Current problems in cancer · 2026
Outcomes for females versus males treated with eribulin mesylate for advanced urothelial carcinoma.
СтатьяКлиническое исследование II фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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D'Souza Anishka A, Groshen Susan G, Tsao-Wei Denice, Ruel Nora, Dorff Tanya B, Lara Primo N, Twardowski Przemyslaw W, Stadler Walter M, Tripathi Abhishek, Synold Timothy W, Quinn David I, Newman Edward M
Аннотация
PURPOSE: Multiple studies of bladder cancer noted worse outcomes in females compared to males. Few focused on prospective comparisons of sex regarding treatment response, survival, and toxicity. This phase 2 study compared outcomes of males and females with locally advanced and metastatic urothelial carcinoma treated with eribulin mesylate.
METHODS: Patients were treated with eribulin on days 1 and 8 of a 21-day cycle. Primary endpoint was best observed response (ORR) per RECIST. Secondary endpoints included disease control (DCR), progression free survival (PFS), overall survival (OS), and toxicity. Pharmacokinetic (PK) parameters were assessed in a subset of patients.
RESULTS: Females and males had similar ORR, DCR, PFS, OS, and toxicities. Thirty-one percent of females and 33% of males experienced a CR or PR (p=0.86); 57% females and 59% of males experienced disease control (p=0.86). There was a higher percentage of CRs amongst females (16% vs 4%). For females and males respectively, median PFS was 4.1 and 4.0 months, while median OS was 9.7 and 9.2 months. Forty-three percent of females and 35% of males experienced Grade 4+ hematologic toxicity (p=0.38). Females had more Grade 2+ nausea and vomiting than males. Females had lower AUCs (median: 913 vs. 1,129 µg/L·hr, p=0.023), but there was no difference in other PK parameters. There was a correlation of poorer baseline ECOG status with grade 3+ non-hematologic toxicity, but this was similar between sexes. Women with baseline grade 1+ anemia were more likely to develop grade 2+ anemia during therapy. Multivariate analysis of baseline characteristics relative to outcome measures did not demonstrate significant differences between females and males.
CONCLUSION: In patients with metastatic urothelial carcinoma treated with eribulin, there were no significant differences in toxicity, ORR, DCR, PFS, or OS between males and females. Females receiving eribulin therapy may warrant use of standard antiemetic prophylaxis more than males.
MICRO ABSTRACT: The study compared the outcomes of males and females with advanced urothelial carcinoma treated with eribulin mesylate. Male and females had similar observed response rates, disease control rates, progression free survival, overall survival (OS), and toxicity. There was a higher rate of complete responses (CR) observed amongst females compared to males, and this may warrant further study.
METHODS: Patients were treated with eribulin on days 1 and 8 of a 21-day cycle. Primary endpoint was best observed response (ORR) per RECIST. Secondary endpoints included disease control (DCR), progression free survival (PFS), overall survival (OS), and toxicity. Pharmacokinetic (PK) parameters were assessed in a subset of patients.
RESULTS: Females and males had similar ORR, DCR, PFS, OS, and toxicities. Thirty-one percent of females and 33% of males experienced a CR or PR (p=0.86); 57% females and 59% of males experienced disease control (p=0.86). There was a higher percentage of CRs amongst females (16% vs 4%). For females and males respectively, median PFS was 4.1 and 4.0 months, while median OS was 9.7 and 9.2 months. Forty-three percent of females and 35% of males experienced Grade 4+ hematologic toxicity (p=0.38). Females had more Grade 2+ nausea and vomiting than males. Females had lower AUCs (median: 913 vs. 1,129 µg/L·hr, p=0.023), but there was no difference in other PK parameters. There was a correlation of poorer baseline ECOG status with grade 3+ non-hematologic toxicity, but this was similar between sexes. Women with baseline grade 1+ anemia were more likely to develop grade 2+ anemia during therapy. Multivariate analysis of baseline characteristics relative to outcome measures did not demonstrate significant differences between females and males.
CONCLUSION: In patients with metastatic urothelial carcinoma treated with eribulin, there were no significant differences in toxicity, ORR, DCR, PFS, or OS between males and females. Females receiving eribulin therapy may warrant use of standard antiemetic prophylaxis more than males.
MICRO ABSTRACT: The study compared the outcomes of males and females with advanced urothelial carcinoma treated with eribulin mesylate. Male and females had similar observed response rates, disease control rates, progression free survival, overall survival (OS), and toxicity. There was a higher rate of complete responses (CR) observed amongst females compared to males, and this may warrant further study.