J Clin Oncol: Effect of neoadjuvant therapy with gemcitabine + cisplatin + pembrolizumab before radical resection of muscular invasive bladder cancer

Patients with muscular invasive bladder cancer (MIBC) have a poor prognosis after definite treatment
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The standard treatment of MIBC includes neoadjuvant chemotherapy based on cisplatin followed by radical cystectomy (RC)

The standard treatment of MIBC includes neoadjuvant chemotherapy based on cisplatin followed by radical cystectomy (RC) The standard treatment of MIBC includes neoadjuvant chemotherapy based on cisplatin followed by radical cystectomy (RC)

This study aimed to evaluate the safety and effectiveness of gemcitabine and cisplatin combined with the immune checkpoint inhibitor pembrolizumab as a neoadjuvant treatment before radical cystectomy of MIBC
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immunity

Recruited clinical T2-4aN0/XM0 MIBC patients suitable for RC
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The first 6 patients received pembrolizumab 200 mg, cisplatin 70 mg/m ² and gemcitabine 1000 mg/m ² on day ¹ , plus gemcitabine 1000 mg/m ² on day 8, and 21 days as a course of treatment , A total of 4 courses

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Pathological remission during surgery (A) and pathological decline (B)

Pathological remission during surgery (A) and pathological decline (B)

From June 2016 to March 2020, a total of 39 patients were recruited (72% in cT2 stage, 23% in cT3 stage, and 5% in cT4a stage)
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The patients received an average of four cycles of treatment

Of the 39 patients, 22 (56% [95% CI, 40-72]) had a pathological stage lower than pT2N0, and 14 (36% [95% CI, 21-53]) had a pathological stage lower than pT0N0 Period

Recurrence-free survival of all patients (A) and patients stratified by pathological response (B)

Recurrence-free survival of all patients (A) and patients stratified by pathological response (B)

The most common adverse events of all grades were thrombocytopenia (74%), anemia (69%), neutropenia (67%), and hypomagnesemia (67%)
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One patient had new-onset type 1 diabetes with ketoacidosis associated with pembrolizumab ; no patient required steroid intervention due to immune-related AEs

diabetes

In summary, the neoadjuvant therapy of gemcitabine + cisplatin + pembrolizumab has reached the primary endpoint of improving pathological decline and is generally safe
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A global study on perioperative chemotherapy combined with pembrolizumab or placebo is ongoing

The neoadjuvant therapy of gemcitabine + cisplatin + pembrolizumab has reached the primary endpoint of improving pathological downstage, and the safe gemcitabine + cisplatin + pembrolizumab neoadjuvant therapy has reached the primary endpoint of improving pathological downstage.

Original source:

Tracy L.

Phase II Study of Gemcitabine and Split- Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer in this message