The US National Comprehensive Cancer Network (NCCN) has issued new guidelines on the management of bladder cancer. The updated recommendations see the PD-1 inhibitor, pembrolizumab, earn a place in the first-line treatment of advanced bladder cancer.
For cisplatin eligible patients with locally advanced or metastatic disease, gemcitabine and cisplatin or dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (DDMVAC) with growth factor support, continue to be recommended standard regimens. For cisplatin ineligible patients, pembrolizumab joins atezolizumab or gemcitabine and carboplatin as recommended standard regimens. The recommendation comes after the earlier inclusion of pembrolizumab as a second-line treatment option with category 1 level evidence.
The inclusion of the PD-1 inhibitor as first-line treatment follows the findings of the phase II KEYNOTE-052 trial which reported overall, complete and partial response rates of 29, 7 and 22 per cent, respectively, with first-line pembrolizumab in 370 cisplatin-ineligible patients with advanced urothelial carcinoma. A positive association with response to pembrolizumab was seen for biomarkers, 18-gene expression profile and immunohistochemistry (IHC) PD-L1 combined positive score. Although pembrolizumab was well tolerated by patients, including elderly patients and those with poor performance status, 18 per cent of participants in experienced grade 3 or higher adverse events.