Int J Clin Oncol: PembrolizumabVS chemotherapy treatment for recurrent advanced urethra cancer.

Open-labeled, randomized, active-controlled KEYNOTE-045 study (NCT02256436) showed that the second-line pembrolizumab significantly improved the total survival (OS) of patients with advanced/metastatic urethra cancer (UC) patients with first-line platinum-containing chemotherapy compared to standard chemotherapy (eucalyptus alcohol, doselataly, or acefluorone).
Pembrolizumab is approved for use in bladder cancer patients in Japan.
analyzed in the subgroup of Japanese patients enrolled in the KEYNOTE-045 study.
the primary endpoints are OS and Progressless Lifetime (PFS).
objective response rate (ORR) and security as the secondary endpoint.
results, 52 Japanese patients (pembrolizumab, n s 30; chemotherapy, n s 22) were followed up at a median of 26.1 months.
patients receiving pembrolizumab had a 19% lower risk of death than chemotherapy (risk ratio of 0.81, 95% CI 0.44-1.50) and AnOS HR of 0.61 (95% CI 0.32-1.15) after the calibration of the baseline covariate.
the 24-month OS rate of Bloomberg's Beaded Single (26.9% vs 14.3%).
pembrolizumab and chemotherapy PFS were 2.0 and 4.9 months respectively (HR 1.71, 95% CI 0.95-3.08).
pembrolizumab and chemotherapy ORR similar (20.0% vs 18.2%) ;p embrolizumab's reaction seier.
67% and 33% of patients, respectively, maintained a response for more than 12 months.
treatment-related adverse events, including level 3-5 events, occur less frequently in pembrolizumab.
the results showed that pembrolizumab provided long-lasting anti-tumor activity in local late/metastatic UC patients with post-platinum chemotherapy progression in the overall population and Japanese subgroup;
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