Arjona, M. F.

Bassi, P. F.

Battaglia, M.

Castro Diaz, D.

Eisendhardt, A.

Giordan, N.

Gontero, P.

Llorente, C.

Marinello, A.

Moreno Sierra, J.

Neisius, A.

Nohales Taurines, G.

Palermo, G.

Racioppi, M.

Ramirez Backhaus, M.

Selli, C.

Simeone, C.

Vom Dorp, F.

P. F. Bassi

M. Racioppi

G. Palermo

C Selli

M. Battaglia

P. Gontero

C. Simeone

A. Eisenhard

F. Vom Dorp

A. Nesius

M. F. Arjona

D. Castro Diaz

M. Ramirez Backhaus

J. Moreno Sierra

C. Llorente

G. Nohales Taurines

N. Giordan

A. Marinello

Archivio della Ricerca - Università di Pisa

732 Oncofid-P-B (paclitaxel-hyaluronic acid) in the intravesical therapy of patients affected byprimary or recurrent Ta G1-G2 papillary cancer of the bladder. A phase II marker lesionstudyEur Urol Suppl 2018; 17(2);e1056Bassi P.F. 1 , Racioppi M. 1 , Palermo G. 1 , Selli C. 2 , Battaglia M. 3 , Gontero P. 4 , Simeone C. 5 , Eisendhardt A. 6 , Vom Dorp F. 7 , NeisiusA. 8 , Arjona M.F. 9 , Castro Diaz D. 10 , Ramirez Backhaus M. 11 , Moreno Sierra J. 12 , Llorente C. 13 , Nohales Taurines G. 14 , Giordan N. 15 ,Marinello A. 151A. Gemelli Foundation Hospital - Catholic University of Sacred Heart , Dept. of Urology, Rome, Italy, 2Azienda Ospedaliera Universitaria di Pisa,Dept. of Urology, Pisa, Italy, 3Ospedale consorziale Policlinico di Bari, Dept. of Urology, Bari, Italy, 4Ospedale Città della Salute e della Scienza diTorino, Dept. of Urology, Turin, Italy, 5Spedali Civili di Brescia, Dept. of Urology, Brescia, Italy, 6Praxiskilinik urologie Rhein-Rurh, Dept. of Urology,Mülheim, Germany, 7Klinik und Poliklinik fur Urologie Kinderurologie und urologische Onkologie Universitasklinikum , Dept. of Urology, Essen,Germany, 8Urologische Klinik und Policlinik Universitatsmedizin der Johannes Gutenberg- Universitat, Dept. of Urology, Mainz, Germany, 9Hospitaldel Henares, Dept. of Urology, Madrid, Spain, 10Hospital La Laguna, Dept. of Urology, Santa Cruz de Tenerife, Spain, 11Instituto Valenciano deOncologia, Dept. of Urology, Valencia, Spain, 12Hospital clinico San Carlos, Dept. of Urology, Madrid, Spain, 13Hospital Universitario FundacionAlcorcon, Dept. of Urology, Madrid, Spain, 14Hospital del Mar, Dept. of Urology, Barcelona, Spain, 15Fidia Pharma Group, Dept. of Pharmaceuticals,Abano Terme, ItalyIntroduction & Objectives: The standard of care for papillary non–muscle-invasive bladder cancer (NMIBC) is transurethral resection, followedby intravescical instillation with chemo- or immunotherapy to prevent recurrences. BCG or mitomycin C are the options of choice, although limitedefficacy and high frequency of side effects is being constantly reported with both approaches. The primary objective of the present study wasto assess the ablative activity of intravesical administration of Paclitaxel-hyaluronic acid solution (Oncofid-P-B 600 mg) on a multiple primary orrecurrent Ta G1-G2 papillary tumor, adopting the “marker lesion” approach. The secondary objectives were: To evaluate time to relapse afterOncofid-P-B instillation during the maintenance phase; to determine number and percentage of patients with relapse at final visit; to evaluate thesafety profile of Oncofid-P-B given by intravesical instillation.Materials & Methods: This was a phase II, open-label, non-randomised, multicentre, international study with a first 6 weeks treatment phasefollowed by a 6+6 months maintenance phase. A total of 101 patients were screened in 14 sites localized in Germany (3), Italy (5) and Spain (6).60 patients constituted the safety population (SP) and 52 patients the per protocol population (PP).Results: The rate of complete response (CR) after 6 weekly instillations of Oncofid-P-B was of 45.0% (27 CR/60 patients) in the SP and 46.2% (24/52) in the PP population. CR rate was higher for the subset of patients who had not previously been treated with any chemo/immunotherapy (16/28 - 57.1% in the SP and 15/25 – 60.0% in the PP). A total of 12 (50.0%) out of the 24 patients included in the maintenance phase had a relapse,for these patients the median time to relapse from the first study drug administration was 15.70 months (95% CI: 9.9). Regarding recurrence-free survival of the patients in maintenance phase, the probability to be free of recurrence after 3, 6, 9 and 12 months from the first study drugadministration was of 98.2%, 96.4%, 74.4% and 58.9%, respectively. One case of death reported during the study was considered as not related33rd Annual EAU Congress CopenhagenEur Urol Suppl 2018; 17(2);e1056to the study medication. Eight serious adverse events were reported in 6 patients, but only one (urinary tract infection) was considered drug relatedand resolved 5 days after treatment with antibiotics. None of the adverse events led to study discontinuation.Conclusions: CR in patients with NMIBC (Ta-G1-G2) was observed in 45% of the patients treated with 6 weekly intravesical administration ofOncofid-P-B with a very good tolerability and safety profile. Higher rate of CR (57.1% in the SP and 60.0% in the PP) was reported in patients whowere not previously treated with chemo/immunotherapy.33rd Annual EAU Congress CopenhagenEur Urol Suppl 2018; 17(2);e1057

English

Oncofid-P-B (paclitaxel-hyaluronic acid) in the intravesical therapy of patients affected by primary or recurrent Ta G1-G2 papillary cancer of the bladder. A phase II marker study.

Archivio istituzionale della ricerca - Università di Brescia

Oncofid-P-B (paclitaxel-hyaluronic acid) in the intravesical therapy of patients affected by primary or recurrent Ta G1-G2 papillary cancer of the bladder. A phase II marker lesion study

https://arpi.unipi.it/bitstream/11568/918945/1/ONCOFID%20EAU%202018.pdf

Oncofid-P-B (paclitaxel-hyaluronic acid) in the intravesical therapy of patients affected by primary or recurrent Ta G1-G2 papillary cancer of the bladder. A phase II marker lesion study

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Archivio istituzionale della ricerca - Università di Brescia