Author’s reply to ‘Prevention of IVR: a need for investigation’

Author’s reply to ‘Prevention of IVR: a need for investigation’ Japanese Journal of Japanese Journal of Clinical Oncology, 2018, 48(3) 297 Clinical Oncology JJCO doi: 10.1093/jjco/hyx192 Advance Access Publication Date: 10 January 2018 Letter Letter Author’s reply to ‘Prevention of IVR: a need for investigation’ Shinichi Yamashita , Akihiro Ito, and Yoichi Arai Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan *For reprints and all correspondence: Shinichi Yamashita, Department of Urology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi Aoba-ku, Sendai, Miyagi 980-8574, Japan. E-mail: yamashita@uro.med.tohoku.ac.jp We appreciate your interest in our prospective, single-arm, multicen- for the upper urinary tract urothelial carcinoma (JCOG1403:UTUC ter clinical trial in which we showed that early ureteral ligation THP Phase III, UMIN000024267). In the study protocol, ureteral decreases the rate of intravesical recurrence (IVR) after radical ligation is performed during radical nephroureterectomy to avoid nephroureterectomy in patients with renal pelvic cancer (1). We the downstream tumor seeding (2). This might reveal the effect of applied propensity score-matching analysis to extract a historical ureteral ligation on IVR after radical nephroureterectomy. In add- control from the patients who underwent radical nephroureterect- ition, several subgroup analyses might be possible in the trial. omy for upper urinary tract urothelial carcinoma in the same group. Finally, early ureteral ligation is convenient in clinical practice. Our findings suggested that early ureteral ligation might help to pre- Therefore, we hope that this procedure will help to prevent IVR vent IVR after radical nephroureterectomy for renal pelvic cancer. after radical nephroureterectomy for renal pelvic cancer. Indeed, our study had some limitations, such as a small sample size. Thus, our findings should be confirmed by larger prospective Conflict of interest statement trials. In addition, 22 patients received intravesical instillation of pir- arubicin ((2′R)-4′-O-tetrahydropyranyldoxorubicin (THP) after rad- None declared. ical nephroureterectomy, which is now recommended to prevent IVR. However, such therapy had not been established when this study was started. We evaluated a subset of patients without THP References intravesical instillation to assess the distinct effect of early ureteral 1. Yamashita S, Ito A, Mitsuzuka K, et al. Efficacy of early ureteral ligation ligation and found that the 1- and 2-year IVR-free survival rates of on prevention of intravesical recurrence after radical nephroureterectomy patients with renal pelvic cancer with and without early ligation were for upper urinary tract urothelial carcinoma: a prospective single-arm 86 and 86%, and 73 and 61%, respectively (P = 0.033) (1). multicenter clinical trial. Jpn J Clin Oncol 2017;47:870–5. To start up a phase III trial to clarify the effects of early ureteral 2. Miyamoto K, Ito A, Wakabayashi M, et al. A phase III trial of a single early ligation in Japan is difficult. However, the Japan Clinical Oncology intravesical instillation of pirarubicin to prevent bladder recurrence after rad- Group has undertaken a phase III trial of a single early intravesical ical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, instillation of THP to prevent IVR after radical nephroureterectomy UTUC THP Phase III). Jpn J Clin Oncol 2017 [Epub ahead of print]. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 297 Downloaded from https://academic.oup.com/jjco/article-abstract/48/3/297/4797158 by Ed 'DeepDyve' Gillespie user on 16 March 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Japanese Journal of Clinical Oncology Oxford University Press

Author’s reply to ‘Prevention of IVR: a need for investigation’

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Abstract

Japanese Journal of Japanese Journal of Clinical Oncology, 2018, 48(3) 297 Clinical Oncology JJCO doi: 10.1093/jjco/hyx192 Advance Access Publication Date: 10 January 2018 Letter Letter Author’s reply to ‘Prevention of IVR: a need for investigation’ Shinichi Yamashita , Akihiro Ito, and Yoichi Arai Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan *For reprints and all correspondence: Shinichi Yamashita, Department of Urology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi Aoba-ku, Sendai, Miyagi 980-8574, Japan. E-mail: yamashita@uro.med.tohoku.ac.jp We appreciate your interest in our prospective, single-arm, multicen- for the upper urinary tract urothelial carcinoma (JCOG1403:UTUC ter clinical trial in which we showed that early ureteral ligation THP Phase III, UMIN000024267). In the study protocol, ureteral decreases the rate of intravesical recurrence (IVR) after radical ligation is performed during radical nephroureterectomy to avoid nephroureterectomy in patients with renal pelvic cancer (1). We the downstream tumor seeding (2). This might reveal the effect of applied propensity score-matching analysis to extract a historical ureteral ligation on IVR after radical nephroureterectomy. In add- control from the patients who underwent radical nephroureterect- ition, several subgroup analyses might be possible in the trial. omy for upper urinary tract urothelial carcinoma in the same group. Finally, early ureteral ligation is convenient in clinical practice. Our findings suggested that early ureteral ligation might help to pre- Therefore, we hope that this procedure will help to prevent IVR vent IVR after radical nephroureterectomy for renal pelvic cancer. after radical nephroureterectomy for renal pelvic cancer. Indeed, our study had some limitations, such as a small sample size. Thus, our findings should be confirmed by larger prospective Conflict of interest statement trials. In addition, 22 patients received intravesical instillation of pir- arubicin ((2′R)-4′-O-tetrahydropyranyldoxorubicin (THP) after rad- None declared. ical nephroureterectomy, which is now recommended to prevent IVR. However, such therapy had not been established when this study was started. We evaluated a subset of patients without THP References intravesical instillation to assess the distinct effect of early ureteral 1. Yamashita S, Ito A, Mitsuzuka K, et al. Efficacy of early ureteral ligation ligation and found that the 1- and 2-year IVR-free survival rates of on prevention of intravesical recurrence after radical nephroureterectomy patients with renal pelvic cancer with and without early ligation were for upper urinary tract urothelial carcinoma: a prospective single-arm 86 and 86%, and 73 and 61%, respectively (P = 0.033) (1). multicenter clinical trial. Jpn J Clin Oncol 2017;47:870–5. To start up a phase III trial to clarify the effects of early ureteral 2. Miyamoto K, Ito A, Wakabayashi M, et al. A phase III trial of a single early ligation in Japan is difficult. However, the Japan Clinical Oncology intravesical instillation of pirarubicin to prevent bladder recurrence after rad- Group has undertaken a phase III trial of a single early intravesical ical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, instillation of THP to prevent IVR after radical nephroureterectomy UTUC THP Phase III). Jpn J Clin Oncol 2017 [Epub ahead of print]. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 297 Downloaded from https://academic.oup.com/jjco/article-abstract/48/3/297/4797158 by Ed 'DeepDyve' Gillespie user on 16 March 2018

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Japanese Journal of Clinical OncologyOxford University Press

Published: Mar 1, 2018

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