Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial

T. van Doeveren; P. J. van Leeuwen; K. K.H. Aben; M. van der Aa; M. Barendrecht; E. R. Boevé; E. B. Cornel; A. G. van der Heijden; K. Hendricksen; W. Hirdes; A. Kooistra; B. K. Kroon; A. M. Leliveld; R. P. Meijer; H. van Melick; B. Merks; T. M. de Reijke; P. de Vries; L. F.A. Wymenga; B. Wijsman; J. L. Boormans

doi:10.1016/j.conctc.2018.01.007

Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial

T. van Doeveren, P. J. van Leeuwen, K. K.H. Aben, M. van der Aa, M. Barendrecht, E. R. Boevé, E. B. Cornel, A. G. van der Heijden, K. Hendricksen, W. Hirdes, A. Kooistra, B. K. Kroon, A. M. Leliveld, R. P. Meijer, H. van Melick, B. Merks, T. M. de Reijke, P. de Vries, L. F.A. Wymenga, B. WijsmanJ. L. Boormans

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Abstract

Background: Following radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22–47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy. Aim: To reduce the risk of bladder cancer recurrence by a single intravesical instillation of Mitomycin immediately (within 3 h) before radical nephro-ureterectomy or partial ureterectomy. Methods: Adult patients (age ≥ 18 years) with a (suspicion of a) urothelial carcinoma of the UUT undergoing radical nephro-ureterectomy or partial ureterectomy will be eligible and will receive a single intravesical instillation of Mitomycin within 3 h before surgery. In total, 170 patients will be included in this prospective, observational study. Follow-up will be according to current guidelines. Results: The primary endpoint is the bladder cancer recurrence rate up to two years after surgery. Secondary endpoints are: a) the compliance rate; b) oncological outcome; c) possible side-effects; d) the quality of life; e) the calculation of costs of a single neoadjuvant instillation with Mitomycin and f) molecular characterization of UUT tumors and intravesical recurrences. Conclusions: A single intravesical instillation of Mitomycin before radical nephro-ureterectomy or partial ureterectomy may reduce the risk of a bladder recurrence in patients treated for UUT urothelial carcinoma and will circumvent the disadvantages of current therapy.

Original language	English
Pages (from-to)	121-129
Number of pages	9
Journal	Contemporary Clinical Trials Communications
Volume	9
DOIs	https://doi.org/10.1016/j.conctc.2018.01.007
Publication status	Published - 1 Mar 2018

Keywords

Bladder cancer
Chemotherapy
Nephro-ureterectomy
Upper urinary tract
Urothelial carcinoma

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van Doeveren, T., van Leeuwen, P. J., Aben, K. K. H., van der Aa, M., Barendrecht, M., Boevé, E. R., Cornel, E. B., van der Heijden, A. G., Hendricksen, K., Hirdes, W., Kooistra, A., Kroon, B. K., Leliveld, A. M., Meijer, R. P., van Melick, H., Merks, B., de Reijke, T. M., de Vries, P., Wymenga, L. F. A., ... Boormans, J. L. (2018). Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial. Contemporary Clinical Trials Communications, 9, 121-129. https://doi.org/10.1016/j.conctc.2018.01.007

@article{884dfe8e6e6a46a7b4e701ade7ae36f3,

title = "Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial",

abstract = "Background: Following radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22–47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy. Aim: To reduce the risk of bladder cancer recurrence by a single intravesical instillation of Mitomycin immediately (within 3 h) before radical nephro-ureterectomy or partial ureterectomy. Methods: Adult patients (age ≥ 18 years) with a (suspicion of a) urothelial carcinoma of the UUT undergoing radical nephro-ureterectomy or partial ureterectomy will be eligible and will receive a single intravesical instillation of Mitomycin within 3 h before surgery. In total, 170 patients will be included in this prospective, observational study. Follow-up will be according to current guidelines. Results: The primary endpoint is the bladder cancer recurrence rate up to two years after surgery. Secondary endpoints are: a) the compliance rate; b) oncological outcome; c) possible side-effects; d) the quality of life; e) the calculation of costs of a single neoadjuvant instillation with Mitomycin and f) molecular characterization of UUT tumors and intravesical recurrences. Conclusions: A single intravesical instillation of Mitomycin before radical nephro-ureterectomy or partial ureterectomy may reduce the risk of a bladder recurrence in patients treated for UUT urothelial carcinoma and will circumvent the disadvantages of current therapy.",

keywords = "Bladder cancer, Chemotherapy, Nephro-ureterectomy, Upper urinary tract, Urothelial carcinoma",

author = "{van Doeveren}, T. and {van Leeuwen}, {P. J.} and Aben, {K. K.H.} and {van der Aa}, M. and M. Barendrecht and Boev{\'e}, {E. R.} and Cornel, {E. B.} and {van der Heijden}, {A. G.} and K. Hendricksen and W. Hirdes and A. Kooistra and Kroon, {B. K.} and Leliveld, {A. M.} and Meijer, {R. P.} and {van Melick}, H. and B. Merks and {de Reijke}, {T. M.} and {de Vries}, P. and Wymenga, {L. F.A.} and B. Wijsman and Boormans, {J. L.}",

note = "Funding Information: The REBACARE is supported by grants from the Dutch Cancer Society ( KWF 10319 ) and the Netherlands Comprehensive Cancer Organization. Funding Information: The REBACARE is supported by grants from the Dutch Cancer Society (KWF 10319) and the Netherlands Comprehensive Cancer Organization. Publisher Copyright: {\textcopyright} 2018",

year = "2018",

month = mar,

day = "1",

doi = "10.1016/j.conctc.2018.01.007",

language = "English",

volume = "9",

pages = "121--129",

}

van Doeveren, T, van Leeuwen, PJ, Aben, KKH, van der Aa, M, Barendrecht, M, Boevé, ER, Cornel, EB, van der Heijden, AG, Hendricksen, K, Hirdes, W, Kooistra, A, Kroon, BK, Leliveld, AM, Meijer, RP, van Melick, H, Merks, B, de Reijke, TM, de Vries, P, Wymenga, LFA, Wijsman, B & Boormans, JL 2018, 'Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial', Contemporary Clinical Trials Communications, vol. 9, pp. 121-129. https://doi.org/10.1016/j.conctc.2018.01.007

TY - JOUR

T1 - Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial

AU - van Doeveren, T.

AU - van Leeuwen, P. J.

AU - Aben, K. K.H.

AU - van der Aa, M.

AU - Barendrecht, M.

AU - Boevé, E. R.

AU - Cornel, E. B.

AU - van der Heijden, A. G.

AU - Hendricksen, K.

AU - Hirdes, W.

AU - Kooistra, A.

AU - Kroon, B. K.

AU - Leliveld, A. M.

AU - Meijer, R. P.

AU - van Melick, H.

AU - Merks, B.

AU - de Reijke, T. M.

AU - de Vries, P.

AU - Wymenga, L. F.A.

AU - Wijsman, B.

AU - Boormans, J. L.

N1 - Funding Information: The REBACARE is supported by grants from the Dutch Cancer Society ( KWF 10319 ) and the Netherlands Comprehensive Cancer Organization. Funding Information: The REBACARE is supported by grants from the Dutch Cancer Society (KWF 10319) and the Netherlands Comprehensive Cancer Organization. Publisher Copyright: © 2018

PY - 2018/3/1

Y1 - 2018/3/1

N2 - Background: Following radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22–47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy. Aim: To reduce the risk of bladder cancer recurrence by a single intravesical instillation of Mitomycin immediately (within 3 h) before radical nephro-ureterectomy or partial ureterectomy. Methods: Adult patients (age ≥ 18 years) with a (suspicion of a) urothelial carcinoma of the UUT undergoing radical nephro-ureterectomy or partial ureterectomy will be eligible and will receive a single intravesical instillation of Mitomycin within 3 h before surgery. In total, 170 patients will be included in this prospective, observational study. Follow-up will be according to current guidelines. Results: The primary endpoint is the bladder cancer recurrence rate up to two years after surgery. Secondary endpoints are: a) the compliance rate; b) oncological outcome; c) possible side-effects; d) the quality of life; e) the calculation of costs of a single neoadjuvant instillation with Mitomycin and f) molecular characterization of UUT tumors and intravesical recurrences. Conclusions: A single intravesical instillation of Mitomycin before radical nephro-ureterectomy or partial ureterectomy may reduce the risk of a bladder recurrence in patients treated for UUT urothelial carcinoma and will circumvent the disadvantages of current therapy.

AB - Background: Following radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22–47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy. Aim: To reduce the risk of bladder cancer recurrence by a single intravesical instillation of Mitomycin immediately (within 3 h) before radical nephro-ureterectomy or partial ureterectomy. Methods: Adult patients (age ≥ 18 years) with a (suspicion of a) urothelial carcinoma of the UUT undergoing radical nephro-ureterectomy or partial ureterectomy will be eligible and will receive a single intravesical instillation of Mitomycin within 3 h before surgery. In total, 170 patients will be included in this prospective, observational study. Follow-up will be according to current guidelines. Results: The primary endpoint is the bladder cancer recurrence rate up to two years after surgery. Secondary endpoints are: a) the compliance rate; b) oncological outcome; c) possible side-effects; d) the quality of life; e) the calculation of costs of a single neoadjuvant instillation with Mitomycin and f) molecular characterization of UUT tumors and intravesical recurrences. Conclusions: A single intravesical instillation of Mitomycin before radical nephro-ureterectomy or partial ureterectomy may reduce the risk of a bladder recurrence in patients treated for UUT urothelial carcinoma and will circumvent the disadvantages of current therapy.

KW - Bladder cancer

KW - Chemotherapy

KW - Nephro-ureterectomy

KW - Upper urinary tract

KW - Urothelial carcinoma

UR - http://www.scopus.com/inward/record.url?scp=85041486447&partnerID=8YFLogxK

U2 - 10.1016/j.conctc.2018.01.007

DO - 10.1016/j.conctc.2018.01.007

M3 - Article

C2 - 29696234

AN - SCOPUS:85041486447

SN - 2451-8654

VL - 9

SP - 121

EP - 129

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

ER -

Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial

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Keywords

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