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Synergo Neo-Adjuvant Treatment-Cumulative Experience until 2006
Patients with an excessive tumor burden and/or multifocality, CIS, for whom a single
surgery cannot suffice to accomplish complete tumor eradication, and patients
facing cystectomy, pose a therapeutic challenge to the treating urologist.
Herein we report our experience with neo-adjuvant treatment in 219 intermediate-high risk STCCB patients
(85% high-risk, 15% intermediate risk patients).
treated at the following centers:
| Italy: |
HSR Hospital, Milan; University Policlinic Hospital, Palermo;
IEO hospital, Milan; Galliera Hospital, Genoa;
; Treviglio Hosptial, Treviglio; Magenta Hospital, Magenta;
Humanitas Gavazzeni, Bergamo; Ascoli-Piceno Hospital
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| Israel: |
Bnai Zion Hospital, Haifa;
Wolfson Medical Center, Holon;
Hadassah Medical Center, Jerusalem
Rabin Medical Center, Belinson Campus, Petah-Tikva;
Meir Medical Centre, Kefar-Saba;
Carmel Hospital, Haifa
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| Germany: |
Mannheim University Hospital; Muenchen-Harlaching (Krankenhaus),
Munich
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| The Netherlands: |
UMC St Radboud, Nijmegen
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| France: |
St. Louis Hospital, Paris
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Patients' characteristics:
219 intermediate-high risk STCCB patients (85% high-risk, 15% intermediate risk patients).
| Age: |
Mean: 70 years
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Range: 37-97
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| Gender: |
162 Males (74%)
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57 Females (26%)
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Number of patients who had previously
undergone BCG therapy: 119 (54%)
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Number of patients who had previously
undergone chemotherapy : 156 (71%)
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The attainment of disease-free state, and the duration of the disease-free interval were
determined by video-cystoscopy every 3 months, for a period of up to 2 years. Biopsies and urine cytology were
performed as indicated. The beginning of the disease-free interval is defined
as the point of complete tumor eradication.
In many cases, disease-free state was induced by Synergo® treatments;
in some patients this had to be assisted by a single surgery.
CR (Complete Response) - No evidence of disease following Synergo treatment
PR (Partial Response) - reduction of >50% in tumor volume
NC (No change) - tumor unchanhed or only mildly reduced in volume
The length of disease-free interval after complete eradication, was recorded.
Results
| 1. |
Follow-up results:
In 175 out of 216 patients (80%), Synergo® neo adjuvant treatment induced complete tumor eradication
In 31 patients (14%), some minor residue required single surgical resection (TUR / TUF)
following tumor mass reduction induced by Synergo® treatment ( = Neo-Adjuvant approach).
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13 out of 219 patients (6%) were categorized as non-responders.
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| 2. |
Side effects:
Mild pain during session, dysuria, hematuria and frequency during the first
few days after treatment. Reduced bladder capacity occurred in 3 (1.4%) patients.
All patients resumed normal daily activity after each treatment.
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Conclusions
Synergo® technology is efficacious and safe, accomplishing 80%
complete eradication. Synergo offers a potential treatment option for
this obstinate patient group. After an average follow-up of 372 days
58% of patients who had at least one follow-up visit remained tumor free.
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