Haematological Toxicity in Patients Treated with Cisplatin and Gemcitabine for Bladder Cancer: the Weston Park Hospital, Sheffield, Experience

2006 ◽  
Vol 18 (8) ◽  
pp. 638-639
Author(s):  
S.J. Clenton ◽  
P. Kirkbride ◽  
C.J. Ferguson
2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 406-406 ◽  
Author(s):  
Victoria K Woodcock ◽  
Karin Purshouse ◽  
Chrissie Butcher ◽  
Caroline Haddon ◽  
Gillian Verrall ◽  
...  

406 Background: Intravesical BCG has been the mainstay of therapy following TURBT for intermediate risk NMIBC for many years and is thought to act through activation of non-specific local immunity. With the recent success of checkpoint inhibitor treatment in metastatic bladder cancer, we sought to investigate the anti-PD1 inhibitor pembrolizumab as a potential agent for use in patients with intermediate risk NMIBC in a phase I/II study. The primary aim of the phase I safety run-in was to assess the safety and tolerability of intravesical pembrolizumab after TURBT in patients with intermediate risk NMIBC. Methods: Eligible patients had recurrent NMIBC for which adjuvant treatment post TURBT was a reasonable treatment option, ECOG PS 0-1 and adequate end organ function. Pembrolizumab was administered by intravesical instillation once weekly for a total of 6 doses. Intra-patient dose escalation was performed in three paired patient cohorts with doses starting at 50mg and increasing through 100mg to a maximum of 200mg. Adverse events (AEs) were assessed using CTCAE v4.03 with dose limiting toxicity (DLT) defined as a clinically significant, drug related, grade 4 haematological or ≥ grade 3 non-haematological toxicity occurring within 7 days of administration of the first treatment at a given dose for that patient. Results: In the first 4 patients treated, no DLTs were seen during dose escalation. Drug-related AEs included Grade 1 dysuria, fatigue and nausea. Grade 1-2 urinary tract infections, Grade 1 cystitis and Grade 3 urosepsis (SAE) were observed but assessed as probably not related to pembrolizumab. Recruitment of a final cohort of two patients at repeated doses of 200mg is ongoing to confirm safety and tolerability of this dose. Conclusions: Administration of intravesical pembrolizumab was safe and well tolerated in patients with NMIBC following TURBT. A randomised, parallel group, phase II marker-lesion study to assess the safety, efficacy and tolerability of either intravesical pembrolizumab or intravenous pembrolizumab in a larger cohort of patients with intermediate risk recurrent NMIBC is planned. Clinical trial information: NCT03167151.


Author(s):  
Jessica Marinaro ◽  
Alexander Zeymo ◽  
Jillian Egan ◽  
Filipe Carvalho ◽  
Ross Krasnow ◽  
...  

2007 ◽  
Vol 177 (4S) ◽  
pp. 260-260 ◽  
Author(s):  
Hiroaki Kawanishi ◽  
Yoshiyuki Matsui ◽  
Toshinari Yamasaki ◽  
Takeshi Takahashi ◽  
Hiroyuki Nishiyama ◽  
...  

2007 ◽  
Vol 177 (4S) ◽  
pp. 259-259
Author(s):  
Thomas Nelius ◽  
Hanua Huang ◽  
Stephanie Filleur ◽  
Steven C. Campbell ◽  
Werner de Riese ◽  
...  

2007 ◽  
Vol 177 (4S) ◽  
pp. 258-258
Author(s):  
A. Karim Kader ◽  
Jun Liu ◽  
Una Shao ◽  
Colin P.N. Dinney ◽  
Jie Lin ◽  
...  

2007 ◽  
Vol 177 (4S) ◽  
pp. 256-256
Author(s):  
Steven Smith ◽  
Gary Oxford ◽  
Dan Theodorescu

2007 ◽  
Vol 177 (4S) ◽  
pp. 255-255
Author(s):  
Eiji Kikuchi ◽  
Jun Nakashima ◽  
Keiichi Yamazaki ◽  
Akira Miyajima ◽  
Yutaka Horiguchi ◽  
...  
Keyword(s):  

2007 ◽  
Vol 177 (4S) ◽  
pp. 254-254
Author(s):  
Justin J. Cohen ◽  
Bayan T. Takizawa ◽  
Hristos Z. Kaimkliotis ◽  
David J. Rosenberg ◽  
Marcia A. Wheeler ◽  
...  

2007 ◽  
Vol 177 (4S) ◽  
pp. 297-297
Author(s):  
Kristina Schwamborn ◽  
Rene Krieg ◽  
Ruth Knüchel-Clarke ◽  
Joachim Grosse ◽  
Gerhard Jakse

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