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Cisplatin and gemcitabine with or without berzosertib in urothelial carcinoma

JAMA Sep 01, 2021

Pal SK, Frankel PH, Mortazavi A, et al. - The results indicate that in patients with metastatic urothelial cancer, the addition of berzosertib to cisplatin with gemcitabine did not prolong progression-free survival relative to cisplatin with gemcitabine alone, and a trend toward inferior survival was observed with this combination. Despite attenuated dosing of cisplatin with gemcitabine, Berzosertib plus cisplatin with gemcitabine was correlated with significantly higher hematologic toxicities.

  • Researchers randomized a total of 87 patients, 41 patients received cisplatin with gemcitabine alone, and 46 received cisplatin with gemcitabine plus berzosertib.

  • Sixty-seven was the median age (range, 32-84) years, and 68 patients (78%) were men.

  • As per the findings, 8.0 months was the median progression-free survival for both arms (Bajorin risk-adjusted hazard ratio, 1.22; 95% CI, 0.72-2.08).

  • Compared with cisplatin with gemcitabine alone, median overall survival was shorter with cisplatin with gemcitabine plus berzosertib (14.4 vs 19.8 months; Bajorin risk-adjusted hazard ratio, 1.42; 95% CI, 0.76-2.68).

  • They further observed higher rates of grade 3 vs grade 4 thrombocytopenia (59% vs 39%) and neutropenia (37% vs 27%) with cisplatin with gemcitabine and berzosertib compared with cisplatin with gemcitabine alone; consequently, there is a need for more dose reductions in the experimental arm.

  • The results showed that patients in the experimental arm received a median cisplatin dose of 250 mg/m2, which was significantly lower than the median dose of 370 mg/m2 in the control arm (P < .001).

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