Long-term follow-up after intraoperative radiotherapy (IORT) for breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10594-10594
Author(s):  
U. S. Kraus-Tiefenbacher ◽  
C. Herskind ◽  
L. Bauer ◽  
F. Melchert ◽  
F. Wenz

10594 Background: IORT for breast cancer with new treatment modalities is becoming increasingly important. In our department IORT is delivered by a mobile x-ray source (Intrabeam) producing isotropic 50 kV x-ray fields. Because this treatment modality includes single high doses to the normal breast tissue, careful evaluation of early and late toxicity is mandatory. Methods: Between 2/02 and 12/05 161 patients received IORT either as a tumour-bed boost (103) before 46 Gy external beam radiotherapy (EBRT) or as partial breast irradiation (58). Median age was 64.6 years (35–95), median tumour size was 15 mm (1–45). Spherical applicators (2.0 -5.0 cm diameter) were inserted into the tumourbed, giving a single dose of 20 Gy. Follow-up (f/u) included physical examination and ultrasound 1 week, 2 months, then every 6 months after therapy and mammography at yearly intervals. Radiobiological modelling of the expected spatial distribution of late reaction was done for typical cases using the linear-quadratic model with special consideration of relative biologic effectiveness, spatial dose distribution and dose rate. Results: Mean (f/u) time was 22 months. Minor postoperative side effects included erythema (5%), delayed wound healing (4%), mastitis (1%) and hematoseroma (4%). A fibrotic induration of the tumour bed was observed in 9, 18, 22, 23 and 26% of the patients at 2, 6 12, 24 and 36 month (f/u). Reoperation was required in 2 patients after 10 and 12 months, one mastectomy due to a fibrotic change of the whole breast and one local drainage of a fat necrosis. Conclusions: Although 2/3 of the patients were treated with a combination of IORT and EBRT, acute reactions in all patients were mild. Predominant late effect was an induration of the tumour bed which slowly began to resolve 1–3 years after therapy. The low level of clinically late reactions observed so far is in agreement with radiobiologic predictions from radiobiological modelling. No significant financial relationships to disclose.

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 607-607
Author(s):  
U. S. Kraus-Tiefenbacher ◽  
C. Herskind ◽  
L. Bauer ◽  
A. Scheda ◽  
F. Wenz

607 Background: IORT for breast cancer using either electrons or low-energy x-rays is of increasing interest over the last few years. In our institution, IORT is delivered by a mobile x-ray source (Intrabeam™) producing isotropic 50 kV x-ray fields. Because this treatment method includes single high doses to the normal breast tissue, careful and long-term evaluation of early and late toxicity is mandatory. To date there are still fewdata on long-term follow-up of patients treated with low-energy x-rays. Methods: Between 2/02 and 12/06 204 breast cancer patients received IORT either as a tumour-bed boost (133) followed by 46 Gy external beam radiotherapy (EBRT) or as partial breast irradiation (PBI) only (71). Median age was 66.4 years (35–95), median tumour size was 9 mm (1–45). Spherical applicators (median 4. 0 cm) were inserted into the tumour-cavity and a single dose of 20 Gy was given. Follow-up (f/u) included physical examination and ultrasound 1 week, 2 months, then every 6 months after therapy and mammography at yearly intervals. Radiobiological modelling of the expected spatial distribution of late reactions was done for typical cases using the linear-quadratic model with special consideration of relative biological effectiveness, spatial dose distribution and dose rate. Results: Median f/u was 28 months (1–56). Minor postoperative side effects included erythema (5%), delayed wound healing (4%), mastitis (1%) and hematoseroma (4%). A fibrotic induration of the tumour bed was observed in 9, 18, 24, 23, 26% and 24% of the patients at 2, 6 12, 24, 36 and 48 month f/u. These fibrosis rates were distributed equally in both groups. Reoperation was required in 2 patients after 10 (fibrosis) and 12 months (fat necrosis). Conclusions: Although two thirds of the patients were treated with a combination of IORT and EBRT, acute reactions in all patients were mild. A fibrotic induration confined to the tumourbed was observed in up to 25% of all patients after 2 years. The low level of clinically observed late reactions so far is in agreement with predictions from radiobiological modelling. No significant financial relationships to disclose.


2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Harriet B. Eldredge-Hindy ◽  
Anne L. Rosenberg ◽  
Nicole L. Simone

In well-selected patients who choose to pursue breast conservation therapy (BCT) for early-stage breast cancer, partial breast irradiation (PBI) delivered externally or intraoperatively, may be a viable alternative to conventional whole breast irradiation. Two large, contemporary randomized trials have demonstrated breast intraoperative radiotherapy (IORT) to be noninferior to whole breast external beam radiotherapy (EBRT) when assessing for ipsilateral breast tumor recurrence in select patients. Additionally, IORT and other PBI techniques are likely to be more widely adopted in the future because they improve patient convenience by offering an accelerated course of treatment. Coupled with these novel techniques for breast radiotherapy (RT) are distinct toxicity profiles and unique cosmetic alterations that differ from conventional breast EBRT and have the potential to impact disease surveillance and patient satisfaction. This paper will review the level-one evidence for treatment efficacy as well as important secondary endpoints like RT toxicity, breast cosmesis, quality of life, patient satisfaction, and surveillance mammography following BCT with IORT.


2020 ◽  
Vol 13 (8) ◽  
Author(s):  
Solmaz Hashemi ◽  
Seyedmohammadreza Javadi ◽  
Mohammad Esmaeil Akbari ◽  
Hamid Reza Mirzaei ◽  
Seied Rabi Mahdavi

Background: Radiotherapy plays an essential role in breast cancer treatment following breast conserving surgery even in good-risk patients with ductal carcinoma in situ (DCIS) histology. It can be delivered by many techniques, among which is intraoperative radiotherapy (IORT). In recent years, intraoperative radiation therapy has had the same outcome compared with EBRT. Objectives: We studied whether whole breast radiotherapy (WBRT) could safely be replaced by IORT and its ability to control local recurrence like EBRT in pure DCIS. Methods: We assigned 138 patients into the external beam radiotherapy (EBRT), radical, and boost groups. The patients were treated during the last 6 years in the Cancer Research Center of Shahid Beheshti University of Medical Sciences. A total of 57 patients received EBRT, 45 patients received the radical dose of radiotherapy by IORT (36 patients received intraoperative electron radiotherapy [IOeRT] and 9 patients received intraoperative X-ray radiotherapy [IOxRT]) according to the IRIORT consensus protocol, and 36 patients received the boost dose of radiotherapy by IORT (15 patients received IOeRT and 21 patients received IOxRT). The IORT and EBRT groups were compared. The primary endpoint was local recurrence and death and the secondary endpoint was the role of variables in local recurrence. Results: With the mean follow-up of 37 months for the IORT group and 40.1 months for the EBRT group, local recurrence occurred in 8.8% (5 patients), 13.9% (5 patients), and 2.2% (1 patient) of the patients in the EBRT, boost, and radical groups, respectively. Concerning the local recurrence, no significant difference was observed between the radical and EBRT groups (P = 0.058) and between the boost and EBRT groups (P = 0.12). Hazard ratios (HRs) of grade, hormone receptor (HR), tumor size, and age in disease-free survival were evaluated and none of these variables had a significant role in local recurrence. Conclusions: IORT is a good alternative for WBRT in DCIS patients because of its non-inferiority results in comparison with EBRT. Being careful about age, tumor size, biological markers, and margin status is of high importance when using IORT for DCIS.


2020 ◽  
Vol 61 (4) ◽  
pp. 602-607
Author(s):  
Mariko Kawamura ◽  
Yoshiyuki Itoh ◽  
Takeshi Kamomae ◽  
Masataka Sawaki ◽  
Toyone Kikumori ◽  
...  

Abstract Although phase III trials have been published comparing whole breast irradiation (WBI) with accelerated partial breast irradiation (APBI) using intraoperative radiotherapy (IORT), long-term follow-up results are lacking. We report the 10-year follow-up results of a prospective phase I/II clinical trial of IORT. The inclusion criteria were as follows: (i) tumor size <2.5 cm, (ii) desire for breast-conserving surgery, (iii) age >50 years, (iv) negative margins after resection and (v) sentinel lymph node-negative disease. A single dose of IORT (19–21 Gy) was delivered to the tumor bed in the operation room just after wide local excision of the primary breast cancer using a 6–12 MeV electron beam. Local recurrence was defined as recurrence or new disease within the treated breast and was evaluated annually using mammography and ultrasonography. A total of 32 patients were eligible for evaluation. The median patient age was 65 years and the median follow-up time was 10 years. Two patients experienced local recurrence just under the nipple, out of the irradiated field, after 8 years of follow-up. Three patients had contralateral breast cancer and one patient experienced bone metastasis after 10 years of follow-up. No patient experienced in-field recurrence nor breast cancer death. Eight patients had hypertrophic scarring at the last follow-up. There were no lung or heart adverse effects. This is the first report of 10-year follow-up results of IORT as APBI. The findings suggest that breast cancer with extended intraductal components should be treated with great caution.


2010 ◽  
Vol 28 (18_suppl) ◽  
pp. LBA517-LBA517 ◽  
Author(s):  
M. Baum ◽  
D. J. Joseph ◽  
J. S. Tobias ◽  
F. K. Wenz ◽  
M. R. Keshtgar ◽  
...  

LBA517 Background: After breast conserving surgery, 90% of local recurrences (LR) occur within the index quadrant. Hence, restricting the radiation therapy to the immediate area around the tumour bed after removal of the primary tumour may be adequate (Vaidya JS, et al. Br Cancer.1996;74:820-4) Methods: Having safely piloted a new technique of partial breast irradiation (Vaidya JS, Baum M, Tobias JS et al Ann Oncol 2001;12:1075-80) we launched the TARGIT-A trial in March 2000 comparing TARGIT vs. standard whole breast external beam radiotherapy (EBRT) after breast conserving surgery in patients ≥45 years with invasive duct carcinoma. LR was the primary outcome measure (core protocol: www.thelancet.com/protocol-reviews/99PRT-47 ). Trial accrual from 31 international centers is complete (n=2232), with 80% power to detect a difference in relapse rate of 2.5% - the non-inferiority margin. Results: Median age was 63 (IQR 57-69), median tumor size 13mm (IQR 9-18mm), lymph nodes 17%+ve. Median follow-up is 24.6 months (max 10 years). Wound breakdown or delayed healing were reported in 28 of the TARGIT group and 20 in the EBRT group (p=0.24). RTOG grade 3 toxicity (nil grade 4) was seen in 6 vs. 21 (p=0.004) respectively. Overall local toxicity was equivalent (34/1092 TARGIT v. 41/1096 EBRT, p=0.42). The Kaplan-Meier estimate of LR in the breast, was 0.31% (CI 0.08-1.26) for TARGIT versus 0.29% for EBRT (CI 0.07-1.16) at 24 months. Conclusions: In the TARGIT group, the radiotherapy toxicity was significantly lower than in the EBRT group, while the increase in wound complications was not statistically significant. This analysis suggests that at a median follow-up of 24 months the local control with TARGIT is comparable to EBRT. Longer term follow-up is essential and accrual in similar studies is encouraged. [Table: see text]


2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 94-94
Author(s):  
M. R. Keshtgar ◽  
N. R. Williams ◽  
T. Corica ◽  
C. Saunders ◽  
M. Bulsara ◽  
...  

94 Background: The randomized controlled TARGIT Trial was designed to determine noninferiority between the novel technique of TARGIT [intra-operative radiotherapy with Intrabeam (Carl Zeiss, Germany)] and conventional external beam radiotherapy (EBRT) in women with early breast cancer. The main outcome objective is risk of local relapse within the treated breast. We report here data from a subprotocol assessing cosmesis in 114 women over 50 years old participating in the TARGIT Trial from one center (Perth, Australia). Methods: Frontal view digital photographs from were assessed, blind to treatment, using specialist software (BCCT.core 2.0, INESC Porto, Portugal) that produces an objective composite score based on symmetry, color, and scar. Data on patient and tumor characteristics were obtained from hospital notes. Statistical analysis was by generalized estimating equations (GEE) on all data, and logistic regression analysis at year 1 only. Results: Photographs were taken at baseline (before surgery) and 1, 2, 3, and 4 years after initial breast-conserving surgery; none of the 114 patients had subsequent breast surgery. Median age at randomization was 62 years (IQR 56 to 68). The composite scores were dichotomized into Excellent and Good (EG), and Fair and Poor (FP). There was a nonsignificant 45% increase in the odds of having an outcome of EG for patients in the TARGIT group relative to the EBRT group (OR=1.45, 95%CI 0.78 – 2.69, p=0.245) after adjusting for tumour size. The results were similar when adjusted for tumor grade and age of the patient. For year 1 there was a statistically significant 2.35 fold increase in the odds of having an outcome of EG for patients in the TARGIT group relative to the EBRT group (OR=2.35, 95%CI 1.02 – 5.45, p=0.047) after adjusting for age of the patient, tumor size, and grade. Conclusions: These results confirm a significantly better cosmetic outcome with TARGIT compared to EBRT in the first year after surgery.


The Breast ◽  
2009 ◽  
Vol 18 (5) ◽  
pp. 327-334 ◽  
Author(s):  
M. Ruch ◽  
J. Brade ◽  
C. Schoeber ◽  
U. Kraus-Tiefenbacher ◽  
A. Schnitzer ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12508-e12508
Author(s):  
Rufus J. Mark ◽  
Valerie Gorman ◽  
Michal Wolski ◽  
Steven McCullough

e12508 Background: Randomized trials in stage 0-II breast cancer have proven that APBI given via HDR implant in 5 days is equivalent to whole breast irradiation (WBI) given in 5-6 weeks in regard to breast tumor local recurrence (LR). However, complications have been significant. Recently APBI using non-invasive IMRT given in 5 fractions has been shown in another randomized trial with 10 year follow-up to be equivalent to WBI in 6 weeks, with respect to LR. IMRT was superior in regard to acute effects, late effects, and cosmesis. In the randomized clinical trial of APBI IMRT, the Clinical Target Volume (CTV) was defined by the injection of individual fiducial markers bordering the surgical cavity. We have used the Biozorb fiducial system to localize the CTV for IMRT. We sought to confirm the APBI IMRT results with this simpler less labor intensive fiducial placement system. Methods: Between 2017 and 2021, 214 patients have undergone IMRT targeted to a Biozorb defined CTV with the walls of the surgical cavity sewn to the Biozorb device. Eligible patients were older than age 40, had tumor sizes < 3 cm, negative surgical margins, and negative sentinel node dissections. IMRT dose was 30 Gy given in 5 fractions. Dose Constraints were as follows : V-30 Gy < 105%, Ipsilateral Breast V-15 Gy < 50%, Ipsilateral Lung V-10 Gy < 20%, Contralateral Lung V-5 Gy < 10%, Heart V-3 Gy < 20%, Contralateral Breast Dmax < 2 Gy and Skin Dmax < 27 Gy. The Planning Target Volume (PTV) ranged from 27 to 355 cc with a median of 80 cc. PTV = CTV + 1-2 cm. Results: Follow-up ranged from 1-39 months with a median of 20 months. LR has been 0% (0/214). There have been no skin reactions or seromas. Infection has occurred in one patient (0.5%). Four (1.9%) patients developed pain around the Biozorb site. This resolved on a short courses of steroids in all cases. Cosmetic results as rated by the Surgeon, Radiation Oncologist, and Nurse, were rated excellent in 99.0% (212/214) of cases. Conclusions: Non-invasive APBI with IMRT given qd over 5 days targeted to Biozorb has resulted in LR, complications, and cosmetic results which compare favorably to invasive APBI given bid with HDR implant. At last follow-up, there have been no LR, skin reactions, or significant complications. Cosmesis has been excellent in 99.0% of patients.


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