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External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study.

ABSTRACT: External beam accelerated partial breast irradiation (APBI) is an increasingly popular technique for treatment of patients with early stage breast cancer following breast-conserving surgery. Here we present 5-year results of a prospective trial.From October 2003 through November 2005, 98 evaluable patients with stage I breast cancer were enrolled in the first dose step (32 Gy delivered in 8 twice-daily fractions) of a prospective, multi-institutional, dose escalation clinical trial of 3-dimensional conformal external beam APBI (3D-APBI). Median age was 61 years; median tumor size was 0.8 cm; 89% of tumors were estrogen receptor positive; 10% had a triple-negative phenotype; and 1% had a HER-2-positive subtype. Median follow-up was 71 months (range, 2-88 months; interquartile range, 64-75 months).Five patients developed ipsilateral breast tumor recurrence (IBTR), for a 5-year actuarial IBTR rate of 5% (95% confidence interval [CI], 1%-10%). Three of these cases occurred in patients with triple-negative disease and 2 in non-triple-negative patients, for 5-year actuarial IBTR rates of 33% (95% CI, 0%-57%) and 2% (95% CI, 0%-6%; P<.0001), respectively. On multivariable analysis, triple-negative phenotype was the only predictor of IBTR, with borderline statistical significance after adjusting for tumor grade (P=.0537).Overall outcomes were excellent, particularly for patients with estrogen receptor-positive disease. Patients in this study with triple-negative breast cancer had a significantly higher IBTR rate than patients with other receptor phenotypes when treated with 3D-APBI. Larger, prospective 3D-APBI clinical trials should continue to evaluate the effect of hormone receptor phenotype on IBTR rates.

SUBMITTER: Pashtan IM

PROVIDER: S-EPMC3455124 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study.

Pashtan Itai M IM Recht Abram A Ancukiewicz Marek M Brachtel Elena E Abi-Raad Rita F RF D'Alessandro Helen A HA Levy Antonin A Wo Jennifer Y JY Hirsch Ariel E AE Kachnic Lisa A LA Goldberg Saveli S Specht Michelle M Gadd Michelle M Smith Barbara L BL Powell Simon N SN Taghian Alphonse G AG

International journal of radiation oncology, biology, physics 20120530 3

<h4>Purpose</h4>External beam accelerated partial breast irradiation (APBI) is an increasingly popular technique for treatment of patients with early stage breast cancer following breast-conserving surgery. Here we present 5-year results of a prospective trial.<h4>Methods and materials</h4>From October 2003 through November 2005, 98 evaluable patients with stage I breast cancer were enrolled in the first dose step (32 Gy delivered in 8 twice-daily fractions) of a prospective, multi-institutional ...[more]

PMID: 22652104

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Project description:PurposeMost studies examining accelerated partial breast irradiation (APBI) have used twice-daily fractionation. Cosmesis with this approach has produced mixed results, and the optimal fractionation scheme remains unknown. We sought to evaluate the safety and efficacy of APBI with a total dose of 40 Gy in 10 daily fractions.Methods and materialsBetween 2010 and 2014, we prospectively enrolled 106 patients to receive APBI after lumpectomy for invasive or in situ node-negative breast cancer. Radiation was administered via 3-dimensional conformal techniques.ResultsThe median age was 62 years (range, 39-85), and all patients underwent APBI per protocol. With a median follow-up of 58 months, we evaluated patient-reported local toxicity and recurrence outcomes. Of 106 patients, 16 (15%) experienced grade ≥2 skin toxicity. The most common significant toxicities were acute cutaneous changes at 4 to 9 weeks after radiation therapy, including grade 2 erythema in 2 patients (1.8%) and skin color changes in 4 patients (3.8%). Only 2 instances of grade 3 toxicity were reported, including 1 patient with acute moist desquamation after radiation therapy and another with fibrosis at 2 years. Planning target volume and breast V20 were significantly predictive of skin/subcutaneous toxicity, with evidence that limiting breast V20 to <45% may improve tolerability. Overall, 3 breast cancer recurrences arose: 1 local recurrence in the original quadrant (3 years after APBI), 1 in a different ipsilateral quadrant (5 years after APBI), and 1 with distant disease 2 years after APBI.ConclusionsIn an appropriately selected group of patients with early stage breast cancer, APBI to a dose of 40 Gy in 10 daily fractions was well tolerated, with most patients (99%) reporting excellent/good cosmesis. Planning target volume and breast V20 should be carefully constrained to limit local morbidity. Longer follow-up will be needed to establish efficacy and subsequent local recurrence rates.

Project description:BackgroundAccelerated partial breast irradiation (APBI) is an alternative breast-conserving therapy approach where radiation is delivered in less time compared to whole breast irradiation (WBI), resulting in improved patient convenience, less toxicity, and cost savings. This prospective randomized study compares the external beam APBI with commonly used moderate hypofractionated WBI in terms of feasibility, safety, tolerance, and cosmetic effects.MethodsEarly breast cancer patients after partial mastectomy were equally randomized into two arms- external APBI and moderate hypofractionated WBI. External beam technique using available technical innovations commonly used in targeted hypofractionated radiotherapy to minimize irradiated volumes was used (cone beam computed tomography navigation to clips in the tumor bed, deep inspiration breath hold technique, volumetric modulated arc therapy dose application, using flattening filter free beams and the six degrees of freedom robotic treatment couch). Cosmetics results and toxicity were evaluated using questionnaires, CTCAE criteria, and photo documentation.ResultsThe analysis of 84 patients with a median age of 64 years showed significantly fewer acute adverse events in the APBI arm regarding skin reactions, local and general symptoms during a median follow-up of 37 months (range 21-45 months). A significant difference in favor of the APBI arm in grade ≥ 2 late skin toxicity was observed (p = 0.026). Late toxicity in the breast area (deformation, edema, fibrosis, and pain), affecting the quality of life and cosmetic effect, occurred in 61% and 17% of patients in WBI and APBI arms, respectively. The cosmetic effect was more favorable in the APBI arm, especially 6 to 12 months after the radiotherapy.ConclusionExternal APBI demonstrated better feasibility and less toxicity than the standard regimen in the adjuvant setting for treating early breast cancer patients. The presented study confirmed the level of evidence for establishing the external APBI in daily clinical practice.Trial registrationNCT06007118.

Project description:PurposeThis study aimed to prospectively characterize toxicity and cosmesis after accelerated partial breast irradiation (APBI) with 3-dimensional conformal radiation therapy (CRT) or single-entry, multilumen, intracavitary brachytherapy.Methods and materialsA total of 281 patients with pTis, pT1N0, or pT2N0 (≤3.0 cm) breast cancer treated with segmental mastectomy were prospectively enrolled from December 2008 through August 2014. APBI was delivered using 3-dimensional CRT (n = 29) or with SAVI (n = 176), Contura (n = 56), or MammoSite (n = 20) brachytherapy catheters. Patients were evaluated at protocol-specified intervals, at which time the radiation oncologist scored cosmetic outcome, toxicities, and recurrence status using a standardized template.ResultsThe median follow-up time is 41 months. Grade 1 seroma and fibrosis were more common with brachytherapy than with 3-dimensional CRT (50.4% vs 3.4% for seroma; P < .0001 and 66.3% vs 44.8% for fibrosis; P = .02), but grade 1 edema was more common with 3-dimensional CRT than with brachytherapy (17.2% vs 5.6%; P = .04). Grade 2 to 3 pain was more common with 3-dimensional CRT (17.2% vs 5.2%; P = .03). Actuarial 5-year rates of fair or poor radiation oncologist-reported cosmetic outcome were 9% for 3-dimensional CRT and 24% for brachytherapy (P = .13). Brachytherapy was significantly associated with inferior cosmesis on mixed model analysis (P = .003). Significant predictors of reduced risk of adverse cosmetic outcome after brachytherapy were D0.1cc (skin) ≤102%, minimum skin distance >5.1 mm, dose homogeneity index >0.54, and volume of nonconformance ≤0.89 cc. The 5-year ipsilateral breast recurrence was 4.3% for brachytherapy and 4.2% for 3-dimensional CRT APBI patients (P = .95).ConclusionsBrachytherapy APBI is associated with higher rates of grade 1 fibrosis and seroma than 3-dimensional CRT but lower rates of grade 1 edema and grade 2 to 3 pain than 3-dimensional CRT. Rates of radiation oncologist-reported fair or poor cosmetic outcomes are higher with brachytherapy. We identified dosimetric parameters that predict reduced risk of adverse cosmetic outcome after brachytherapy-based APBI. Ipsilateral breast recurrence was equivalent for brachytherapy and 3-dimensional CRT.

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External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study.

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External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study.

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