Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Daily Versus Weekly Boost to the Tumor Bed

Cooper, Benjamin; Formenti-Ujlaki, G.F.; Li, Xiaochun; Shin, S.; Fenton-Kerimian, M.; Guth, Amber; Roses, Daniel F.; Hitchen, C.; Rosenstein, Barry S.; DeWyngaert, J. Keith; Goldberg, Judith D.; Formenti, Silvia C.

doi:10.1016/j.ijrobp.2015.12.373

Cited by 21 publications

(12 citation statements)

References 28 publications

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“…Three-week courses of HF-WBI have also been accomplished using a concurrent boost, as in the aforementioned hypofractionated RNI trial which used a hybrid IMRT approach [75]. A randomized trial using a HF-WBI dose regimen of 40.5 Gy in 15 fractions compared daily 0.5 Gy boost (total 48 Gy to the tumor bed) to weekly 2 Gy boost (total 46.5 Gy) using IMRT, and at a median of 45 months found no difference in efficacy, acute or late toxicity, or breast cosmesis [80]. The Radiation Therapy Oncology Group (RTOG) is conducting the RTOG 1005 randomized Phase III trial which is testing HF-WBI of 40 Gy in 15 fractions with a simultaneous integrated boost to 48 Gy, using optional IMRT, compared to standard CF-WBI or HF-WBI with sequential boost [81].…”

Section: Five-year Viewmentioning

confidence: 99%

Hypofractionated radiation treatment in the management of breast cancer

Gupta

Ohri

Haffty

2018

Expert Review of Anticancer Therapy

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The standard treatment for early-stage breast cancer is breast conservation therapy, consisting of breast conserving surgery followed by adjuvant radiation treatment (RT). Conventionally-fractionated whole breast irradiation (CF-WBI) has been the standard RT regimen, but recently shorter courses of hypofractionated whole breast irradiation (HF-WBI) have been advocated for patient convenience and reduction in healthcare costs and resources. Areas covered: This review covers the major randomized European and Canadian trials comparing HF-WBI to CF-WBI with long-term follow-up, as well as additional recently closed randomized trials that further seek to define the applicability of HF-WBI in clinical practice. Randomized data is summarized in terms of clinical utility and for a variety of clinical applications. Recently published consensus guidelines and practical implementation of HF-WBI including its broader effect on the healthcare system are reviewed. Finally, an assessment of the emerging evidence in support of hypofractionation for locally advanced disease is presented. Expert commentary: HF-WBI has replaced CF-WBI as the accepted standard of care in most women with early-stage breast cancer who do not require regional nodal irradiation. Early data supports the continued study of hypofractionation in the locally advanced setting, however broad adoption awaits longer follow-up and additional data from ongoing clinical trials.

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Section: Five-year Viewmentioning

confidence: 99%

Hypofractionated radiation treatment in the management of breast cancer

Gupta

Ohri

Haffty

2018

Expert Review of Anticancer Therapy

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“…Another limitation of this study is the unconventional dose and fractionation scheme used, but radiobiological modeling confirmed by long term clinical data30, 31, 32, 33 have demonstrated equivalence to the standard fractionation of 46 to 50 Gy to the breast with a sequential boost of 14 or 10 Gy to the tumor cavity, over a total of 6 weeks. Radiation Therapy Oncology Group 1005 is comparing accelerated radiation with a concomitant boost versus standard fractionation with a sequential boost.…”

Section: Discussionmentioning

confidence: 93%

Preplanning prediction of the left anterior descending artery maximum dose based on patient, dosimetric, and treatment planning parameters

Cooper

Shin

et al. 2016

Advances in Radiation Oncology

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PurposeMaximum dose to the left anterior descending artery (LADmax) is an important physical constraint to reduce the risk of cardiovascular toxicity. We generated a simple algorithm to guide the positioning of the tangent fields to reliably maintain LADmax <10 Gy.Methods and materialsDosimetric plans from 146 consecutive women treated prone to the left breast enrolled in prospective protocols of accelerated whole breast radiation therapy, with a concomitant daily boost to the tumor bed (40.5 Gy/15 fraction to the whole breast and 48 Gy to the tumor bed), provided the training set for algorithm development. Scatter plots and correlation coefficients were used to describe the bivariate relationships between LADmax and several parameters: distance from the tumor cavity to the tangent field edge, cavity size, breast separation, field size, and distance from the tangent field. A logistic sigmoid curve was used to model the relationship of LADmax and the distance from the tangent field. Furthermore, we tested this prediction model on a validation data set of 53 consecutive similar patients.ResultsA lack of linear relationships between LADmax and distance from cavity to LAD (−0.47), cavity size (−0.18), breast separation (−0.02), or field size (−0.28) was observed. In contrast, distance from the tangent field was highly negatively correlated to LADmax (-0.84) and was used in the models to predict LADmax. From a logistic sigmoid model we selected a cut-point of 2.46 mm (95% confidence interval, 2.19-2.74 mm) greater than which LADmax is <10 Gy (95% confidence interval, 9.30-10.72 Gy) and LADmean is <3.3 Gy.ConclusionsPlacing the edge of the tangents at least 2.5 mm from the closest point of the contoured LAD is likely to assure LADmax is <10 Gy and LADmean is <3.3 Gy in patients treated with prone accelerated breast radiation therapy.

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“…521 articles were found, of which 83 articles were found to be relevant. Ten of these studies are prospective trials, and medium to long-term outcomes have been reported for seven (20)(21)(22)(23)(24)(25)(26). These are summarized below.…”

Section: Simultaneous Integrated Boost (Sib)mentioning

confidence: 99%

HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

Chatterjee

Chakraborty

Group³

2020

Preprint

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Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

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Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Daily Versus Weekly Boost to the Tumor Bed

Cited by 21 publications

References 28 publications

Hypofractionated radiation treatment in the management of breast cancer

Hypofractionated radiation treatment in the management of breast cancer

Preplanning prediction of the left anterior descending artery maximum dose based on patient, dosimetric, and treatment planning parameters

HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

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