Effectiveness and safety of avelumab maintenance in patients aged ≥75 years with advanced urothelial cancer: a sub-analysis of the meet-URO 25 (MALVA) study.
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Roviello Giandomenico, Gambale Elisabetta, De Gennaro Aquino Irene, Maruzzo Marco, Messina Carlo, Vascotto Ismaela Anna, Rossi Virginia, Bimbatti Davide, Erbetta Elisa, Messina Marco, Mennitto Alessia, Rebuzzi Sara Elena, Nasso Cecilia, Mercinelli Chiara, Catalano Martina, Maiorano Brigida Anna, Fanelli Martina, Sorarù Mariella, Scolari Federico, Mela Marinella Micol, Galli Luca, Salfi Alessia, Rizzo Mimma, Puglisi Silvia, Orlando Valentina, Fornarini Giuseppe, Rametta Alessandro, Giannatempo Patrizia, Cerbone Linda, Doni Laura, Pillozzi Serena, Antonuzzo Lorenzo
Аннотация
METHODS: This multicenter retro-prospective Italian study included 251 patients with advanced UC who received avelumab maintenance between 2021 and 2023. Outcomes were compared between patients aged ≥75 and <75 years. Primary endpoints were progression-free survival (PFS) and overall survival (OS).
RESULTS: Among 96 elderly and 155 younger patients, median PFS was 7.2 months (95% CI, 4.9-17.5) and 6.7 months (95% CI, 4.9-9.3), respectively (p = 0.547), while median OS was 28.1 months (95% CI, 17.3-42.1) versus 18.5 months (95% CI, 12.0-38.6) (p = 0.238). Immune-related adverse events were infrequent and generally comparable across age groups. In multivariable analyses, lung metastases independently predicted worse OS in elderly patients, whereas bone metastases and concomitant corticosteroid therapy were adverse prognostic factors in younger patients.
CONCLUSIONS: Avelumab maintenance demonstrated similar efficacy and safety in elderly and younger patients, supporting its use regardless of age. In the evolving therapeutic landscape of advanced UC, this treatment strategy remains a relevant and practical option, particularly for elderly or comorbid patients who may not be candidates for more intensive first-line combinations.