Preliminary results of a prospective trial of image-guided 3D conformal accelerated partial breast irradiation (APBI).

125 Background: External beam APBI is noninvasive and may offer better coverage of tumor sites in proximity to skin or chest wall than brachytherapy. To improve conformality and accuracy of treatment, we conducted a prospective IRB-approved clinical trial of APBI with implanted gold markers for image guidance. Cosmetic assessments through patient and physician questionnaires were collected. Adverse events were graded according to Common Terminology Criteria for Adverse Events v3.0. This is our preliminary report on toxicity and cosmetic outcomes. Methods: Thirty-four pts were enrolled from 12/06 to 4/10. Eligibility criteria included age > 40, unifocal disease, ductal histology, tumor ≤ 3 cm, surgical margin ≥ 2 mm, and planning target volume: breast volume ratio < 0.2. Vascular invasion, positive axillary nodes, high-grade ductal carcinoma in situ, and extensive intraductal component were excluded. Three gold fiducials were sutured into the operative site at the time of partial mastectomy. The clinical target volume comprised the surgical cavity including all surgical clips and gold fiducials + 10-15 mm. Prescribed dose was 3.85 Gy b.i.d. to 38.5 Gy, using 4–5 non-coplanar beams. Special breathing technique and image guidance with electronic portal imaging were used. Results: Median follow-up is 18 months (range 7-47 months). Most pts had mild acute reactions with only 6% grade 2 erythema. Late toxicities include hyperpigmentation (71% grade 1), fibrosis (26% grade 1, 32% grade 2), skin dimpling or indentation (38% grade 1, 3% grade 2), telangiectasias (12% grade 1), rib fractures in the treatment area (3% grade 2). The only grade 3 toxicity was a seroma requiring surgical excision in one pt. Cosmesis was rated by the pt versus (v.) physician as excellent/good in 85% v. 94%, 80% v. 90%, and 84% v. 85% of the pts at prior to treatment, 6 months, and one year respectively. Ninety-one percent of patients were “totally satisfied with the treatment and results.” No breast recurrences have been observed. Conclusions: Image-guided APBI is well-tolerated, with high patient satisfaction. Early cosmesis results, as assessed by both pts and physicians, are comparable to whole-breast radiotherapy.

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Outcomes for APBI with strut-based brachytherapy: First 100 accrued patients (5-year median follow-up).

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.26_suppl.114 ◽

2014 ◽

Vol 32 (26_suppl) ◽

pp. 114-114

Author(s):

Robert R. Kuske ◽

Coral Quiet ◽

Margaret B. Snyder ◽

Maureen Lyden ◽

Deanna J. Attai ◽

...

Keyword(s):

Adverse Events ◽

Ductal Carcinoma ◽

Target Volume ◽

Invasive Disease ◽

Accelerated Partial Breast Irradiation ◽

Partial Breast Irradiation ◽

Serious Adverse Events ◽

Conventional Dose ◽

Estrogen Receptor Positive

114 Background: The SAVI Collaborative Research Group (SCRG), was created to study the long-term outcomes of women receiving accelerated partial breast irradiation (APBI) using strut-based applicators. The outcomes for the first 100 accrued patients in the study are reported. Methods: Patients for this subset analysis weretaken as the initial 100 treated across all participating sites. Median follow-up of this cohort was 56.3 months at the time of the abstract. Patients were treated with APBI using the strut-based brachytherapy device with conventional dose and fractionation (3.4 Gy x 10 fx, BID). Treatment planning goals for the planning target volume were a V90>90%, V150<50 cc, and V200<20 cc. Patients were followed regularly by their radiation oncologist and outcomes were graded based on the CTCAE v3.0 (common terminology criteria for adverse events, version 3.0). Recurrence (raw and actuarial) rates were also calculated based on the follow up. Cosmesis was graded using the Harvard Scale. Results: 75 patients had invasive disease and 25 had ductal carcinoma in situ. The median age was 60.5 yrs (range 40-85 yrs), with 84% post-menopausal. Median tumor size was 10.0 mm (range 0.7-35 mm) with 92% being estrogen receptor positive. 65% of patients had at least one round of hormone therapy and 7% had chemotherapy. All patients completed APBI as planned with no serious adverse events. All patients met the dosimetric criteria. Good/excellent cosmesis was seen in >94% of subjects at all times of follow up (6-60 months). The 5-yr actuarial rates for TR/MM were 2.2%, 1.5% and 4.2% for all subjects, invasive and DCIS subgroups, respectively. The 5-yr actuarial rates for IBTR were 3.3%, 3.0% and 4.2% for all subjects, invasive and DCIS subgroups, respectively. Conclusions: For these initially treated 100 patients with a median 5 years of follow up, strut-based brachytherapy appears to be a well-tolerated, effective treatment with low rates of toxicities and local control as good as other brachytherapy APBI methods.

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Transforming Growth Factor Beta-1 (TGF-β1) is a Serum Biomarker of Radiation Induced Fibrosis in Patients Treated with Intracavitary Accelerated Partial Breast Irradiation: Preliminary Results of a Prospective Trial

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2010.07.389 ◽

2010 ◽

Vol 78 (3) ◽

pp. S157-S158

Author(s):

S.R. Coplowitz ◽

K. Chao ◽

D. Nori ◽

B. Parashar ◽

L. Riley ◽

...

Keyword(s):

Growth Factor ◽

Transforming Growth Factor Beta ◽

Transforming Growth Factor ◽

Prospective Trial ◽

Accelerated Partial Breast Irradiation ◽

Partial Breast Irradiation ◽

Breast Irradiation ◽

Radiation Induced ◽

Growth Factor Beta ◽

Tgf Β1

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Five-day accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) in stage 0-II breast cancer: A report of 214 cases with up to 39 month follow-up.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e12508 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e12508-e12508

Author(s):

Rufus J. Mark ◽

Valerie Gorman ◽

Michal Wolski ◽

Steven McCullough

Keyword(s):

Breast Cancer ◽

Intensity Modulated Radiation Therapy ◽

Target Volume ◽

Accelerated Partial Breast Irradiation ◽

Partial Breast Irradiation ◽

Breast Irradiation ◽

Skin Reactions ◽

Cosmetic Results ◽

Non Invasive

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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