@article{MTMT:1118079, title = {Fat necrosis after partial-breast irradiation with brachytherapy or electron irradiation versus standard whole-breast radiotherapy--4-year results of a randomized trial.}, url = {https://m2.mtmt.hu/api/publication/1118079}, author = {Lovey, K and Fodor, János and Major, Tibor and Szabo, E and Orosz, Zsolt and Sulyok, Z and Jánváry, Zsolt Levente and Fröhlich, Georgina and Kásler, Miklós and Polgár, Csaba}, doi = {10.1016/j.ijrobp.2007.03.055}, journal-iso = {INT J RADIAT ONCOL}, journal = {INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS}, volume = {69}, unique-id = {1118079}, issn = {0360-3016}, abstract = {PURPOSE: To examine the incidence and clinical relevance of fat necrosis after accelerated partial-breast irradiation (PBI) using interstitial high-dose-rate brachytherapy (HDR-BT) in comparison with partial-breast electron irradiation (ELE) and whole-breast irradiation (WBI). METHODS AND MATERIALS: Between 1998 and 2004, 258 early-stage breast cancer patients were randomized to receive 50 Gy WBI (n = 130) or PBI (n = 128). The latter consisted of either 7 x 5.2 Gy HDR-BT (n = 88) or 50 Gy ELE (n = 40). The incidence of fat necrosis, its impact on cosmetic outcome, accompanying radiologic features, and clinical symptoms were evaluated. RESULTS: The 4-year actuarial rate of fat necrosis was 31.1% for all patients, and 31.9%, 36.5%, and 17.7% after WBI, HDR-BT and ELE, respectively (p(WBI/HDR-BT) = 0.26; p(WBI/ELE) = 0.11; p(ELE/HDR-BT) = 0.025). The respective rate of asymptomatic fat necrosis was 20.2%, 25.3%, and 10% of patients. The incidence of symptomatic fat necrosis was not significantly different after WBI (8.5%), HDR-BT (11.4%), and ELE (7.5%). Symptomatic fat necrosis was significantly associated with a worse cosmetic outcome, whereas asymptomatic fat necrosis was not. Fat necrosis was detectable with mammography and/or ultrasound in each case. Additional imaging examinations were required in 21% of cases and aspiration cytology in 42%. CONCLUSIONS: Asymptomatic fat necrosis is a common adverse event of breast-conserving therapy, having no significant clinical relevance in the majority of the cases. The incidence of both symptomatic and asymptomatic fat necrosis is similar after conventional WBI and accelerated partial-breast HDR-BT.}, keywords = {Follow-Up Studies; Aged; Adult; Female; Middle Aged; Humans; Aged, 80 and over; Incidence; Radiotherapy Dosage; Breast Neoplasms/*radiotherapy; Fat Necrosis/*epidemiology/etiology/radiography; Electrons/adverse effects/therapeutic use; Breast/*pathology/radiation effects; Brachytherapy/adverse effects/methods}, year = {2007}, eissn = {1879-355X}, pages = {724-731}, orcid-numbers = {Major, Tibor/0000-0002-4672-6910; Jánváry, Zsolt Levente/0000-0002-4583-4901; Fröhlich, Georgina/0000-0001-6428-6536; Kásler, Miklós/0000-0002-7235-8787; Polgár, Csaba/0000-0001-7245-0762} } @article{MTMT:1118078, title = {Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial.}, url = {https://m2.mtmt.hu/api/publication/1118078}, author = {Polgár, Csaba and Fodor, János and Major, Tibor and Németh, György and Lovey, K and Orosz, Zsolt and Sulyok, Z and Takácsi-Nagy, Zoltán and Kásler, Miklós}, doi = {10.1016/j.ijrobp.2007.04.022}, journal-iso = {INT J RADIAT ONCOL}, journal = {INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS}, volume = {69}, unique-id = {1118078}, issn = {0360-3016}, abstract = {PURPOSE: To report the 5-year results of a randomized study comparing the survival and cosmetic results of breast-conserving treatment with partial breast irradiation (PBI) or conventional whole breast irradiation (WBI). METHODS AND MATERIALS: Between 1998 and 2004, 258 selected patients with T1 N0-1mi, Grade 1-2, nonlobular breast cancer without presence of extensive intraductal component and resected with negative margins were randomized after breast-conserving surgery to receive 50 Gy/25 fractions WBI (n = 130) or PBI (n = 128). The latter consisted of either 7 x 5.2 Gy high-dose-rate (HDR) multicatheter brachytherapy (BT; n = 88) or 50 Gy/25 fractions electron beam (EB) irradiation (n = 40). RESULTS: At a median follow-up of 66 months, the 5-year actuarial rate of local recurrence was 4.7% and 3.4% in the PBI and WBI arms, respectively (p = 0.50). There was no significant difference in the 5-year probability of overall survival (94.6% vs. 91.8%), cancer-specific survival (98.3% vs. 96.0%), and disease-free survival (88.3% vs. 90.3%). The rate of excellent to good cosmetic result was 77.6% in the PBI group (81.2% after HDR BT; 70.0% after EB) and 62.9% in the control group (52.2% after telecobalt; 65.6% after 6-9-MV photons; p(WBI/PBI) = 0.009). CONCLUSIONS: Partial breast irradiation using interstitial HDR implants or EB to deliver radiation to the tumor bed alone for a selected group of early-stage breast cancer patients produces 5-year results similar to those achieved with conventional WBI. Significantly better cosmetic outcome can be achieved with carefully designed HDR multicatheter implants compared with the outcome after WBI.}, keywords = {Follow-Up Studies; Aged; Adult; Female; Middle Aged; Humans; Neoplasm Staging; Aged, 80 and over; Treatment Outcome; Chemotherapy, Adjuvant; Radiotherapy Dosage; Disease-Free Survival; Salvage Therapy; Combined Modality Therapy/methods; *Mastectomy, Segmental; Breast Neoplasms/mortality/pathology/*radiotherapy/*surgery; Brachytherapy/methods}, year = {2007}, eissn = {1879-355X}, pages = {694-702}, orcid-numbers = {Polgár, Csaba/0000-0001-7245-0762; Major, Tibor/0000-0002-4672-6910; Takácsi-Nagy, Zoltán/0000-0002-3261-0271; Kásler, Miklós/0000-0002-7235-8787} } @article{MTMT:2571215, title = {Clinical experience with the MammoSite (R) radiation therapy system for brachytherapy of breast cancer: Results from an international phase II trial}, url = {https://m2.mtmt.hu/api/publication/2571215}, author = {Niehoff, P and Polgár, Csaba and Ostertag, H and Major, Tibor and Sulyok, Z and Kimmig, B and Kovacs, G}, doi = {10.1016/j.radonc.2006.05.010}, journal-iso = {RADIOTHER ONCOL}, journal = {RADIOTHERAPY AND ONCOLOGY}, volume = {79}, unique-id = {2571215}, issn = {0167-8140}, abstract = {Background and purpose: In a prospective multi-center phase II trial, we investigated the MammoSite (R) Radiation Therapy System, a new device for delivering intracavitary brachytherapy following breast conserving surgery. The MammoSite (R) is a dual lumen, closed ended catheter with a small, spherical inflatable balloon and a port for connecting a remote afterloader to the central lumen. We analyzed the surgical procedure and placement of the MammoSite (R), treatment planning and radiation delivery complications and cosmesis, as well the comfort for the patients. Patients and methods: Between 2002 and 2004 a total of 32 patients (pts) were implanted using the MammoSite (R). The reference isodose was defined 1 cm from the balloon surface. We analyzed the post-implant anatomic position of the applicator and the geometric form of the balloon via ultrasound, CT and X-ray, related side effects, cosmetic outcome and patient quality of life. Results: Twenty-three out of 32 patients (72%) were eligible for Mammosite (R) intracavitary brachytherapy. Twenty-eight percentage had to be excluded because of different reasons. Eleven patients were treated with primary brachytherapy with a total dose of 34 Gy (2 X 3.4 Gy) and 12 had a boost with a mean dose of 13.3 Gy (range: 7.5-15 Gy; 2 X 2.5 Gy) combined with EBRT and doses ranged between 46 and 50 Gy. In three cases a balloon rupture occurred. We observed two abscesses within 3 months of implantation and serious seroma development in 10 patients (39%). Skin related side effects were erythema in 21 patients (91%), hyperpigmentation in 13 patients (56%) and teleangiectasia in six patients (26%) after mean follow-up 20 months. Conclusions: The MammoSite (R) Radiation Therapy System is a feasible treatment modality for intracavitary brachytherapy of breast cancer after breast conserving surgery. The advantage of the system is only one applicator is necessary for the delivery of a fractionated radiotherapy. In addition, patient tolerance of the procedure is high. Critical issues concern possible overdosages at the skin reflected by a high rate of late skin damage after only 20 months of follow-up time. The method could serve as an alternative to conventional multi-catheter brachytherapy for a selected group of patients. (c) 2006 Elsevier Ireland Ltd. All rights reserved.}, keywords = {WOMEN; IRRADIATION; TOXICITY; VOLUME; RADIOTHERAPY; Brachytherapy; breast cancer; CONSERVING SURGERY; DOSE-RATE BRACHYTHERAPY; partial breast irradiation; BOOST; APPLICATOR; SEGMENTAL-MASTECTOMY; phase II trial; MammoSite (R)}, year = {2006}, eissn = {1879-0887}, pages = {316-320}, orcid-numbers = {Polgár, Csaba/0000-0001-7245-0762; Major, Tibor/0000-0002-4672-6910} } @article{MTMT:2571221, title = {Early European experience with the MammoSite radiation therapy system for partial breast brachytherapy following breast conservation operation in low-risk breast cancer}, url = {https://m2.mtmt.hu/api/publication/2571221}, author = {Niehoff, P and Ballardini, B and Polgár, Csaba and Major, Tibor and Hammer, J and Richetti, A and Kovacs, G}, doi = {10.1016/j.breast.2006.05.002}, journal-iso = {BREAST}, journal = {BREAST}, volume = {15}, unique-id = {2571221}, issn = {0960-9776}, abstract = {Preliminary results of ultrasound studies do exist in the literature on the successful use of the MammoSite Radiation Therapy System (RTS), a new device for delivering brachytherapy following breast-conserving surgery. In Europe, some groups started a prospective multicentre trial to investigate the use of the MammoSite RTS. In this early publication, we analysed the surgical procedure and placement of the MammoSite, treatment planning and radiation delivery complications, and early cosmesis, as well as the comfort of the patients. Between June 2002 and March 2005, a total of 54 low-risk breast cancer patients fulfilling the enrolment criteria were implanted intra- or postoperatively using the MammoSite applicator. After inflating the balloon in the excision cavity, the reference isodose was defined 1 cm from the balloon's surface. Twenty-eight patients were treated with primary brachytherapy with a total dose of 34 Gy (2 x 3.4 Gy) and 16 patients had a boost with a mean dose of 13.3 Gy (range: 7.5-15 Gy; 2 x 2.5 Gy) combined with external beam radiotherapy (EBRT). Doses ranged between 46 and 50 Gy. We analysed the postimplant anatomic position of the applicator in relation to the skin and chest wall as well as the geometric form of the balloon via ultrasound, computed tomography and X-ray before, during and after the treatment. Forty-four out of 54 patients (81.5%) were eligible for MammoSite RTS brachytherapy. Ten patients were excluded from the trial due to the strict study criteria and received no brachytherapy. Balloon rupture occurred in two cases. We observed seroma in 16 patients (36%); furthermore, an abscess developed in two patients (4.5%) within 3 months of implantation. Postoperative air gaps and haematoma were successfully reduced by draining the operation cavity in one institution. At a mean follow-up of 14 months (range 3-31 months), the skin-related side effects observed were skin discoloration or inflammation in 36 patients (82%) and teleangiectasia in eight patients (18%). The MammoSite RTS is a feasible treatment modality for postoperative partial breast irradiation after breast-conserving surgery for selected low-risk breast cancer patients. The main advantage of the system is the necessity of only one applicator for the delivery of fractionated radiotherapy over a 5-day treatment period. In addition, patient tolerance of the procedure is high. Based on this early experience, the method may serve as a successful alternative to conventional multicatheter brachytherapy for a highly select group of patients, but we have to bear in mind the higher level of acute toxicity. (c) 2006 Elsevier Ltd. All rights reserved.}, keywords = {Brachytherapy; breast cancer; partial breast irradiation; MammoSite}, year = {2006}, eissn = {1532-3080}, pages = {319-325}, orcid-numbers = {Polgár, Csaba/0000-0001-7245-0762; Major, Tibor/0000-0002-4672-6910} } @article{MTMT:1118059, title = {High-dose-rate brachytherapy alone versus whole breast radiotherapy with or without tumor bed boost after breast-conserving surgery: seven-year results of a comparative study.}, url = {https://m2.mtmt.hu/api/publication/1118059}, author = {Polgár, Csaba and Major, Tibor and Fodor, János and Németh, György and Orosz, Zsolt and Sulyok, Z and Udvarhelyi, Nóra and Somogyi, A and Takácsi-Nagy, Zoltán and Lovey, K and Ágoston, Péter Zoltán and Kásler, Miklós}, doi = {10.1016/j.ijrobp.2004.05.012}, journal-iso = {INT J RADIAT ONCOL}, journal = {INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS}, volume = {60}, unique-id = {1118059}, issn = {0360-3016}, abstract = {PURPOSE: To report the 7-year results of a prospective study of accelerated partial breast irradiation (APBI) using interstitial high-dose-rate brachytherapy and compare the treatment results with those achieved by standard, whole breast radiotherapy (WBRT), with or without a tumor bed boost (TBB). METHODS AND MATERIALS: Between 1996 and 1998, 45 prospectively selected patients with T1N0-N1mi (single nodal micrometastasis), nonlobular breast cancer without the presence of an extensive intraductal component and with negative surgical margins were treated with APBI using interstitial high-dose-rate implants. A total dose of 30.3 Gy (n = 8) and 36.4 Gy (n = 37) in seven fractions within 4 days was delivered to the tumor bed plus a 1-2-cm margin. During the same period, 80 patients, who met the eligibility criteria for APBI but who were treated with 50 Gy WBRT with (n = 36) or without (n = 44) a 10-16-Gy TBB, were selected as controls. The median follow-up for the APBI and control groups was 81 and 83 months, respectively. Local control, relapse-free survival, cancer-specific survival, late side effects, and cosmetic results were assessed. RESULTS: The crude rate of total ipsilateral breast failure was 6.7% (3 of 45), 11.4% (5 of 44), and 8.3% (3 of 36) for patients treated with APBI, WBRT, and WBRT + TBB, respectively. The differences in the 5- and 7-year actuarial rates of ipsilateral breast recurrence were not statistically significant among patients treated with APBI (4.4% and 9.0%), WBRT (4.7% and 14.8%), and WBRT + TBB (5.7% and 9.5%). No statistically significant difference in either the 7-year probability of relapse-free survival (79.8%, 73.5%, and 77.7% for APBI, WBRT, and WBRT + TBB, respectively) or cancer-specific survival (93.3%, 92.9%, and 93.9% for APBI, WBRT, and WBRT + TBB, respectively) was found. The 7-year actuarial elsewhere breast failure rate was 9.0% in the APBI group and 8.3% in the control group (p = 0.80). The rate of excellent/good cosmetic results was 84.4% in the APBI group and 68.3% in the control group (p = 0.04). The corresponding rates of asymptomatic fat necrosis were 20.0% and 20.6%. Symptomatic fat necrosis occurred in 1 patient (2.2%) treated with APBI. The incidence of Grade 2 or worse late radiation side effects was similar for both groups (26.7% vs. 28.6%). CONCLUSION: Accelerated partial breast irradiation using interstitial high-dose-rate implants, with proper patient selection and quality assurance, yields similar 7-year results to those achieved with standard breast-conserving therapy. APBI does not increase the risk of elsewhere breast failures.}, keywords = {Aged; Adult; Female; Middle Aged; Humans; Prospective Studies; Combined Modality Therapy; Radiotherapy Dosage; Mastectomy, Segmental; Skin/radiation effects; Radiation Injuries/pathology; Neoplasms, Second Primary/pathology; Breast Neoplasms/pathology/*radiotherapy/surgery; Brachytherapy/*methods}, year = {2004}, eissn = {1879-355X}, pages = {1173-1181}, orcid-numbers = {Polgár, Csaba/0000-0001-7245-0762; Major, Tibor/0000-0002-4672-6910; Takácsi-Nagy, Zoltán/0000-0002-3261-0271; Ágoston, Péter Zoltán/0000-0003-0264-630X; Kásler, Miklós/0000-0002-7235-8787} } @article{MTMT:1241510, title = {Partial breast irradiation with interstitial 60Co brachytherapy results in frequent grade 3 or 4 toxicity. Evidence based on a 12-year follow-up of 70 patients}, url = {https://m2.mtmt.hu/api/publication/1241510}, author = {Póti, Zsuzsa and Nemeskéri, Csaba and Fekésházy, Attila and Sáfrány, Géza and Bajzik, Gábor and P, Nagy Zoltán and Bidlek, Mária and Sinkovics, István and Udvarhelyi, Nóra and Liszkay, Gabriella and Repa, Imre and Galuska, László and Trón, Lajos and Mayer, Árpád and Ésik, Olga}, doi = {10.1016/j.ijrobp.2003.08.013}, journal-iso = {INT J RADIAT ONCOL}, journal = {INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS}, volume = {58}, unique-id = {1241510}, issn = {0360-3016}, abstract = {To investigate the radiation-induced toxicity and cosmesis of brachytherapy (BT) alone in early stage breast cancer.A total of 70 women diagnosed with Stage I or II breast carcinoma participated in a BT study at the Municipal Oncoradiological Center, Uzsoki Hospital, Budapest, Hungary, between November 1987 and June 1992. They had undergone breast-conserving surgery with an unknown surgical margin. The postoperative tumor bed irradiation was performed with interstitial (60)Co sources with an active length of 4 cm, with 10-mm center-to-center spacing arranged in a single plane. The median number of inserted sources was 5 (range, 2-8), with a linear activity of 133-137 MBq/cm at the beginning of the study. The 50 Gy delivered dose at 5 mm from the surface of the (60)Co sources was administered during 10-22 h to the virtual postoperative lumpectomy cavity (i.e., plane). For radiobiologic considerations, the clinical target volume (CTV) was calculated retrospectively with a 10-mm safety margin, resulting in a 72-cm(3) median CTV (range, 36-108 cm(3)) irradiated with a reference dose of 28 Gy. In the assessment of the skin and subcutaneous toxicity, the RTOG late radiation morbidity scoring system was applied. The radiosensitivity of the cultured fibroblasts was determined by clonogenic assay to check whether individual radiosensitivity played a role in the development and course of radiation-induced side-effects.The median follow-up was 12 years (range, 10-15 years). The population of the final study (34 cases) comprised all survivors with tumor-free breasts (27 cases) and patients with breasts erroneously ablated/excised for misinterpreted radiation-induced sequelae (7 patients). A total of 97% of the cohort (33/34) had grade > or =2, and 59% (20/34) had grade > or =3 radiation-induced toxicity. By the end of the follow-up, 85% of the patients experienced Grade > or =2 telangiectasis and 41% had Grade 3 telangiectasis. Eighty-eight percent had fibrosis of some form, and 35% had grade > or =3 fibrosis. Forty-one percent of the cohort displayed fat necrosis, which was always accompanied by Grade > or =3 fibrosis or telangiectasis. The cosmetic results were poor in 50% (17/34) of the patients. The radiosensitivity of the fibroblasts was increased in only 2/24 patients (8% of the investigated cases, in agreement with data published for the general population). Comparisons of our fibrosis prevalence data with those of others allowed an estimate of 0.47 h(-1) for the rate of recovery of DNA damage in the fibroblasts.Interstitial (60)Co BT of the breast tumor bed alone with a limited CTV (median, 72 cm(3)) and a total dose of 28 Gy is associated with a high rate (59%) of grade > or =3 radiation-induced toxicity and a high rate (50%) of poor cosmetic outcome at the end of a median follow-up of 12 years. A relatively high BT dose rate (1.3-2.8 Gy/h) applied during a short overall treatment time (10-22 h) and a possible geographic miss (close to skin implantation) might have contributed to the development of these sequelae.}, year = {2004}, eissn = {1879-355X}, pages = {1022-1033}, orcid-numbers = {Bajzik, Gábor/0000-0002-0996-9294; Liszkay, Gabriella/0000-0001-6161-2033} } @article{MTMT:1118050, title = {Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer: five-year results of a phase I-II study and initial findings of a randomized phase III trial.}, url = {https://m2.mtmt.hu/api/publication/1118050}, author = {Polgár, Csaba and Sulyok, Z and Fodor, János and Orosz, Zsolt and Major, Tibor and Takácsi-Nagy, Zoltán and Mangel, László Csaba and Somogyi, A and Kásler, Miklós and Németh, György}, doi = {10.1002/jso.10110}, journal-iso = {J SURG ONCOL}, journal = {JOURNAL OF SURGICAL ONCOLOGY}, volume = {80}, unique-id = {1118050}, issn = {0022-4790}, abstract = {BACKGROUND AND OBJECTIVES: The objectives of this study were to test the feasibility of sole interstitial high-dose-rate brachytherapy (HDR-BT) after breast-conserving surgery (BCS) for T1 breast cancer in a phase I-II study, and to present the initial findings of a phase III trial comparing the efficacy of tumor bed radiotherapy (TBRT) alone with conventional whole breast radiotherapy (WBRT). METHODS: Forty-five prospectively selected patients with T1 breast cancer undergoing BCS were enrolled into a phase I-II study of TBRT alone, using interstitial HDR implants. HDR-BT of 7 x 4.33 Gy (n = 8) and 7 x 5.2 Gy (n = 37) was delivered to the tumor bed. Based on the results of this phase I-II study, a further 126 patients were randomized to receive 50 Gy WBRT (n = 63) or TBRT alone (n = 63); the latter consisted of either 7 x 5.2 Gy HDR-BT (n = 46) or 50-Gy wide-field electron irradiation (n = 17). Breast cancer related events and side effects were assessed. RESULTS: In the phase I-II study, at a median follow-up of 57 months, 2 (4.4%) local, 3 (6.7%) axillary, and 3 (6.7%) distant failures were observed. Two patients (4.4%) died of breast cancer. The 5-year probability of cancer-specific, relapse-free and local recurrence-free survival was 90.0%, 85.9%, and 95.6%, respectively. The cosmetic results were judged to be excellent in 44 of 45 patients (97.8%). Severe (higher than grade 2) skin sequelae or fibrosis was not found. Symptomatic fat necrosis occurred in one patient (2.2%). In the phase III study, at a median follow-up of 30 months, the locoregional tumor control was 100% in both arms. The 3-year probability of cancer-specific and relapse-free survival was 98.1% and 98.4% in the WBRT group and 100% and 94.4% in the TBRT group, respectively (P = NS). There was no significant difference between the two treatment arms regarding the incidence of radiation side effects. CONCLUSIONS: Five-year results of our phase I-II study prove that sole HDR-BT of the tumor bed with careful patient selection and adequate quality assurance is a feasible alternative to WBRT. However, long-term results of phase III trials are required to determine the equivalence of TBRT alone, compared with WBRT in the management of selected patients with early breast cancer.}, keywords = {Aged; Adult; Female; Middle Aged; Humans; Feasibility Studies; Survival Rate; Dose-Response Relationship, Radiation; Radiotherapy Dosage; Lymph Node Excision; *Mastectomy, Segmental; Breast Neoplasms/mortality/*radiotherapy/surgery; *Brachytherapy/mortality}, year = {2002}, eissn = {1096-9098}, pages = {121-128}, orcid-numbers = {Polgár, Csaba/0000-0001-7245-0762; Major, Tibor/0000-0002-4672-6910; Takácsi-Nagy, Zoltán/0000-0002-3261-0271; Kásler, Miklós/0000-0002-7235-8787} }