Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in <i>EGFR</i>-Mutated Lung Cancer
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- Vanita Noronha
- Tata Memorial Center, Mumbai, India
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- Vijay Maruti Patil
- Tata Memorial Center, Mumbai, India
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- Amit Joshi
- Tata Memorial Center, Mumbai, India
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- Nandini Menon
- Tata Memorial Center, Mumbai, India
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- Anuradha Chougule
- Tata Memorial Center, Mumbai, India
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- Abhishek Mahajan
- Tata Memorial Center, Mumbai, India
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- Amit Janu
- Tata Memorial Center, Mumbai, India
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- Nilendu Purandare
- Tata Memorial Center, Mumbai, India
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- Rajiv Kumar
- Tata Memorial Center, Mumbai, India
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- Sucheta More
- Tata Memorial Center, Mumbai, India
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- Supriya Goud
- Tata Memorial Center, Mumbai, India
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- Nandkumar Kadam
- Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India
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- Nilesh Daware
- Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India
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- Atanu Bhattacharjee
- Tata Memorial Center, Mumbai, India
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- Srushti Shah
- Tata Memorial Center, Mumbai, India
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- Akanksha Yadav
- Tata Memorial Center, Mumbai, India
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- Vaishakhi Trivedi
- Tata Memorial Center, Mumbai, India
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- Vichitra Behel
- Tata Memorial Center, Mumbai, India
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- Amit Dutt
- Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, India
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- Shripad Dinanath Banavali
- Tata Memorial Center, Mumbai, India
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- Kumar Prabhash
- Tata Memorial Center, Mumbai, India
説明
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Standard first-line therapy for EGFR-mutant advanced non–small-cell lung cancer (NSCLC) is an epidermal growth factor receptor (EGFR)–directed oral tyrosine kinase inhibitor. Adding pemetrexed and carboplatin chemotherapy to an oral tyrosine kinase inhibitor may improve outcomes. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> This was a phase III randomized trial in patients with advanced NSCLC harboring an EGFR-sensitizing mutation and a performance status of 0 to 2 who were planned to receive first-line palliative therapy. Random assignment was 1:1 to gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m<jats:sup>2</jats:sup> and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed (gefitinib plus chemotherapy [Gef+C]). The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), response rate, and toxicity. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Between 2016 and 2018, 350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174). Twenty-one percent of patients had a performance status of 2, and 18% of patients had brain metastases. Median follow-up time was 17 months (range, 7 to 30 months). Radiologic response rates were 75% and 63% in the Gef+C and Gef arms, respectively ( P = .01). Estimated median PFS was significantly longer with Gef+C than Gef (16 months [95% CI, 13.5 to 18.5 months] v 8 months [95% CI, 7.0 to 9.0 months], respectively; hazard ratio for disease progression or death, 0.51 [95% CI, 0.39 to 0.66]; P < .001). Estimated median OS was significantly longer with Gef+C than Gef (not reached v 17 months [95% CI, 13.5 to 20.5 months]; hazard ratio for death, 0.45 [95% CI, 0.31 to 0.65]; P < .001). Clinically relevant grade 3 or greater toxicities occurred in 51% and 25% of patients in the Gef+C and Gef arms, respectively ( P < .001). </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Adding pemetrexed and carboplatin chemotherapy to gefitinib significantly prolonged PFS and OS but increased toxicity in patients with NSCLC. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 38 (2), 124-136, 2020-01-10
American Society of Clinical Oncology (ASCO)