Long-term results of organ preservation rate and progression risk in high-risk non-muscle-invasive bladder cancer (NMIBC) patients treated with radiofrequency-induced thermochemotherapy effect (RITE) with the Synergo system.

456 Background: High risk NMIBC is a dangerous BC with a challenging treatment by BCG or early cystectomy to cure. The first has bad treatment tolerance and a remission of about 35%, whereas the last offer a curing perspective of 84% with extremely bad living conditions. RITE checked prospectively the therapy in respect to organ preservation, curing rate and risk of progression over 10 years in a single institution experience. Methods: All patients were EORTC high risk NMIBC. Treatment with induction phase: 8 treatments weekly with 2x40 mg Mitomycin C, 42°C intravesically induced by RITE. Followed by a re-resection of the bladder at week 11 to ensure complete remission and maintenance with treatments every 6 weeks with 2x20 mg Mitomycin C for 6 times. Cystoscopy controls were performed first 2 years every 3 month and following in 6 month until now. Study started in 2006 ongoing until today. Results: We enrolled 67 patients (4 female, 63 male), 65.7% Cis positive rate. 85% of the patients were treated alternatively to BCG with primary RITE whereas 15% were BCG failure patients treated alternatively to indicated cystectomy. Tumor persistence at week 11 after induction therapy proven by TURB was (10/67) 14.9% resulting in early cystectomy (4/10). Mean recurrence free time 3.5 years. In case of recurrence 10.4% progressed to MIBC including 6% metastatic tumors, high risk NMIBC was observed in 6% resulting in cystectomy and low risk NMIBC recurrence was 1.5% with organ preservation. BC death rate was 1 out of 67. Incomplete treatments induced by SAE of RITE was 9%. Bladder preservation rate was 80.6% with a long-lasting effectiveness ( > 5 years) of 14/26 (53.8%). Conclusions: The RITE method is in short- and long-term manner a powerful procedure to cure and maintain a recurrence free BC status in high risk NMIBC with a very low risk for cystectomy and a minimal risk for systemic progression resulting in BC death. The organ preservation rate was achieved in 80.6% lasting for up to 11 years longest. RITE is an alternative to BCG and preferable to early cystectomy in high risk NMIBC.

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The German study group of intravesical hyperthermia-chemotherapy in non-muscle-invasive bladder cancer presents their long-term results in efficacy and tolerability for optimized adjuvant therapy and bladder preservation.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.6_suppl.268 ◽

2013 ◽

Vol 31 (6_suppl) ◽

pp. 268-268 ◽

Cited By ~ 1

Author(s):

Gerson Lüdecke ◽

Florian Hasner ◽

Herbert Hanitzsch ◽

Matthias Schmidt ◽

Keyword(s):

High Risk ◽

Organ Preservation ◽

Long Term Results ◽

Bladder Preservation ◽

Protocol Violation ◽

Risk Situation ◽

Muscle Invasive ◽

High Risk Situation ◽

Free Rate

268 Background: In NMIBC recurrence and progression in high-risk BC are the dominant aspects for the clinical management. Intravesical chemotherapy and BCG treatment are the techniques to reduce both risks. HTC has a potentiating synergistic action in BC cell death induction. In consequence we proved HTC in the adjuvant indication and the ablativ indication in high-risk BC. Methods: We treated 138 patients in 1,443 treatment sessions in 3 institutions with intravesical hyperthermia-chemotherapy with Mitomycin C applied with the Synergo device. After an initial inductive weekly therapy for 6 to 8 weeks maintenance followed once every 6 weeks 6 times and cystoscopy every 3 month. Results: In the adjuvant indication 52 patients were treated. The over all recurrence free rate was 78.3% over 2.9 years in mean (3.6m – 6.9y). Only 10 patients recurred but none progressed or needed a cystectomy. In the ablative indication 86 patients were treated. For efficacy 69 could be evaluated. 17 patients must be excluded because of protocol violation or extra-vesical TCC or simultanious second malignancy. 85.5% of the patients (58) reached CR and this persited for 26.1 months in mean. 48 patients (69.6%) were tumor free over the hole investigation time. In total 8 patients (11.6%) needed a cystectomy. 3 patient (4.3%) progressed to metastatic disease and the other 5 demonstrated low-risk new tumors again treated transurethral. In total 53 patient (76.8%) achieved organ preservation in high-risk situation. Side effects included allergy, UTI, spasm, difficulties with catheterization and nocturia ascending from 1.4% to 5.6%. Conclusions: HTC is a safe and effective therapy in NMIBC to prevent intermediate risk BC patients for recurrence and to ensure organ preservation in high-risk BC patients in more than 75% with a long lasting efficacy.

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Long-term outcomes of endovascular aneurysm repair for challenging aortic necks using the Talent endograft

Vascular ◽

10.1258/vasc.2011.oa0286 ◽

2011 ◽

Vol 19 (3) ◽

pp. 132-140 ◽

Cited By ~ 1

Author(s):

Jeffrey Jim ◽

Brian G Rubin ◽

Patrick J Geraghty ◽

Luis A Sanchez

Keyword(s):

High Risk ◽

Risk Group ◽

Endovascular Aneurysm Repair ◽

High Risk Group ◽

Low Risk ◽

Long Term Results ◽

Long Term Outcomes ◽

Aneurysm Repair ◽

Related Mortality

The aim of the present paper is to evaluate the long-term outcomes of endovascular aneurysm repair (EVAR) for challenging aortic necks. Subgroup analyses were performed on 156 patients from the prospective multicenter Talent eLPS (enhanced Low Profile Stent Graft System) trial. Patients with high-risk aortic necks (length < 15 mm or diameter ≥28 mm) were compared with the remaining patients. Patients with high-risk ( n = 86) and low-risk necks ( n = 70) had similar age and gender distribution. Despite similar prevalences of co-morbidities, the high-risk group had higher Society for Vascular Surgery scores. The high-risk group also had larger maximum aneurysm diameters (56.6 versus 53.0 mm, P < 0.02). There were lower freedoms from major adverse events (MAEs) for the high-risk group at 30 days (84.9 versus 95.7%; P < 0.04) and 365 days (73.4 versus 89.2%; P = 0.02). Effectiveness endpoints at 12 m showed no significant differences. Freedom from all-cause mortality at 30 days (96.5 versus 100%) and aneurysm-related mortality at 365 days (96.0 versus 100%) were similar. At five years, there were no differences in endoleaks or change in aneurysm diameter. All migrations occurred in the high-risk group. The five-year freedom from aneurysm-related mortality for the high- and low-risk groups was 93.2 and 100%, respectively. In conclusion, despite a higher rate of MAEs within the first year and higher migration rates at five years, EVAR in aneurysms with challenging aortic necks can be treated with acceptable long-term results.

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Should adult medulloblastoma patients at low risk receive adjuvant chemotherapy? Long-term results of a prospective study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.2018 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 2018-2018

Author(s):

E. Franceschi ◽

A. Tosoni ◽

M. Ermani ◽

V. Blatt ◽

P. Amistà ◽

...

Keyword(s):

High Risk ◽

Adjuvant Chemotherapy ◽

Survival Rates ◽

Low Risk ◽

Long Term Results ◽

High Risk Patients ◽

Significant Difference ◽

Risk Patients

2018 Background: Due to the rarity of medulloblastoma (MB) in adults, the few studies available on this condition are retrospective, and the follow-up tends to be short. Furthermore, the different therapeutic strategies used in these patients makes it difficult to assess survival rates and prognostic factors. Methods: Between January 1989 and February 2001, a prospective phase II trial was performed to evaluate the efficacy of treatment for adults with medulloblastoma. Patients were completely staged with a neuroradiological examination of the brain and neuraxis and by CSF cytology, according to Chang’s staging system. Low risk patients received radiotherapy alone, while high risk patients were given 2 cycles of upfront chemotherapy followed by radiotherapy and adjuvant chemotherapy. The results of the preliminary analysis of this study at a median follow-up of 3.7 years are reported elsewhere. The present papers reports on the long- term results of the same trial. Results: After a median follow up of 7.6 years, among a total of 36 enrolled adults with medulloblastoma, overall progression free survival (PFS) and overall survival (OS) at 5 years were 72% (range 59% to 84%) and 75% (62% to 91%), respectively. No difference was found between low and high risk patients in terms of PFS and OS at 5 years: in low-risk patients the 5-year PFS was 80% (range, 59–100%) and the 5-year OS, 80% (range, 58 - 100%); in high-risk patients the 5-year PFS was 69% (range, 54 -89%) and the 5-year OS, 73% (range, 58 - 92%). Conclusions: A long-term follow-up is essential to evaluate the real impact of treatments in adult patients with MB. Since there is no significant difference between low-risk and high-risk patients for PFS and OS, the use of chemotherapy is also questionable in low-risk patients. No significant financial relationships to disclose.

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