Renal / Urothelial cancer
Trends in the use of neoadjuvant chemotherapy and oncological outcomes for high-risk upper tract urothelial carcinoma: a multicenter retrospective study
- Author(s)：
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Tomoko Hamaya1, Shingo Hatakeyama1, Toshikazu Tanaka2, Yuka Kubota3, Kyo Togashi4, Shogo Hosogoe5, Naoki Fujita1, Ayumu Kusaka6, Noriko Tokui7, Teppei Okamoto1, Hayato Yamamoto1, Tohru Yoneyama1, Takahiro Yoneyama1,
Yasuhiro Hashimoto1, Chikara Ohyama1 - Affiliation(s)：
- 1Department of Urology, Graduate of Medicine, Hirosaki University, 2Department of Urology, Aomori Prefectural Central Hospital,3Miyagi Children's Hospital,4Department of Urology, Tsugaru General Hospital,5Department of Urology, Hakodate Municipal Hospital,6Department of Urology, Misawa City Hospital,7Department of Urology, Odate Municipal General Hospital
Objective: To evaluate temporal trends in neoadjuvant chemotherapy (NAC) utilization and outcomes in patients with locally advanced upper tract urothelial carcinoma (UTUC).
Materials and Methods: We included 289 patients from six hospitals who underwent radical nephroureterectomy (RNU) for locally advanced UTUC (≧cT3 or cN+) between 2000 and 2020. These patients received RNU alone or 2-4 courses of NAC with either cisplatin- or carboplatin-based regimen. We evaluated the temporal changes in NAC use and compared the visceral recurrence-free, cancer-specific, and overall survival rates. The effect of NAC on oncological outcomes was examined using multivariate Cox regression analysis with inverse probability of treatment weighting (IPTW) models.
Results: Of 289 patients, 144 underwent NAC followed by RNU (NAC group) and 145 underwent RNU alone (Ctrl group). NAC use increased significantly from 14% (2000- 2010) to 68% (2011-2020). Pathological downstaging was significantly higher in the NAC group than in the Ctrl group. IPTW-adjusted multivariable analyses showed that NAC significantly improved the oncological outcomes in the NAC group compared with the Ctrl group. Moreover, carboplatin-based NAC significantly improved the oncological outcomes in the NAC group compared with the Ctrl group among patients with chronic kidney disease stage ≧3. There were no significant differences in oncological outcomes between the cisplatin- and carboplatin-based regimens.
Conclusions: NAC use for high-risk UTUC increased significantly after 2010. Platinum-based short-term NAC followed by immediate RNU may not impede and potentially improves oncological outcomes.
Correlation between immune-related adverse events and clinical efficacy in metastatic renal cell carcinoma patients treated with nivolumab: a real-world multi-institutional retrospective study
- Author(s)：
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Taigo Kato1, Akira Nagahara2, Norihiko Kawamura3, Wataru Nakata4, Tetsuji Soda5, Kyosuke Matsuzaki6, Koji Hatano1,
Atsunari Kawashima1, Kensaku Nishimura6, Shingo Takada5, Masao Tsujihata4, Tetsuya Takao3, Kazuo Nishimura2,
Motohide Uemura1, Norio Nonomura1 - Affiliation(s)：
- 1Urology, Graduate School of Medicine, Osaka University, 2Urology, Osaka International Cancer Institute,3Urology, Osaka General Medical Center,4Urology, Osaka Rosai Hospital,5Urology, Osaka Police Hospital,6Urology, National Hospital Organization Osaka National Hospital
Background
Recently, some repots showed that immune-related adverse events (irAEs) caused by immune checkpoint inhibitors (ICIs) were correlated with favorable clinical outcome in patients with melanoma. However, in metastatic renal cell carcinoma (mRCC) patients, there have been few reports about the correlation between irAEs and clinical efficacy of anti-programmed cell death protein-1 (PD-1) therapy.
Patients and methods
We retrospectively investigated 160 mRCC patients who started nivolumab monotherapy between September 2016 and July 2019. IrAEs were defined as patients' AEs having a potential immunological basis that required close follow-up, or steroid therapy. We compared the data of patients who received nivolumab into two groups based on the occurrence of irAEs and assessed clinical efficacy in both groups.
Results
Of all mRCC patients, 47 patients (29.4%) developed irAEs. In patients who developed irAEs, the objective response rate and disease control rate were 38.8% and 77.6%, which were significantly higher when compared to that in patients without irAEs (p = 0.012 and p < 0.001, respectively). Furthermore, the incidence of irAEs were significantly associated with an increase in progression-free survival (PFS) (Hazard ratio (HR) = 0.4867; p = 0.0006) and overall survival (OS) (HR = 0.526; p = 0.0252). Importantly, PFS and OS seemed to be similar in patients who discontinued treatment because of irAEs and in those who did not discontinue because of irAEs (p = 0.36 and p = 0.35, respectively).
Conclusion
Development of irAEs robustly correlates with clinical benefit for mRCC patients receiving nivolumab monotherapy in real-world settings.
Efficacy of nivolumab in patients with metastatic renal cell cancer: final analysis of Japanese real-world clinical chart review study
- Author(s)：
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Satoru Masui1, Nobuyuki Hinata2, Junji Yonese3, Yasutomo Nakai4, Suguru Shirotake5, Ario Takeuchi6, Teruo Inamoto7,
Masahiro Nozawa8, Kosuke Ueda9, Toru Etsunaga10, Takahiro Osawa11, Motohide Uemura12, Naoto Morishima13, Hiroaki Ito14,
Hirotsugu Uemura8 - Affiliation(s)：
- 1Division of Reparative and Regenerative Medicine, Nephro-Urologic Surgery and Andrology, Graduate School of Medicine, Mie University, 2Division of Urology, Graduate School of Medicine, Kobe University,3Department of Urology, Cancer Institute Hospital of JFCR,4Department of Urology, Osaka International Cancer Institute,5Department of Uro-Oncology, International Medical Center, Saitama Medical University,6Department of Urology, Graduate School of Medical Sciences, Kyushu University,7Department of Urology, Osaka Medical College,8Department of Urology, Faculty of Medicine, Kindai University,9Department of Urology, School of Medicine, Kurume University,10Department of Urology, Isesaki Municipal Hospita,11Department of Urology, Graduate School of Medicine, Hokkaido University,12Department of Urology, Graduate School of Medicine, Osaka University,13Oncology Medical Affairs, Ono Pharmaceutical Co., Ltd.,14Oncology Medical, Bristol-Myers Squibb K.K.
BACKGROUND: Based on results of the global phase 3 CheckMate 025 study, nivolumab (NIVO) was approved in Japan for patients with unresectable renal cell carcinoma (RCC) or metastatic renal cell carcinoma (mRCC) in 2016. However, the clinical characteristics of patients enrolled in this clinical study were limited. Thus, it is necessary to clarify outcomes of NIVO in patients with mRCC in a real-world setting in Japan.
OBJECTIVE: To evaluate the efficacy and treatment pattern of NIVO in patients with mRCC in clinical practice in Japan.
METHODS: This was a multicenter, non-interventional medical record review study conducted at 17 centers in Japan. This 36-month follow-up analysis included patients with mRCC treated with NIVO for the first time, between February 1 and October 31, in 2017. Endpoints included overall survival (OS), progression-free survival (PFS), and drug use information. Subgroup analyses by treatment line of NIVO or post-treatment following NIVO were also conducted.
RESULTS: Of 212 patients enrolled, 208 were eligible. Of those eligible, 76.0% were males, the mean age was 66.5 years, and 76.9% and 6.3% had RCC with a clear cell carcinoma and brain metastasis, respectively. The median OS was not reached (NR), median PFS was 7.1 months (95% confidence interval [CI]: 5.3-9.7), and the median duration of response was 21.6 months (95% CI: 8.3-NE [Not estimable]). Of the 208 evaluable patients, 36.5%, 30.8%, and 31.7% were treated with NIVO as the second, third, and fourth or later line, respectively, and the median OS for each line was not reached. The efficacy by other subgroups will also be shown in this presentation.
CONCLUSION: This study showed the long-term efficacy of NIVO treatment in Japanese patients with mRCC in real-world clinical practice, which was consistent with the results of CheckMate 025.
