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surgical resection + PHDRB + EBRT. Brachytherapy dose was 4 Gy bid x 4 (16 Gy total dose) for R0 resections, 4 Gy bid x 6 (24 Gy total dose) for R1 resections and 4 Gy bid x 8 (32 Gy total dose) for R2 resections. Radiation treatment was completed with EBRT to 45 Gy in 25 treatments, 1.8Gy/day, 4 to 5 weeks after surgery (concomitant chemotherapy was added according to the specific disease site protocol).
Results: 108 out of 111 patients (97.3%) could be treated with the PHDRB implant as prescribed. In the remaining three patients, the catheters had to be removed before the end of the PHDRB course due to infection in two and displacement in one. RTOG grade 1-2 and 3-5complications that may be attributable to the use of PHDRB were seen in 2 and 14 patients, respectively. Out of the grade 3-5 complications, three were implant-related (bleeding upon removal in 1, need for catheter relocation in 2) and 11 radiation-related (neuropathy in 2, soft tissue necrosis in 4, pelvic bleeding in 4, ENT bleeding in 1). Five of the six patients who may have died as a consequence of PHDRB, 5 had recurrent disease, four after prior radiation. Three-year local control was 89%, 98% in unirradiated patients and 58% in previously irradiated patients (p=0.0001). Regional control was 76%, 84% in unirradiated patients and 53% in previously irradiated patients (p=0.0043). Freedom from distant failure was 66%, 72% in unirradiated patients and 4 6 % in previously irradiated patients (p=0.0039). Three-year local control was 100% for R0 resections and 87% for R1 resections (p=0.16).
Conclusions: PHDRB can be safely used after surgical resection. Three-year local control rates are excellent even after R1 resections, both in unirradiated and previously irradiated patients. 123 oral • Low dose rate intraoperative brachytherapy in soft tissue sarcomas involving neurovascular structures
C. Llace/, M. Delannes2, M. Minsat ~, E. Stoeckle ~, P. Matter, P. Bonneviale2, B.N. B J , C. Chevreau 2, N. Daly-Schweitzer2, L. Thomas ~ ~lnstitut Bergonie, Regional Cancer Center, Radiation Therapy, Bordeaux Cedex, France 21nstitut Claudius Regaud, Toulouse, France Purpose: The aim of this study was to evaluate intraoperative brachytherapy in the management of soft tissue sarcomas involving neurovascular structures, its impact on local control and complications. Material and methods: Between January 1989 and December 2002, 98 patients underwent intraoperative implant in conjunction with conservative surgery. From the data, we have excluded one patient with metastatic disease, one child, and three patients with radiation induced sarcomas. Brachytherapy was part of the initial treatment in 79 cases and was performed in recurrent disease in 19 cases. We have focused our attention on the group of patients with primary sarcomas involving neurovascular structures who have been treated with conservative surgery, intraoperative brachytherapy and external radiation therapy (n -- 79). In this group, patients characteristics were as followed: 43 male, 36 female, mean age 52 years; 58/79 were located in the lower limb, 75/79 were T l b , T2b tumors involving neurovascular structures; mean tumor size was 9 cm. There were 12 histologic types, with grade II/111 in 66/79. The conservative surgery was performed as first treatment in 57 cases, after chemotherapy in 17 cases and after primary external radiation in 5 cases. The brachytherapy technique was realized according to Paris system rules: plastic tubes were inserted under visual control intraoperatively. After orthogonal radiographs and CT scan, computed dosimetry was
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realized. The tubes (mean length 70 mm, mean number wires 10, mean spacing 15mm)were loaded with Iridium 192 (64 cases) or connected to microselectron PDR (15 cases) with a median delay from surgery of four days. The mean given dose by brachytherapy was 20 Gy with a mean dose rate of 50 cGy/h The mean given dose of external radiotherapy was 46 Gy.
Results: With a median follow up of 58 months, the 5 year actuarial survival was 69% and the local free disease at 5 years was 90%. Acute side effects occurred in 20/79 requiring surgical repair in 10 patients. Late side effects occurred in 35/79 (4 bone fractures, 3 join stiffness, 8 peripheral neuropathy, 8 fibrosis, 2 muscles and 16 vascular damage), requiring surgical repair in 8 cases. Amputation was not required for complications. Prognostic factors were studied on the occurrence of acute and late side effects and on local control. The only significant factor correlated with late side effects was localization in lower limb (p = 0.027). Conclusion: Intraoperative brachytherapy is efficient with good local control in case of neurovascular structures involvement and it offers a conservative option with usual acute complications according to localization, but significant late complications. 124 oral Brachytherapy for penile cancer: results for 49 patients
J. Crook 1, L. Grimard, B. Esche2, J. Jezioranskl ~, G. Pond4 IPrincess Margaret Hospital, Radiation Oncology, Toronto, Canada 2Ottawa Regional Cancer Center, Radiation Oncology, Ottawa, Canada 3Princess Margaret Hospital, Radiation Physics, Toronto, Canada 4Princess Margaret Hospital, Biostatistics, Toronto, Canada Purpose: Squamous cell carcinoma (SCC) of the penis is a rare but psychologically devastating malignancy. At the Ottawa Regional Cancer Center and the Princess Margaret Hospital in Toronto, brachytherapy has been used as the treatment of choice for penile preservation in T1 and T2 tumors. Methods: From 09/89 to 09/03, 49 men had brachytherapy for penile SCC. Median age was 58 years (range 22-93). 51% of tumors were T1, 33% T2 and 8% T3, while 4% were in-situ and 4% Tx. 31% were well differentiated, 45% moderately and 2% poorly, while 20% were unspecified and one tumor was verrucous. All tumors in Toronto had PDR brachytherapy (n=23) while those in Ottawa had either Iridium wire (n=22) or seeds (n=4). Four patients had a single plane implant using a plastic tube technique while all others had a volume implant using pre-drilled plexi-glass templates and 2 or 3 parallel planes of needles (median 6). Median needle spacing was 14 mm (range 10-18), median dose rate 57 cGy/hour (range 33-160) and median duration 102 hours (range 36-188). PDR dose rates were 50 cGy/hr-61.2 cGy/hr with no correction in total dose which was 60 Gy in all cases. Results: Median follow-up is 33.4 months (range 2-140). At 5 years, actuarial overall survival is 78.2%, cause specific survival 89.8%. Four men died of penile cancer, and 6 died of other causes with no evidence of recurrence. Actuarial rate of never having experienced any type of failure at 5 years is 63.7% and for local failure is 83.8%. All 5 local failures were successfully salvaged by surgery; two other men required penectomy for necrosis. The soft tissue necrosis rate is 16% and the urethral stenosis rate 12%. Five of 8 regional failures were salvaged by lymph node dissection +_ external radiation. Four of 5 men with distant failure have died of disease and one is alive with disease. 42 of 49 men had an intact and tumor free penis at last follow-up or death. The actuarial penile preservation rate at 5 years is 85.1%.
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Conclusion: Brachytherapy is an effective treatment for T1, T2 and selected T3 SCC of the penis. Close follow-up is mandatory as local failures and many regional failures can be salvaged by surgery. 125 oral Gliasite radiotherapy system for treatment of recurrent malignant glioma: a multi-institutional analysis
A. Gabayan ~, A. Sanan 2, M. Lachaine ~, J. Woolfenden 3, B. Stea ~ ~University of Arizona, Radiation Oncology, Tucson, U.S.A. 2University of Arizona, Neurosurgery, Tucson, U.S.A ~University of Arizona, Nuclear Medicine, Tucson, U.S.A. Purpose: To evaluate the cumulative experience of several institutions in treating recurrent malignant glioma with the GliaSite Radiotherapy System (RTS). Materials & Methods: Seven institutions provided data on 60 eligible patients with recurrent high-grade glioma with a median age of 56 years and KPS -> 50. All had previously received 60 Gy of external beam radiation with or without chemotherapy. Following maximal debulking of the recurrent tumor, an inflatable balloon catheter (GliaSite RTS) was placed and inflated to conform to the resection cavity. Two weeks after surgery the device was loaded with the liquid 1l~s (Iotrex) radiation source through a subcutaneous port to deliver low dose rate brachytherapy for 3-6 days. The average dose was 60 Gy to a depth of 5-10 mm from the balloon surface. Results: The median survival measured from the date of GIiaSite implantation was 278 days. Multivariate methods were used to explore the effects of various prognostic factors on the patient survival time; KPS (p=0.0078) and exposure to previous chemotherapy (p=0.03) predicted for improved survival. Patients with KPS >80 and who received chemotherapy had a median survival of 325 days. The Gliasite RTS was very well tolerated and there were no treatment related complications or toxicities. There were no cases of pathologically documented cases of radiation necrosis. Conclusion: When compared to published retrospective studies, the GliaSite RTS appears to provide a small survival benefit in patients with recurrent malignant glioma. The GliaSite RTS can safely deliver a high dose of uniform radiation to the areas at greatest risk for recurrence while sparing the normal surrounding brain tissue. This is also a well-tolerated outpatient procedure that does not diminish a patient's quality of life. Based on our results, a phase III randomized trial is warranted to test the role of this novel treatment approach for the management of recurrent high-grade gliomas. 126 oral Endovascular Brachytherapy with 192Iridium after FemoropopliteaI-Stenting. Results from the Vienna-5 Trial
B. Pokraiac 1, R. Wolfram 2, A. Budinsky 2, R. Schmid 1, C. Kirisits ~, R. Poetter ~, E. Minar 2 1Vienna University Hospital, Department of radiotherapy & radiobiology, Vienna, Austria 2University Hospital of Vienna, Angiology, Vienna, Austria Purpose: To evaluate the efficacy of endovascular brachytherapy (EVBT) for the prevention of restenosis after femoropopliteal stenting in high-risk patients. Materials and methods: A total of 88 patients with femoropopliteal lesions (mean treatment length 16.8 _+7.3 cm) were included into the trial. Patients underwent PTA and stent implantation and were randomized in a double blinded fashion to receive either gamma-EBT with an ~921ridium source or treatment with non-radioactive source. A dose of 14 Gy was
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prescribed at 2ram into the arterial wall (target depth = vessel radius + 2mm). The primary endpoint was angiographic binary restenosis >50% at 6 months.
Results: Revascularization and EBT were successfully accomplished in all patients, The overall 6-month recurrence rate was 34.8% in the Stent- vs. 33.3% in the Stent plus EBT group, (p=0.89). Nine (10.2%) patients developed early reocclusion of the stented segment (2 patients [4.3%] in the Stent- and 7 [16.7%] in the Stent + EVBT group), among those 3 patients in the EBT group within the first 24 hours after intervention. Late thrombotic occlusion (LTO >30 days) was observed in 3 patients in the Stent plus EBT group. The recurrence rate after 12 months was: Stent: 58.7%, Stent + EVBT 43.9%, (p=0.17), respectively. Conclusion: ETB does not improve 6-months patency after femoropopliteal stenting in high risk patients, due to a high incidence of early and late thrombotic occlusions. However, after 12 months trend toward significant lowering of restenosis with EVBT was observed. Optimization of antiplatelet therapy is necessary in future.