Publications by authors named "David E Wazer"

107 Publications

Multi-institutional registry study evaluating the feasibility and toxicity of accelerated partial breast irradiation using noninvasive image-guided breast brachytherapy.

Brachytherapy 2021 Feb 25. Epub 2021 Feb 25.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, RI; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, MA.

Purpose: The noninvasive image-guided breast brachytherapy (NIBB) technique is a novel noninvasive yet targeted method for accelerated partial breast irradiation. We established a multi-institutional registry to evaluate the toxicity and efficacy of this technique across various practice settings.

Methods And Materials: Institutions using the NIBB technique were invited to participate. Data for acute/late toxicity, cosmetic outcome, and tumor recurrence were collected. Toxicity and cosmetic outcome were graded based on the Common Terminology Criteria for Adverse Events version 3.0 and NRG/Radiation Therapy Oncology Group scale, respectively. Treatment variables were analyzed for association with outcomes.

Results: A total of 252 patients from eight institutions were analyzed. The median age was 69 years. The mean tumor size was 1.1 cm (0.1-4.0 cm). Treatment was delivered 10 fractions (34-36 Gy) in 75% and five fractions (28.5 Gy) in 22%. B.i.d. fractionation was used in 9%. Acute radiation dermatitis was Grade 0-1, 2, and 3 in 77%, 19%, and 4%, respectively. One hundred ninety-one patients with a median followup of 18 months (4-72 months) were evaluable for late outcomes. Late toxicity Grades 2 and 3 were observed in 8.8% and 1%, respectively. Cosmetic outcome was excellent, good, and fair/poor in 62%, 36%, and 2%, respectively. B.i.d. fractionation was associated with higher acute and late toxicity. Second-generation applicators were associated with lower late toxicity and better cosmetic outcome. Actuarial freedom from ipsilateral breast tumor recurrence and true recurrence were 98.3% and 98.3% at 2 years and 90.9% and 95.4% at 5 years, respectively.

Conclusions: Accelerated partial breast irradiation using NIBB was well tolerated with a low rate of acute and late toxicity across various practice settings. Ipsilateral breast tumor recurrence and cosmetic outcomes were favorable. b.i.d. fractionation was associated with higher toxicity. Longer followup is needed to confirm late endpoints.
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http://dx.doi.org/10.1016/j.brachy.2021.01.002DOI Listing
February 2021

Mammographically guided noninvasive breast brachytherapy: Preoperative partial breast radiotherapy markedly improves targeting accuracy and decreases irradiated volume.

Brachytherapy 2021 Mar-Apr;20(2):339-344. Epub 2020 Dec 5.

Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI; Tufts Medical Center, Tufts University School of Medicine, Boston, MA.

Purpose: Mammographically based noninvasive image-guided breast brachytherapy (NIBB) partial breast irradiation (PBI) is ideally suited for preoperative treatment. We hypothesize that delivering NIBB PBI to the preoperative tumor volume compared with the postoperative lumpectomy bed would simplify target identification and allow for a reduction in irradiated volume along each orthogonal axis.

Methods And Materials: Patients with invasive breast cancer treated with NIBB PBI at our institution were identified. Preoperative NIBB treatments were modeled along orthogonal craniocaudal and mediolateral axes with an applicator encompassing the gross lesion plus a 1 cm clinical target volume margin. Preoperative treatment volumes were calculated along each axis using the selected applicator surface area multiplied by the preoperative mammogram separation. The actual applicator size and breast separation from the first fraction of postoperative treatment was used to calculate the postoperative treatment volume. Paired -test was used to compare the preoperative and postoperative treatment separation, area, and volume for each patient.

Results: Forty-eight patients with Stage I-II breast cancer had imaging and treatment data available for review. Along the axis, the mean preoperative treatment volume was significantly less than the mean postoperative treatment volume (116 cm vs. 204 cm , respectively; p < 0.0001). Similarly, along the mediolateral axis, the mean preoperative treatment volume was significantly less than the mean postoperative treatment volume (125 cm vs. 216 cm , respectively; p < 0001).

Conclusions: Based on our retrospective comparison, PBI delivered using NIBB to the preoperative tumor may reduce the volume of healthy breast tissue receiving radiation as compared with NIBB to the postoperative tumor bed.
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http://dx.doi.org/10.1016/j.brachy.2020.10.013DOI Listing
December 2020

Phase 2 Trial of Accelerated Partial Breast Irradiation (APBI) Using Noninvasive Image Guided Breast Brachytherapy (NIBB).

Int J Radiat Oncol Biol Phys 2020 12 25;108(5):1143-1149. Epub 2020 Jul 25.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, Rhode Island; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, Massachusetts.

Purpose: Noninvasive image guided breast brachytherapy (NIBB) is a novel approach to delivery of accelerated partial breast irradiation (APBI) that may hold advantages over established techniques. NIBB is not invasive but maintains a high level of precision by using breast immobilization via breast compression and image guidance; it therefore does not require large planning tumor volume margins. We present the primary outcomes of this prospective phase 2 study (BrUOG Br-251).

Methods And Materials: Eligible patients with early-stage breast cancer underwent NIBB APBI using a dose 34 Gy in 10 fractions delivered daily or twice a day. Treatment was delivered using an Ir-192 high-dose-rate source via specialized applicators. Two orthogonal treatment axes were used for each fraction. The primary endpoints were late toxicity and cosmesis assessed at 2 and 5 years. Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. Cosmesis was assessed using the NRG/Radiation Therapy Oncology Group scale. Ipsilateral breast tumor recurrence was defined as any recurrence or new primary in the treated breast.

Results: Forty patients underwent protocol treatment. Median patient age was 68 years (50-92 years). Mean tumor size was 1.1 cm (0.3-3.0 cm). Among the cohort, 62.5% had invasive carcinoma and 37.5% had ductal carcinoma in situ. Thirty-nine percent elected to receive hormone therapy. No grade ≥3 late toxicities were observed at any time point. Grade 2 toxicity was 5% and 10% at 2 and 5 years, respectively. Telangiectasia grade 1 and 2 occurred in 27.5% and 5%, respectively. Breast separation of >7 cm was associated with telangiectasia (P < .01). The rate of good to excellent cosmetic outcome was 95% at 2 years and 100% at 5 years. With a median follow-up of 68 months, the actuarial 5-year freedom from ipsilateral breast tumor recurrence was 93.3% (±4.8%), and overall survival was 93.7% (±4.4%).

Conclusions: NIBB to deliver APBI is well tolerated with a low incidence of significant late toxicity and has favorable cosmetic outcomes. Continued evaluation of the NIBB APBI technique in a larger cohort is warranted.
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http://dx.doi.org/10.1016/j.ijrobp.2020.07.2312DOI Listing
December 2020

Update on Partial Breast Irradiation.

Clin Breast Cancer 2020 Apr 17. Epub 2020 Apr 17.

Department of Radiation Oncology, Lifespan Cancer Institute, Alpert Medical School of Brown University, Providence, RI.

For early-stage breast cancer, partial breast irradiation (PBI) allows for reduction in the irradiated volume of normal tissues by confining the radiation target to the area surrounding the lumpectomy cavity after breast-conserving surgery. This approach has been supported by phase 2 data. However, widespread adoption of PBI has awaited the results of randomized controlled trials. This review discusses the results of randomized controlled trials comparing whole breast irradiation to PBI, including the recently published National Surgical Adjuvant Breast and Bowel Project (NSABP) B39/Radiotherapy Oncology Group (RTOG) 0413, and the Canadian RAPID trials. PBI techniques, dose/fractionation schedules, and patient selection are also reviewed.
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http://dx.doi.org/10.1016/j.clbc.2020.04.003DOI Listing
April 2020

Partial Breast Irradiation Is the Preferred Standard of Care for a Majority of Women With Early-Stage Breast Cancer.

J Clin Oncol 2020 07 22;38(20):2268-2272. Epub 2020 May 22.

Department of Radiation Oncology, Lifespan Cancer Institute, Alpert Medical School, Brown University, Providence, RI.

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http://dx.doi.org/10.1200/JCO.19.02594DOI Listing
July 2020

Novel and programmatic improvements to the workflow associated with the AccuBoost breast brachytherapy procedure.

Brachytherapy 2020 May - Jun;19(3):372-379. Epub 2020 Apr 2.

Department of Radiation Oncology, The Warren Alpert Medical School of Brown University, Providence, RI. Electronic address:

Purpose: While the noninvasive breast brachytherapy (NIBB) treatment procedure, known as AccuBoost, for breast cancer patients is well established, the treatment quality can be improved by the efficiency of the workflow delivery. A formalized approach evaluated the current workflow through failure modes and effects analysis and generated insight for developing new procedural workflow techniques to improve the clinical treatment process.

Methods And Materials: AccuBoost treatments were observed for several months while gathering details on the multidisciplinary workflow. A list of possible failure modes for each procedure step was generated and organized by timing within the treatment process. A team of medical professionals highlighted procedural steps that unnecessarily increased treatment time, as well as introduced quality deficiencies involving applicator setup, treatment planning, and quality control checks preceding brachytherapy delivery. Procedural improvements and their impact on the clinical workflow are discussed.

Results: The revised clinical workflow included the following key procedural enhancements. Prepatient arrival: Improvement of prearrival preparation requires advance completion of dose calculation documentation with patient-specific setup data. Patient arrival pretreatment: Physicists carry out dwell time calculations and check the plan, while the therapist concurrently performs several checks of the ensuing hardware configuration.

Treatment: An electronic method to export the associated HDR brachytherapy paperwork to the electronic medical record system with electronic signatures and captured approvals was generated. Posttreatment: The therapist confirms the applicators were appropriately positioned, and treatment was delivered as expected.

Conclusions: The procedural improvements reduced the overall treatment time, improved consistency across users, and eased performance of this special procedure for all participants.
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http://dx.doi.org/10.1016/j.brachy.2020.01.007DOI Listing
January 2021

New Cardiac Abnormalities After Radiotherapy in Breast Cancer Patients Treated With Trastuzumab.

Clin Breast Cancer 2020 06 19;20(3):246-252. Epub 2019 Dec 19.

Department of Radiation Oncology, Rhode Island Hospital, Providence, RI.

Purpose: To evaluate cardiac imaging abnormalities after modern radiotherapy and trastuzumab in breast cancer patients.

Patients And Methods: All patients treated with trastuzumab and radiotherapy for breast cancer between 2006 and 2014 with available cardiac imaging (echocardiogram or multigated acquisition scan) were retrospectively analyzed. Cardiac abnormalities included myocardial abnormalities (atrial or ventricular dilation, hypertrophy, hypokinesis, and impaired relaxation), decreased ejection fraction > 10%, and valvular abnormalities (thickening or stenosis of the valve leaflets). Breast laterality (left vs. right) and heart radiation dose volume parameters were analyzed for association with cardiac imaging abnormalities.

Results: A total of 110 patients with 57 left- and 53 right-sided breast cancers were evaluated. Overall, 37 patients (33.6%) developed a new cardiac abnormality. Left-sided radiotherapy was associated with an increase in new cardiac abnormalities (relative risk [RR] = 2.51; 95% confidence interval [CI], 1.34-4.67; P = .002). Both myocardial and valvular abnormalities were associated with left-sided radiotherapy (myocardial: RR = 2.21; 95% CI, 1.06-4.60; P = .029; valvular: RR = 3.30; 95% CI, 0.98-10.9; P = .044). There was no significant difference in decreased ejection fraction between left- and right-sided radiotherapy (9.6% vs. 2.1%; P = .207). A mean heart dose > 2 Gy as well as volume of the heart receiving 20 Gy (V20), V30, and V40 correlated with cardiac abnormalities (mean heart dose > 2 Gy: RR = 2.00; P = .040).

Conclusion: New cardiac abnormalities, including myocardial and valvular dysfunction, are common after trastuzumab and radiotherapy. The incidence of new abnormalities correlates with tumor laterality and cardiac radiation dose exposure. Long-term follow-up is needed to understand the clinical significance of these early imaging abnormalities.
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http://dx.doi.org/10.1016/j.clbc.2019.12.006DOI Listing
June 2020

Late complications of radiation therapy for breast cancer: evolution in techniques and risk over time.

Gland Surg 2018 Aug;7(4):371-378

Department of Radiation Oncology, Tufts Medical Center and Tufts University School of Medicine, Boston, MA, USA.

Radiation therapy in combination with surgery, chemotherapy, and endocrine therapy as indicated, has led to excellent local and distant control of early stage breast cancers. With the majority of these patients surviving long term, mitigating the probability and severity of late toxicities is vital. Radiation to the breast, with or without additional fields for nodal coverage, has the potential to negatively impact long term cosmetic outcome of the treated breast as well as cause rare, but severe, complications due to incidental dosage to the heart, lungs and contralateral breast. The long-term clinical side-effects of breast radiation have been studied extensively. This review aims to discuss the risk of developing late complications following breast radiation and how modern techniques can be used to diminish these risks.
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http://dx.doi.org/10.21037/gs.2018.01.05DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6107587PMC
August 2018

Five fraction accelerated partial breast irradiation using noninvasive image-guided breast brachytherapy: Feasibility and acute toxicity.

Brachytherapy 2018 Sep - Oct;17(5):825-830. Epub 2018 Jun 21.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, RI; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, MA.

Purpose: To improve efficiency, convenience, and cost, a prospective phase II trial was initiated to evaluate accelerated partial breast irradiation delivered with noninvasive image-guided breast brachytherapy (NIBB) via five once-daily fractions.

Methods And Materials: Women ≥50 years old with early-stage breast cancer undergoing breast conserving surgery were enrolled. Eligibility criteria included invasive carcinoma ≤2.0 cm or ductal carcinoma in situ ≤3.0 cm, ER positive (if invasive), lymph node negative, LVI absent, and margins negative by 2 mm. Patients received a total dose of 28.5 Gy in five daily fractions. NIBB was delivered using two orthogonal axes for each fraction. Applicators were selected to encompass the lumpectomy cavity with a 1.0 cm clinical target volume margin and 0 to 0.5 cm planning target volume margin. Acute and late toxicity was assessed based on CTCAE v3.0.

Results: Forty patients with a mean age of 67 years underwent protocol treatment. Mean tumor size was 1.0 cm (0.3-2.0 cm). Eighty percent had invasive carcinoma and the remainder had ductal carcinoma in situ. Mean tumor bed volume was 21 cc (5-79 cc) and mean breast volume was 1319 cc (499-3044 cc). Mean breast separation with compression was 6.7 cm (3.5-8.9 cm). All patients tolerated well. Median discomfort with compression was 1 (range: 0-7) on a 10-point pain scale. Acute skin reaction was Grade 0-1 in 70%, Grade 2 in 28%, and Grade 3 in 3%. Acute skin toxicity was not associated with breast size but was associated with larger breast separation with compression (p < 0.01) and larger applicator size (p < 0.01). No Grade 3+ late toxicity or local recurrences have been observed at a median followup of 14 months.

Conclusions: Accelerated partial breast irradiation delivered using NIBB over five daily fractions is a convenient treatment option that is feasible and well tolerated.
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http://dx.doi.org/10.1016/j.brachy.2018.05.006DOI Listing
March 2019

BRCA1 Mutations Associated With Increased Risk of Brain Metastases in Breast Cancer: A 1: 2 Matched-pair Analysis.

Am J Clin Oncol 2018 12;41(12):1252-1256

Departments of Radiation Oncology.

Background: Brain metastases (BM) occur in ∼5% of breast cancer patients. BRCA1-associated cancers are often basal-like and basal-like cancers are known to have a predilection for central nervous system metastases. We performed a matched-pair analysis of breast cancer patients with and without BRCA mutations and compared the frequency of BM in both groups.

Materials And Methods: From a database of 1935 patients treated for localized breast cancer at our institution from 2009 to 2014 we identified 20 patients with BRCA1 or BRCA2 mutations and manually matched 40 patients without BRCA mutations accounting for age, stage, estrogen receptor expression, and human epidermal growth factor receptor 2 (HER2) expression. Comparisons of freedom from brain metastasis, brain metastasis-free survival, and overall survival were made using the log rank test. Testing for a basal-type phenotype using the immunohistochemistry definition (ER/PR/HER2 and either CK 5/6 or EGFR) was performed for BRCA patients who developed BM and their matched controls.

Results: We analyzed 60 patients: 20 BRCA and 40 were matched controls. Median follow-up was 37 and 49 months, respectively. Three years freedom from brain metastasis was 84% for BRCA patients and 97% for BRCA controls (P=0.049). Three years brain metastasis-free survival was 84% and 97% for the BRCA+ and controls, respectively (P=0.176). Mean time to brain failure was 11 months from diagnosis for the BRCA patients. All 3 BRCA1 patients who developed BM were of a basal-type triple negative phenotype.

Conclusions: Breast cancer patients with germline BRCA1 mutations appear to have a shorter interval to brain progression while accounting for confounding factors.
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http://dx.doi.org/10.1097/COC.0000000000000466DOI Listing
December 2018

Genomic Assays and Individualized Treatment of Ductal Carcinoma In Situ in the Era of Value-Based Cancer Care.

J Clin Oncol 2016 11 31;34(33):3953-3955. Epub 2016 Oct 31.

Kara-Lynne Leonard and David E. Wazer, Alpert Medical School of Brown University, Providence, RI.

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http://dx.doi.org/10.1200/JCO.2016.69.8332DOI Listing
November 2016

The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation.

Brachytherapy 2018 Jan - Feb;17(1):154-170. Epub 2017 Oct 23.

Department of Radiation Oncology, Tufts University School of Medicine, Boston, MA; Department of Radiation Oncology, Brown University, Providence, RI.

Purpose: Adjuvant radiation after breast-conserving surgery remains the standard-of-care treatment for patients with ductal carcinoma in situ and early-stage invasive breast cancer. Multiple alternatives to standard whole-breast irradiation exist including accelerated partial-breast irradiation (APBI). Therefore, the purpose of this APBI guideline is to provide updated data for clinicians as well as recommendations regarding appropriate patient selection and techniques to deliver APBI.

Methods: Members of the American Brachytherapy Society with expertise in breast cancer and breast brachytherapy in particular created an updated guideline for appropriate patient selection based on an extensive literature search and clinical experience. In addition, data were evaluated with respect to APBI techniques and recommendations presented.

Results: Appropriate candidates for APBI include patients aged 45 years or older, all invasive histologies and ductal carcinoma in situ, tumors 3 cm or less, node negative, estrogen receptor positive/negative, no lymphovascular space invasion, and negative margins. With respect to techniques, the strongest evidence is for interstitial brachytherapy and intensity-modulated radiation therapy APBI with moderate evidence to support applicator brachytherapy or three-dimensional conformal radiotherapy APBI. Intraoperative radiation therapy and electronic brachytherapy should not be offered regardless of technique outside of clinical trial.

Conclusions: The updated guidelines presented offer clinicians with a summary of data supporting APBI and guidelines for the appropriate and safe utilization of the technique.
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http://dx.doi.org/10.1016/j.brachy.2017.09.004DOI Listing
July 2018

Feasibility and safety of cavity-directed stereotactic radiosurgery for brain metastases at a high-volume medical center.

Adv Radiat Oncol 2016 Jul-Sep;1(3):141-147. Epub 2016 Jun 23.

Department of Radiation Oncology, Rhode Island Hospital, Providence, Rhode Island.

Objective: Our objective was to report safety and efficacy of stereotactic radiosurgery (SRS) to the surgical bed following resection of brain metastases.

Methods: Eighty-seven consecutive patients who underwent cavity-directed SRS to the operative bed for the treatment of brain metastases between 2002 and 2010 were evaluated. SRS required a gadolinium-enhanced, high-resolution, T1-weighted magnetic resonance imaging for tumor targeting and delivered a median dose of 18 Gy (14-22 Gy) prescribed to encompass the entire resection cavity. Whole brain irradiation was reserved for salvage. Patients were followed every 3 months with clinical examination and magnetic resonance imaging. Overall survival, local and regional recurrence, and factors affecting these outcomes were evaluated using Kaplan-Meier and log-rank analyses.

Results: The median imaging follow-up was 7.1 months, with >40% of patients having imaging for ≥1 year. Local control at 1 and 2 years was 82% and 75%, respectively. Cavity recurrence was more common with a tumor diameter >3 cm ( < .020) or resection cavity volume >14 mL ( < .050). One-year local control for tumors <2 cm, 2 cm to 3 cm, and >3 cm were 100%, 86%, and 72%, respectively. Neither subtotal resection nor target margins >2 mm to 3 mm affected local control. The median overall survival was 14.3 months with actuarial 5-year survival of 20%. Actuarial regional central nervous system recurrence was 44% at 1 year. On univariate analysis, only the presence of extracranial disease was associated with survival ( < .001) and central nervous system failure ( < .030).

Conclusions: Excellent local control is achievable with cavity-directed SRS in well-selected patients, particularly for lesions with diameter <3 cm and resection cavity volumes <14 mL. Long-term survival is possible for select patients.
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http://dx.doi.org/10.1016/j.adro.2016.06.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5514013PMC
June 2016

American Brachytherapy Society consensus report for accelerated partial breast irradiation using interstitial multicatheter brachytherapy.

Brachytherapy 2017 Sep - Oct;16(5):919-928. Epub 2017 Jul 1.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, RI; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, MA.

Purpose: To develop a consensus report for the quality practice of accelerated partial breast irradiation (APBI) using interstitial multicatheter brachytherapy (IMB).

Methods And Materials: The American Brachytherapy Society Board appointed an expert panel with clinical and research experience with breast brachytherapy to provide guidance for the current practice of IMB. This report is based on a comprehensive literature review with emphasis on randomized data and expertise of the panel.

Results: Randomized trials have demonstrated equivalent efficacy of APBI using IMB compared with whole breast irradiation for select patients with early-stage breast cancer. Several techniques for placement of interstitial catheters are described, and importance of three-dimensional planning with appropriate optimization is reviewed. Optimal target definition is outlined. Commonly used dosing schemas include 50 Gy delivered in pulses of 0.6-0.8 Gy/h using pulsed-dose-rate technique and 34 Gy in 10 fractions, 32 Gy in eight fractions, or 30 Gy in seven fractions using high-dose-rate technique. Potential toxicities and strategies for toxicity avoidance are described in detail. Dosimetric constraints include limiting whole breast volume that receives ≥50% of prescription dose to <60%, skin dose to ≤100% of prescription dose (≤60-70% preferred), chest wall dose to ≤125% of prescription dose, Dose Homogeneity Index to >0.75 (>0.85 preferred), V < 45 cc, and V < 14 cc. Using an optimal implant technique coupled with optimal planning and appropriate dose constraints, a low rate of toxicity and a good-to-excellent cosmetic outcome of ≥90% is expected.

Conclusions: IMB is an effective technique to deliver APBI for appropriately selected women with early-stage breast cancer. This consensus report has been created to assist clinicians in the appropriate practice of APBI using IMB.
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http://dx.doi.org/10.1016/j.brachy.2017.05.012DOI Listing
April 2018

Postmastectomy Radiation Therapy Is Associated With Improved Survival in Node-Positive Male Breast Cancer: A Population Analysis.

Int J Radiat Oncol Biol Phys 2017 06 13;98(2):384-391. Epub 2017 Feb 13.

Department of Radiation Oncology, The Alpert Medical School of Brown University, Rhode Island Hospital, Providence, Rhode Island.

Purpose: Because of its rarity, there are no randomized trials investigating postmastectomy radiation therapy (PMRT) in male breast cancer. This study retrospectively examines the impact of PMRT in male breast cancer patients in the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database.

Methods And Materials: The SEER database 8.3.2 was queried for men ages 20+ with a diagnosis of localized or regional nonmetastatic invasive ductal/lobular carcinoma from 1998 to 2013. Included patients were treated by modified radical mastectomy (MRM), with or without adjuvant external beam radiation. Univariate and multivariate analyses evaluated predictors for PMRT use after MRM. Kaplan-Meier overall survival (OS) curves of the entire cohort and a case-matched cohort were calculated and compared by the log-rank test. Cox regression was used for multivariate survival analyses.

Results: A total of 1933 patients were included in the unmatched cohort. There was no difference in 5-year OS between those who received PMRT and those who did not (78% vs 77%, respectively, P=.371); however, in the case-matched analysis, PMRT was associated with improved OS at 5 years (83% vs 54%, P<.001). On subset analysis of the unmatched cohort, PMRT was associated with improved OS in men with 1 to 3 positive nodes (5-year OS 79% vs 72% P=.05) and those with 4+ positive nodes (5-year OS 73% vs 53% P<.001). On multivariate analysis of the unmatched cohort, independent predictors for improved OS were use of PMRT: HR=0.551 (0.412-0.737) and estrogen receptor-positive disease: HR=0.577 (0.339-0.983). Predictors for a survival detriment were higher grade 3/4: HR=1.825 (1.105-3.015), larger tumor T2: HR=1.783 (1.357-2.342), T3/T4: HR=2.683 (1.809-3.978), higher N-stage: N1 HR=1.574 (1.184-2.091), N2/N3: HR=2.328 (1.684-3.218), black race: HR=1.689 (1.222-2.336), and older age 81+: HR=4.164 (1.497-11.582).

Conclusions: There may be a survival benefit with the addition of PMRT for male breast cancer with node-positive disease.
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http://dx.doi.org/10.1016/j.ijrobp.2017.02.007DOI Listing
June 2017

Multi-institutional Nomogram Predicting Survival Free From Salvage Whole Brain Radiation After Radiosurgery in Patients With Brain Metastases.

Int J Radiat Oncol Biol Phys 2017 02 1;97(2):246-253. Epub 2016 Oct 1.

Department of Radiation Oncology, Rhode Island Hospital, Brown University Warren Alpert Medical School, Providence, Rhode Island. Electronic address:

Purpose: Optimal patient selection for stereotactic radiosurgery (SRS) as the initial treatment for brain metastases is complicated and controversial. This study aimed to develop a nomogram that predicts survival without salvage whole brain radiation therapy (WBRT) after upfront SRS.

Methods And Materials: Multi-institutional data were analyzed from 895 patients with 2095 lesions treated with SRS without prior or planned WBRT. Cox proportional hazards regression model was used to identify independent pre-SRS predictors of WBRT-free survival, which were integrated to build a nomogram that was subjected to bootstrap validation.

Results: Median WBRT-free survival was 8 months (range, 0.1-139 months). Significant independent predictors for inferior WBRT-free survival were age (hazard ratio [HR] 1.1 for each 10-year increase), HER2(-) breast cancer (HR 1.6 relative to other histologic features), colorectal cancer (HR 1.4 relative to other histologic features), increasing number of brain metastases (HR 1.09, 1.32, 1.37, and 1.87 for 2, 3, 4, and 5+ lesions, respectively), presence of neurologic symptoms (HR 1.26), progressive systemic disease (HR 1.35), and increasing extracranial disease burden (HR 1.31 for oligometastatic and HR 1.56 for widespread). Additionally, HER2(+) breast cancer (HR 0.81) and melanoma (HR 1.11) trended toward significance. The independently weighted hazard ratios were used to create a nomogram to display estimated probabilities of 6-month and 12-month WBRT-free survival with a corrected Harrell's C concordance statistic of 0.62.

Conclusions: Our nomogram can be used at initial evaluation to help select patients best suited for upfront SRS for brain metastases while reducing expense and morbidity in patients who derive minimal or no benefit.
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http://dx.doi.org/10.1016/j.ijrobp.2016.09.043DOI Listing
February 2017

Stereotactic Body Radiation Therapy Boost After Concurrent Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer: A Phase 1 Dose Escalation Study.

Int J Radiat Oncol Biol Phys 2016 12 31;96(5):1021-1027. Epub 2016 Aug 31.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, Rhode Island; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, Massachusetts.

Purpose: Stereotactic body radiation therapy (SBRT) boost to primary and nodal disease after chemoradiation has potential to improve outcomes for advanced non-small cell lung cancer (NSCLC). A dose escalation study was initiated to evaluate the maximum tolerated dose (MTD).

Methods And Materials: Eligible patients received chemoradiation to a dose of 50.4 Gy in 28 fractions and had primary and nodal volumes appropriate for SBRT boost (<120 cc and <60 cc, respectively). SBRT was delivered in 2 fractions after chemoradiation. Dose was escalated from 16 to 28 Gy in 2 Gy/fraction increments, resulting in 4 dose cohorts. MTD was defined when ≥2 of 6 patients per cohort experienced any treatment-related grade 3 to 5 toxicity within 4 weeks of treatment or the maximum dose was reached. Late toxicity, disease control, and survival were also evaluated.

Results: Twelve patients (3 per dose level) underwent treatment. All treatment plans met predetermined dose-volume constraints. The mean age was 64 years. Most patients had stage III disease (92%) and were medically inoperable (92%). The maximum dose level was reached with no grade 3 to 5 acute toxicities. At a median follow-up time of 16 months, 1-year local-regional control (LRC) was 78%. LRC was 50% at <24 Gy and 100% at ≥24 Gy (P=.02). Overall survival at 1 year was 67%. Late toxicity (grade 3-5) was seen in only 1 patient who experienced fatal bronchopulmonary hemorrhage (grade 5). There were no predetermined dose constraints for the proximal bronchial-vascular tree (PBV) in this study. This patient's 4-cc PBV dose was substantially higher than that received by other patients in all 4 cohorts and was associated with the toxicity observed: 20.3 Gy (P<.05) and 73.5 Gy (P=.07) for SBRT boost and total treatment, respectively.

Conclusions: SBRT boost to both primary and nodal disease after chemoradiation is feasible and well tolerated. Local control rates are encouraging, especially at doses ≥24 Gy in 2 fractions. Toxicity at the PBV is a concern but potentially can be avoided with strict dose-volume constraints.
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http://dx.doi.org/10.1016/j.ijrobp.2016.08.032DOI Listing
December 2016

The Role of MRI in the Follow-up of Women Undergoing Breast-conserving Therapy.

Am J Clin Oncol 2016 06;39(3):314-9

*Department of Radiation Oncology, Cleveland Clinic, Taussig Cancer Institute, Cleveland ∥Northeast Ohio Medical University, Rootstown, OH †Department of Radiation Oncology, Rutgers Robert Wood Johnson Medical School and the Cancer Institute of New Jersey, New Brunswick, NJ ‡Department of Radiation Oncology, Tufts University School of Medicine, Boston, MA §Department of Radiation Oncology, Brown University, Providence, RI ¶Michigan Healthcare Professionals/21st Century Oncology, Farmington Hills, MI.

Objectives: Breast-conserving therapy (BCT) represents a standard of care in the management of breast cancer. However, unlike mastectomy, women treated with BCT require follow-up imaging of the treated breast as well as the contralateral breast as part of posttreatment surveillance. Traditionally, surveillance has consisted of clinical exams and mammograms. However, magnetic resonance imaging (MRI) has emerged as a breast imaging technique utilized as part of high-risk screening programs as well as part of the initial diagnosis and workup of women considered for BCT. At this time, the role of MRI as part of follow-up for women treated with BCT remains unclear.

Methods: A systematic review was performed to evaluate the role of MRI following BCT.

Results: Although there is no randomized evidence supporting the routine use of MRI in surveillance post-BCT, a review of the literature demonstrates that MRI (1) has increased sensitivity as compared with mammography to detect recurrences, and (2) can help evaluate mammographic abnormalities before biopsy and/or surgery.

Conclusions: In patients with higher risk of local recurrence, surveillance with MRI may represent an effective surveillance strategy though subgroups benefiting have not been identified nor has the impact on quality of life and cost been evaluated.
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http://dx.doi.org/10.1097/COC.0000000000000290DOI Listing
June 2016

Introduction: The Changing Spectrum of Breast Cancer.

Authors:
David E Wazer

Semin Radiat Oncol 2016 Jan 4;26(1):1-2. Epub 2015 Sep 4.

Department of Radiation Oncology, Alpert Medical School of Brown University, Providence, RI; Department of Radiation Oncology, Tufts University School of Medicine, Boston, MA.

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http://dx.doi.org/10.1016/j.semradonc.2015.09.002DOI Listing
January 2016

In Regard to Vaidya et al.

Int J Radiat Oncol Biol Phys 2015 Aug 14;92(5):952-953. Epub 2015 Jul 14.

Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1016/j.ijrobp.2015.05.032DOI Listing
August 2015

Predictors for long-term survival free from whole brain radiation therapy in patients treated with radiosurgery for limited brain metastases.

Front Oncol 2015 11;5:110. Epub 2015 May 11.

Department of Radiation Oncology, Tufts Medical Center , Boston, MA , USA ; Department of Radiation Oncology, Rhode Island Hospital , Providence, RI , USA.

Purpose: To identify predictors for prolonged survival free from salvage whole brain radiation therapy (WBRT) in patients with brain metastases treated with stereotactic radiosurgery (SRS) as their initial radiotherapy approach.

Materials And Methods: Patients with brain metastases treated with SRS from 2001 to 2013 at our institution were identified. SRS without WBRT was typically offered to patients with 1-4 brain metastases, Karnofsky performance status ≥70, and life expectancy ≥3 months. Three hundred and eight patients met inclusion criteria for analysis. Medical records were reviewed for patient, disease, and treatment information. Two comparison groups were identified: those with ≥1-year WBRT-free survival (N = 104), and those who died or required salvage WBRT within 3 months of SRS (N = 56). Differences between these groups were assessed by univariate and multivariate analyses.

Results: Median survival for all patients was 11 months. Among patients with ≥1-year WBRT-free survival, median survival was 33 months (12-107 months) with only 21% requiring salvage WBRT. Factors significantly associated with prolonged WBRT-free survival on univariate analysis (p < 0.05) included younger age, asymptomatic presentation, RTOG RPA class I, fewer brain metastases, surgical resection, breast primary, new or controlled primary, absence of extracranial metastatic disease, and oligometastatic disease burden (≤5 metastatic lesions). After controlling for covariates, asymptomatic presentation, breast primary, single brain metastasis, absence of extracranial metastases, and oligometastatic disease burden remained independent predictors for favorable WBRT-free survival.

Conclusion: A subset of patients with brain metastases can achieve long-term survival after upfront SRS without the need for salvage WBRT. Predictors identified in this study can help select patients that might benefit most from a treatment strategy of SRS alone.
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http://dx.doi.org/10.3389/fonc.2015.00110DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4426730PMC
June 2015

Prescription dose evaluation for APBI with noninvasive image-guided breast brachytherapy using equivalent uniform dose.

Brachytherapy 2015 Jul-Aug;14(4):496-501. Epub 2015 Apr 18.

Department of Radiation Oncology, Rhode Island Hospital, Brown Alpert Medical School, Providence, RI; Department of Radiation Oncology, Tufts Medical Center, Boston, MA; Department of Radiation Oncology, Tufts University School of Medicine, Boston, MA.

Purpose: Noninvasive image-guided breast brachytherapy (NIBB) is an attractive novel approach to deliver accelerated partial breast irradiation (APBI). Calculations of equivalent uniform dose (EUD) were performed to identify the appropriate APBI dose for this technique.

Methods And Materials: APBI plans were developed for 15 patients: five with three-dimensional conformal APBI (3D-CRT), five with multi-lumen intracavitary balloons (m-IBB), and five simulating NIBB treatment. Prescription doses of 34.0 and 38.5 Gy were delivered in 10 fractions for m-IBB and 3D-CRT, respectively. Prescription doses ranging from 34.0 to 38.5 Gy were considered for NIBB. Dose-volume histogram data from all 3D-CRT, m-IBB, and NIBB plans were used to calculate the biologically effective EUD and corresponding EUD to the PTV_eval using the following equation: EUD = EUBED/(n [1 + EUD/α/β]). An α/β value of 4.6 Gy was assumed for breast tumor. EUD for varying NIBB prescription doses were compared with EUD values for the other APBI techniques.

Results: Mean PTV_eval volume was largest for 3D-CRT (372.9 cm(3)) and was similar for NIBB and m-IBB (88.7 and 87.2 cm(3), respectively). The EUD value obtained by prescribing 38.5 Gy with 3D-CRT APBI was 38.6 Gy. The EUD value of 34.0 Gy prescribed with m-IBB was 34.4 Gy. EUD values for NIBB ranged from 33.9 to 38.2 Gy for prescription doses ranging from 34.0 to 38.5 Gy.

Conclusions: Using EUD calculations to compare APBI techniques and treatment doses, a prescription dose of 36.0 Gy in 10 fractions using NIBB has a comparable biologic equivalent dose to other established brachytherapy techniques.
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http://dx.doi.org/10.1016/j.brachy.2015.03.007DOI Listing
February 2016

Brachytherapy: where has it gone?

J Clin Oncol 2015 Mar 9;33(9):980-2. Epub 2015 Feb 9.

Tufts Medical Center, Tufts University School of Medicine, Boston, MA, and Rhode Island Hospital, The Alpert Medical School of Brown University, Providence, RI.

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http://dx.doi.org/10.1200/JCO.2014.59.8128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5320953PMC
March 2015

A flawed study should not define a new standard of care.

Int J Radiat Oncol Biol Phys 2015 Feb;91(2):255-7

Department of Radiation Oncology, Rhode Island Hospital, The Alpert Medical School of Brown University, Providence, Rhode Island; Department of Radiation Oncology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts. Electronic address:

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http://dx.doi.org/10.1016/j.ijrobp.2014.09.019DOI Listing
February 2015

Local recurrence and survival following stereotactic radiosurgery for brain metastases from small cell lung cancer.

Pract Radiat Oncol 2015 Jan-Feb;5(1):e37-44. Epub 2014 May 3.

Department of Radiation Oncology, Tufts Medical Center, Boston, Massachusetts; Department of Radiation Oncology, Rhode Island Hospital, Providence, Massachusetts.

Purpose: Stereotactic radiosurgery (SRS) represents a treatment option for patients with brain metastases from small cell lung cancer (SCLC) following prior cranial radiation. Inferior local control has been described. We reviewed our failure patterns following SRS treatment to evaluate this concern.

Methods And Materials: Individuals with SCLC who received SRS for brain metastases from 2004 to 2011 were identified. Central nervous system (CNS) disease was detected and followed by gadolinium-enhanced, high-resolution magnetic resonance (MR) imaging. SRS dose was prescribed to the tumor periphery. Local recurrence was defined by increasing lesion size or enhancement, MR-spectroscopy, and perfusion changes consistent with recurrent disease or pathologic confirmation. Any new enhancing lesion not identified on the SRS planning scan was considered a regional failure. Overall survival (OS) and CNS control were evaluated using the Kaplan-Meier method. Factors predicted to influence outcome were tested by univariate log-rank analysis and Cox regression.

Results: Fifteen males and 25 females (median age of 61 years [range, 36-79]) of which 39 received prior brain irradiation were identified. In all, 132 lesions (3.3 per patient) between 0.4 and 4.7 cm received a median dose of 16 Gy (12-22 Gy). Thirteen metastases (10%) ultimately recurred locally with 6- and 12-month control rates of 81% and 69%, respectively. Only 1 of 110 metastases <2 cm recurred. Local failure was more likely for size >2 cm (P < .001) and dose <16 Gy (P < .001). The median OS was 6.5 months, and the time to regional CNS recurrence was 5.2 months. For patients with single brain metastases, both OS (P = .037) and regional CNS recurrence (P = .003) were improved. CNS control (P = .001), and survival (P = .057), were also longer for patients with controlled systemic disease.

Conclusions: Local control following SRS for SCLC metastases is achievable for lesions <2 cm. For metastases >2 cm, local failure is more common than expected. Patients with controlled systemic disease and limited CNS involvement would benefit most from aggressive treatment.
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http://dx.doi.org/10.1016/j.prro.2014.03.006DOI Listing
October 2015

Factors influencing eligibility for breast boost using noninvasive image-guided breast brachytherapy.

Brachytherapy 2014 Nov-Dec;13(6):579-83. Epub 2014 Aug 13.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, RI; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, MA.

Purpose: Noninvasive image-guided breast brachytherapy (NIBB) allows for accurate targeting of the tumor bed (TB) for breast boost by using breast immobilization and image guidance. However, not all patients are candidates for this technique.

Methods: Consecutive patients treated for breast cancer were evaluated. Patients with very small breast size (cup ≤ A) for whom immobilization could not be achieved were treated with electrons. All others underwent simulation for NIBB boost. The rate of eligibility for NIBB, reasons for ineligibility, and related patient and anatomic factors were analyzed.

Results: Of 52 patients evaluated, 6 patients were ineligible for NIBB because of small breast size. Of the remaining patients who underwent simulation for NIBB boost, 33 patients (72%) were treated with NIBB. Reasons for ineligibility were the absence of identifiable TB (n = 5), inability to position patient/breast to adequately target the TB (n = 4), posterior TB location (n = 3), and discomfort during compression (n = 1). The likelihood of being eligible for NIBB boost was dependent on breast size: ≤A (0%), B (50%), C (71%), D-DD (77%), and >DD (80%) (p = 0.002). The presence of surgical clips also predicted eligibility for NIBB: 79% clips vs. 45% without clips (p = 0.05). A posterior TB location was not associated with ineligibility (p = 0.2).

Conclusions: NIBB boost is feasible in most patients. Patients with larger breast size are more likely to be good candidates. Posterior TB location can be challenging for NIBB, but most patients are still candidates. Surgical clips are very helpful in defining the TB and greatly increase the likelihood of eligibility for NIBB.
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http://dx.doi.org/10.1016/j.brachy.2014.07.003DOI Listing
May 2015

The rationale, technique, and feasibility of partial breast irradiation using noninvasive image-guided breast brachytherapy.

Brachytherapy 2014 Sep-Oct;13(5):493-501. Epub 2014 Jul 3.

Department of Radiation Oncology, Rhode Island Hospital, Brown University, Providence, RI; Department of Radiation Oncology, Tufts Medical Center, Tufts University, Boston, MA.

Purpose: Noninvasive image-guided breast brachytherapy (NIBB) is a novel approach to deliver accelerated partial breast irradiation (APBI). NIBB is noninvasive, yet maintains a high degree of precision by using breast immobilization and image guidance. This makes NIBB an attractive alternative to existing APBI techniques.

Methods And Materials: Forty patients were enrolled to an institutional review board-approved prospective clinical trial evaluating APBI using NIBB. The NIBB technique is described in detail. Briefly, patients were treated with the breast compressed and immobilized sequentially in two orthogonal axes for each fraction. Radiation was delivered using collimated emissions from a high-dose-rate iridium-192 source via specialized applicators. The prescribed dose was 34.0 Gy in 10 fractions. Feasibility and tolerability of treatment were assessed.

Results: All patients completed protocol treatment. The median age was 68 years. Sixty-three percent of patients had invasive carcinoma, and 37% had ductal carcinoma in situ. All were node negative. Ninety-three percent of patients were postmenopausal. Mean tumor size, tumor bed volume, and breast volume were 1.1 cm, 22.4 cc, and 1591 cc, respectively. NIBB treatment was well tolerated. Median patient-reported discomfort was 1 on a 10-point pain scale. Treatment delivery times were reasonable. The average treatment time per axis was 14 min (5-20 min), and the average time from start of first treatment axis to completion of orthogonal axis was 43 min (30-63 min). Acute skin toxicity was Grade 0, 1, and 2 in 20%, 53%, and 28% of patients, respectively. There were no Grade 3 or greater acute toxicities observed.

Conclusions: NIBB holds promise as an alternative method to deliver APBI. NIBB is feasible and well tolerated by patients. Further investigation of NIBB to deliver APBI is warranted.
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http://dx.doi.org/10.1016/j.brachy.2014.05.014DOI Listing
October 2014

Radiotherapy for breast cancer, the TARGIT-A trial.

Lancet 2014 May;383(9930):1718-9

Advocate Cancer Institute at Advocate Christ Medical Center, Oak Lawn, IL, USA; Department of Surgery, University of Illinois, Chicago, IL, USA.

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http://dx.doi.org/10.1016/S0140-6736(14)60829-1DOI Listing
May 2014

Local control and results of Leksell Gamma Knife therapy for the treatment of uveal melanoma.

Ophthalmic Surg Lasers Imaging Retina 2014 Mar-Apr;45(2):125-31

Background And Objective: To evaluate the effectiveness of Leksell Gamma Knife stereotactic radio-surgery (Elekta, Stockholm, Sweden) with respect to local tumor control, visual acuity, and radiation side effects for uveal melanoma.

Patients And Methods: Retrospective, non-comparative case series of 23 patients with uveal melanoma treated with Gamma Knife stereotactic radiosurgery at Tufts Medical Center from 2000 to 2012. Patients received single-fraction stereotactic radiation therapy of 20-25 gray (Gy) (mean: 21.7 Gy), primarily at the 50% isodose line. Follow-up was 4 to 121 months (median: 41.5 months). Main outcome measures included local tumor control, metastasis, visual acuity, and complications of therapy.

Results: In 21 of 23 patients (91%), local control was achieved with a single session of Gamma Knife therapy. Both patients who did not have local control, as well as a third patient (three of 23, 13%) developed liver metastases. Visual acuity was 20/200 or better in eight of 23 patients (35%) at last follow-up. Radiation side effects severe enough to cause vision loss were present in 14 of 23 patients (61%).

Conclusion: Gamma Knife therapy may be an effective alternative to enucleation in patients with uveal melanoma who are deemed less satisfactory candidates for brachytherapy or wish to avoid surgery.
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http://dx.doi.org/10.3928/23258160-20140306-05DOI Listing
September 2014

Patterns of care of radiation therapy in patients with stage IV rectal cancer: a Surveillance, Epidemiology, and End Results analysis of patients from 2004 to 2009.

Cancer 2014 Mar 13;120(5):731-7. Epub 2013 Nov 13.

Department of Radiation Oncology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts.

Background: According to the 2013 National Comprehensive Cancer Network guidelines, pelvic radiation therapy (RT) is one of the preferred regimens for patients with metastatic rectal cancer (mRC). The objective of this study was to analyze patterns of care and outcomes data for the receipt of RT among patients with mRC using the Surveillance, Epidemiology, and End Results (SEER) database.

Methods: Patients with stage IV rectal or rectosigmoid cancer were identified in the SEER database (2004-2009). Patients were stratified according to their primary disease site (rectum vs rectosigmoid), tumor (T) classification, and lymph node (N) classification. Treatment regimens (with or without surgical resection, with or without RT) were recorded. The Fisher exact test was used to compare RT rates based on stratified factors. Two and five-year survival rates were compared among treatment groups.

Results: In total, 6873 patients with stage IV rectal cancer and 3417 patients with rectosigmoid cancer were identified. Overall, 20.5% of patients with rectal cancer underwent surgery alone, whereas 38.7% received RT with or without surgery. Within the rectosigmoid group, 51.4% of patients underwent surgery alone, and 15.1% received RT with or without surgery. The use of RT differed significantly between patients with in situ (Tis) through T2 tumors versus T3/T4 tumors (P < .001) and between those with N0 disease versus N1/N2 disease (P < .001). The 2-year and 5-year survival rates differed between treatment groups, with the highest survival rates observed among those who received combined surgery and RT.

Conclusions: The primary treatments for patients with mRC include RT with or without surgery. RT is used more commonly in patients with primary rectal (vs rectosigmoid) tumors, N0 disease, or Tis-T2 tumors. Treatment with combination surgery and RT is associated with prolonged survival.
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http://dx.doi.org/10.1002/cncr.28467DOI Listing
March 2014