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:
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
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.
Medical Enterprises Europe B.V.
Assumburg 152B
1081GC, Amsterdam, The Netherlands
Tel: +31 (0) 20 6423719
Fax: +31 (0) 20 6421161
R&D Center:
MEL Medical Enterprises Ltd.
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Petah-Tikva, 49170, ISRAEL
Tel: 972 3 9244830
Fax: 972 3 9245340
