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
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
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.
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