Patient-reported outcomes (PROs) in NRG oncology/NSABP B-39/RTOG 0413: A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) in stage 0, I, or II breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 508-508 ◽  
Author(s):  
Patricia A. Ganz ◽  
Reena S. Cecchini ◽  
Julia R. White ◽  
Frank Vicini ◽  
Thomas B. Julian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Outcomes ◽  
Pain Scale ◽  
Local Tumor Control ◽  
Phase Iii ◽  
Partial Breast Irradiation ◽  
Tumor Control ◽  
Breast Irradiation ◽  
Related Symptom ◽  
Patient Reported

508 Background: PBI is an alternative to WBI, with potentially greater therapy (tx) compliance, and better integration with chemotherapy (CTX). NSABP B-39/RTOG 0413 clinical outcome results from 2018 did not show equivalence of PBI to WBI in local tumor control; PBI was statistically inferior, but with clinically small differences. PBI may be an acceptable alternative to WBI for some women. Understanding cosmesis and quality of life (QOL) treatment outcomes is important. Methods: B-39/0413 included a prospective QOL substudy with PRO evaluation of breast cancer treatment outcomes (cosmesis, function, pain) and fatigue using BCTOS and SF-36 vitality scales. Secondary QOL parameters included treatment related symptoms, perceived convenience of care, and the BPI pain scale. The study sample was stratified by CTX or not, as CTX is given before WBI but after PBI. PRO assessments occurred before randomization, the last day of adjuvant tx [CTX or radiation], 4 wks later, and 6, 12, 24, and 36 mo later. Primary aims included comparisons of change in fatigue from baseline to end of tx and equivalency of change in cosmesis from baseline to 36 mo for PBI v WBI. Separate analyses were done for CTX and non-CTX pts, controlling for axillary dissection. Each comparison used α=0.0125. Planned sample size was 964. Results: From 3-23-05 to 5-27-09, 975 pts were enrolled in the PRO study; 950 had follow-up data. 504 did not receive CTX and 446 received CTX. In non-CTX pts, PBI had less fatigue (p=0.011) and did not meet criteria for cosmesis equivalence (97.5% CI, -0.02 to 0.22; ∆=0.20). In CTX pts, PBI had worse fatigue (p=0.011) and equivalent cosmesis to WBI (97.5% CI, -0.09 to 0.21; ∆=0.24). In both groups, PBI pts reported less pain at end of tx. In non-CTX pts, PBI had more pain at 36 mo but in CTX pts, there was no difference. Convenience of care and treatment related symptom outcomes will be presented. Conclusions: In non-CTX pts, PBI is more convenient with less fatigue and slightly poorer cosmesis at 36 mo. Cosmesis was equivalent at 36 mo in CTX pts. Support: U10CA180868, -180822, UG1CA189867. Clinical trial information: NCT00103181.

scholarly journals Intraoperative irradiation in breast cancer: preliminary results in 80 patients as partial breast irradiation or anticipated boost prior to hypo-fractionated whole breast irradiation

2021 ◽  
Author(s):  
X. Li ◽  
J. Sanz ◽  
N. Argudo ◽  
M. Vernet-Tomas ◽  
N. Rodríguez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Patient Reported Outcomes ◽  
Well Being ◽  
Partial Breast Irradiation ◽  
X Rays ◽  
Breast Irradiation ◽  
Intraoperative Irradiation ◽  
Patient Reported ◽  
First Results ◽  
Good Cosmesis

Abstract Purpose To present the first results of intraoperative irradiation (IORT) in breast cancer with a low-energy photon system used as partial breast irradiation (PBI) or as an anticipated boost before whole breast hypo-fractionated irradiation (IORT + WBI), concerning tolerance, side effects, quality of life, and patient-reported outcomes. Materials and methods Eighty patients treated with an Intrabeam® system of 50 kV X-rays received a 20 Gy dose intraoperatively were included. Moderate daily hypofractionation of 2.7 Gy in 15 fractions up to 40.5 Gy was administered if high-risk factors were present. Acute post-operative toxicity, surgery complications, chronic toxicity, patient-reported cosmesis and Breast-Q questionnaire were performed at follow-up visits. Results Thirty-one patients were treated as PBI and the remaining 49 as IORT + WBI. Only the IORT + WBI group presented acute toxicity, mainly mild acute dermatitis (11 patients) and one subacute mastitis. A total of 20 patients presented fibrosis (18 patients grade I, 2 patients grade II), 15 (30.5%) patients in the IORT + WBI group and 3 (9.6%) patients in the group of PBI. The cosmesis evaluation in 73 patients resulted poor, fair, good or excellent in 2, 7, 38 and 26 patients, respectively. In PBI group Breast-Q scored higher, especially in terms of their psychosocial well-being (78 vs 65) and satisfaction with radiation-induced toxicity (77 vs 72, respectively) compared to IORT + WBI group. Conclusion IORT is a well-tolerated procedure with low toxicity, good cosmesis and favorable patient-reported outcomes mainly when administered as PBI.

Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial

2020 ◽  
Vol 38 (35) ◽  
pp. 4175-4183 ◽  
Author(s):  
Icro Meattini ◽  
Livia Marrazzo ◽  
Calogero Saieva ◽  
Isacco Desideri ◽  
Vieri Scotti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Phase Iii ◽  
Accelerated Partial Breast Irradiation ◽  
Long Term Results ◽  
Partial Breast Irradiation ◽  
Whole Breast Irradiation ◽  
Breast Irradiation ◽  
Once Daily

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.

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 ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Local Recurrence ◽  
Phase I ◽  
Critical Evaluation ◽  
Intraoperative Radiotherapy ◽  
Phase Iii ◽  
Accelerated Partial Breast Irradiation ◽  
Partial Breast Irradiation ◽  
Breast Irradiation

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.

scholarly journals National Surgical Adjuvant Breast and Bowel Project (NSABP)

2006 ◽  
Vol 9 (S1) ◽  
pp. 402-411
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Ductal Carcinoma ◽  
Phase Iii ◽  
Partial Breast Irradiation ◽  
List Type ◽  
Breast Irradiation ◽  
National Surgical Adjuvant Breast ◽  
Bowel Project

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Surgical Adjuvant Breast and Bowel Project (NSABP). Clinical trials include: NSABP B-35 – A clinical trial comparing anastrozole with tamoxifen in postmenopausal patients with ductal carcinoma in situ (DCIS) undergoing lumpectomy with radiation therapy.NSABP B-36 – A clinical trial of adjuvant therapy comparing six cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) to four cycles of adriamycin and cyclophosphamide (AC) in patients with node-negative breast cancer.NSABP B-38 – A phase III, adjuvant trial comparing three chemotherapy regimens in women with node-positive breast cancer: docetaxel/doxorubicin/cyclophosphamide (TAC); dose-dense (DD) doxorubicin/cyclophosphamide followed by DD paclitaxel (DD AC→P): DD AC followed by DD paclitaxel plus gemcitabine (DD AC→PG).NSABP B-39 – A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer.

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.

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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