scholarly journals A phase I/II trial of intraoperative breast radiotherapy in an Asian population: 10-year results with critical evaluation

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.

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.


2007 ◽  
Vol 25 (8) ◽  
pp. 996-1002 ◽  
Author(s):  
Mary Ella Sanders ◽  
Troy Scroggins ◽  
Federico L. Ampil ◽  
Benjamin D. Li

Whole-breast irradiation, as part of breast-conservation therapy (BCT), has well-established results, good cosmesis, and low toxicity. Results from the BCT trials suggest that the risk for ipsilateral breast cancer recurrence resides within close proximity to the original tumor site. This leads investigators to consider the role of an accelerated and more tumor bed–focused course of radiotherapy. Accelerated partial-breast irradiation (APBI) involves treating a limited volume of breast tissue, with dose of irradiation per fraction increased and the treatment time course decreased. Four currently available methods of APBI are interstitial brachytherapy, intracavitary brachytherapy, intraoperative radiotherapy, and three-dimensional conformal external-beam radiotherapy. Patient selection is critical. This review article presents some preliminary clinical observations and limitations that suggest a potential role for APBI as a more user-friendly mode for delivering radiotherapy after lumpectomy for early breast cancer.


2020 ◽  
Vol 38 (35) ◽  
pp. 4175-4183 ◽  
Author(s):  
Icro Meattini ◽  
Livia Marrazzo ◽  
Calogero Saieva ◽  
Isacco Desideri ◽  
Vieri Scotti ◽  
...  

PURPOSE To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer. PATIENTS AND METHODS The primary end point was to determine the 5-year difference in ipsilateral breast tumor recurrence (IBTR) between 30 Gy in 5 once-daily fractions (APBI arm) and 50 Gy in 25 fractions with a tumor bed boost (WBI arm) after breast-conserving surgery. RESULTS Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk, were randomly assigned (WBI, n = 260; APBI, n = 260) between 2005 and 2013. Median follow-up was 10.7 years. The 10-year cumulative incidence of IBTR was 2.5% (n = 6) in the WBI and 3.7% (n = 9) in the APBI arm (hazard ratio [HR], 1.56; 95% CI, 0.55 to 4.37; P = .40). Overall survival at 10 years was 91.9% in both arms (HR, 0.95; 95% CI, 0.50 to 1.79; P = .86). Breast cancer–specific survival at 10 years was 96.7% in the WBI and 97.8% in the APBI arm (HR, 0.65; 95% CI, 0.21 to 1.99; P = .45). The APBI arm showed significantly less acute toxicity ( P = .0001) and late toxicity ( P = .0001) and improved cosmetic outcome as evaluated by both physician ( P = .0001) and patient ( P = .0001). CONCLUSION The 10-year cumulative IBTR incidence in early breast cancer treated with external APBI using IMRT technique in 5 once-daily fractions is low and not different from that after WBI. Acute and late treatment-related toxicity and cosmesis outcomes were significantly in favor of APBI.


2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 83-83
Author(s):  
J. B. Wilkinson ◽  
C. Shah ◽  
M. Amin ◽  
S. F. Shaitelman ◽  
L. Nadeau ◽  
...  

83 Background: To determine clinical outcomes for patients treated with accelerated partial breast irradiation (APBI) based on breast cancer subtype. Methods: We evaluated 516 consecutive patients who received APBI with a minimum follow-up of 6 months. Methods of APBI delivery included interstitial brachytherapy (n=221), balloon-based brachytherapy (n=201), and 3D-CRT (n=106). Women were assigned a breast cancer subtype (BCST) based on results of testing for estrogen (ER), progesterone (PR), and human epidermal growth factor (HER2/neu) receptors. Those without test results for all three receptors were excluded. 278 patients were eligible and submitted for analysis. Receptor subtypes were approximated as follows: ER+, PR+/–, and HER-2 negative [luminal A (LA), 164 pts.]; ER+, PR+/–, and HER-2 positive [luminal B (LB), 81 pts.]; ER/PR–, HER-2+ [HER-2 (H2), 5 pts.], and ER/PR/HER-2 negative [basal (B), 28 pts.]. An analysis was then performed to estimate IBTR, RNF, DM, DFS, CSS, and OS. Results: Mean age was 66 years, median follow-up was 4.9 yrs. Basal and H2 subtype patients had higher histologic grades (Gr. 3 = 75% vs. 10% LA/LB, p<0.001), larger tumors (13.0mm vs. 10.7mm LA/LB, p=0.05), and were more likely to receive chemotherapy (68% vs. 15% LA/LB, p<0.001). Basal subtype patients were also more likely to be African American (18% vs. 4% LA/LB, p=0.002). Margin and nodal status were similar between all BCSTs. At five years, IBTR rates were 2.9%, 3.2%, 0%, and 4.8% for LA, LB, H2, and B subtypes, respectively (p=0.75). The IBTR within the B subtype group was due to a single elsewhere failure, the rate of which was not statistically different than that for the LA subtype (2.9%, p=0.30). DM was only seen in LA (2.5%) and LB (1.4%) (p=0.87). Disease-free survival (95-100%), CSS (97%-100%), and OS (80-100%) (Table) were also not statistically different (p=0.98, 0.85, 0.24, respectively) between BCST categories. Conclusions: Five-year local control rates after treatment with APBI are excellent for luminal, HER2, and triple-negative phenotypes of early-stage breast cancer. Further study of BCST is important and may be useful when counseling patients on adjuvant treatment options following breast-conserving surgery.


2010 ◽  
Vol 186 (12) ◽  
pp. 651-657 ◽  
Author(s):  
Marie-Luise Sautter-Bihl ◽  
Felix Sedlmayer ◽  
Wilfried Budach ◽  
Jürgen Dunst ◽  
Rita Engenhart- Cabillic ◽  
...  

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