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  1. Article: Radiation for inflammatory breast cancer: Updates.

    Stauder, Michael C

    International review of cell and molecular biology

    2023  Volume 384, Page(s) 25–46

    Abstract: Inflammatory breast cancer (IBC) is a diagnosis based on a constellation of clinical features of edema (peau d'orange) of a third or more of the skin of the breast with a palpable border and a rapid onset of breast erythema. Incidence of IBC has ... ...

    Abstract Inflammatory breast cancer (IBC) is a diagnosis based on a constellation of clinical features of edema (peau d'orange) of a third or more of the skin of the breast with a palpable border and a rapid onset of breast erythema. Incidence of IBC has increased over time, although it still makes up only 1-4% of all breast cancer diagnoses. Despite recent encouraging data on clinical outcomes, the published local-regional control rates remain consistently lower than the rates for non-IBC. In this review, we focus on radiotherapy, provide a framework for multi-disciplinary care for IBC, describe local-regional treatment techniques for IBC; highlight new directions in the management of patients with metastatic IBC and offer an introduction to future directions regarding the optimal treatment and management of IBC.
    MeSH term(s) Humans ; Female ; Inflammatory Breast Neoplasms/radiotherapy ; Inflammatory Breast Neoplasms/diagnosis ; Inflammatory Breast Neoplasms/pathology ; Breast Neoplasms/radiotherapy ; Breast Neoplasms/pathology
    Language English
    Publishing date 2023-10-19
    Publishing country Netherlands
    Document type Review ; Journal Article
    ZDB-ID 2427220-6
    ISSN 1937-6448 ; 0074-7696
    ISSN 1937-6448 ; 0074-7696
    DOI 10.1016/bs.ircmb.2023.10.004
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: How should radiation be done for inflammatory breast cancer patients?-a narrative review of modern literature.

    Corrigan, Kelsey L / Woodward, Wendy A / Stauder, Michael C

    Chinese clinical oncology

    2022  Volume 10, Issue 6, Page(s) 60

    Abstract: Objective: This review highlights the considerations of the radiation oncologist when managing patients with inflammatory breast cancer (IBC) as well as the radiation oncologist's role as a member of the multi-disciplinary team.: Background: IBC ... ...

    Abstract Objective: This review highlights the considerations of the radiation oncologist when managing patients with inflammatory breast cancer (IBC) as well as the radiation oncologist's role as a member of the multi-disciplinary team.
    Background: IBC makes up only 1-4% of all breast cancer diagnoses but incidence is increasing. IBC is diagnosed based on a constellation of clinical features, including the rapid onset of breast erythema and edema (peau d'orange) of one-third or more of the skin of the breast and with a palpable border to the edema. Most published IBC local-regional control rates are consistently lower than those observed in non-IBC, which the highlights the need for deliberate treatment techniques to maximize clinical outcomes.
    Methods: For this narrative review, we discuss the principles of radiation target delineation and dose escalation; highlight new findings in the local-regional management of IBC; provide a critical evaluation of the recent literature evaluating local-regional treatment of IBC; and offer a brief introduction to possible future directions regarding the optimal treatment and management of IBC based on our institutional experience.
    Conclusions: IBC is an aggressive type of breast cancer that warrants multi-disciplinary care from breast surgical, medical, and radiation oncology. Several strategies exist to enhance the effect of radiation therapy (RT) on local-regional control, including hyperfractionation, use of bolus, increased total RT dose, and radiosensitizers, which are currently being tested in randomized trials. With an individualized patient approach, local-regional control rates are improving for IBC.
    MeSH term(s) Humans ; Inflammatory Breast Neoplasms/therapy ; Literature, Modern
    Language English
    Publishing date 2022-01-04
    Publishing country China
    Document type Journal Article ; Review
    ZDB-ID 2828547-5
    ISSN 2304-3873 ; 2304-3873
    ISSN (online) 2304-3873
    ISSN 2304-3873
    DOI 10.21037/cco-21-153
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Association Between Symptom Burden and Early Lymphatic Abnormalities After Regional Nodal Irradiation for Breast Cancer.

    Yoder, Alison K / Xu, Tianlin / Youssef, Peter / DeSnyder, Sarah / Marqueen, Kathryn E / Isales, Lynn / Lin, Ruitao / Smith, Benjamin D / Woodward, Wendy A / Stauder, Michael C / Strom, Eric A / Aldrich, Melissa B / Shaitelman, Simona F

    Practical radiation oncology

    2023  Volume 14, Issue 3, Page(s) e180–e189

    Abstract: Purpose: Dermal backflow visualized on near-infrared fluorescence lymphatic imaging (NIRF-LI) signals preclinical lymphedema that precedes the development of volumetrically defined lymphedema. We sought to evaluate whether dermal backflow correlates ... ...

    Abstract Purpose: Dermal backflow visualized on near-infrared fluorescence lymphatic imaging (NIRF-LI) signals preclinical lymphedema that precedes the development of volumetrically defined lymphedema. We sought to evaluate whether dermal backflow correlates with patient-reported lymphedema outcomes (PRLO) surveys in breast cancer patients treated with regional nodal irradiation (RNI).
    Methods and materials: Patients with breast cancer planned for axillary dissection and RNI prospectively underwent perometry, NIRF-LI, and PRLOs (the Lymphedema Symptom Intensity and Distress Survey [LSIDS] and QuickDASH) at baseline, after surgery, and at 6, 12, and 18 months after radiation. Clinical lymphedema was defined as an arm volume increase ≥5% over baseline. Trends over time were assessed using analysis of variance testing. The association between survey responses and both dermal backflow and lymphedema was assessed using a linear mixed-effects model.
    Results: Sixty participants completed at least 2 sets of measurements and surveys and were eligible for analysis. Fifty-four percent of patients had cT3-T4 disease, 53% cN3 disease, and 75% had a body mass index >25. Dermal backflow and clinical lymphedema increased from 10% to 85% and from 0% to 40%, respectively, from baseline to 18 months. In the adjusted model, soft tissue sensation, neurologic sensation, and functional LSIDS subscale scores were associated with presence of dermal backflow (all P < .05). Both dermal backflow and lymphedema were associated with QuickDASH score (P < .05).
    Conclusions: In this high-risk cohort, we found highly prevalent early signs of lymphedema, with increased symptom burden from baseline. Presence of dermal backflow correlated with PRLO measures, highlighting a potential NIRF-LI use to identify patients for early intervention trials after RNI.
    MeSH term(s) Humans ; Female ; Breast Neoplasms/radiotherapy ; Middle Aged ; Lymphedema/etiology ; Aged ; Prospective Studies ; Adult ; Lymph Nodes/radiation effects ; Lymph Nodes/pathology ; Symptom Burden
    Language English
    Publishing date 2023-10-31
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2655748-4
    ISSN 1879-8519 ; 1879-8500
    ISSN (online) 1879-8519
    ISSN 1879-8500
    DOI 10.1016/j.prro.2023.10.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Locoregional Management and Prognostic Factors in Breast Cancer With Ipsilateral Internal Mammary and Axillary Lymph Node Involvement.

    Andring, Lauren M / Diao, Kevin / Sun, Susie / Patel, Miral / Whitman, Gary J / Schlembach, Pamela / Arzu, Isadora / Joyner, Melissa M / Shaitelman, Simona F / Hoffman, Karen / Stauder, Michael C / Smith, Benjamin D / Woodward, Wendy A

    International journal of radiation oncology, biology, physics

    2022  Volume 113, Issue 3, Page(s) 552–560

    Abstract: Purpose: Patients with breast cancer and ipsilateral axillary and internal mammary (IM) lymph node involvement (cN3b) often forgo IM node resection. Therefore, radiation is important for curative therapy. However, prognosis is not well described in the ... ...

    Abstract Purpose: Patients with breast cancer and ipsilateral axillary and internal mammary (IM) lymph node involvement (cN3b) often forgo IM node resection. Therefore, radiation is important for curative therapy. However, prognosis is not well described in the era of modern systemic therapy, and limited data exist to guide optimal locoregional treatment recommendations.
    Methods and materials: We retrospectively reviewed 117 patients with nonmetastatic cN3b breast cancer treated at our institution between 2014 and 2019. Staging included ultrasound evaluation of all regional nodal basins. All patients received neoadjuvant chemotherapy, resection of the breast primary, and axillary nodal dissection, followed by adjuvant radiation to the breast/chest wall and regional nodes. Institutional guidelines recommend a 10-Gy boost to radiographically resolved nodes, and a 16-Gy boost to unresolved nodes. Overall survival, recurrence-free survival (RFS), locoregional RFS, internal mammary RFS, and distant metastasis-free survival were evaluated with Kaplan-Meier analysis. A multivariable model for RFS was constructed.
    Results: Median follow-up for 117 patients was 3.82 years. Median age at diagnosis was 46 years and 56 patients (48%) were receptor group ER+/HER2-. Mastectomy was performed in 96 patients (82%), 38 (32%) had biopsy-confirmed IMC involvement, and 8 (7%) had IM node dissection. The median initial radiation dose was 50 Gy (range, 50-55 Gy) and IMC boost 10 Gy (range, 0-16 Gy). The 5-year overall survival, IM RFS, locoregional RFS, distant metastasis-free survival, and RFS were 74%, 98%, 89%, 68%, and 67%, respectively. On multivariable analysis, a clinical complete response of the IM nodes or ypN0 (pathologic complete response of nodes) status had improved 5-year RFS with hazard ratios of 0.24 (P = .006) and 0.27 (P = .05), respectively. Extranodal extension or lymphovascular invasion were associated with worse 5-year RFS with hazard ratios of 4.13 (P = .001) and 2.25 (P = .04), respectively.
    Conclusions: Multimodality therapy provides excellent locoregional control of 89% at 5 years for patients with cN3b breast cancer. Adjuvant radiation yields a 5-year IM RFS of 98%. Clinical and pathologic response of IM nodes are independently prognostic for RFS.
    MeSH term(s) Breast Neoplasms/drug therapy ; Breast Neoplasms/radiotherapy ; Disease-Free Survival ; Female ; Humans ; Lymph Node Excision ; Lymph Nodes/pathology ; Mastectomy ; Neoplasm Recurrence, Local ; Prognosis ; Retrospective Studies
    Language English
    Publishing date 2022-03-04
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 197614-x
    ISSN 1879-355X ; 0360-3016
    ISSN (online) 1879-355X
    ISSN 0360-3016
    DOI 10.1016/j.ijrobp.2022.02.037
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation.

    Reddy, Jay P / Lei, Xiudong / Bloom, Elizabeth S / Reed, Valerie K / Schlembach, Pamela J / Arzu, Isidora / Mayo, Lauren / Chun, Stephen G / Ahmad, Neelofur R / Stauder, Michael C / Gopal, Ramesh / Kaiser, Kels / Fang, Penny / Smith, Benjamin D

    International journal of radiation oncology, biology, physics

    2022  Volume 115, Issue 3, Page(s) 629–644

    Abstract: Purpose: Evidence supports use of partial-breast irradiation (PBI) in the management of early breast cancer, but the optimal dose-fractionation remains unsettled.: Methods and materials: We conducted a phase 2 clinical trial (OPAL trial) to evaluate ... ...

    Abstract Purpose: Evidence supports use of partial-breast irradiation (PBI) in the management of early breast cancer, but the optimal dose-fractionation remains unsettled.
    Methods and materials: We conducted a phase 2 clinical trial (OPAL trial) to evaluate a novel PBI dosing schedule of 35 Gy in 10 daily fractions. Patients with close (<2 mm) margins also received a boost of 9 Gy in 3 fractions. Eligible patients underwent margin-negative lumpectomy for ductal carcinoma in situ or estrogen receptor-positive invasive breast cancer, up to 3 cm, pTis-T2 N0. The primary outcome was any grade ≥2 toxic effect occurring from the start of radiation through 6 months of follow-up. Secondary outcomes included patient-reported cosmesis, breast pain, and functional status, measured using the Breast Cancer Treatment Outcomes Scale, and physician-reported cosmesis, measured using the Radiation Therapy and Oncology Group scale. The Cochran-Armitage trend test and multivariable mixed-effects longitudinal growth curve models compared outcomes for the OPAL study population with those for a control group of similar patients treated with whole-breast irradiation (WBI) plus boost.
    Results: All 149 patients enrolled on the OPAL trial received the prescribed dose, and 17.4% received boost. The median age was 64 years; 83.2% were White, and 73.8% were overweight or obese. With median follow-up of 2.0 years, 1 patient (0.7%) experienced in-breast recurrence. Prevalence of the primary toxicity outcome was 17.4% (26 of 149 patients) in the OPAL trial compared with 72.7% (128 of 176 patients) in the control WBI-plus-boost cohort (P < .001). In longitudinal multivariable analysis, treatment on the OPAL trial was associated with improved patient-reported cosmesis (P < .001), functional status (P = .004), breast pain (P = .004), and physician-reported cosmesis (P < .001).
    Conclusions: Treatment with daily PBI was associated with substantial reduction in early toxicity and improved patient- and physician-reported outcomes compared with WBI plus boost. Daily external-beam partial-breast irradiation with 13 or fewer fractions merits further prospective evaluation.
    MeSH term(s) Humans ; Middle Aged ; Female ; Treatment Outcome ; Mastodynia/etiology ; Breast Neoplasms/pathology ; Carcinoma, Intraductal, Noninfiltrating/radiotherapy ; Carcinoma, Intraductal, Noninfiltrating/pathology ; Radiotherapy, Adjuvant/adverse effects ; Radiotherapy, Adjuvant/methods ; Mastectomy, Segmental
    Language English
    Publishing date 2022-10-08
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 197614-x
    ISSN 1879-355X ; 0360-3016
    ISSN (online) 1879-355X
    ISSN 0360-3016
    DOI 10.1016/j.ijrobp.2022.09.083
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Stereotactic Body Radiation Therapy (SBRT) for Unresectable Pancreatic Carcinoma.

    Stauder, Michael C / Miller, Robert C

    Cancers

    2010  Volume 2, Issue 3, Page(s) 1565–1575

    Abstract: Survival in patients with unresectable pancreatic carcinoma is poor. Studies by Mayo Clinic and the Gastrointestinal Tumor Study Group (GITSG) have established combined modality treatment with chemotherapy and radiation as the standard of care. Use of ... ...

    Abstract Survival in patients with unresectable pancreatic carcinoma is poor. Studies by Mayo Clinic and the Gastrointestinal Tumor Study Group (GITSG) have established combined modality treatment with chemotherapy and radiation as the standard of care. Use of gemcitabine-based chemotherapy alone has also been shown to provide a benefit, but 5‑year overall survival still remains less than 5%. Conventional radiotherapy is traditionally delivered over a six week period and high toxicity is seen with the concomitant use of chemotherapy. In contrast, SBRT can be delivered in 3-5 days and, when used as a component of combined modality therapy with gemcitabine, disruption to the timely delivery of chemotherapy is minimal. Early single-institution reports of SBRT for unresectable pancreatic carcinoma demonstrate excellent local control with acceptable toxicity. Use of SBRT in unresectable pancreatic carcinoma warrants further investigation in order to improve the survival of patients with historically poor outcomes.
    Language English
    Publishing date 2010-08-09
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers2031565
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  7. Article ; Online: Prediction of breast cancer-related lymphedema by dermal backflow detected with near-infrared fluorescence lymphatic imaging.

    Aldrich, Melissa B / Rasmussen, John C / DeSnyder, Sarah M / Woodward, Wendy A / Chan, Wenyaw / Sevick-Muraca, Eva M / Mittendorf, Elizabeth A / Smith, Benjamin D / Stauder, Michael C / Strom, Eric A / Perkins, George H / Hoffman, Karen E / Mitchell, Melissa P / Barcenas, Carlos H / Isales, Lynn E / Shaitelman, Simona F

    Breast cancer research and treatment

    2022  Volume 195, Issue 1, Page(s) 33–41

    Abstract: Purpose: Mild breast cancer-related lymphedema (BCRL) is clinically diagnosed as a 5%-10% increase in arm volume, typically measured no earlier than 3-6 months after locoregional treatment. Early BCRL treatment is associated with better outcomes, yet ... ...

    Abstract Purpose: Mild breast cancer-related lymphedema (BCRL) is clinically diagnosed as a 5%-10% increase in arm volume, typically measured no earlier than 3-6 months after locoregional treatment. Early BCRL treatment is associated with better outcomes, yet amid increasing evidence that lymphedema exists in a latent form, treatment is typically delayed until arm swelling is obvious. In this study, we investigated whether near-infrared fluorescence lymphatic imaging (NIRF-LI) surveillance could characterize early onset of peripheral lymphatic dysfunction as a predictor of BCRL.
    Methods: In a prospective, longitudinal cohort/observational study (NCT02949726), subjects with locally advanced breast cancer who received axillary lymph node dissection and regional nodal radiotherapy (RT) were followed serially, between 2016 and 2021, before surgery, 4-8 weeks after surgery, and 6, 12, and 18 months after RT. Arm volume was measured by perometry, and lymphatic (dys) function was assessed by NIRF-LI.
    Results: By 18 months after RT, 30 of 42 study subjects (71%) developed mild-moderate BCRL (i.e., ≥ 5% arm swelling relative to baseline), all manifested by "dermal backflow" of lymph into lymphatic capillaries or interstitial spaces. Dermal backflow had an 83% positive predictive value and 86% negative predictive value for BCRL, with a sensitivity of 97%, specificity of 50%, accuracy of 83%, positive likelihood ratio of 1.93, negative likelihood ratio of 0.07, and odds ratio of 29.00. Dermal backflow appeared on average 8.3 months, but up to 23 months, before the onset of mild BCRL.
    Conclusion: BCRL can be predicted by dermal backflow, which often appears months before arm swelling, enabling early treatment before the onset of edema and irreversible tissue changes.
    MeSH term(s) Breast Cancer Lymphedema/diagnostic imaging ; Breast Cancer Lymphedema/etiology ; Breast Neoplasms/complications ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/radiotherapy ; Female ; Humans ; Lymph Node Excision/adverse effects ; Lymphatic Vessels/diagnostic imaging ; Lymphedema/diagnostic imaging ; Lymphedema/etiology ; Prospective Studies
    Language English
    Publishing date 2022-07-10
    Publishing country Netherlands
    Document type Journal Article ; Observational Study
    ZDB-ID 604563-7
    ISSN 1573-7217 ; 0167-6806
    ISSN (online) 1573-7217
    ISSN 0167-6806
    DOI 10.1007/s10549-022-06667-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Prospective, early longitudinal assessment of lymphedema-related quality of life among patients with locally advanced breast cancer: The foundation for building a patient-centered screening program.

    Gandhi, Anusha / Xu, Tianlin / DeSnyder, Sarah M / Smith, Grace L / Lin, Ruitao / Barcenas, Carlos H / Stauder, Michael C / Hoffman, Karen E / Strom, Eric A / Ferguson, Susan / Smith, Benjamin D / Woodward, Wendy A / Perkins, George H / Mitchell, Melissa P / Garner, Desmond / Goodman, Chelain R / Aldrich, Melissa / Travis, Marigold / Lilly, Susan /
    Bedrosian, Isabelle / Shaitelman, Simona F

    Breast (Edinburgh, Scotland)

    2023  Volume 68, Page(s) 205–215

    Abstract: Background: We examined how breast cancer-related lymphedema (BCRL) affects health-related quality of life (HRQOL), productivity, and compliance with therapeutic interventions to guide structuring BCRL screening programs.: Methods: We prospectively ... ...

    Abstract Background: We examined how breast cancer-related lymphedema (BCRL) affects health-related quality of life (HRQOL), productivity, and compliance with therapeutic interventions to guide structuring BCRL screening programs.
    Methods: We prospectively followed consecutive breast cancer patients who underwent axillary lymph node dissection (ALND) with arm volume screening and measures assessing patient-reported health-related quality of life (HRQOL) and perceptions of BCRL care. Comparisons by BCRL status were made with Mann-Whitney U, Chi-square, Fisher's exact, or t tests. Trends over time from ALND were assessed with linear mixed-effects models.
    Results: With a median follow-up of 8 months in 247 patients, 46% self-reported ever having BCRL, a proportion that increased over time. About 73% reported fear of BCRL, which was stable over time. Further in time from ALND, patients were more likely to report that BCRL screening reduced fear. Patient-reported BCRL was associated with higher soft tissue sensation intensity, biobehavioral, and resource concerns, absenteeism, and work/activity impairment. Objectively measured BCRL had fewer associations with outcomes. Most patients reported performing prevention exercises, but compliance decreased over time; patient-reported BCRL was not associated with exercise frequency. Fear of BCRL was positively associated with performing prevention exercises and using compressive garments.
    Conclusions: Both incidence and fear of BCRL were high after ALND for breast cancer. Fear was associated with improved therapeutic compliance, but compliance decreased over time. Patient-reported BCRL was more strongly associated with worse HRQOL and productivity than was objective BCRL. Screening programs must support patients' psychological needs and aim to sustain long-term compliance with recommended interventions.
    MeSH term(s) Humans ; Female ; Breast Neoplasms/pathology ; Prospective Studies ; Quality of Life ; Early Detection of Cancer ; Lymphedema/etiology ; Breast Cancer Lymphedema/etiology ; Lymph Node Excision/adverse effects ; Patient-Centered Care
    Language English
    Publishing date 2023-02-24
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1143210-x
    ISSN 1532-3080 ; 0960-9776
    ISSN (online) 1532-3080
    ISSN 0960-9776
    DOI 10.1016/j.breast.2023.02.011
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  9. Article ; Online: Inflammatory Breast Cancer: What to Know About This Unique, Aggressive Breast Cancer.

    Menta, Arjun / Fouad, Tamer M / Lucci, Anthony / Le-Petross, Huong / Stauder, Michael C / Woodward, Wendy A / Ueno, Naoto T / Lim, Bora

    The Surgical clinics of North America

    2018  Volume 98, Issue 4, Page(s) 787–800

    Abstract: Inflammatory breast cancer (IBC) is a rare form of breast cancer that accounts for only 2% to 4% of all breast cancer cases. Despite its low incidence, IBC contributes to 7% to 10% of breast cancer caused mortality. Despite ongoing international efforts ... ...

    Abstract Inflammatory breast cancer (IBC) is a rare form of breast cancer that accounts for only 2% to 4% of all breast cancer cases. Despite its low incidence, IBC contributes to 7% to 10% of breast cancer caused mortality. Despite ongoing international efforts to formulate better diagnosis, treatment, and research, the survival of patients with IBC has not been significantly improved, and there are no therapeutic agents that specifically target IBC to date. The authors present a comprehensive overview that aims to assess the present and new management strategies of IBC.
    MeSH term(s) Breast Neoplasms/epidemiology ; Breast Neoplasms/pathology ; Breast Neoplasms/therapy ; Combined Modality Therapy ; Female ; Humans ; Inflammatory Breast Neoplasms/epidemiology ; Inflammatory Breast Neoplasms/pathology ; Inflammatory Breast Neoplasms/therapy
    Language English
    Publishing date 2018-05-24
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 215713-5
    ISSN 1558-3171 ; 0039-6109
    ISSN (online) 1558-3171
    ISSN 0039-6109
    DOI 10.1016/j.suc.2018.03.009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Proton Accelerated Partial Breast Irradiation: Clinical Outcomes at a Planned Interim Analysis of a Prospective Phase 2 Trial.

    Pasalic, Dario / Strom, Eric A / Allen, Pamela K / Williamson, Tyler D / Poenisch, Falk / Amos, Richard A / Woodward, Wendy A / Stauder, Michael C / Shaitelman, Simona F / Smith, Benjamin D / Perkins, George H / Tereffe, Welela / Hoffman, Karen E

    International journal of radiation oncology, biology, physics

    2020  Volume 109, Issue 2, Page(s) 441–448

    Abstract: Purpose: To perform a planned interim analysis of acute (within 12 months) and late (after 12 months) toxicities and cosmetic outcomes after proton accelerated partial breast irradiation (APBI).: Methods and materials: A total of 100 patients with ... ...

    Abstract Purpose: To perform a planned interim analysis of acute (within 12 months) and late (after 12 months) toxicities and cosmetic outcomes after proton accelerated partial breast irradiation (APBI).
    Methods and materials: A total of 100 patients with pTis or pT1-2 N0 (≤3cm) breast cancer status after segmental mastectomy were enrolled in a single-arm phase 2 study from 2010 to 2019. The clinically determined postlumpectomy target volume, including tumor bed surgical clips and operative-cavity soft-tissue changes seen on imaging plus a radial clinical expansion, was irradiated with passively scattered proton APBI (34 Gy in 10 fractions delivered twice daily with a minimum 6-hour interfraction interval). Patients were evaluated at protocol-specific time intervals for recurrence, physician reports of cosmetic outcomes and toxicities, and patient reports of cosmetic outcomes and satisfaction with the treatment or experience.
    Results: Median follow-up was 24 months (interquartile range [IQR], 12-43 months). Local control and overall survival were 100% at 12 and 24 months. There were no acute or late toxicities of grade 3 or higher; no patients experienced fat necrosis, fibrosis, infection, or breast shrinkage. Excellent or good cosmesis at 12 months was reported by 91% of patients and 94% of physicians; at the most recent follow-up, these were 94% and 87%, respectively. The most commonly reported late cosmetic effect was telangiectasis (17%). The total patient satisfaction rate for treatment and results at 12 and 24 months was 96% and 100%, respectively. Patients' mean time away from work was 5 days (IQR, 2-5 days), and the median out-of-pocket cost was $700 (IQR, $100-$1600). The mean left-sided heart dose was 2 cGy (range, 0.2-75 cGy), and the mean ipsilateral lung dose was 19 cGy (range, 0.2-164 cGy).
    Conclusions: Proton APBI is a maturing treatment option with high local control, favorable intermediate-term cosmesis, high treatment satisfaction, low treatment burden, and exceptional heart and lung sparing.
    MeSH term(s) Aged ; Breast Neoplasms/pathology ; Breast Neoplasms/radiotherapy ; Breast Neoplasms/surgery ; Female ; Follow-Up Studies ; Humans ; Mastectomy ; Middle Aged ; Patient Satisfaction ; Prospective Studies ; Proton Therapy ; Treatment Outcome
    Language English
    Publishing date 2020-09-16
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article
    ZDB-ID 197614-x
    ISSN 1879-355X ; 0360-3016
    ISSN (online) 1879-355X
    ISSN 0360-3016
    DOI 10.1016/j.ijrobp.2020.09.009
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