| 000 | 03490nam a2200349 4500 | ||
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| 001 | ESSALUD | ||
| 005 | 20260821122750.0 | ||
| 007 | ta | ||
| 008 | t pe ||||| |||| 00| 0 spa d | ||
| 040 | _aBMG | ||
| 041 | _aeng | ||
| 100 |
_aZhou, Caicun _eAutor _954258 |
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| 245 | _aFirst-line sunvozertinib in NSCLC with EGFR exon 20 insertion mutations | ||
| 300 | _apáginas: 765-775 | ||
| 520 | _aBackground: Sunvozertinib received accelerated approval for use in later lines of therapy for patients with advanced non–small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Data are needed on the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC. Methods: In this phase 3, international trial, we randomly assigned, in a 1:1 ratio, patients with advanced nonsquamous NSCLC with EGFR exon 20 insertions to receive sunvozertinib or chemotherapy (carboplatin–pemetrexed). The primary end point was progression-free survival as assessed by blinded independent central review. Crossover to the sunvozertinib group was allowed after disease progression was confirmed. Secondary end points included overall survival, investigator-assessed progression-free survival, objective response (complete or partial response), change in tumor size, and duration of response. Results: A total of 324 patients were randomly assigned to receive sunvozertinib (163 patients) or chemotherapy (161 patients). Treatment with sunvozertinib led to significantly longer median progression-free survival than chemotherapy (10.3 vs. 7.5 months; hazard ratio for disease progression or death, 0.65; 95% confidence interval, 0.50 to 0.85; P<0.001). At 12 months, progression-free survival was reported in 46.1% of the patients in the sunvozertinib group and in 26.7% of those in the chemotherapy group; the data for overall survival were immature (38.9% maturity). The percentage of patients with an objective response was 58.9% in the sunvozertinib group and 31.1% in the chemotherapy group; the median best percentage change in tumor size was −42.1% and −24.7% respectively, and the median duration of response was 11.2 and 7.1 months. Grade 3 or higher adverse events were reported in 75.5% of the patients in the sunvozertinib group and in 56.7% of those in the chemotherapy group. In the sunvozertinib group, the most common adverse events of grade 3 or higher included increased serum creatine kinase levels, diarrhea, and anemia. No deaths were attributed to adverse events considered by the investigators to be related to sunvozertinib. Conclusions: The efficacy of sunvozertinib was superior to that of chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertions. | ||
| 650 |
_aCÁNCER DE PULMÓN _953712 |
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| 650 |
_aNEUMOLOGÍA _925628 |
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| 650 |
_aCUIDADOS INTENSIVOS GENERAL _954115 |
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| 650 |
_aTRATAMIENTOS EN ONCOLOGÍA _953734 |
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| 700 |
_aGreillier, Laurent _954259 |
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| 700 |
_aLiu, Geoffrey _954260 |
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| 700 |
_aJohn, Thomas _954261 |
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| 700 |
_aXing, Ligang _954262 |
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| 700 |
_aKowalski, Dariusz _954263 |
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| 700 |
_aMemmott, Regan M. _954264 |
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| 700 |
_aYazici, Ozan _954265 |
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| 700 |
_aSun, Meili _954266 |
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| 700 |
_aShu, Catherine A. _954267 |
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| 700 |
_aPons-Tostivint, Elvire _954268 |
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| 773 | 0 |
_022717 _922650 _dMassachusetts NEJM Group _oNEJM12 _tThe New England Journal of Medicine _wESSALUD _x0028-4793 |
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| 942 |
_cARTICULOS _e2026-08-21 _zsqb |
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| 999 |
_c22854 _d22854 |
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