Safety and quality of cystectomy and pelvic lymph node dissection after neoadjuvant durvalumab and cisplatin/gemcitabine.

Details

Serval ID
serval:BIB_29095525B6AB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Safety and quality of cystectomy and pelvic lymph node dissection after neoadjuvant durvalumab and cisplatin/gemcitabine.
Journal
BJU international
Author(s)
Afferi L., Spahn M., Hayoz S., Strebel R.T., Rothschild S.I., Seifert H., Özdemir B.C., Kiss B., Maletzki P., Engeler D., Wirth G., Hadaschik B., Lucca I., John H., Sauer A., Müntener M., Bubendorf L., Schneider M., Musilova J., Petrausch U., Cathomas R.
Working group(s)
Swiss Group for Clinical Cancer Research (SAKK)
ISSN
1464-410X (Electronic)
ISSN-L
1464-4096
Publication state
Published
Issued date
09/2024
Peer-reviewed
Oui
Editor
Swiss Group for Clinical Cancer Research
Volume
134
Number
3
Pages
388-397
Language
english
Notes
Publication types: Journal Article ; Clinical Trial, Phase II
Publication Status: ppublish
Abstract
To report on the surgical safety and quality of pelvic lymph node dissection (PLND) in patients treated with radical cystectomy (RC) and PLND for muscle-invasive bladder cancer (MIBC) after neoadjuvant chemo-immunotherapy.
The Swiss Group for Clinical Cancer Research (SAKK) 06/17 was an open-label single-arm phase II trial including 61 cisplatin-fit patients with clinical stage (c)T2-T4a cN0-1 operable urothelial MIBC or upper urinary tract cancer. Patients received neoadjuvant cisplatin/gemcitabine and durvalumab followed by surgery. Prospective quality assessment of surgeries was performed via central review of intraoperative photographs. Postoperative complications were assessed using the Clavien-Dindo Classification. Data were analysed descriptively.
A total of 50 patients received RC and PLND. All patients received neoadjuvant chemo-immunotherapy. The median (interquartile range) number of lymph nodes removed was 29 (23-38). No intraoperative complications were registered. Grade ≥III postoperative complications were reported in 12 patients (24%). Complete nodal dissection (100%) was performed at the level of the obturator fossa (bilaterally) and of the left external iliac region; in 49 patients (98%) at the internal iliac region and at the right external iliac region; in 39 (78%) and 38 (76%) patients at the right and left presacral level, respectively.
This study supports the surgical safety of RC and PLND following neoadjuvant chemo-immunotherapy in patients with MIBC. The extent and completeness of protocol-defined PLND varies between patients, highlighting the need to communicate and monitor the surgical template.
Keywords
Humans, Cystectomy/methods, Lymph Node Excision/methods, Male, Urinary Bladder Neoplasms/surgery, Urinary Bladder Neoplasms/drug therapy, Urinary Bladder Neoplasms/pathology, Neoadjuvant Therapy, Cisplatin/administration & dosage, Cisplatin/therapeutic use, Gemcitabine, Female, Aged, Middle Aged, Deoxycytidine/analogs & derivatives, Deoxycytidine/administration & dosage, Deoxycytidine/therapeutic use, Antibodies, Monoclonal/administration & dosage, Antibodies, Monoclonal/therapeutic use, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Pelvis, Prospective Studies, bladder cancer, chemotherapy, cisplatin, immunotherapy, lymph node dissection, neoadjuvant therapy, quality control, radical cystectomy
Pubmed
Web of science
Create date
11/03/2024 11:25
Last modification date
05/09/2024 9:00
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