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001-es BibID:	BIBFORM121119
035-os BibID:	(scopus)85129206270 (wos)000808093200006
Első szerző:	Lindskog, Magnus
Cím:	Ilixadencel, a Cell-based Immune Primer, plus Sunitinib Versus Sunitinib Alone in Metastatic Renal Cell Carcinoma : a Randomized Phase 2 Study / Lindskog Magnus, Laurell Anna, Kjellman Anders, Melichar Bohuslav, Rey Pablo Maroto, Zielinski Henryk, Villacampa Felipe, Bigot Pierre, Zoltan Bajory, Parikh Omi, Alba David Vazquez, Jellvert Asa, Flaskó Tibor, Gallardo Enrique, Caparrós Maria José Ribal, Purkalne Gunta, Suenaert Peter, Karlsson-Parra Alex, Ljungberg Börje
Dátum:	2022
ISSN:	2666-1683
Megjegyzések:	Background: The prognosis of patients with synchronous metastatic renal cell carcinoma (mRCC) is poor. Whereas single-agent tyrosine kinase inhibition (TKI) is clearly insufficient, the effects can be enhanced by combinations with immune checkpoint inhibitors. Innovative treatment options combining TKI and other immune-stimulating agents could prove beneficial. Objective: To evaluate the clinical effects on metastatic disease when two doses of allogeneic monocyte-derived dendritic cells (ilixadencel) are administrated intratumorally followed by nephrectomy and treatment with sunitinib compared with nephrectomy and sunitinib monotherapy, in patients with synchronous mRCC. Design, setting, and participants: A randomized (2:1) phase 2 multicenter trial enrolled 88 patients with newly diagnosed mRCC to treatment with the combination ilixadencel/sunitinib (ILIXA/SUN; 58 patients) or sunitinib alone (SUN; 30 patients). Outcome measurements and statistical analysis: The primary endpoints were 18-mo survival rate and overall survival (OS). A secondary endpoint was objective response rate (ORR) assessed up to 18 mo after enrollment. Statistic evaluations included Kaplan-Meier estimates, log-rank tests, Cox regression, and stratified Cochran-Mantel-Haenszel tests. Results and limitations: The median OS was 35.6 mo in the ILIXA/SUN arm versus 25.3 mo in the SUN arm (hazard ratio 0.73, 95% confidence interval 0.42?1.27; p = 0.25), while the 18-mo OS rates were 63% and 66% in the ILIXA/SUN and SUN arms, respectively. The confirmed ORR in the ILIXA/SUN arm were 42.2% (19/45), including three patients with complete response, versus 24.0% (six/25) in the SUN arm (p = 0.13) without complete responses. The study was not adequately powered to detect modest differences in survival. Conclusions: The study failed to meet its primary endpoints. However, ilixadencel in combination with sunitinib was associated with a numerically higher, nonsignificant, confirmed response rate, including complete responses, compared with sunitinib monotherapy. Patient summary: We studied the effects of intratumoral vaccination with ilixadencel followed by sunitinib versus sunitinib only in a randomized phase 2 study. The combination treatment showed numerically higher numbers of confirmed responses, suggesting an immunologic effect.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Allogeneic dendritic cells Ilixadencel Intratumoral administration Metastatic renal cell carcinoma Off the shelf Phase 2 trial Randomized Sunitinib
Megjelenés:	European Urology Open Science. - 40 (2022), p. 38-45. -
További szerzők:	Laurell, Anna Kjellman, Anders Melichar, Bohuslav Rey, Pablo Maroto Zielinski, Henryk Villacampa, Felipe Bigot, Pierre Bajory Zoltán Parikh, Omi Alba, David Vazquez Jellvert, Asa Flaskó Tibor (1960-) (urológus) Gallardo, Enrique Caparrós, Maria José Ribal Purkalne, Gunta Suenaert, Peter Karlsson-Parra, Alex Ljungberg, Börje
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