Phase 1 Clinical Trial of Stereotactic Body Radiation Therapy Concomitant With Neoadjuvant Chemotherapy for Breast Cancer

Bondiau, Pierre‐Yves; Courdi, A.; Bahadoran, Phillipe; Chamorey, Emmanuel; Queille‐Roussel, C.; Lallement, M.; Birtwisle-Peyrottes, Isabelle; Chapellier, C.; Pacquelet-Cheli, Sandrine; Ferrero, Jean-­Marc

doi:10.1016/j.ijrobp.2012.10.034

Cited by 75 publications

(53 citation statements)

References 15 publications

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“…A study of re-excision specimens provides further support for a TB-to-CTV margin in a similar ballpark to that derived from the Holland data [ 80 ]. In this study, the maximal distance of residual disease from the initial excision margin was measured in 333 patients who had undergone an initial excisional resection with a rim of normal breast parenchyma around the clinically apparent tumor or the tissue at the tip of the needle localization wire and then re-excision of margins for inadequate surgical clearance or questionable postsurgical mammography results at the discretion of the surgeon or radiation oncologist.…”

Section: Histopathological Examination Of Re-excision Specimenssupporting

confidence: 60%

Short Course Breast Radiotherapy

Arthur¹,

Vicini²,

Wazer³

et al. 2016

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Section: Histopathological Examination Of Re-excision Specimenssupporting

confidence: 60%

Short Course Breast Radiotherapy

Arthur¹,

Vicini²,

Wazer³

et al. 2016

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“…Researchers at the University of Maryland enrolled women with early stage breast cancer on a clinical trial evaluating the impact of preoperative partial breast irradiation on pathologic complete response (NCT01014715). Bondiau et al conducted a phase I study testing 5 dose levels of focused radiotherapy delivered during preoperative chemotherapy in high-risk patients that may not otherwise have been candidates for breast conservation 21 . Surgery and conventional post-operative radiotherapy followed neoadjuvant chemoradiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Preoperative Single-Fraction Partial Breast Radiation Therapy: A Novel Phase 1, Dose-Escalation Protocol With Radiation Response Biomarkers

Horton

Blitzblau

Yoo

et al. 2015

International Journal of Radiation Oncology*Biology*Physics

114

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Summary This phase I dose-escalation trial evaluates the feasibility of single-dose preoperative partial breast irradiation delivered with external beam techniques in early stage breast cancer patients. No acute dose-limiting toxicity was observed at 15, 18, or 21Gy. Paired pre- and post-radiation imaging and tumor biopsies offer unique insight into the biology of breast cancer radiation response. Purpose Women with biologically favorable early stage breast cancer are increasingly treated with accelerated partial breast radiation (PBI). However, treatment-related morbidities have been linked to the large post-operative treatment volumes required for external beam PBI. Relative to external beam delivery, alternative PBI techniques require equipment that is not universally available. To address these issues, we designed a phase I trial utilizing widely available technology to 1) evaluate the safety of a single radiation treatment delivered preoperatively to the small-volume, intact breast tumor and 2) identify imaging and genomic markers of radiation response. Methods Women 55 or older with clinically node negative, ER+ and/or PR+, HER2-, T1 invasive carcinomas or low-intermediate grade in situ disease ≤2cm were enrolled (n=32). Intensity-modulated radiotherapy was used to deliver 15 Gy (n=8), 18 Gy (n=8), or 21Gy (n=16) to the tumor with a 1.5cm margin. Lumpectomy was performed within 10 days. Paired pre- and post-radiation MRI images and patient tumor samples were analyzed. Results No dose-limiting toxicity was observed. At a median follow-up of 23 months, there have been no recurrences. Physician-rated cosmetic outcomes were good/excellent and chronic toxicities were grade 1-2 (fibrosis, hyperpigmentation) in patients receiving preoperative radiation only. Evidence of dose-dependent changes in vascular permeability, cell density, and expression of genes regulating immunity and cell death were seen in response to radiation. Conclusions Preoperative single-dose radiotherapy to intact breast tumors is well-tolerated. Radiation response is marked by early indicators of cell death in this biologically favorable patient cohort. This study represents a first-step towards a novel PBI approach. Preoperative radiation should be tested in future clinical trials as it has the potential to challenge the current treatment paradigm and provide a path forward to identify radiation response biomarkers.

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“…[19][20][21][22][23] SABR has also been successfully implemented for the local control of metastatic lesions in multiple sites. 19,[24][25][26] RCC has traditionally been considered a radioresistant tumor.…”

Section: Discussionmentioning

confidence: 99%

Stereotactic radiation therapy of renal cancer inferior vena cava tumor thrombus

Hannan

Margulis

Chun

et al. 2015

Cancer Biology & Therapy

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Renal Cell Carcinoma (RCC) is a common malignancy world-wide that is rising in incidence. Up to 10% of RCC patients present with inferior vena cava (IVC) tumor thrombus (IVC-TT). Although surgery is the only treatment with proven efficacy for IVC-TT, the surgical management of advanced (level III and IV) IVC-TT is difficult with high morbidity and mortality, and offers a poor survival outcome. Currently, there are no treatment options in the setting of recurrent or unresectable RCC IVC-TT. Even though RCC may be resistant to conventionally fractionated radiation therapy, hypofractionated radiation has shown excellent control rates for both primary and metastatic RCC. We report our experience treating 2 RCC patients with Level IV IVC-TT -one recurrent and the other unresectable-with stereotactic ablative radiation therapy (SABR). The first patient is a 75-year-old gentleman with a level IV RCC IVC-TT who presented 9 months after his radical nephrectomy and thrombectomy with a growing level IV IVC-TT that became refractory to 4 targeted agents. He received SABR of 50Gy in 5 fractions and at 2-year follow-up is doing well with a significant decrease in the enhancement and size of the IVC-TT. The second patient is an 83-year-old gentleman who presented with metastatic RCC and level IV IVC-TT but was not a surgical candidate. After progression on temsirolimus, he received SABR of 36Gy in 4 fractions to his IVC-TT and survived 18 months post-SABR. Both patients improved symptomatically and did not experience any acute or late treatment-related toxicity. Their survival of 24 months and 18 months are comparable to the reported median survival of 20 months in patients with level IV IVC-TT that underwent surgical resection. Therefore, SABR can be a potentially safe treatment option in the unresectable setting for RCC patients with IVC-TT and should be further evaluated in prospective trials.

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Phase 1 Clinical Trial of Stereotactic Body Radiation Therapy Concomitant With Neoadjuvant Chemotherapy for Breast Cancer

Cited by 75 publications

References 15 publications

Short Course Breast Radiotherapy

Short Course Breast Radiotherapy

Preoperative Single-Fraction Partial Breast Radiation Therapy: A Novel Phase 1, Dose-Escalation Protocol With Radiation Response Biomarkers

Stereotactic radiation therapy of renal cancer inferior vena cava tumor thrombus

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