Cancer Research and Treatment

Original Articles

Efficacy and Safety of Lenvatinib Plus Everolimus in Metastatic Renal Cell Carcinoma After Immune Checkpoint and VEGFR Tyrosine Kinase Inhibitors Treatment: So Heun Lee, Inkeun Park, Shinkyo Yoon, Jae Lyun Lee; Received June 17, 2025 Accepted August 12, 2025 Published online August 13, 2025; DOI: https://doi.org/10.4143/crt.2025.628 [Accepted]

Abstract PDF: Purpose
Real-world data on the efficacy and safety of lenvatinib plus everolimus in metastatic renal cell carcinoma (RCC) after failure of immune checkpoint inhibitors (ICIs) and/or VEGFR-targeted tyrosine kinase inhibitors (TKIs) remain limited.
Materials and Methods
This single-center retrospective study included patients with metastatic RCC treated with lenvatinib plus everolimus as second-line or later therapy at Asan Medical Center, Korea, between September 2017 and June 2024. Data on dose adjustments, treatment response, survival, and adverse events were collected from electronic medical records. Primary endpoints were objective response rate (ORR) and progression-free survival (PFS); secondary endpoints included overall survival (OS), time to progression (TTP), adverse events, and prognostic factors.
Results
A total of 83 patients were included, predominantly with clear cell histology (90.4%). The median number of prior therapies was four (range, 1-7), with 80.7% receiving the combination as fourth-line or beyond. All had prior anti-angiogenic TKI exposure, 86.7% had received ICIs, and 37.3% had prior mTOR inhibitor therapy. The ORR was 40.0%, with disease control at 81.3%. Median PFS and OS were 5.4 months (95% CI, 4.4-6.8) and 8.5 months (95% CI, 6.3-12.1), respectively. Efficacy was consistent across key subgroups. During the treatment, lenvatinib dose reductions were required in 55.4% of patients, and 26.5% experienced treatment interruptions. Grade ≥3 proteinuria occurred in 22.9%.
Conclusion
Lenvatinib plus everolimus demonstrated promising efficacy in heavily pretreated patients with metastatic RCC, including those previously exposed to VEGFR-targeted TKIs and/or ICIs. Further studies are warranted to optimize treatment strategies in this patient population.

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Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma in the East Asian Subgroup of the Phase 3 KEYNOTE-564 Study: Se Hoon Park, Yen-Hwa Chang, Jae Lyun Lee, Toni K. Choueiri, Go Kimura, Jinsoo Chung, Naoya Masumori, Kazuo Nishimura, Minoru Kato, Haruaki Kato, Kazuyuki Numakura, Chao-Hsiang Chang, Satoshi Anai, Hiroyuki Tsunemori, Chung-Hsin Chen, Jianxin Lin, Aymen Elfiky, Joseph E. Burgents, Hiroshi Kitamura; Received March 29, 2025 Accepted June 25, 2025 Published online June 26, 2025; DOI: https://doi.org/10.4143/crt.2025.365 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub

Purpose
Adjuvant pembrolizumab improved disease-free survival (DFS) and overall survival (OS) versus placebo in participants with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy in the global phase 3 KEYNOTE-564 study. This post hoc subgroup analysis evaluated the efficacy and safety of adjuvant pembrolizumab in East Asian (Japan, South Korea, and Taiwan) participants enrolled in KEYNOTE-564.
Materials and Methods
Eligible participants were randomly assigned 1:1 to receive adjuvant pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 17 cycles. The primary endpoint was DFS by investigator assessment. OS was a key secondary endpoint. Safety was a secondary endpoint.
Results
The East Asian subgroup included 126 participants (pembrolizumab, n=58; placebo, n=68). Median follow-up was 62.1 months (range, 49.6 to 73.0 months). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41 to 1.20). Median DFS was not reached with pembrolizumab versus 58.8 months with placebo; estimated 48-month rate was 61.3% versus 51.2%. Hazard ratio for OS was 0.47 (95% confidence interval, 0.15 to 1.49). Median OS was not reached with pembrolizumab and placebo; estimated 48-month rate was 94.8% versus 91.2%. Treatment-related adverse events occurred in 70.7% of participants (29.3% grade 3 or 4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3 or 4) receiving placebo. No pembrolizumab-related deaths occurred.
Conclusion
In the KEYNOTE-564 East Asian subgroup, adjuvant pembrolizumab provided DFS and OS benefits versus placebo and had a safety profile consistent with the global results. These results further support pembrolizumab as adjuvant treatment for East Asian patients with RCC at increased risk of recurrence after nephrectomy.

Citations

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Reply to Editorial Comment: Racial Disparities in Patient Survival and Clinical Features of Recurrence After Surgery for Nonmetastatic Renal Cell Carcinoma: An International Multicenter Study
Masaki Kobayashi, Hajime Tanaka, Yasuhisa Fujii
JU Open Plus.2025;[Epub] CrossRef

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Genitourinary cancer

A Multicenter Phase II Study of Modified FOLFIRINOX for First-Line Treatment for Advanced Urachal Cancer (ULTIMA; KCSG GU20-03): Inkeun Park, Jae Lyun Lee, Shinkyo Yoon, Sang Joon Shin, Seong-Hoon Shin, Jung Hoon Kim, Kwonoh Park, Hyo Jin Lee; Cancer Res Treat. 2026;58(1):284-291. Published online February 13, 2025; DOI: https://doi.org/10.4143/crt.2024.1231

Abstract PDF PubReader ePub

Purpose
This study aimed to assess the efficacy and safety of first-line modified FOLFIRINOX in patients with advanced urachal cancer.
Materials and Methods
The ULTIMA trial (NCT04611724) is a single-arm, open-label, multicenter phase II study evaluating modified FOLFIRINOX (oxaliplatin 85 mg/m² over 2 hours, irinotecan 150 mg/m² over 1.5 hours, leucovorin 400 mg/m² over 2 hours, and 5-fluorouracil 2,400 mg/m² over 46 hours) plus prophylactic pegteograstim in patients with recurrent or metastatic urachal cancer every 2 weeks for up to 12 cycles, or until disease progression or unacceptable toxicity. The primary endpoint was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and the incidence of febrile neutropenia.
Results
Between April 2021 and November 2023, 21 patients with advanced urachal cancer were enrolled across five cancer centers. The median age was 50 years (range, 28 to 68 years), with 15 male patients. The most common metastatic site was the lung (47.6%), followed by lymph nodes (38.1%) and peritoneal seeding (33.3%). Two patients and 11 patients achieved a complete and partial response, respectively, yielding an ORR of 61.9%. The study met its primary endpoint in the first stage. With a median follow-up of 23.3 months, the median PFS was 9.3 months (95% confidence interval [CI], 6.7 to 11.9), and the median OS was 19.7 months (95% CI, 14.3 to 25.1). The treatment regimen was well tolerated, with no unexpected adverse events, and no instances of febrile neutropenia or grade 4 adverse events.
Conclusion
In this preliminary analysis of the ULTIMA trial, Modified FOLFIRINOX demonstrated a promising ORR and PFS in patients with advanced urachal cancer. Completing the full study is essential to confirm the potential role of this regimen in the management of advanced urachal cancer.

Citations

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Metastatic urachal carcinoma treated with trifluridine/tipiracil and bevacizumab: a case report
Takafumi Kitazono, Taichi Isobe, Satoshi Nishiyori, Wataru Kusano, Kenro Tanoue, Tomoyasu Yoshihiro, Hirofumi Ohmura, Kyoko Yamaguchi, Mamoru Ito, Kenji Tsuchihashi, Koichi Akashi, Eishi Baba
International Cancer Conference Journal.2025; 14(3): 280. CrossRef
Urachal cancer: a clinical, diagnostic, and therapeutic update
Henning Reis, Tibor Szarvas, Gladell P. Paner
Current Opinion in Urology.2025;[Epub] CrossRef

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General

Significant Dissatisfaction with an Outdated System: A Survey on the Experience of Application for Off-Label Use of Anti-cancer Drugs by the Korean Society of Medical Oncology: Jae Lyun Lee, Dong-Hoe Koo, Young-Woong Won, Young Saing Kim, Hee Kyung Ahn, Seungtaek Lim; Cancer Res Treat. 2025;57(4):942-950. Published online February 11, 2025; DOI: https://doi.org/10.4143/crt.2024.749

Abstract PDF Supplementary Material PubReader ePub: Purpose
This study evaluates the experiences and satisfaction levels of Korean medical oncologists with the prior authorization system for the off-label use of anti-cancer drugs. Conducted by the Korean Society of Medical Oncology (KSMO), the survey aimed to identify challenges and areas for improvement in the current regulatory framework.
Materials and Methods
A cross-sectional web-based survey was carried out between May 4 and May 14, 2023, targeting 261 active KSMO medical oncologists. Invitations were sent via email, and the survey, comprising 19 questions, was hosted on Microsoft Forms. The questions covered personal characteristics, work environment, experiences with the pre-application process, and post-approval experiences.
Results
For the 261 invitations sent, 110 responses (42.1%) were received. Most respondents had over 10 years of experience and worked in tertiary hospitals. Although 93.6% were familiar with the pre-application system, 67.3% expressed moderate to high dissatisfaction. The key issues included complex applications, long approval period, stringent criteria, and inconsistent reviews. Additionally, 74.4% of respondents spent over 3 hours on first-time applications, with 68.3% experiencing rejections. Emotional responses to rejections were largely negative, with many feeling disregarded. Post-approval, patients of 96.8% of respondents faced financial burdens leading to treatment discontinuation. Most oncologists (86.0%) supported selective reimbursement if the disease was controlled for a certain period.
Conclusion
The survey highlights significant dissatisfaction with the current system, suggesting the need for streamlining the application process, easing approval criteria, and reconsidering the financial aspects of post-approval treatments to support patient care and oncologists’ decision-making autonomy.

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Genitourinary cancer

Pemetrexed Maintenance versus Observation in Patients with Advanced Urothelial Carcinoma Who Completed First-Line Platinum-Based Chemotherapy without Disease Progression (PREMIER, KCSG GU16-05): Inkeun Park, Shinkyo Yoon, Ilhwan Kim, Kwonoh Park, Suee Lee, Bhumsuk Keam, Joo-Hwan Park, Jin Young Kim, Yoon Ji Choi, Byeong Seok Sohn, Jae Lyun Lee; Cancer Res Treat. 2025;57(4):1167-1177. Published online December 27, 2024; DOI: https://doi.org/10.4143/crt.2024.1003

Abstract PDF PubReader ePub: Purpose
Platinum-based chemotherapy is the standard treatment for advanced urothelial carcinoma (aUC). Switch maintenance therapy after first-line (1L) treatment may delay disease progression. This study evaluated pemetrexed as switch maintenance therapy versus observation in aUC patients without disease progression after initial chemotherapy.
Materials and Methods
Eligible aUC patients who did not progress after 4-6 cycles of cisplatin or carboplatin-based chemotherapy were randomized 1:1 to receive maintenance pemetrexed (500 mg/m² intravenously every 3 weeks, up to 16 cycles) or observation. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), response rate, and safety.
Results
The trial was closed early due to slow accrual after avelumab approval. From October 2016 to December 2022, 97 patients were randomized to pemetrexed (n=49) or observation (n=48). The median age was 69 years (range, 43 to 90) and 66 (range, 33 to 82), respectively, with 63% and 73% of patients being male, respectively. The median PFS was 6.0 months (95% confidence interval [CI], 3.4 to 8.5) with pemetrexed versus 2.3 months (95% CI, 1.8 to 2.7) with observation (p=0.044; hazard ratio [HR], 0.64; 95% CI, 0.41 to 0.99). The median OS was 18.1 months (95% CI, 6.9 to 29.4) for pemetrexed and 17.9 months (95% CI, 16.1 to 19.7) for observation (p=0.913; HR, 1.03; 95% CI, 0.61 to 1.73). Common adverse events in the pemetrexed group included anemia (30.6%), fatigue (18.4%), and neutropenia (12.2%), primarily grade 1 or 2.
Conclusion
The PREMIER trial showed that switch maintenance pemetrexed significantly prolonged PFS in aUC patients post-1L platinum-based chemotherapy, with a favorable safety profile. Further studies on combination maintenance therapies are warranted.

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General

The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group: Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yun, Byung-Ho Nam, Dae Young Zang; Cancer Res Treat. 2025;57(1):39-46. Published online July 10, 2024; DOI: https://doi.org/10.4143/crt.2024.421

Abstract PDF PubReader ePub: Purpose
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.

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Genitourinary cancer

Clinical Outcomes of Small Cell Carcinoma of the Genitourinary Tract and the Prognostic Significance of the Tumor Immune Microenvironment: Jaewon Hyung, Hyung-Don Kim, Gi Hwan Kim, Yong Mee Cho, Yeon-Mi Ryu, Sang-Yeob Kim, Inkeun Park, Shinkyo Yoon, Jae Lyun Lee; Cancer Res Treat. 2024;56(2):624-633. Published online November 29, 2023; DOI: https://doi.org/10.4143/crt.2023.1076

Abstract PDF Supplementary Material PubReader ePub: Purpose
Small cell carcinoma of the genitourinary tract (GU SCC) is a rare disease with a poor prognosis. There are only limited treatment options due to insufficient understanding of the disease. In this study, we analyzed the clinical outcomes of patients with GU SCC and their association with the tumor immune phenotype.
Materials and Methods
Patients diagnosed with GU SCC were included. Survival outcomes according to the primary location (prostate and non-prostate) and stages (limited disease [LD] and extensive disease [ED]) were analyzed. We performed multiplex immunohistochemistry (IHC) in non-prostate SCC patients and analyzed the immune cell population.
Results
A total of 77 patients were included in this study. Their median age was 71 years, 67 patients (87.0%) were male, and 48 patients (62.3%) had non-prostate SCC. All patients with ED (n=31, 40.3%) received etoposide plus platinum (EP) as initial treatment and median overall survival (OS) was 9.7 months (95% confidence interval [CI], 7.1 to 18.6). Patients with LD (n=46, 59.7%) received EP followed by radiotherapy or surgery, and 24-months OS rate was 63.6% (95% CI, 49.9 to 81.0). The multiplex IHC analysis of 21 patients with non-prostate SCC showed that patients with a higher density of programmed death-ligand 1–expressing CD68+CD206+ M2-like macrophages had significantly worse OS outcomes with an adjusted hazards ratio of 4.17 (95% CI, 1.25 to 14.29; adjusted p=0.02).
Conclusion
Patients with GU SCC had a poor prognosis, even those with localized disease. The tumor immune phenotypes were significantly associated with survival. This finding provides new insights for treating GU SCC.

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Real-World Study Evaluating Safety and Effectiveness of Axitinib in Korean Patients with Renal Cell Carcinoma after Failure of One Prior Systemic Therapy: Sang Joon Shin, Jae Lyun Lee, Tae Gyun Kwon, Byoung Young Shim, Ho Seok Chung, Sang-Hee Kim, Se Hoon Park; Cancer Res Treat. 2023;55(2):643-651. Published online November 28, 2022; DOI: https://doi.org/10.4143/crt.2022.883

Abstract PDF Supplementary Material PubReader ePub

Purpose
This post-marketing surveillance (PMS) study was conducted to monitor the usage of axitinib (Inlyta) in clinical practice of Korean patients with advanced renal cell carcinoma (RCC) with disease progression during or after a prior systemic therapy in real world.
Materials and Methods
In this multicenter, observational study, patients indicated for oral axitinib 5 mg twice daily as second-line therapy for advanced RCC were followed up under routine clinical practices, and their safety and effectiveness outcomes were collected.
Results
Between 2012 and 2021, 125 patients were enrolled, and data from 111 patients were analyzed. Median age was 65 years (range, 30 to 84 years), 81% was male, and 110 (99%) had clear cell RCC. The median daily dose of axitinib was 10 mg (range, 4.36 to 15.95 mg) with a median administration period of 5.6 months (range, 15 to 750 days). Eighty-three percentage of patients experienced any grade of adverse events, 71% of which were related to study treatment, including diarrhea (36%), hypertension (21%), stomatitis (17%), decreased appetite (14%), palmar-plantar erythrodysesthesia syndrome (12%), and asthenia (11%). Most adverse events were generally well tolerated and manageable, with 13% of grade ≥ 3. Axitinib dose reduction was required in 20% of the adverse events and discontinuation in 8%. Median progression-free survival was 12.4 months (95% confidence interval [CI], 9.6 to 18.9). Objective responses were observed in 30% of patients (95% CI, 21 to 39) with 4% of complete response and 26% of partial response.
Conclusion
No new safety signal was found in the present PMS study of Korean RCC patients. Axitinib showed consistent outcomes in terms of effectiveness and safety confirming that the drug is a valid option for second-line therapy in patients with advanced RCC in a real-world setting.

Citations

Citations to this article as recorded by

Chemotherapy-related hand–foot syndrome and hand–foot skin reaction: a review of management and possible approaches for Asian patients by the Japanese pharmacist-led oncodermatology study team
Yohei Iimura, Hirotoshi Iihara, Yoshitaka Saito, Hisanaga Nomura, Takuya Iwamoto, Mayumi Kotera, Yusuke Tsuchiya, Tatsuya Sumiya, Mariko Kono, Daisuke Hirate, Tomohiro Kurokawa, Toshinobu Hayashi, Hironobu Hashimoto, Junichi Higuchi, Ryuta Urakawa, Hiroyu
International Journal of Clinical Oncology.2025; 30(12): 2474. CrossRef
Axitinib

Reactions Weekly.2024; 1991(1): 45. CrossRef

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The Prognosis and the Role of Adjuvant Chemotherapy for Node-Positive Bladder Cancer Treated with Neoadjuvant Chemotherapy Followed by Surgery: Hyehyun Jeong, Kye Jin Park, Yongjune Lee, Hyung-Don Kim, Jwa Hoon Kim, Shinkyo Yoon, Bumsik Hong, Jae Lyun Lee; Cancer Res Treat. 2022;54(1):226-233. Published online May 6, 2021; DOI: https://doi.org/10.4143/crt.2021.365

Abstract PDF Supplementary Material PubReader ePub

Purpose
This study aims to evaluate the prognosis of pathologically node-positive bladder cancer after neoadjuvant chemotherapy, the role of adjuvant chemotherapy in these patients, and the value of preoperative clinical evaluation for lymph node metastases.
Materials and Methods
Patients who received neoadjuvant chemotherapy followed by partial/radical cystectomy and had pathologically confirmed lymph node metastases between January 2007 and December 2019 were identified and analyzed.
Results
A total of 53 patients were included in the study. The median age was 61 years (range, 34 to 81 years) with males comprising 86.8%. Among the 52 patients with post-neoadjuvant/pre-operative computed tomography results, only 33 patients (63.5%) were considered positive for lymph node metastasis. Sixteen patients (30.2%) received adjuvant chemotherapy (AC group), and 37 patients did not (no AC group). With the median follow-up duration of 67.7 months, the median recurrence-free survival (RFS) and the median overall survival (OS) was 8.5 months and 16.2 months, respectively. The 2-year RFS and OS rates were 23.3% and 34.6%, respectively. RFS and OS did not differ between the AC group and no AC group (median RFS, 8.8 months vs. 6.8 months, p=0.772; median OS, 16.1 months vs. 16.3 months, p=0.479). Thirty-eight patients (71.7%) experienced recurrence. Distant metastases were the dominant pattern of failure in both the AC group (91.7%) and no AC group (76.9%).
Conclusion
Patients with lymph node-positive disease after neoadjuvant chemotherapy followed by surgery showed high recurrence rates with limited survival outcomes. Little benefit was observed with the addition of adjuvant chemotherapy.

Citations

Citations to this article as recorded by

A Predictive Nomogram for Development of Lymph Node Metastasis in Muscle-Invasive Bladder Cancer Following Neoadjuvant Therapy
Garrett K. Harada, Steven N. Seyedin, Olivia Heutlinger, Armon Azizi, Audree Hsu, Arash Rezazadeh, Michael Daneshvar, Greg E. Gin, Edward M. Uchio, Giovanna A. Giannico, Jeremy P. Harris, Aaron B. Simon, Jeffrey V. Kuo, Nataliya Mar
Advances in Radiation Oncology.2025; 10(1): 101671. CrossRef
Resultados oncológicos de pacientes con afectación ganglionar tras quimioterapia neoadyuvante y cistectomía radical para el cáncer de vejiga músculo-invasivo: estudio observacional multicéntrico del Grupo de Trabajo de Carcinoma Urotelial de la sección de
G. Marcq, W. Kassouf, M. Roumiguié, B. Pradere, L.S. Mertens, S. Albisinni, A. Cimadamore, J. Yuen-Chun Teoh, M. Moschini, E. Laukhtina, A. Mari, F. Soria, A. Gallioli, F. del Giudice, D. d’Andrea, W. Krajewski, J.B. Beauval, E. Xylinas, D. Pouessel, P. S
Actas Urológicas Españolas.2025; 49(2): 501701. CrossRef
Oncological outcomes of patients with node positive disease following neoadjuvant chemotherapy and radical cystectomy for muscle-invasive bladder cancer: A multicenter observational study of the EAU Young Academic Urologists (YAU) urothelial carcinoma wor
G. Marcq, W. Kassouf, M. Roumiguié, B. Pradere, L.S. Mertens, S. Albisinni, A. Cimadamore, J. Yuen-Chun Teoh, M. Moschini, E. Laukhtina, A. Mari, F. Soria, A. Gallioli, F. del Giudice, D. d’Andrea, W. Krajewski, J.B. Beauval, E. Xylinas, D. Pouessel, P. S
Actas Urológicas Españolas (English Edition).2025; 49(2): 501701. CrossRef
Differential Outcomes in Bladder Cancer After Neoadjuvant Chemotherapy: An International Multi-Institutional Study Comparing Isolated Nodal Disease vs Persistent Muscle-Invasive Disease
Andres M. Acosta, Mohammed Saad, Alcides Chaux, Jennifer B. Gordetsky, Lan Zheng, Charles Guo, Mohamed Bikhet, Adeboye O. Osunkoya, Katrina Collins, Muhammad T. Idrees, Geert J.L.H. van Leenders, Pilar Gonzalez-Peramato, Kristine M. Cornejo, Michelle S. H
Urology.2025; 200: 127. CrossRef
Demonstrating the non-inferiority of robotic radical cystectomy for cT3–cT4 urothelial carcinoma in the era of neoadjuvant chemotherapy: a propensity score-matched analysis
Il Woo Park, Tae Il Noh, Seok Ho Kang, Jong Jin Oh, Seung Hwan Jeong, Won Sik Ham, Jieun Heo, Hyun Hwan Sung, Byong Chang Jeong, Geehyun Song, Ho Kyung Seo, Kyung Hwan Kim, Jong Kil Nam, Wook Nam, Yun-Sok Ha, Joongwon Choi, Wan Song, Bumjin Lim
Journal of Robotic Surgery.2025;[Epub] CrossRef
Influence of Neoadjuvant Chemotherapy on Survival Outcomes of Radical Cystectomy in Pathologically Proven Positive and Negative Lymph Nodes
Krystian Kaczmarek, Bartosz Małkiewicz, Karolina Skonieczna-Żydecka, Artur Lemiński
Cancers.2023; 15(19): 4901. CrossRef
Comparison of responses to neoadjuvant and adjuvant chemotherapies in muscle-invasive bladder cancer
Serhat Sekmek, Gökhan Ucar, Irfan Karahan, Dogan Bayram, Selin Aktürk Esen, Ismet Seven, Mehmet Ali Nahit Sendur, Dogan Uncu
African Journal of Urology.2023;[Epub] CrossRef

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Genitourinary Cancer

Use of Gemcitabine plus Carboplatin is Associated with Poor Outcomes in Urothelial Carcinoma Patients with Chronic Kidney Disease Stage 4-5: Hyung-Don Kim, Hyeon-Su Im, Jwa Hoon Kim, Hyehyun Jeong, Shin Kyo Yoon, Inkeun Park, Jae Lyun Lee; Cancer Res Treat. 2021;53(4):1166-1173. Published online March 4, 2021; DOI: https://doi.org/10.4143/crt.2021.091

Abstract PDF Supplementary Material PubReader ePub

Purpose
This study aimed to investigate the clinical outcomes with gemcitabine-carboplatin (GCb), the standard treatment for patients with advanced urothelial carcinoma (UC) who are ineligible for cisplatin-based regimens, in advanced UC patients with a glomerular filtration rate (GFR) < 30 mL/min.
Materials and Methods
A retrospective cohort study involving GCb-treated advanced UC patients with GFR < 60 mL/min (n=89) was performed. Clinical outcomes were compared between subgroups with GFR < 30 mL/min and GFR ≥ 30 mL/min but < 60 mL/min.
Results
Most baseline characteristics were comparable between the two subgroups. Patients with GFR < 30 mL/min had a significantly lower objective response rate (12.5%) compared to those with higher GFR levels (56.7%) (p=0.004). The number of GCb cycles was significantly lower in patients with GFR < 30 mL/min (median 2 cycles) than in those with higher GFR levels (median 6 cycles) (p=0.002). Compared to those with GFR ≥ 30 mL/min but < 60 mL/min, patients with GFR < 30 mL/min showed significantly worse progression-free survival (PFS) and overall survival (OS) (p < 0.001 for both). Further stratification of patient subgroups according to their GFR (i.e., GFR ≥ 45 mL/min but < 60 mL/min vs. GFR ≥ 30 mL/min but < 45 mL/min vs. GFR < 30 mL/min) revealed significantly different PFS and OS (p < 0.001 for both).
Conclusion
The use of GCb is discouraged in advanced UC patients with GFR < 30 mL/min. Alternative therapeutic approaches with better efficacy are warranted for these patients.

Citations

Citations to this article as recorded by

Real‐World Outcomes of First‐Line Systematic Treatment in Locally Advanced or Metastatic Upper Urinary Tract Urothelial Carcinoma With Renal Impairment (YUSHIMA Study)
Tomoki Kimura, Motohiro Fujiwara, Yuya Maezawa, Kensaku Ishihara, Naoki Inoue, Kenji Tanabe, Keita Izumi, Masahiro Toide, Takanobu Yamamoto, Sho Uehara, Saori Araki, Masaharu Inoue, Ryoji Takazawa, Noboru Numao, Yukihiro Ohtsuka, Yuma Waseda, Hajime Tanak
International Journal of Urology.2025; 32(10): 1369. CrossRef
Contemporary management of metastatic urothelial carcinoma
Jong Jin Oh, Sung Kyu Hong
Investigative and Clinical Urology.2025; 66(5): 375. CrossRef
Onconephrology: mitigation of renal injury in chemotherapy administration
Umut Selamet, Rebecca S. Ahdoot, Reed Salasnek, Lama Abdelnour, Ramy M. Hanna
Current Opinion in Nephrology & Hypertension.2024; 33(2): 257. CrossRef
Management of bladder cancer in older patients
Shingo Hatakeyama, Shintaro Narita, Kazutaka Okita, Takuma Narita, Hiromichi Iwamura, Naoki Fujita, Junichi Inokuchi, Yoshiyuki Matsui, Hiroshi Kitamura, Chikara Ohyama
Japanese Journal of Clinical Oncology.2022; 52(3): 203. CrossRef

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Bevacizumab Plus Erlotinib Combination Therapy for Advanced Hereditary Leiomyomatosis and Renal Cell Carcinoma-Associated Renal Cell Carcinoma: A Multicenter Retrospective Analysis in Korean Patients: Yeonjoo Choi, Bhumsuk Keam, Miso Kim, Shinkyo Yoon, Dalyong Kim, Jong Gwon Choi, Ja Young Seo, Inkeun Park, Jae Lyun Lee; Cancer Res Treat. 2019;51(4):1549-1556. Published online March 25, 2019; DOI: https://doi.org/10.4143/crt.2019.086

Abstract PDF Supplementary Material PubReader ePub

Purpose
Hereditary leiomyomatosis and renal cell carcinoma (HLRCC) is a rare genetic syndrome resulting from germline mutations in fumarate hydratase. The combination of bevacizumab plus erlotinib showed promising interim results for HLRCC-associated RCC. Based on these results, we analyzed the outcome of bevacizumab plus erlotinib in Korean patients with HLRCC-associated RCC.
Materials and Methods
We retrospectively reviewed the efficacy and safety of bevacizumab plus erlotinib in patients with HLRCC-associated RCC who were confirmed to have germline mutations in fumarate hydratase. The primary endpoint was the objective response rate (ORR), while the secondary endpoints were progression-free survival (PFS) and overall survival (OS).
Result
We identified 10 patients with advanced HLRCC-associated RCC who received bevacizumab plus erlotinib. Median age at diagnosis was 41 years, and five of the patients had received the combination as first- or second-line treatments. The ORR was 50% and the median PFS and OS were 13.3 and 14.1 months, respectively. Most adverse events were predictable and manageable by conventional measures, except for one instance where a patient died of gastrointestinal bleeding.
Conclusion
This is the first real-world outcome of the treatment of advanced HLRCC-associated RCC. Bevacizumab plus erlotinib therapy showed promising activity with moderate toxicity. We should be increasingly aware of HLRCC-associated RCC and bevacizumab plus erlotinib should be a first-line treatment for this condition, unless other promising data are published.

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Phase II Study of Dovitinib in Patients with Castration-Resistant Prostate Cancer (KCSG-GU11-05): Yoon Ji Choi, Hye Sook Kim, Se Hoon Park, Bong-Seog Kim, Kyoung Ha Kim, Hyo Jin Lee, Hong Suk Song, Dong-Yeop Shin, Ha Young Lee, Hoon-Gu Kim, Kyung Hee Lee, Jae Lyun Lee, Kyong Hwa Park; Cancer Res Treat. 2018;50(4):1252-1259. Published online January 2, 2018; DOI: https://doi.org/10.4143/crt.2017.438

Abstract PDF PubReader ePub

Purpose
Fibroblast growth factor (FGF) signals are important in carcinogenesis and progression of prostate cancer. Dovitinib is an oral, pan-class inhibitor of vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, and fibroblast growth factor receptor (FGFR). We evaluated the efficacy and toxicity of dovitinib in men with metastatic castration resistant prostate cancer (mCRPC).
Materials and Methods
This study was a single-arm, phase II, open-label, multicenter trial of dovitinib 500 mg/day (5-days-on/2-days-off schedule). The primary endpointwas 16-week progression-free survival (PFS). Secondary endpoints were overall survival (OS), toxicity and prostate-specific antigen (PSA) response rate. Biomarker analyses for VEGFR2, FGF23, and FGFR2 using multiplex enzyme-linked immunosorbent assay was performed.
Results
Forty-four men were accrued from 11 hospitals. Eighty percent were post-docetaxel. Median PSA was 100 ng/dL, median age was 69, 82% had bone metastases, and 23% had liver metastases. Median cycles of dovitinibwas 2 (range, 0 to 33). Median PFSwas 3.67 months (95% confidence interval [CI], 1.36 to 5.98) and median OS was 13.70 months (95% CI, 0 to 27.41). Chemotherapy-naïve patients had longer PFS (17.90 months; 95% CI, 9.23 to 28.57) compared with docetaxel-treated patients (2.07 months; 95% CI, 1.73 to 2.41; p=0.001) and the patients with high serum VEGFR2 level over median level (7,800 pg/mL) showed longer PFS compared with others (6.03 months [95% CI, 4.26 to 7.80] vs. 1.97 months [95% CI, 1.79 to 2.15], p=0.023). Grade 3 related adverse events were seen in 40.9% of patients. Grade 1-2 nausea, diarrhea, fatigue, anorexia, and all grade thrombocytopenia are common.
Conclusion
Dovitinib showed modest antitumor activity with manageable toxicities in men with mCRPC. Especially, patients who were chemo-naïve benefitted from dovitinib.

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Case Reports

Conventional Cisplatin-Based Combination Chemotherapy Is Effective in the Treatment of Metastatic Spermatocytic Seminoma with Extensive Rhabdomyosarcomatous Transformation: Yumun Jeong, Jaekyung Cheon, Tae-Oh Kim, Doo-Ho Lim, Sunpyo Lee, Young-Mi Cho, Jun Hyuk Hong, Jae Lyun Lee; Cancer Res Treat. 2015;47(4):931-936. Published online September 11, 2014; DOI: https://doi.org/10.4143/crt.2014.049

Abstract PDF PubReader ePub

A 52-year-old man was presented with a huge left testicular mass and palpable cervical lymphadenopathy with retroperitoneal lymph node enlargement on an abdominal computed tomography. A left radical orchiectomy and an ultrasound-guided neck node biopsy were performed. A pathological examination revealed spermatocytic seminoma with extensive rhabdomyosarcomatous transformation, a condition known to be highly resistant to platinum-based chemotherapy. The patient received four cycles of etoposide, ifosfamide and cisplatin (VIP) chemotherapy. A repeat computed tomography revealed a substantial regression consistent with a partial response. Retroperitoneal lymph node dissection was attempted, which revealed rhabdomyosarcoma; however, complete microscopic resection was not achieved. After surgery, the residual abdominal lymph node progressed and salvage paclitaxel, ifosfamide and cisplatin (TIP) chemotherapy was employed, which again achieved a partial response. Here, we present a first case report of a spermatocytic seminoma with extensive rhabdomyosarcomatous transformation and multiple metastatic lymphadenopathies that showed a favorable response to platinum-based systemic chemotherapy.

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Spermatocytic tumor coexisting with a contralateral inguinoscrotal undifferentiated sarcoma: a case report
Lisa Surer, Pia Kraft, Yasmin Heiniger, Nadim Abo Youssef, Michel Bihl, Hubert John, Peter Bode
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Spermatocytic tumor associated with metastases: report of a rare case and literature review
Jianbai Chen, Xiaorong Mou, Zhiming Zhang, Wei Zhang, Zhiyong Nie, Xiaoping Gao, Yanyao Gao, Jianxin Qiu
Frontiers in Pharmacology.2025;[Epub] CrossRef
Case of the month from the Department of Medical Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Australia: recurrent metastatic spermatocytic tumour successfully treated with salvage systemic chemotherapy
Jane McKenzie, Catherine Mitchell, Jeremy Lewin, Ciara Conduit
BJU International.2024; 134(6): 922. CrossRef
Sarcomatoid Spermatocytic Tumour: Report of a Rare Case and Literature Review
André Fontes Dias, Eugénia Dvindenko, Filipa Santos, Rafael Cabrera
International Journal of Surgical Pathology.2023; 31(5): 728. CrossRef
Spermatocytic Tumor: A Review
Simona Secondino, Alessandra Viglio, Giuseppe Neri, Giulia Galli, Carlotta Faverio, Federica Mascaro, Richard Naspro, Giovanni Rosti, Paolo Pedrazzoli
International Journal of Molecular Sciences.2023; 24(11): 9529. CrossRef
Spermatocytic seminoma of testis associated with undifferentiated sarcoma revealed in metastatic disease: A review and case report analysis
Mehdi Chennoufi, Ibrahim Boukhannous, Mohamed Mokhtari, Anouar El Moudane, Ali Barki
Urology Case Reports.2021; 38: 101732. CrossRef

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Sunitinib Treatment for Metastatic Renal Cell Carcinoma in Patients with Von Hippel-Lindau Disease: Ho Cheol Kim, Jung Su Lee, Sang Hyung Kim, Hoon Sub So, Chang Yoon Woo, Jae Lyun Lee; Cancer Res Treat. 2013;45(4):349-353. Published online December 31, 2013; DOI: https://doi.org/10.4143/crt.2013.45.4.349

Abstract PDF PubReader ePub

Von Hippel-Lindau (VHL) disease is an autosomal dominant disease that produces a variety of tumors and cysts in the central nervous system and visceral organs, including renal cell carcinoma (RCC). RCC in patients with VHL disease does not frequently metastasize, therefore, the response to treatment and prognosis of metastatic RCC developed in patients with VHL disease has not been reported. Sunitinib is an oral, multitargeted receptor tyrosine kinase inhibitor with antiangiogenic and antitumor activity. Here, we report on four patients with metastatic RCC in VHL disease who received sunitinib and achieved partial responses that have lasted for a prolonged period of time.

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Harmanjot Singh, Mukul K. Divatia, Donghwa Baek, Jae Y. Ro
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The VHL/HIF Axis in the Development and Treatment of Pheochromocytoma/Paraganglioma
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Stéphane Oudard, Reza Elaidi, Mara Brizard, Céline Le Rest, Valérie Caillet, Sophie Deveaux, Gérard Benoit, Jean-Michel Corréas, Farida Benoudiba, Philippe David, Alain Gaudric, Pascal Hammel, Dominique Joly, Marc Olivier Timsit, Arnaud Méjean, Stéphane R
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Original Articles

Effect of Combination Chemotherapy with Docetaxel Plus Cisplatin in Patients with Advanced Non-Small Cell Lung Cancer: Hee Jung Kang, Min Kyoung Kim, Young Gil Kim, Jae Lyun Lee, Kyung Hee Lee, Myung Soo Hyun, Sung Hwa Bae, Hun Mo Ryoo; Cancer Res Treat. 2003;35(4):299-303. Published online August 31, 2003; DOI: https://doi.org/10.4143/crt.2003.35.4.299

Abstract PDF: PURPOSE
This study was conducted to evaluate the efficacy and safety of combination chemotherapy, with docetaxel and cisplatin, as a first line treatment for advanced non-small cell lung cancer.
MATERIALS AND METHODS
Between March 1998 and December 2001, 35 patients with advanced non-small cell lung cancer were enrolled in this study. The patients were treated at 3-week intervals, with one course of a regimen consisting of docetaxel (75 mg/m2 IV for 1 hours) on day 1 and cisplatin (60 mg/m2 IV) on day 2.
RESULTS
The median age of the patients was 60.3 years. Of the 35 patients, 20 and 15 had stage IIIb and stage IV diseases, respectively. A complete response was observed in 1 patient and partial response in 15, with an overall response rate of 46%. The overall median survival duration was 40.3+/-25.2 weeks. The median time to progression and response duration were 21.6+/-5.5 and 15.1+/-5.9 weeks, respectively. The survival duration was statistically significantly longer in the response group (50.6 weeks) than in the non-response group (31.6 weeks) (p<0.05). Of the hematological side effects, grades III and IV leukopenia were observed in 4.8% of patients. Grades III and IV nausea and vomiting were observed in 48.5%, and grades I and II neuropathy in 11.4% of the treated patients. These toxicities were well tolerable and reversible. There were no hypersensitivity reactions.
CONCLUSION
Docetaxel and cisplatin combination chemotherapy is relatively effective and safe in advanced non-small cell lung cancer patients.

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Overexpression of c-met Protein in Gastric Cancer and Role of uPAR as a Therapeutic Target: Hyun A Oh, Gu Lee, Hee Jung Kang, Yong Gil Kim, Sung Hwa Bae, Jae Lyun Lee, Kyung Hee Lee, Myung Soo Hyun, Dong Suk Kim; Cancer Res Treat. 2003;35(1):9-15. Published online February 28, 2003; DOI: https://doi.org/10.4143/crt.2003.35.1.9

Abstract PDF

PURPOSE
One of the members of the tyrosine kinase receptor family is the protein product of the c-met proto-oncogene, which is the receptor for hepatocyte growth factor (HGF). HGF is known as a potent mitogen and motogen for many kinds of carcinoma cells, and has been found to simulate the growth and progression of gastric cancer cells through HGF-receptors. In addition, the urokinase-type plasminogen activator (uPA) and receptor (uPAR) also play important roles in the invasion and metastasis. MATERIALS AND METHODS: The expression of c-met protein was investigated using immunohistochemical staining of 50 paraffin embedded gastric cancers, and by measuring the serum uPAR levels, before and after an operation, in gastric cancer patients using an ELISA assay. RESULTS: Of the 50 cases, 32 (64%) expressed the c-met protein. The c-met protein expression was significantly correlated with the TNM staging (p<0.05), but the other prognostic factors were not significant variables. According to a Kaplan-Meier's plot, the one and three year overall survival rates were 94 and 70% in patients not expressing the c-met protein, and 81 and 33% in those that did, and the Survival curves revealed a significantly different prognosis (p=0.04). Elevated serum uPAR levels (> or=3257.8 pg/ml, control+/-mean 2SD) were observed in 9 (34.6%) of 26 gastric cancer patients, but in none of control subjects. Average serum uPAR levels were 2980.8+/-616.2 pg/ml before the operation and 2404.7+/-455.9 pg/ml after, and decreased significantly after surgical resection (p<0.05). The serum uPAR level correlated significantly with lymph node metastasis and vessel invasion (p<0.05) CONCLUSION: The expression of c-met protein, and the level of uPAR, may be prognostic factors in gastric cancer.

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