000 03255nam a2200301 4500
001 ESSALUD
005 20260817161158.0
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040 _aBMG
041 _aeng
100 _aWu, Yi-Long
_eAutor
_954114
245 _aSelpercatinib in early-stage RET fusion–positive non–small-cell lung cancer
300 _apáginas: 660-670
520 _aBackground: Selpercatinib, a highly selective, potent, and central nervous system–penetrant RET inhibitor, is approved for RET fusion–positive advanced or metastatic non–small-cell lung cancer (NSCLC). The efficacy and safety of selpercatinib in early-stage NSCLC are unknown. Methods: We conducted a phase 3, double-blind trial involving patients with RET fusion–positive NSCLC who had received definitive therapy with curative intent (surgery or radiotherapy with adjuvant systemic anticancer therapy, if applicable). Patients were randomly assigned to receive adjuvant selpercatinib or placebo for up to 3 years. The primary end point was investigator-assessed event-free survival in patients with stage II or IIIA disease. Secondary end points were investigator-assessed event-free survival in patients with stage IB, II, or IIIA disease; event-free survival as assessed by blinded independent central review; overall survival; and safety. Results: A total of 151 patients were assigned to receive selpercatinib (75 patients) or placebo (76 patients). Median follow-up was 24 months and 27 months in the respective groups. Among 109 patients with stage II or IIIA disease, 2-year investigator-assessed event-free survival was 92% with selpercatinib and 61% with placebo (hazard ratio for disease recurrence, progression, or death, 0.17; 95% confidence interval [CI], 0.06 to 0.51; P<0.001). Event-free survival as assessed by blinded independent central review was consistent with investigator-assessed event-free survival. Among the 151 patients with stage IB, II, or IIIA NSCLC, investigator-assessed event-free survival at 2 years was 94% with selpercatinib and 70% with placebo (hazard ratio for disease recurrence, progression, or death, 0.16; 95% CI, 0.06 to 0.48; P<0.001). The most common adverse events during the treatment period were increased levels of alanine aminotransferase and aspartate aminotransferase (grade ≥3 in 17% and 19% of patients, respectively, in the selpercatinib group). Three deaths occurred, all in the placebo group, owing to disease progression. Conclusions: Among patients with stage II or IIIA RET fusion–positive NSCLC, event-free survival was significantly longer with adjuvant selpercatinib than with placebo.
650 _aCÁNCER DE PULMÓN
_953712
650 _aNEUMOLOGÍA
_925628
650 _aCUIDADOS INTENSIVOS GENERAL
_954115
650 _aTRATAMIENTOS EN ONCOLOGÍA
_953734
700 _aHochmair, Maximilian
_954116
700 _aYang, Yi
_954117
700 _aYang, Xue-Ning
_954118
700 _aTsuboi, Masahiro
_954119
700 _aPaz-Ares, Luis
_954120
700 _aYang, James Chih-Hsin
_954121
773 0 _022717
_922647
_dMassachusetts NEJM Group
_oNEJM010
_tThe New England Journal of Medicine
_wESSALUD
_x0028-4793
942 _cARTICULOS
_e2026-08-17
_zSQB
999 _c22826
_d22826