Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study.
Rattachement africain : us, ca, kr, th, se, es, ua, de, gb, be. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
4510 Background: In KEYNOTE-905/EV-303 (NCT03924895), neoadj-adj EV + pembro and radical cystectomy (RC) + pelvic lymph node dissection (PLND) showed significant and meaningful improvements in EFS, OS, and pathologic complete response vs RC + PLND in pts with MIBC who were ineligible for or declined cisplatin (cis) therapy. Prespecified exploratory HRQoL outcomes are reported. Methods: Pts with MIBC who were ineligible/declined cis were randomized 1:1 to neoadj-adj EV + pembro and RC + PLND or RC + PLND (control). HRQoL was analyzed in pts who completed ≥1 PRO assessment. EQ-5D-5L and Functional Assessment of Cancer Therapy (FACT)–Bladder-Cystectomy (Bl-Cys) with FACT-general (FACT-G) and Bladder Cancer Index (BCI) were assessed predose on D1 of neoadjuvant cycles 1 (baseline [BL]), 2, and 3; pre- and post-surgery; and predose on D1 of adjuvant cycles 1, 2, 4, 8, and 12 in the EV + pembro arm. In the control arm, assessments were at pre- (BL) and post-surgery. In both treatment (Tx) arms, assessments were also done at Tx discontinuation, Q12W for ≤2y, and Q24W thereafter. End points included mean (95% CI) change from BL to post-surgery wk 18 in FACT-G score; FACT–Bl-Cys scores (Bl-Cys subscale and Trial Outcome Index [TOI]); BCI urinary, bowel, and sexual scores; and EQ-5D-5L visual analog scale (VAS). Results: At post-surgery wk 18, completion and compliance rates for all assessments were ≥65% in the EV + pembro arm and >86% in the control arm. Mean changes from BL to post-surgery wk 18 were similar between arms for FACT-G total and FACT–Bl-Cys subscale scores; FACT–Bl-Cys TOI score; BCI urinary, bowel, and sexual scores; and EQ-5D-5L VAS score (Table). BCI sexual and bowel score diminution was observed in both arms. For all PRO assessments, mean changes from BL over time were similar between Tx. Conclusions: The addition of neoadj-adj EV + pembro did not decrease HRQoL 18 wk post-surgery relative to RC + PLND alone; BCI bowel and sexual domains worsened in both arms, consistent with prior reports of RC impact. Given the superior efficacy and manageable safety, these results support the benefit/risk profile of EV + pembro and RC + PLND as Tx for pts with MIBC ineligible for or declining cis. Clinical trial information: NCT03924895 . Mean change from BL to post-surgery wk 18, (95% CI), n EV + pembro Control FACT-G total score −2.73 (−6.22 to 0.75)n = 102 −2.84 (−6.11 to 0.43)n = 75 FACT–Bl-Cys (subscale/symptom index) total score 1.31 (−0.70 to 3.32)n = 102 1.85 (−0.59 to 4.29)n = 75 FACT–Bl-Cys TOI −1.89 (−5.61 to 1.84)n = 102 −0.58 (−4.35 to 3.20)n = 75 BCI urinary −2.03 (−6.12 to 2.07)n = 101 −0.05 (−5.90 to 5.80)n = 70 BCI bowel −4.75 (−8.73 to −0.77)n = 101 −4.27 (−7.93 to −0.61)n = 70 BCI sexual −15.46 (−20.53 to −10.39)n = 94 −17.88 (−24.36 to −11.40)n = 61 EQ-5D-5L VAS −2.52 (−7.23 to −2.19)n = 102 −0.39 (−5.14 to 4.36)n = 75
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study.
- Date Crossref
- 01/06/2026
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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University of Chicago, Indiana University Health et Indiana University Melvin and Bren Simon Comprehensive Cancer Center, avec 9 autres affiliations.
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