KMID : 1001020230210030241
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Journal of Urologic Oncology 2023 Volume.21 No. 3 p.241 ~ p.248
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Early Experience With Pembrolizumab in Bacillus Calmette-Guerin Unresponsive Non-Muscle-Invasive Bladder Cancer
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Lee Chung-Un
Song Wan Kang Min-Yong Sung Hyun-Hwan Jeon Hwang-Gyun Seo Seong-Il Jeon Seong-Soo Park Se-Hoon Jeong Byong-Chang
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Abstract
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Purpose : Radical cystectomy (RC) is recommended for patients with non-muscle-invasive bladder cancer (NMIBC) who are unresponsive to intravesical bacillus Calmette-Guerin (BCG) instillation. However, RC is a very risky treatment, and some patients cannot undergo RC due to old age, patient preference, and comorbidities. In this study, we investigated the efficacy of pembrolizumab, a programmed cell death protein 1 inhibitor, in patients with NMIBC unresponsive to intravesical BCG instillation.
Materials and Methods : Between December 2016 and February 2023, 24 patients who experienced recurrence after BCG treatment and subsequently received pembrolizumab were enrolled. We evaluated the patients¡¯ response to pembrolizumab therapy using urine cytology, cystoscopic examination (with/without biopsy), and/or computed tomography imaging. The primary endpoint was the complete response (CR) rate 3 months after the first dose of pembrolizumab. Patients were followed up every 3 months for the first 2 years and every 6 months thereafter. Kaplan-Meier survival analysis was used to illustrate CR and the individual treatment course was demonstrated.
Results : The median follow-up period was 16 months (range, 2-68 months) and the median number of pembrolizumab administrations was 5 times (range, 3-39 times). Thirteen of the 18 patients (54.2%) with BCG-unresponsive NMIBC achieved CR at 3 months. The median duration of CR maintenance was 15 months (range, 5-47 months). Five patients (20.8%) showed no recurrence for 12 months after pembrolizumab administration. Seven patients underwent RC, and pathological reports showed T2 stage in 3 patients. To date, 1 patient (4.2%) has died.
Conclusions : Our early experience with pembrolizumab treatment for BCG-unresponsive NMIBC showed better results than those of the KEYNOTE-057 trial, which reported a CR rate of 40% at 3 months. However, long-term data and more cases are required to establish pembrolizumab therapy in patients with BCG-unresponsive NMIBC in a real-world setting.
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KEYWORD
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BCG vaccine, Non-muscle invasive bladder neoplasms, Pembrolizumab
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