse effects and evaluated the utility of measuring the trough plasma concentration of afatinib as the first EGFR-TKI treatment for NSCLC in a prospective multicenter study. Twenty-four patients treated with afatinib were enrolled in this study. All blood samples were collected at the trough point, and plasma concentrations were measured using high-performance liquid chromatography–tandem mass spectrometry. Logistic regression analysis for the dose reduction of afatinib was performed, and the receiver operating characteristic (ROC) curve was plotted. Although all patients started afatinib at 40 mg/day, plasma concentrations were variable, and mean and median trough plasma concentrations were 32.9 ng/mL and 32.5 ng/mL in this study, respectively. Minimum and maximum trough plasma concentrations were 10.4 ng/mL and 72.7 ng/mL, respectively. This variability was speculated to involve personal parameters such as laboratory data. However, no patient characteristics or laboratory data examined correlated with the trough plasma concentration of afatinib, except albumin. Albumin showed a weak correlation with plasma concentration (r = 0.60, p = 0.009). The trough plasma concentration of afatinib was significantly associated with the dose reduction of afatinib (p = 0.047). The area under the ROC curve (AUC) for the trough plasma concentration of afatinib was 0.81. The cut-off value was 21.4 ng/mL. The sensitivity and specificity of the cut-off as a risk factor were 0.80 and 0.75. 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Measuring plasma concentrations of afatinib appears valuable to predict adverse effects and continue effective therapy.</description><subject>Albumin</subject><subject>Creatinine</subject><subject>Diarrhea</subject><subject>Dosage</subject><subject>Enzyme inhibitors</subject><subject>Epidermal growth factor</subject><subject>Epidermal growth factor receptors</subject><subject>High-performance liquid chromatography</subject><subject>Laboratories</subject><subject>Mass spectroscopy</subject><subject>Mucositis</subject><subject>Mutation</subject><subject>Non-small cell lung carcinoma</subject><subject>Patients</subject><subject>Pharmacokinetics</subject><subject>Plasma</subject><subject>Protein-tyrosine kinase</subject><subject>Proteins</subject><subject>Quality of life</subject><subject>Regression analysis</subject><subject>Risk factors</subject><subject>Side effects</subject><subject>Small cell lung carcinoma</subject><subject>Stomatitis</subject><issn>2072-6694</issn><issn>2072-6694</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpdkc9LwzAUx4MobsydvQa8eKlLmiZpLsKYPzYYKrJ7SNJ0y-iambSK_70tG6J7l_fgffjwHl8ArjG6I0SgiVG1sSFigjOSpfQMDFPE04QxkZ3_mQdgHOMWdUUI5oxfgkGHi5wRPgQvc7feJKvg2_UGvlUq7hSc-c5bN0E1ztfQl3BadmPtNFxEOI3RG6caW8Av12zgg48WvtuiNT19BS5KVUU7PvYRWD09rmbzZPn6vJhNl4khad4kmcJKU0RybTTiTAluC2oKZanmpSUIWUatyihC1OaF4DrHHAvNhNCkNIaMwP1Bu2_1zhaHayu5D26nwrf0ysn_m9pt5Np_ypwgyrDoBLdHQfAfrY2N3LlobFWp2vo2ypRSihGhPO3QmxN069tQd9_1VJYxTGkvnBwoE3yMwZa_x2Ak-7TkSVrkB3mGiDs</recordid><startdate>20210708</startdate><enddate>20210708</enddate><creator>Takahashi, Takayuki</creator><creator>Terazono, Hideyuki</creator><creator>Suetsugu, Takayuki</creator><creator>Sugawara, Hideki</creator><creator>Arima, Junko</creator><creator>Nitta, Mina</creator><creator>Tanabe, Toru</creator><creator>Okutsu, Kayu</creator><creator>Ikeda, Ryuji</creator><creator>Mizuno, Keiko</creator><creator>Inoue, Hiromasa</creator><creator>Takeda, Yasuo</creator><general>MDPI AG</general><general>MDPI</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TO</scope><scope>7XB</scope><scope>8FE</scope><scope>8FH</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>LK8</scope><scope>M2O</scope><scope>M7P</scope><scope>MBDVC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-2657-4454</orcidid><orcidid>https://orcid.org/0000-0001-8080-3812</orcidid></search><sort><creationdate>20210708</creationdate><title>High-Trough Plasma Concentration of Afatinib Is Associated with Dose Reduction</title><author>Takahashi, Takayuki ; 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Early prediction of adverse effects based on the pharmacokinetics of afatinib enables support for quality of life (QOL) in patients with no change in efficacy. We examined the pharmacokinetic relationship between trough plasma concentration and adverse effects and evaluated the utility of measuring the trough plasma concentration of afatinib as the first EGFR-TKI treatment for NSCLC in a prospective multicenter study. Twenty-four patients treated with afatinib were enrolled in this study. All blood samples were collected at the trough point, and plasma concentrations were measured using high-performance liquid chromatography–tandem mass spectrometry. Logistic regression analysis for the dose reduction of afatinib was performed, and the receiver operating characteristic (ROC) curve was plotted. Although all patients started afatinib at 40 mg/day, plasma concentrations were variable, and mean and median trough plasma concentrations were 32.9 ng/mL and 32.5 ng/mL in this study, respectively. Minimum and maximum trough plasma concentrations were 10.4 ng/mL and 72.7 ng/mL, respectively. This variability was speculated to involve personal parameters such as laboratory data. However, no patient characteristics or laboratory data examined correlated with the trough plasma concentration of afatinib, except albumin. Albumin showed a weak correlation with plasma concentration (r = 0.60, p = 0.009). The trough plasma concentration of afatinib was significantly associated with the dose reduction of afatinib (p = 0.047). The area under the ROC curve (AUC) for the trough plasma concentration of afatinib was 0.81. The cut-off value was 21.4 ng/mL. The sensitivity and specificity of the cut-off as a risk factor were 0.80 and 0.75. In summary, the trough plasma concentration of afatinib was associated with continued or reduced dosage because of the onset of several adverse effects, and a threshold was seen. Adverse effects not only lower QOL but also hinder continued treatment. Measuring plasma concentrations of afatinib appears valuable to predict adverse effects and continue effective therapy.</abstract><cop>Basel</cop><pub>MDPI AG</pub><pmid>34298637</pmid><doi>10.3390/cancers13143425</doi><orcidid>https://orcid.org/0000-0002-2657-4454</orcidid><orcidid>https://orcid.org/0000-0001-8080-3812</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Albumin Creatinine Diarrhea Dosage Enzyme inhibitors Epidermal growth factor Epidermal growth factor receptors High-performance liquid chromatography Laboratories Mass spectroscopy Mucositis Mutation Non-small cell lung carcinoma Patients Pharmacokinetics Plasma Protein-tyrosine kinase Proteins Quality of life Regression analysis Risk factors Side effects Small cell lung carcinoma Stomatitis |
title | High-Trough Plasma Concentration of Afatinib Is Associated with Dose Reduction |
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