Phase II trial of carboplatin, S-1, and gefitinib as first-line triplet chemotherapy for advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations
Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), is an effective treatment for advanced non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations. However, there have been little evidence-based studies of gefitinib in combination with platinum-doublet therapy in these patients. We performed a phase II trial to determine the efficacy and safety of triplet chemotherapy with gefitinib, carboplatin, and S-1 as a first-line treatment. This was a multicentre, single-arm, phase II trial of carboplatin, S-1, and gefitinib in advanced NSCLC patients with activating EGFR mutations. Patients received four courses of these drugs in 3-4 week cycles. In each cycle, carboplatin (area under curve = 5) was administered on day 1, S-1 (80 mg/m(2)) on days 1-14, and gefitinib (250 mg) every day. Subsequently, the same regimen without carboplatin was administered until disease progression or unacceptable toxicity occurred. The 1-year progression-free survival (PFS) was the primary endpoint, while response rate (RR), PFS, overall survival (OS), and safety were secondary endpoints. Thirty-five patients were enrolled into this study. The 1-year PFS was 74.3% and the overall RR was 85.7%. The median PFS for all patients was 17.6 months (95% confidence interval 15.5-∞), but the median OS was not reached, because 28 patients were still alive after a median follow-up time of 21.4 months. Haematological adverse events (grade 3 or higher) included neutropaenia (17.1%), thrombocytopenia (14.3%), and anaemia (5.7%), while non-haematological adverse events (grade 3 or higher) included elevated aminotransferase (20.0%), diarrhoea (14.3%), and febrile neutropaenia (2.9%). No interstitial lung disease or treatment-related deaths occurred. Combination chemotherapy with carboplatin, S-1, and gefitinib is efficacious and well tolerated as a first-line treatment in advanced NSCLC patients with activating EGFR mutations.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2015 |
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| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:32 |
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| Enthalten in: |
Medical oncology (Northwood, London, England) - 32(2015), 3 vom: 24. März, Seite 40 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tamiya, Akihiro [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 25.04.2016 Date Revised 08.04.2022 published: Print-Electronic JPRN: UMIN000005503 Citation Status MEDLINE |
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| doi: |
10.1007/s12032-014-0474-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM245611584 |
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| 245 | 1 | 0 | |a Phase II trial of carboplatin, S-1, and gefitinib as first-line triplet chemotherapy for advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations |
| 264 | 1 | |c 2015 | |
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| 500 | |a Date Revised 08.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a JPRN: UMIN000005503 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), is an effective treatment for advanced non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations. However, there have been little evidence-based studies of gefitinib in combination with platinum-doublet therapy in these patients. We performed a phase II trial to determine the efficacy and safety of triplet chemotherapy with gefitinib, carboplatin, and S-1 as a first-line treatment. This was a multicentre, single-arm, phase II trial of carboplatin, S-1, and gefitinib in advanced NSCLC patients with activating EGFR mutations. Patients received four courses of these drugs in 3-4 week cycles. In each cycle, carboplatin (area under curve = 5) was administered on day 1, S-1 (80 mg/m(2)) on days 1-14, and gefitinib (250 mg) every day. Subsequently, the same regimen without carboplatin was administered until disease progression or unacceptable toxicity occurred. The 1-year progression-free survival (PFS) was the primary endpoint, while response rate (RR), PFS, overall survival (OS), and safety were secondary endpoints. Thirty-five patients were enrolled into this study. The 1-year PFS was 74.3% and the overall RR was 85.7%. The median PFS for all patients was 17.6 months (95% confidence interval 15.5-∞), but the median OS was not reached, because 28 patients were still alive after a median follow-up time of 21.4 months. Haematological adverse events (grade 3 or higher) included neutropaenia (17.1%), thrombocytopenia (14.3%), and anaemia (5.7%), while non-haematological adverse events (grade 3 or higher) included elevated aminotransferase (20.0%), diarrhoea (14.3%), and febrile neutropaenia (2.9%). No interstitial lung disease or treatment-related deaths occurred. Combination chemotherapy with carboplatin, S-1, and gefitinib is efficacious and well tolerated as a first-line treatment in advanced NSCLC patients with activating EGFR mutations | ||
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| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
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| 650 | 7 | |a Quinazolines |2 NLM | |
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| 700 | 1 | |a Tamiya, Motohiro |e verfasserin |4 aut | |
| 700 | 1 | |a Shiroyama, Takayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Saijo, Nobuhiko |e verfasserin |4 aut | |
| 700 | 1 | |a Nakatani, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Minomo, Shojiro |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuji, Taisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Takeuchi, Naoko |e verfasserin |4 aut | |
| 700 | 1 | |a Omachi, Naoki |e verfasserin |4 aut | |
| 700 | 1 | |a Kurata, Kanako |e verfasserin |4 aut | |
| 700 | 1 | |a Suzuki, Hidekazu |e verfasserin |4 aut | |
| 700 | 1 | |a Okamoto, Norio |e verfasserin |4 aut | |
| 700 | 1 | |a Okishio, Kyoichi |e verfasserin |4 aut | |
| 700 | 1 | |a Hirashima, Tomonori |e verfasserin |4 aut | |
| 700 | 1 | |a Atagi, Shinji |e verfasserin |4 aut | |
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