TY - JOUR AU - Polgár, Csaba AU - Ott, OJ AU - Hildebrandt, G AU - Kauer-Dorner, D AU - Knauerhase, H AU - Major, Tibor AU - Lyczek, J AU - Guinot, JL AU - Dunst, J AU - Miguelez, CG AU - Slampa, P AU - Allgauer, M AU - Lossl, K AU - Polat, B AU - Kovacs, G AU - Fischedick, AR AU - Fietkau, R AU - Resch, A AU - Kulik, A AU - Arribas, L AU - Niehoff, P AU - Guedea, F AU - Schlamann, A AU - Potter, R AU - Gall, C AU - Uter, W AU - Strnad, V ED - Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology, (GEC-ESTRO) / Collaborative Organization TI - Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial JF - LANCET ONCOLOGY J2 - LANCET ONCOL VL - 18 PY - 2017 IS - 2 SP - 259 EP - 268 PG - 10 SN - 1470-2045 DO - 10.1016/S1470-2045(17)30011-6 UR - https://m2.mtmt.hu/api/publication/3173126 ID - 3173126 AB - BACKGROUND: We previously confirmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-effects and cosmetic results of the trial. METHODS: We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0-IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1:1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratified by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-effects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. FINDINGS: Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6.6 years (IQR 5.8-7.6), no patients had any grade 4 toxities, and three (<1%) of 484 patients in the APBI group and seven (2%) of 393 in the whole-breast irradiation group had grade 3 late skin toxicity (p=0.16). No patients in the APBI group and two (<1%) in the whole-breast irradiation group developed grade 3 late subcutaneous tissue toxicity (p=0.10). The cumulative incidence of any late side-effect of grade 2 or worse at 5 years was 27.0% (95% CI 23.0-30.9) in the whole-breast irradiation group versus 23.3% (19.9-26.8) in the APBI group (p=0.12). The cumulative incidence of grade 2-3 late skin toxicity at 5 years was 10.7% (95% CI 8.0-13.4) in the whole-breast irradiation group versus 6.9% (4.8-9.0) in the APBI group (difference -3.8%, 95% CI -7.2 to 0.4; p=0.020). The cumulative risk of grade 2-3 late subcutaneous tissue side-effects at 5 years was 9.7% (95% CI 7.1-12.3) in the whole-breast irradiation group versus 12.0% (9.4-14.7) in the APBI group (difference 2.4%; 95% CI -1.4 to 6.1; p=0.28). The cumulative incidence of grade 2-3 breast pain was 11.9% (95% CI 9.0-14.7) after whole-breast irradiation versus 8.4% (6.1-10.6) after APBI (difference -3.5%; 95% CI -7.1 to 0.1; p=0.074). At 5 years' follow-up, according to the patients' view, 413 (91%) of 454 patients had excellent to good cosmetic results in the whole-breast irradiation group versus 498 (92%) of 541 patients in the APBI group (p=0.62); when judged by the physicians, 408 (90%) of 454 patients and 503 (93%) of 542 patients, respectively, had excellent to good cosmetic results (p=0.12). No treatment-related deaths occurred, but six (15%) of 41 patients (three in each group) died from breast cancer, and 35 (85%) deaths (21 in the whole-breast irradiation group and 14 in the APBI group) were unrelated. INTERPRETATION: 5-year toxicity profiles and cosmetic results were similar in patients treated with breast-conserving surgery followed by either APBI with interstitial brachytherapy or conventional whole-breast irradiation, with significantly fewer grade 2-3 late skin side-effects after APBI with interstitial brachytherapy. These findings provide further clinical evidence for the routine use of interstitial multicatheter brachytherapy-based APBI in the treatment of patients with low-risk breast cancer who opt for breast conservation. FUNDING: German Cancer Aid. LA - English DB - MTMT ER - TY - JOUR AU - Vratislav, Strnad AU - Oliver, J Ott AU - Guido, Hildebrandt AU - Daniela, Kauer-Dorner AU - Hellen, Knauerhase AU - Major, Tibor AU - Jaroslaw, Lyczek AU - Jose, Luis Guinot AU - Jürgen, Dunst AU - Cristina, Gutierrez Miguelez AU - Pavel, Slampa AU - Michael, Allgäuer AU - Kristina, Lössl AU - Bülent, Polat AU - György, Kovács AU - Arnt-René, Fischedick AU - Thomas, G Wendt AU - Rainer, Fietkau AU - Marion, Hindemith AU - Alexandra, Resch AU - Anna, Kulik AU - Leo, Arribas AU - Peter, Niehoff AU - Fernando, Guedea AU - Annika, Schlamann AU - Richard, Pötter AU - Christine, Gall AU - Martina, Malzer AU - Wolfgang, Uter AU - Polgár, Csaba TI - 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial JF - LANCET J2 - LANCET VL - 387 PY - 2016 IS - 10015 SP - 229 EP - 238 PG - 10 SN - 0140-6736 DO - 10.1016/S0140-6736(15)00471-7 UR - https://m2.mtmt.hu/api/publication/2971909 ID - 2971909 N1 - Polgár Csaba hozzájárulása a közleményhez: szerző, a vizsgálat ötletadója, a vizsgálat egyik vezetője, a vizsgálati protokoll szerkesztője, részt vett az adatok statisztikai értékelésében és a kézirat megírásában is. AB - BACKGROUND: In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients with stage 0, I, and IIA breast cancer who underwent breast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results. METHODS: We did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving surgery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519. FINDINGS: Between April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients received APBI using interstitial multicatheter brachytherapy. At 5-year follow-up, nine patients treated with APBI and five patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1.44% (95% CI 0.51-2.38) with APBI and 0.92% (0.12-1.73) with whole-breast irradiation (difference 0.52%, 95% CI -0.72 to 1.75; p=0.42). No grade 4 late side-effects were reported. The 5-year risk of grade 2-3 late side-effects to the skin was 3.2% with APBI versus 5.7% with whole-breast irradiation (p=0.08), and 5-year risk of grade 2-3 subcutaneous tissue late side-effects was 7.6% versus 6.3% (p=0.53). The risk of severe (grade 3) fibrosis at 5 years was 0.2% with whole-breast irradiation and 0% with APBI (p=0.46). INTERPRETATION: The difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival. FUNDING: German Cancer Aid. LA - English DB - MTMT ER - TY - JOUR AU - Polgár, Csaba AU - Major, Tibor AU - Fodor, János AU - Sulyok, Z AU - Somogyi, A AU - Lovey, K AU - Németh, György AU - Kásler, Miklós TI - Accelerated partial-breast irradiation using high-dose-rate interstitial brachytherapy: 12-year update of a prospective clinical study. JF - RADIOTHERAPY AND ONCOLOGY J2 - RADIOTHER ONCOL VL - 94 PY - 2010 IS - 3 SP - 274 EP - 279 PG - 6 SN - 0167-8140 DO - 10.1016/j.radonc.2010.01.019 UR - https://m2.mtmt.hu/api/publication/1323093 ID - 1323093 AB - BACKGROUND AND PURPOSE: To report the 12-year updated results of accelerated partial-breast irradiation (APBI) using multicatheter interstitial high-dose-rate (HDR) brachytherapy (BT). PATIENTS AND METHODS: Forty-five prospectively selected patients with T1N0-N1mi, nonlobular breast cancer without the presence of an extensive intraductal component and with negative surgical margins were treated with APBI after breast-conserving surgery (BCS) using interstitial HDR BT. A total dose of 30.3Gy (n=8) and 36.4Gy (n=37) in seven fractions within 4days was delivered to the tumour bed plus a 1-2cm margin. The median follow-up time was 133months for surviving patients. Local and regional control, disease-free (DFS), cancer-specific (CSS), and overall survival (OS), as well as late side effects, and cosmetic results were assessed. RESULTS: Four (8.9%) ipsilateral breast tumour recurrences were observed, for a 5-, 10-, and 12-year actuarial rate of 4.4%, 9.3%, and 9.3%, respectively. A total of two regional nodal failures were observed for a 12-year actuarial rate of 4.4%. The 12-year DFS, CSS, and OS was 75.3%, 91.1%, and 88.9%, respectively. Grade 3 fibrosis was observed in one patient (2.2%). No patient developed grade 3 teleangiectasia. Fat necrosis requiring surgical intervention occurred in one woman (2.2%). Cosmetic results were rated excellent or good in 35 patients (77.8%). CONCLUSIONS: Twelve-year results with APBI using HDR multicatheter interstitial implants continue to demonstrate excellent long-term local tumour control, survival, and cosmetic results with a low-rate of late side effects. LA - English DB - MTMT ER - TY - JOUR AU - Polgár, Csaba AU - Van, Limbergen E AU - Potter, R AU - Kovacs, G AU - Polo, A AU - Lyczek, J AU - Hildebrandt, G AU - Niehoff, P AU - Guinot, JL AU - Guedea, F AU - Johansson, B AU - Ott, OJ AU - Major, Tibor AU - Strnad, V AU - the, GEC-ESTRO breast cancer working group TI - Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery. recommendations of the Groupe Europeen de Curietherapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009) TS - recommendations of the Groupe Europeen de Curietherapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009) JF - RADIOTHERAPY AND ONCOLOGY J2 - RADIOTHER ONCOL VL - 94 PY - 2010 IS - 3 SP - 264 EP - 273 PG - 10 SN - 0167-8140 DO - 10.1016/j.radonc.2010.01.014 UR - https://m2.mtmt.hu/api/publication/2571279 ID - 2571279 AB - PURPOSE: To give recommendations on patient selection criteria for the use of accelerated partial-breast irradiation (APBI) based on available clinical evidence complemented by expert opinion. METHODS AND MATERIALS: Overall, 340 articles were identified by a systematic search of the PubMed database using the keywords "partial-breast irradiation" and "APBI". This search was complemented by searches of reference lists of articles and handsearching of relevant conference abstracts and book chapters. Of these, 3 randomized and 19 prospective non-randomized studies with a minimum median follow-up time of 4 years were identified. The authors reviewed the published clinical evidence on APBI, complemented by relevant clinical and pathological studies of standard breast-conserving therapy and, through a series of personal communications, formulated the recommendations presented in this article. RESULTS: The GEC-ESTRO Breast Cancer Working Group recommends three categories guiding patient selection for APBI: (1) a low-risk group for whom APBI outside the context of a clinical trial is an acceptable treatment option; including patients ageing at least 50 years with unicentric, unifocal, pT1-2 (30 mm) tumours, and/or EIC positive or LVI positive tumours, and/or 4 or more positive lymph nodes or unknown axillary status (pNx), and (3) an intermediate-risk group, for whom APBI is considered acceptable only in the context of prospective clinical trials. CONCLUSIONS: These recommendations will provide a clinical guidance regarding the use of APBI outside the context of a clinical trial before large-scale randomized clinical trial outcome data become available. Furthermore they should promote further clinical research focusing on controversial issues in the treatment of early-stage breast carcinoma. LA - English DB - MTMT ER - TY - JOUR AU - Lovey, K AU - Fodor, János AU - Major, Tibor AU - Szabo, E AU - Orosz, Zsolt AU - Sulyok, Z AU - Jánváry, Zsolt Levente AU - Fröhlich, Georgina AU - Kásler, Miklós AU - Polgár, Csaba TI - Fat necrosis after partial-breast irradiation with brachytherapy or electron irradiation versus standard whole-breast radiotherapy--4-year results of a randomized trial. JF - INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS J2 - INT J RADIAT ONCOL VL - 69 PY - 2007 IS - 3 SP - 724 EP - 731 PG - 8 SN - 0360-3016 DO - 10.1016/j.ijrobp.2007.03.055 UR - https://m2.mtmt.hu/api/publication/1118079 ID - 1118079 N1 - Megjegyzés-20317363 Cited By (since 1996): 1 AB - 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. LA - English DB - MTMT ER - TY - JOUR AU - Polgár, Csaba AU - Fodor, János AU - Major, Tibor AU - Németh, György AU - Lovey, K AU - Orosz, Zsolt AU - Sulyok, Z AU - Takácsi-Nagy, Zoltán AU - Kásler, Miklós TI - Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. JF - INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS J2 - INT J RADIAT ONCOL VL - 69 PY - 2007 IS - 3 SP - 694 EP - 702 PG - 9 SN - 0360-3016 DO - 10.1016/j.ijrobp.2007.04.022 UR - https://m2.mtmt.hu/api/publication/1118078 ID - 1118078 N1 - Department of Radiotherapy, National Institute of Oncology, Budapest, Hungary Department of Human and Experimental Tumor Pathology, National Institute of Oncology, Budapest, Hungary Department of General and Thoracic Surgery, National Institute of Oncology, Budapest, Hungary Cited By :304 Export Date: 10 July 2023 CODEN: IOBPD Correspondence Address: Polgár, C.; Department of Radiotherapy, , Budapest, Hungary; email: polgar@oncol.hu Chemicals/CAS: cobalt, 7440-48-4 AB - 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. LA - English DB - MTMT ER -