Preoperative Immunotherapy Found Effective and Safe in Bladder Cancer

The 2018 American Association for Cancer Research Annual Meetingfeatured a study in which preoperative tumor-shrinking (neoadjuvant) treatment using an immunotherapy drug, pembrolizumab (brand name Keytruda), in muscle-invasive bladder cancer was found safe and effective.

For disease found to have invaded the muscle layer, bladder cancer treatment involves different approaches. Although these patients are known to benefit from preoperative tumor-shrinking cisplatin -based combination chemotherapy, which prolongs survival, patients and surgeons often prefer radical cystectomy , complete surgical removal of the bladder. This preference is also influenced by the median age at bladder cancer diagnosis being 72 and some patients' general condition being unsuitable for systemic treatment. However, immunotherapies introduced into our clinical practice after 2012 have proved very effective in bladder cancer. Consequently, immunotherapies with fewer side effects than chemotherapy and demonstrated efficacy in bladder cancer have been considered as tumor-shrinking treatment before radical cystectomy.

• 3 New Immunotherapy Approvals for Bladder and Urinary Tract Cancer

Radical cystectomyis surgery performed when cancer invades the bladder muscle layer or, while superficial, spreads across a large part of the bladder. The bladder, all cancerous lymph nodes and nearby organs are surgically removed. When the bladder is removed completely, a system must be created to store urine and eliminate it from the body.

To investigate the effects of preoperative tumor-shrinking immunotherapy on outcomes in muscle-invasive bladder cancer, the phase-2 PURE-01 clinical study was conducted. It administered preoperative pembrolizumab to patients with stage 2 and 3 bladder cancer, a total of 34 patients scheduled for radical cystectomy, with 3 cycles at a dose of 200 mg.

Study Results:

• The results of 22 patients were evaluable.
• The most important result was that 7 patients (%31) achieved, following neoadjuvant treatment, a pathological complete response . In other words, pembrolizumab administered before surgery eliminated all cancer cells.
• In 3 patients, the tumor regressed to noninvasive disease / carcinoma in situ (pTa / is).
• All patients achieving a pathological complete response were PD-L1-positive.
• Tumor mutation burden (TMB) was significantly higher in responding patients' tumors than in those of other patients.
• Side effects included, in 1 patient, grade 3 elevation of liver enzymes (ALT), while 5 had other milder immune-related side effects.

In conclusion, if these interim data are confirmed in a subsequent phase-3 study, treatment of cancers invading the bladder's muscle wall could see our clinical practice change.

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