Prophylactic treatment of dacomitinib-induced skin toxicities in epidermal growth factor receptor-mutated non-small-cell lung cancer : A multicenter, Phase II trial
© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd..
BACKGROUND: Dacomitinib significantly improves progression-free survival and overall survival (OS) compared with gefitinib in patients with non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations. However, dacomitinib often causes skin toxicities, resulting in treatment discontinuation. We aimed to evaluate a prophylactic strategy for skin toxicity induced by dacomitinib.
METHODS: We performed a single-arm, prospective, open-label, multi-institutional phase II trial for comprehensive skin toxicity prophylaxis. Patients with NSCLC harboring EGFR-activating mutations were enrolled and received dacomitinib with comprehensive prophylaxis. The primary endpoint was the incidence of skin toxicity (Grade ≥2) in the initial 8 weeks.
RESULTS: In total, 41 Japanese patients participated between May 2019 and April 2021 from 14 institutions (median age 70 years; range: 32-83 years), 20 were male, and 36 had a performance status of 0-1. Nineteen patients had exon 19 deletions and L858R mutation. More than 90% of patients were perfectly compliant with prophylactic minocycline administration. Skin toxicities (Grade ≥2) occurred in 43.9% of patients (90% confidence interval [CI], 31.2%-56.7%). The most frequent skin toxicity was acneiform rash in 11 patients (26.8%), followed by paronychia in five patients (12.2%). Due to skin toxicities, eight patients (19.5%) received reduced doses of dacomitinib. The median progression-free survival was 6.8 months (95% CI, 4.0-8.6 months) and median OS was 21.6 months (95% CI, 17.0 months-not reached).
CONCLUSION: Although the prophylactic strategy was ineffective, the adherence to prophylactic medication was quite good. Patient education regarding prophylaxis is important and can lead to improved treatment continuity.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Cancer medicine - 12(2023), 14 vom: 01. Juli, Seite 15117-15127 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Iwasaku, Masahiro [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 03.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/cam4.6184 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Iwasaku, Masahiro |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Prophylactic treatment of dacomitinib-induced skin toxicities in epidermal growth factor receptor-mutated non-small-cell lung cancer |b A multicenter, Phase II trial |
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| 500 | |a Date Revised 03.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Dacomitinib significantly improves progression-free survival and overall survival (OS) compared with gefitinib in patients with non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations. However, dacomitinib often causes skin toxicities, resulting in treatment discontinuation. We aimed to evaluate a prophylactic strategy for skin toxicity induced by dacomitinib | ||
| 520 | |a METHODS: We performed a single-arm, prospective, open-label, multi-institutional phase II trial for comprehensive skin toxicity prophylaxis. Patients with NSCLC harboring EGFR-activating mutations were enrolled and received dacomitinib with comprehensive prophylaxis. The primary endpoint was the incidence of skin toxicity (Grade ≥2) in the initial 8 weeks | ||
| 520 | |a RESULTS: In total, 41 Japanese patients participated between May 2019 and April 2021 from 14 institutions (median age 70 years; range: 32-83 years), 20 were male, and 36 had a performance status of 0-1. Nineteen patients had exon 19 deletions and L858R mutation. More than 90% of patients were perfectly compliant with prophylactic minocycline administration. Skin toxicities (Grade ≥2) occurred in 43.9% of patients (90% confidence interval [CI], 31.2%-56.7%). The most frequent skin toxicity was acneiform rash in 11 patients (26.8%), followed by paronychia in five patients (12.2%). Due to skin toxicities, eight patients (19.5%) received reduced doses of dacomitinib. The median progression-free survival was 6.8 months (95% CI, 4.0-8.6 months) and median OS was 21.6 months (95% CI, 17.0 months-not reached) | ||
| 520 | |a CONCLUSION: Although the prophylactic strategy was ineffective, the adherence to prophylactic medication was quite good. Patient education regarding prophylaxis is important and can lead to improved treatment continuity | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Multicenter Study | |
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| 700 | 1 | |a Uchino, Junji |e verfasserin |4 aut | |
| 700 | 1 | |a Chibana, Kenji |e verfasserin |4 aut | |
| 700 | 1 | |a Tanzawa, Shigeru |e verfasserin |4 aut | |
| 700 | 1 | |a Yamada, Takahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Tobino, Kazunori |e verfasserin |4 aut | |
| 700 | 1 | |a Uchida, Yasuki |e verfasserin |4 aut | |
| 700 | 1 | |a Kijima, Takashi |e verfasserin |4 aut | |
| 700 | 1 | |a Nakatomi, Katsumi |e verfasserin |4 aut | |
| 700 | 1 | |a Izumi, Miiru |e verfasserin |4 aut | |
| 700 | 1 | |a Tamiya, Nobuyo |e verfasserin |4 aut | |
| 700 | 1 | |a Kimura, Hideharu |e verfasserin |4 aut | |
| 700 | 1 | |a Fujita, Masaki |e verfasserin |4 aut | |
| 700 | 1 | |a Honda, Ryoichi |e verfasserin |4 aut | |
| 700 | 1 | |a Takumi, Chieko |e verfasserin |4 aut | |
| 700 | 1 | |a Yamada, Tadaaki |e verfasserin |4 aut | |
| 700 | 1 | |a Kaneko, Yoshiko |e verfasserin |4 aut | |
| 700 | 1 | |a Kiyomi, Fumiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Takayama, Koichi |e verfasserin |4 aut | |
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