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
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
Germany: Mannheim University Hospital; Muenchen-Harlaching (Krankenhaus),
Munich
The Netherlands: UMC St Radboud, Nijmegen
France: St. Louis Hospital, Paris

Patients' characteristics:

219 intermediate-high risk STCCB patients (85% high-risk, 15% intermediate risk patients).

Age: Mean: 70 years
Range: 37-97
Gender: 162 Males (74%)
57 Females (26%)
Number of patients who had previously undergone BCG therapy:             119 (54%)
Number of patients who had previously undergone chemotherapy :         156 (71%)

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).

  13 out of 219 patients (6%) were categorized as non-responders.

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.

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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