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1. Efficacy and safety of second-line cabozantinib after immuno-oncology combination therapy for advanced renal cell carcinoma: Japanese multicenter retrospective study

Author

Sazuka, Tomokazu, Matsushita, Yuto, Sato, Hiroaki, Osawa, Takahiro, Hinata, Nobuyuki, Hatakeyama, Shingo, Numakura, Kazuyuki, Ueda, Kosuke, Kimura, Takahiro, Takahashi, Masayuki, Tanaka, Hajime, Kawasaki, Yoshihide, Kurahashi, Toshifumi, Kato, Takuma, Fujita, Kazutoshi, Miyake, Makito, Kojima, Takahiro, Kitamura, Hiroshi, Miyake, Hideaki, and Ichikawa, Tomohiko

Published
2023
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5. The impact of second transurethral resection on survival outcomes in patients with non-muscle-invasive bladder cancer treated with bacillus Calmette–Guérin therapy

Author

Kikuchi, Hiroshi, primary, Abe, Takashige, additional, Miyake, Makito, additional, Miyata, Haruka, additional, Matsumoto, Ryuji, additional, Osawa, Takahiro, additional, Nishimura, Nobutaka, additional, Fujimoto, Kiyohide, additional, Inokuchi, Junichi, additional, Yoneyama, Takahiro, additional, Tomida, Ryotaro, additional, Numakura, Kazuyuki, additional, Matsushita, Yuto, additional, Matsumoto, Kazumasa, additional, Sato, Takuma, additional, Taoka, Rikiya, additional, Kobayashi, Takashi, additional, Kojima, Takahiro, additional, Matsui, Yoshiyuki, additional, Nishiyama, Naotaka, additional, Kitamura, Hiroshi, additional, Nishiyama, Hiroyuki, additional, and Shinohara, Nobuo, additional

Published
2023
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9. The impact of second transurethral resection on survival outcomes in patients with non-muscle-invasive bladder cancer treated with bacillus Calmette–Guérin therapy.

Author

Kikuchi, Hiroshi, Abe, Takashige, Miyake, Makito, Miyata, Haruka, Matsumoto, Ryuji, Osawa, Takahiro, Nishimura, Nobutaka, Fujimoto, Kiyohide, Inokuchi, Junichi, Yoneyama, Takahiro, Tomida, Ryotaro, Numakura, Kazuyuki, Matsushita, Yuto, Matsumoto, Kazumasa, Sato, Takuma, Taoka, Rikiya, Kobayashi, Takashi, Kojima, Takahiro, Matsui, Yoshiyuki, and Nishiyama, Naotaka

Published
2024
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11. Optimal Time Point for Evaluation of Response to Pembrolizumab Treatment in Japanese Patients With Metastatic Urothelial Carcinoma

Author

INAMOTO, TERUO, primary, SATO, RYO, additional, MATSUSHITA, YUTO, additional, UCHIMOTO, TAIZO, additional, NAKAMURA, KO, additional, KOMURA, KAZUMASA, additional, NISHIMURA, KAZUKI, additional, YANO, YUSUKE, additional, NISHIO, KYOSUKE, additional, KINOSHITA, SHOKO, additional, FUKUSHIMA, TATSUO, additional, MATSUNAGA, TOMOHISA, additional, NAKAMORI, KEITA, additional, TSUTSUMI, TAKESHI, additional, TSUJINO, TAKUYA, additional, UEHARA, HIROFUMI, additional, TAKAHARA, KIYOSHI, additional, MIYAKE, HIDEAKI, additional, and AZUMA, HARUHITO, additional

Published
2023
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13. Additional oncological benefit of photodynamic diagnosis with blue light cystoscopy in transurethral resection for primary non‐muscle‐invasive bladder cancer: A comparative study from experienced institutes

Author

Miyake, Makito, primary, Nishimura, Nobutaka, additional, Nakahama, Tomonori, additional, Nishimoto, Koshiro, additional, Oyama, Masafumi, additional, Matsushita, Yuto, additional, Miyake, Hideaki, additional, Fukuhara, Hideo, additional, Inoue, Keiji, additional, Kobayashi, Keita, additional, Matsumoto, Hiroaki, additional, Matsuyama, Hideyasu, additional, Fujii, Tomomi, additional, Hirao, Yoshihiko, additional, and Fujimoto, Kiyohide, additional

Published
2023
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14. The Association of Tumor Immune Microenvironment of the Primary Lesion with Time to Metastasis in Patients with Renal Cell Carcinoma: A Retrospective Analysis

Author

Fujita, Kazutoshi, primary, Kimura, Go, additional, Tsuzuki, Toyonori, additional, Kato, Taigo, additional, Banno, Eri, additional, Kazama, Akira, additional, Yamashita, Ryo, additional, Matsushita, Yuto, additional, Ishii, Daisuke, additional, Fukawa, Tomoya, additional, Nakagawa, Yuki, additional, Fukuyama, Tamaki, additional, Sano, Fumikazu, additional, Kondo, Yukihiro, additional, and Uemura, Hirotsugu, additional

Published
2022
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15. Abstract 2257: DNA adductome analysis in human colorectal tissues

Author

Iwashita, Yuji, primary, Ohtsuka, Shunsuke, additional, Ohnishi, Ippei, additional, Matsushita, Yuto, additional, Yamashita, Takashi, additional, Inaba, Keisuke, additional, Fukazawa, Atsuko, additional, Ochiai, Hideto, additional, Matsumoto, Keigo, additional, Kurono, Nobuhito, additional, Matsushima, Yoshitaka, additional, Mori, Hiroki, additional, Suzuki, Shioto, additional, Suzuki, Shohachi, additional, Tanioka, Fumihiko, additional, and Sugimura, Haruhiko, additional

Published
2022
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16. Risk stratification for the prognosis of patients with chemoresistant urothelial cancer treated with pembrolizumab

Author

Kobayashi, Takashi, Ito, Katsuhiro, Kojima, Takahiro, Kato, Minoru, Kanda, Souhei, Hatakeyama, Shingo, Matsui, Yoshiyuki, Matsushita, Yuto, Naito, Sei, Shiga, Masanobu, Miyake, Makito, Muro, Yusuke, Nakanishi, Shotaro, Kato, Yoichiro, Shibuya, Tadamasa, Hayashi, Tetsutaro, Yasumoto, Hiroaki, Yoshida, Takashi, Uemura, Motohide, Taoka, Rikiya, Kamiyama, Manabu, Ogawa, Osamu, Kitamura, Hiroshi, Nishiyama, Hiroyuki, and The Japan Urological Oncology Group

Subjects
Adult, Male, 0301 basic medicine, Oncology, Urologic Neoplasms, Cancer Research, Prognostic variable, medicine.medical_specialty, overall survival, Pembrolizumab, Antibodies, Monoclonal, Humanized, Risk Assessment, 03 medical and health sciences, Antineoplastic Agents, Immunological, 0302 clinical medicine, Clinical Research, Internal medicine, Humans, metastatic urothelial cancer, Medicine, Aged, Proportional Hazards Models, Retrospective Studies, Aged, 80 and over, Salvage Therapy, Performance status, business.industry, Hazard ratio, Retrospective cohort study, Original Articles, General Medicine, Perioperative, Middle Aged, Prognosis, Progression-Free Survival, Confidence interval, Treatment Outcome, 030104 developmental biology, prognostic variables, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Cohort, multivariate risk stratification model, Female, Original Article, pembrolizumab, business
Abstract

The use of immune checkpoint inhibitors to treat urothelial carcinoma (UC) is increasing rapidly without clear guidance for validated risk stratification. This multicenter retrospective study collected clinicopathological information on 463 patients, and 11 predefined variables were analyzed to develop a multivariate model predicting overall survival (OS). The model was validated using an independent dataset of 292 patients. Patient characteristics and outcomes were well balanced between the discovery and validation cohorts, which had median OS times of 10.2 and 12.5 mo, respectively. The final validated multivariate model was defined by risk scores based on the hazard ratios (HRs) of independent prognostic factors including performance status, site of metastasis, hemoglobin levels, and the neutrophil‐to‐lymphocyte ratio. The median OS times (95% confidence intervals [CIs]) for the low‐, intermediate‐, and high‐risk groups (discovery cohort) were not yet reached (NYR) (NYR–19.1), 6.8 mo (5.8‐8.9), and 2.3 mo (1.2‐2.6), respectively. The HRs (95% CI) for OS in the low‐ and intermediate‐risk groups vs the high‐risk group were 0.07 (0.04‐0.11) and 0.23 (0.15‐0.37), respectively. The objective response rates for in the low‐, intermediate‐, and high‐risk groups were 48.3%, 28.8%, and 10.5%, respectively. These differential outcomes were well reproduced in the validation cohort and in patients who received pembrolizumab after perioperative or first‐line chemotherapy (N = 584). In conclusion, the present study developed and validated a simple prognostic model predicting the oncological outcomes of pembrolizumab‐treated patients with chemoresistant UC. The model provides useful information for external validation, patient counseling, and clinical trial design., A multicenter study using real‐world data of patients who received pembrolizumab treatment for chemoresistant urothelial cancer reports a prognostication model based on 4 risk factors (Eastern Cooperative Oncology Group performance status, site of metastasis, low hemoglobin, and high lymphocyte‐to‐neutrophil ratio). The model was developed using data from the first 463 patients and externally validated by an independent cohort of 292 patients with high concordance and reproducibility.

Published
2020

17. The Association of Tumor Immune Microenvironment of the Primary Lesion with Time to Metastasis in Patients with Renal Cell Carcinoma : A Retrospective Analysis

Author

Fujita, Kazutoshi, Kimura, Go, Tsuzuki, Toyonori, Kato, Taigo, Banno, Eri, Kazama, Akira, Yamashita, Ryo, Matsushita, Yuto, Ishii, Daisuke, Fukawa, Tomoya, Nakagawa, Yuki, Fukuyama, Tamaki, Sano, Fumikazu, Kondo, Yukihiro, Uemura, Hirotsugu, Fujita, Kazutoshi, Kimura, Go, Tsuzuki, Toyonori, Kato, Taigo, Banno, Eri, Kazama, Akira, Yamashita, Ryo, Matsushita, Yuto, Ishii, Daisuke, Fukawa, Tomoya, Nakagawa, Yuki, Fukuyama, Tamaki, Sano, Fumikazu, Kondo, Yukihiro, and Uemura, Hirotsugu

Abstract

The association between the tumor immune microenvironment (TIME) of primary lesions and time to metastasis remains unknown. The aim of our retrospective study was to investigate the differences in the TIME of primary lesions based on time intervals to metastasis, mainly between the synchronous group (SG; metastasis within 3 months) and metachronous group (MG; metastasis after 3 months), and its association with clinicopathological parameters in patients with metastatic renal cell carcinoma (mRCC). SG showed more immunogenic feature of TIME (PD-L1 positivity, CD8+ TIL infiltration) and poor prognostic pathological features (WHO/ISUP grade 4, necrosis, lymphovascular invasion, infiltrative growth pattern, and sarcomatoid differentiation). In addition, we observed that the time to metastasis differed by TIME characteristics (PD-L1 status, immunophenotype), which were associated with the WHO/ISUP grade. The TIME of primary lesions could affect the time to metastasis., Biological or immunological differences in primary lesions between synchronous and metachronous metastatic renal cell carcinoma (mRCC) have been reported. However, the association between the tumor immune microenvironment (TIME) of primary lesions and time to metastasis remains unknown. We investigated the differences in the TIME of primary lesions based on time intervals to metastasis, mainly between the synchronous group (SG; metastasis within 3 months) and metachronous group (MG; metastasis after 3 months), and its association with clinicopathological parameters in patients with mRCC. Overall, 568 patients treated first-line with vascular endothelial growth factor receptor inhibitors comprised the analysis population (SG: N = 307 [54.0%]; MG: N = 261 [46.0%]). SG had a higher proportion of patients with poor prognostic pathological feature tumors: WHO/ISUP grade 4, necrosis, lymphovascular invasion, infiltrative growth pattern, and sarcomatoid differentiation. Regarding the TIME, more immunogenic features were seen in SG than MG, with a higher PD-L1 positivity and a lower proportion of the desert phenotype. This is the first study to examine the differences in the TIME of primary lesions in patients with mRCC based on the time intervals to metastasis. The TIME of primary lesions could affect the time to metastasis.

Published
2022

19. Significant impact of a history of prior or concomitant upper urinary tract cancer on the recurrence and progression of non-muscle invasive bladder cancer

Author

Matsushita, Yuto, primary, Kawakami, Asuka, additional, Sato, Ryo, additional, Watanabe, Kyohei, additional, Watanabe, Hiromitsu, additional, Tamura, Keita, additional, Motoyama, Daisuke, additional, Ito, Toshiki, additional, Sugiyama, Takayuki, additional, Otsuka, Atsushi, additional, and Miyake, Hideaki, additional

Published
2022
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20. Effects of Changes in Erectile Function After Holmium Laser Enucleation of the Prostate on Postoperative Outcomes in Patients With Benign Prostatic Hyperplasia

Author

SATO, RYO, primary, SANO, ASUKA, additional, WATANABE, KYOHEI, additional, MATSUSHITA, YUTO, additional, WATANABE, HIROMITSU, additional, TAMURA, KEITA, additional, MOTOYAMA, DAISUKE, additional, SUGIYAMA, TAKAYUKI, additional, OTSUKA, ATSUSHI, additional, and MIYAKE, HIDEAKI, additional

Published
2022
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21. Geospatial Assessments of DNA Adducts in the Human Stomach: A Model of Field Cancerization

Author

Iwashita, Yuji, primary, Ohnishi, Ippei, additional, Matsushita, Yuto, additional, Ohtsuka, Shunsuke, additional, Yamashita, Takashi, additional, Inaba, Keisuke, additional, Fukazawa, Atsuko, additional, Ochiai, Hideto, additional, Matsumoto, Keigo, additional, Kurono, Nobuhito, additional, Matsushima, Yoshitaka, additional, Mori, Hiroki, additional, Suzuki, Shioto, additional, Suzuki, Shohachi, additional, Tanioka, Fumihiko, additional, and Sugimura, Haruhiko, additional

Published
2021
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24. Second transurethral resection for high-risk non-muscle invasive bladder cancer patients: a propensity score matched analysis

Author

Matsushita, Yuto, Watanabe , Kyohei, Watanabe , Hiromitsu, Tamura , Keita, Motoyama , Daisuke, Ito , Toshiki, Sugiyama , Takayuki, Otsuka, Atsushi, Miyake , Hideaki, Matsushita, Yuto, Watanabe , Kyohei, Watanabe , Hiromitsu, Tamura , Keita, Motoyama , Daisuke, Ito , Toshiki, Sugiyama , Takayuki, Otsuka, Atsushi, and Miyake , Hideaki

Abstract

Second transurethral resection (TUR) is recommended for patients diagnosed with high-risk non-muscle invasive bladder cancer (NMIBC); however, there have been several studies showing conflicting findings regarding the advantage of second TUR. The objective of this study was to investigate the prognostic significance of second TUR using propensity score-matched analysis. This study retrospectively included 164 consecutive patients who underwent initial TUR and were diagnosed with high-risk NMIBC. Of these, 56 subsequently received second TUR, and the remaining 108 underwent initial TUR alone. After adjusting patient variables by propensity score matching, 44 patients were included in each group. There was no significant difference in recurrence-free, progression-free, or overall survival between these two groups. These findings suggested no significant impact of second TUR on the prognosis of high-risk NMIBC patients; therefore, it may be necessary to perform a reassessment focusing on the indication for second TUR by conducting a large-scale prospective study., MINI-ABSTRACT: We investigated the prognostic significance of second transurethral resection for patients with high-risk non-muscle invasive bladder cancer using propensity score-matched analysis. There were no significant impacts on oncological outcomes.

Published
2020

34. Evaluation of CT-Guided Percutaneous Needle Biopsy for Diagnosis of Renal Tumor

Author

Kato, Taiki, Sugiyama, Takayuki, Matsushita, Yuto, Suzuki, Takahisa, Motoyama, Daisuke, Matsumoto, Rikiya, Otsuka, Atsushi, Furuse, Hiroshi, Tsukui, Hiroe, Ushio, Takasuke, Nasu, Hatsuko, and Ozono, Seiichiro

Subjects
Needle biopsy, 494.9, Renal tumor
Abstract

We performed computed tomographic (CT)-guided percutaneous needle biopsy for renal tumors that were difficult to diagnose or were inoperable malignant renal tumors. Nineteen patients who underwent CT-guided percutaneous needle biopsy between November 2007 and March 2015 at Hamamatsu University Hospital were included in this study. The median tumor diameter was 78 mm (40-140 mm). Seventeen patients were diagnosed pathologically by biopsy, but 2 patients could not be diagnosed despite the existence of adequate sample volume. One patient had an adverse complication ; fever (CTCAE ver 4.0 grade 1). The median duration of follow-up was 21 months (0-111 months), no one had tumor seeding along a needle tract. CT-guided percutaneous needle biopsy of renal tumors is helpful for pathological diagnosis and further treatment planning. However, there are still some limitations to obtain an accurate diagnosis.

Published
2017

35. Strangulation of the Penis by Four Metallic Washers

Author

Matsushita, Yuto, Furuse, Hiroshi, Matsumoto, Rikiya, Sugiyama, Takayuki, Nagata, Masao, Otsuka, Atsushi, and Ozono, Seiichiro

Subjects
Metallic washer, Dysuria, Penile strangulation, 494.9
Abstract

We report here a case of strangulation of the penis. A 69-year-old male visited our hospital suffering from a swollen penis and dysuria after installation of four metallic washers to the penis. He had mischievously put them on his penis four days before and subsequently was unable to remove them. We found erosion on the surface of the penis, reduction in blood flow by ultrasonography, and high C-reactive protein levels. Because we could not remove washers by blood removal from glans penis or ring cutter, we performed percutaneous cystostomy and then cut the washers with an electric grinder under general anesthesia. The operation took 2 hours and 25 minutes. The postoperative course was uneventful. Neither disturbance of blood flow nor urethral stricture was found. He completely recovered without erectile dysfunction or difficult urination 7 months after the operation. Management of this rare condition is discussed.

Published
2016

40. Risk stratification for the prognosis of patients with chemoresistant urothelial cancer treated with pembrolizumab.

Author

Kobayashi, Takashi, Ito, Katsuhiro, Kojima, Takahiro, Kato, Minoru, Kanda, Souhei, Hatakeyama, Shingo, Matsui, Yoshiyuki, Matsushita, Yuto, Naito, Sei, Shiga, Masanobu, Miyake, Makito, Muro, Yusuke, Nakanishi, Shotaro, Kato, Yoichiro, Shibuya, Tadamasa, Hayashi, Tetsutaro, Yasumoto, Hiroaki, Yoshida, Takashi, Uemura, Motohide, and Taoka, Rikiya

Abstract

The use of immune checkpoint inhibitors to treat urothelial carcinoma (UC) is increasing rapidly without clear guidance for validated risk stratification. This multicenter retrospective study collected clinicopathological information on 463 patients, and 11 predefined variables were analyzed to develop a multivariate model predicting overall survival (OS). The model was validated using an independent dataset of 292 patients. Patient characteristics and outcomes were well balanced between the discovery and validation cohorts, which had median OS times of 10.2 and 12.5 mo, respectively. The final validated multivariate model was defined by risk scores based on the hazard ratios (HRs) of independent prognostic factors including performance status, site of metastasis, hemoglobin levels, and the neutrophil‐to‐lymphocyte ratio. The median OS times (95% confidence intervals [CIs]) for the low‐, intermediate‐, and high‐risk groups (discovery cohort) were not yet reached (NYR) (NYR–19.1), 6.8 mo (5.8‐8.9), and 2.3 mo (1.2‐2.6), respectively. The HRs (95% CI) for OS in the low‐ and intermediate‐risk groups vs the high‐risk group were 0.07 (0.04‐0.11) and 0.23 (0.15‐0.37), respectively. The objective response rates for in the low‐, intermediate‐, and high‐risk groups were 48.3%, 28.8%, and 10.5%, respectively. These differential outcomes were well reproduced in the validation cohort and in patients who received pembrolizumab after perioperative or first‐line chemotherapy (N = 584). In conclusion, the present study developed and validated a simple prognostic model predicting the oncological outcomes of pembrolizumab‐treated patients with chemoresistant UC. The model provides useful information for external validation, patient counseling, and clinical trial design. [ABSTRACT FROM AUTHOR]

Published
2021
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41. Significance of De Ritis (Aspartate Transaminase/Alanine Transaminase) Ratio as a Significant Prognostic But Not Predictive Biomarker in Japanese Patients with Metastatic Castration-resistant Prostate Cancer Treated with Cabazitaxel

Author

MIYAKE, HIDEAKI, primary, MATSUSHITA, YUTO, additional, WATANABE, HIROMITSU, additional, TAMURA, KEITA, additional, SUZUKI, TAKAHISA, additional, MOTOYAMA, DAISUKE, additional, ITO, TOSHIKI, additional, SUGIYAMA, TAKAYUKI, additional, and OTSUKA, ATSUSHI, additional

Published
2018
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44. Real-world experience of Doxorubicin Monotherapy for Advanced or Metastatic Retroperitoneal Sarcoma: A Single Institutional Study of 16 Cases.

Author

Sato R, Matsushita Y, Sano A, Watanabe K, Watanabe H, Tamura K, Motoyama D, Otsuka A, and Miyake H

Subjects
Humans, Female, Male, Aged, Middle Aged, Treatment Outcome, Aged, 80 and over, Neoplasm Metastasis, Adult, Retrospective Studies, Neoplasm Staging, Doxorubicin adverse effects, Doxorubicin therapeutic use, Doxorubicin administration & dosage, Sarcoma drug therapy, Sarcoma pathology, Sarcoma mortality, Retroperitoneal Neoplasms drug therapy, Retroperitoneal Neoplasms secondary, Retroperitoneal Neoplasms pathology
Abstract

Background/aim: Anthracycline-based chemotherapies including doxorubicin monotherapy are recommended in major guidelines for patients with advanced or metastatic retroperitoneal sarcoma (RPS); however, few studies have reported the outcomes of doxorubicin monotherapy for these patients. We herein investigated the oncological efficacy and safety of doxorubicin monotherapy for patients with advanced or metastatic RPS in real-world clinical practice., Patients and Methods: Sixteen patients diagnosed with advanced or metastatic retroperitoneal sarcoma, receiving doxorubicin monotherapy as first-line treatment between February 2017 and March 2023 at our Institution were analyzed. Response rate, progression-free survival (PFS) periods, overall survival (OS) period, and adverse event (AE) profiles were retrospectively investigated., Results: The median age of patients was 69.5 years. Best responses to doxorubicin were as follows: complete response, 0 patients (0.0%); partial response, 3 (18.8%); stable disease, 9 (56.3%); and progressive disease, 4 (25.0%). The objective response rate and disease control rate were 18.8 and 75.0%, respectively. During the observation period (median, 22 months, range=2-53 months), median PFS and OS periods were 8.0 and 24.0 months, respectively. The following AEs Grade ≥3 occurred: neutropenia in 14 patients (87.5%), febrile neutropenia in 5 (31.3%), leukopenia in 2 (12.5%), thrombocytopenia in 1 (6.3%), and heart failure in 1 (6.3%). Grade ≥3 nausea and vomiting did not occur and there was no treatment-related death., Conclusion: The oncological outcomes of doxorubicin monotherapy for RPS in real-world clinical practice were not inferior to those of the EORTC trial. The incidence of hematological AEs was higher; however, severe gastrointestinal AEs were prevented by prophylactic antiemetics and there were no treatment-related deaths. Collectively, doxorubicin monotherapy with appropriate prophylactic agents is a valid option for patients with advanced or metastatic RPS., (Copyright © 2024, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Published
2024
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45. Non-maintenance intravesical Bacillus Calmette-Guérin induction therapy with eight doses in patients with high- or highest-risk non-muscle invasive bladder cancer: a retrospective non-randomized comparative study.

Author

Miyake M, Iida K, Nishimura N, Miyamoto T, Fujimoto K, Tomida R, Matsumoto K, Numakura K, Inokuchi J, Morizane S, Yoneyama T, Matsumura Y, Abe T, Inoue M, Yamada T, Terada N, Hirao S, Uemura M, Matsushita Y, Taoka R, Kobayashi T, Kojima T, Matsui Y, Kitamura H, and Nishiyama H

Subjects
Administration, Intravesical, Aged, Aged, 80 and over, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Induction Chemotherapy statistics & numerical data, Japan epidemiology, Kaplan-Meier Estimate, Maintenance Chemotherapy statistics & numerical data, Male, Neoplasm Recurrence, Local prevention & control, Progression-Free Survival, Retrospective Studies, Urinary Bladder immunology, Urinary Bladder pathology, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms pathology, Adjuvants, Immunologic administration & dosage, BCG Vaccine administration & dosage, Induction Chemotherapy methods, Neoplasm Recurrence, Local epidemiology, Urinary Bladder Neoplasms drug therapy
Abstract

Background: To explore possible solutions to overcome chronic Bacillus Calmette-Guérin (BCG) shortage affecting seriously the management of non-muscle invasive bladder cancer (NMIBC) in Europe and throughout the world, we investigated whether non-maintenance eight-dose induction BCG (iBCG) was comparable to six-dose iBCG plus maintenance BCG (mBCG)., Methods: This observational study evaluated 2669 patients with high- or highest-risk NMIBC who treated with iBCG with or without mBCG during 2000-2019. The patients were classified into five groups according to treatment pattern: 874 (33%) received non-maintenance six-dose iBCG (Group A), 405 (15%) received six-dose iBCG plus mBCG (Group B), 1189 (44%) received non-maintenance seven-/eight-dose iBCG (Group C), 60 (2.2%) received seven-/eight-dose iBCG plus mBCG, and 141 (5.3%) received only ≤5-dose iBCG. Recurrence-free survival (RFS), progression-free survival, and cancer-specific survival were estimated and compared using Kaplan-Meier analysis and the log-rank test, respectively. Propensity score-based one-to-one matching was performed using a multivariable logistic regression model based on covariates to obtain balanced groups. To eliminate possible immortal bias, 6-, 12-, 18-, and 24-month conditional landmark analyses of RFS were performed., Results: RFS comparison confirmed that mBCG yielded significant benefit following six-dose iBCG (Group B) in recurrence risk reduction compared to iBCG alone (groups A and C) before (P < 0.001 and P = 0.0016, respectively) and after propensity score matching (P = 0.001 and P = 0.0074, respectively). Propensity score-matched sequential landmark analyses revealed no significant differences between groups B and C at 12, 18, and 24 months, whereas landmark analyses at 6 and 12 months showed a benefit of mBCG following six-dose iBCG compared to non-maintenance six-dose iBCG (P = 0.0055 and P = 0.032, respectively). There were no significant differences in the risks of progression and cancer-specific death in all comparisons of the matched cohorts., Conclusions: Although non-maintenance eight-dose iBCG was inferior to six-dose iBCG plus mBCG, the former might be an alternative remedy in the BCG shortage era. To overcome this challenge, further investigation is warranted to confirm the real clinical value of non-maintenance eight-dose iBCG.

Published
2021
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