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VOLGA

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Resultados de VOLGA presentados en #ESMO26 @tompowles1

En pacientes cisplatino inelegible, 3 ciclos de EV + durvalumab perioperatorio se asocia con mejora en SLE (HR 0.51), SG (HR 0.58) y respuestas patológicas del 40%.

De los pacientes ctDNA+ al inicio del estudio (78%), un 60% habían aclarado ctDNA antes de la cistectomía con tratamiento sistémico. Tasas más altas de positividad en ctDNA comparado con otros estudios perioperatorios, probablemente en relación al uso de una metodología más sensible (Natera Ultransensitive Signatera).

@OncoAlert

🔗Publicado hoy en @NEJM

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2608323

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会议摘要
LBA2按 Presidential Symposium I 对上

Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: Results from the phase 3 VOLGA trial

https://esmocongress.esmo.org
引用@
An OncoAlert #Podium2Screen from the #ESMO26 Presidential Session Presented by our @OncoALert 🚨faculty @tompowles1 Perioperative Durvalumab ± Tremelimumab Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer: Results From the Phase 3 VOLGA Trial @jteoh_hk @CPRT65 🔬 Phase 3 VOLGA trial (n=695) Evaluated perioperative durvalumab (D) ± tremelimumab (T) plus neoadjuvant enfortumab vedotin (EV) versus control (radical cystectomy [RC], followed by observation or approved adjuvant therapy) in cisplatin-ineligible muscle-invasive bladder cancer (MIBC). Just PUBLISHED in @NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2608323?referrer=https%3A%2F%2Ft.co%2F Interim analysis; median event-free survival (EFS) follow-up: 22.9 months. ➡️ D + EV: EFS HR 0.51 (95% CI, 0.38–0.67); OS HR 0.58 (95% CI, 0.40–0.83) ➡️ D + T + EV: EFS HR 0.61 (95% CI, 0.47–0.80); OS did not meet statistical significance ➡️ Pathological complete response (pCR): 45% with D + EV vs 10% with control ➡️ Grade 3/4 treatment-related adverse events (TRAEs): 30% with D + EV vs 42% with control ✅ Both primary EFS endpoints were met. Perioperative durvalumab plus 3 cycles of neoadjuvant EV also significantly improved OS. 🎙️ Presenter: Thomas Powles 👥 Investigators: Alexandra Drakaki · Jeremy Teoh · Enrique Grande · Mario Fontes-Sousa · Camillo Porta · Esther Wu · Erik Goluboff · Svetlana Ho · Stephan Hois · Ashok Gupta · James Catto @DrChoueiri @tompowles1 @apolo_andrea @neerajaiims @montypal @Silke_Gillessen @AOmlin @brian_rini @PGrivasMDPhD @TiansterZhang @amerseburger @DrDanielHeng @HHammersMD @scocmem @AndreaNecchi @AmandaNizamMD @drenriquegrande @nataliagandur @AlbigesL @cdanicas @declangmurphy @seanmmcbride @shilpaonc @DrRanaMcKay @scserendipity1 @DrYukselUrun @ravikanesvaran @BraunMDPhD @EfstathiouEleni @mzugman @crisbergerot @niklas_kluemper @Markuseckstein3
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