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Chirag Shah - One of the best experts on this subject based on the ideXlab platform.
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treatment efficacy with accelerated partial breast irradiation apbi final analysis of the american society of breast surgeons mammosite breast brachytherapy registry trial
Annals of Surgical Oncology, 2013Co-Authors: Chirag Shah, P. Beitsch, Ben J Wilkinson, Frank A Vicini, Shahed Badiyan, Martin Keisch, Douglas W Arthur, Maureen LydenAbstract:Background The purpose of this study was to examine data on treatment efficacy, Cosmesis and toxicities for the final analysis of the American Society of Breast Surgeons MammoSite® breast brachytherapy registry trial.
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brachytherapy based partial breast irradiation is associated with low rates of complications and excellent Cosmesis
Brachytherapy, 2013Co-Authors: P. Beitsch, Chirag Shah, Ben J Wilkinson, Frank A Vicini, Martin Keisch, Douglas W Arthur, S S Khwaja, Shahed N Badiyan, Maureen LydenAbstract:Abstract Background Recent retrospective, claims-based analyses have suggested a potential increased rate of toxicities associated with brachytherapy-based accelerated partial breast irradiation (APBI). The purpose of this analysis was to examine Cosmesis and toxicity data from the prospective American Society of Breast Surgeons (ASBS) breast brachytherapy registry trial to compare to the findings from the claims analyses. Methods The ASBS breast brachytherapy registry is a prospective nonblinded multi-institutional registry trial. Patients with Stage 0–II breast cancer undergoing breast conserving therapy were eligible. A total of 1665 patients were enrolled and 1449 treated between 2002 and 2004 with a median followup of 63 months. All patients were treated with the MammoSite (Hologic, Inc.) single-lumen device to deliver adjuvant APBI (34 Gy in 3.4 Gy fractions). Results The rate of excellent/good Cosmesis was 90.6% at 84 months. The rate of a complication (symptomatic seroma, infection, fat necrosis, telangiectasias) at 1 year/any time point was 24.2%/38.5%, whereas the rate of noninfectious complications at 1 year/any time point was 14.8%/28.9%. The rate of symptomatic seroma, fat necrosis, infection, and telangiectasia at any time was 13.4%, 2.5%, 9.6%, and 13.0%, respectively. Conclusions The final toxicity analysis from ASBS breast brachytherapy registry trial confirms the previously noted excellent Cosmesis and toxicity profiles and fails to confirm retrospective claims analyses that have suggested higher rates of toxicity for brachytherapy-based APBI.
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five year outcomes and toxicities using 3 dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation
Clinical Breast Cancer, 2013Co-Authors: Chirag Shah, Ben J Wilkinson, Thomas B Lanni, M S Jawad, Jessica Wobb, Ashley Fowler, Michelle Wallace, Peter Y Chen, I S Grills, Frank A ViciniAbstract:Abstract Background Limited 5-year data exist on clinical outcomes and toxicities for patients undergoing 3-dimensional conformal radiation therapy (3D-CRT) APBI. Patients and Methods Two hundred five patients were treated with 3D-CRT APBI between August, 2000 and December, 2011. Cases with > 1 year of follow-up were analyzed for Cosmesis, chronic toxicities, and clinical outcomes. Outcome by American Society for Radiation Oncology (ASTRO) Consensus Panel (CP) group were also compared. Rates of excellent and good Cosmesis for 3D-CRT were evaluated over time for stability. Results One hundred ninety-two patients were evaluated; median follow-up was 4.8 years (range, 1.0–11.2 years). Seventy-two patients (37.5%) were categorized as ASTRO CP subgroup ‘suitable,' 89 (46.4%) ‘cautionary,' and 31 (16.1%) ‘unsuitable.' At 5 years, the rate of IBTR, regional recurrence, distant metastases, cause-specific survival, and overall survival were 0%, 0%, 2%, 99%, and 92%, respectively. Thirty-seven percent of patients had excellent Cosmesis, 44% good Cosmesis, 15% fair Cosmesis, and 4% poor Cosmesis. No statistically significant differences in excellent (37% vs. 37%; P = .99) or good (49% vs. 37%; P = .28) Cosmesis were noted between patients with Conclusion In the largest group of patients published to date using 3D-CRT to deliver APBI, no local recurrences were noted at 5 years. More than 80% of patients had excellent or good Cosmesis.
Shilpa Mehendale - One of the best experts on this subject based on the ideXlab platform.
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Cosmesis patient satisfaction and quality of life after da vinci single site cholecystectomy and multiport laparoscopic cholecystectomy short term results from a prospective multicenter randomized controlled trial
Surgical Endoscopy and Other Interventional Techniques, 2017Co-Authors: Omar Yusef Kudsi, Andres Castellanos, Srinivas Kaza, Justin C Mccarty, Eugene Dickens, David Martin, Frederick M Tiesenga, Konstantinos Konstantinidis, Petros Hirides, Shilpa MehendaleAbstract:Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique. Prior trials have demonstrated improved Cosmesis with the single-incision technique. Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach. This is the first prospective, randomized, controlled study comparing robotic single-site cholecystectomy (RSSC) and multiport laparoscopic cholecystectomy (MPLC) in terms of Cosmesis and patient satisfaction. Patients with symptomatic benign gallbladder disease were randomized to RSSC or MPLC. Data included perioperative variables such as operative time, conversion and complications and Cosmesis satisfaction, body image perception, quality of life using validated questionnaires, at postoperative visits of 2, 6 weeks and 3 months. One hundred thirty-six patients were randomized to RSSC (N = 83) and MPLC (N = 53) at 8 institutions. Both cohorts were dominated by higher enrollment of females (RSSC = 78%, MPLC = 92%). The RSSC and MPLC cohorts were otherwise statistically matched. Operative time was longer for RSSC (61 min vs. 44 min, P < 0.0001). There were no differences in complication rates. RSSC demonstrated a significant superiority in Cosmesis satisfaction and body image perception (P value < 0.05 at every follow-up). There was no statistically significant difference in patient-reported quality of life. Multivariate analysis of female patients demonstrated significantly higher preference for RSSC over MPLC in Cosmesis satisfaction and body image perception with no difference seen in overall quality of life. Results from this trial show that RSSC is associated with improved Cosmesis satisfaction and body image perception without a difference in observed complication rate. The uncompromised safety and the improved Cosmesis satisfaction and body image perception provided by RSSC for female patients support consideration of the robotic single-site approach. ClinicalTrials.gov identifier NCT01932216.
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Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial
Surgical endoscopy, 2016Co-Authors: Omar Yusef Kudsi, Andres Castellanos, Srinivas Kaza, Justin C Mccarty, Eugene Dickens, David Martin, Frederick M Tiesenga, Konstantinos Konstantinidis, Petros Hirides, Shilpa MehendaleAbstract:Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique. Prior trials have demonstrated improved Cosmesis with the single-incision technique. Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach. This is the first prospective, randomized, controlled study comparing robotic single-site cholecystectomy (RSSC) and multiport laparoscopic cholecystectomy (MPLC) in terms of Cosmesis and patient satisfaction. Patients with symptomatic benign gallbladder disease were randomized to RSSC or MPLC. Data included perioperative variables such as operative time, conversion and complications and Cosmesis satisfaction, body image perception, quality of life using validated questionnaires, at postoperative visits of 2, 6 weeks and 3 months. One hundred thirty-six patients were randomized to RSSC (N = 83) and MPLC (N = 53) at 8 institutions. Both cohorts were dominated by higher enrollment of females (RSSC = 78%, MPLC = 92%). The RSSC and MPLC cohorts were otherwise statistically matched. Operative time was longer for RSSC (61 min vs. 44 min, P
Frank A Vicini - One of the best experts on this subject based on the ideXlab platform.
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rtog 95 17 a phase ii trial to evaluate brachytherapy as the sole method of radiation therapy for stage i and ii breast carcinoma year 5 toxicity and Cosmesis
Brachytherapy, 2014Co-Authors: Rachel Rabinovitch, Frank A Vicini, K Winter, Robert R Kuske, John S Bolton, Doug Arthur, Troy Scroggins, Beryl Mccormick, Julia WhiteAbstract:Abstract Purpose Radiation Therapy Oncology Group (RTOG) 95-17, a Phase II trial to evaluate multicatheter brachytherapy (mCathBrachy) as the sole method of radiation therapy for Stage I–II breast cancer (BrCa), was the first cooperative group trial in North America to evaluate accelerated partial breast irradiation (APBI) and include patient-reported outcomes (PROs). This report presents the year-5 toxicity and Cosmesis data. Methods and Materials After lumpectomy and axillary dissection for invasive BrCa (tumor size Results Grade (G) 1–2 skin toxicity developed in 78% of the pts and G3 in 13% (no G4). The tx effects included skin dimpling/indentation (37%), fibrosis (45%), telangiectasias (45%), skin catheter marks (54%), and symptomatic fat necrosis (15%). Breast asymmetry was reported in 73%. Rates of excellent-to-good Cosmesis were similar between PROs (66%) and radiation oncologists (68%). The PROs of tx satisfaction at year-5 was 75%. Conclusions RTOG 95-17 documents the year-5 skin toxicity and tx effects of mCathBrachy APBI, which are associated with PROs of good-to-excellent Cosmesis and high tx satisfaction. This emphasizes the importance of PROs when assessing BrCa tx. National Surgical Adjuvant Breast and Bowel Project B39/RTOG 0413 will allow for definitive comparisons between APBI and whole breast radiation therapy.
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treatment efficacy with accelerated partial breast irradiation apbi final analysis of the american society of breast surgeons mammosite breast brachytherapy registry trial
Annals of Surgical Oncology, 2013Co-Authors: Chirag Shah, P. Beitsch, Ben J Wilkinson, Frank A Vicini, Shahed Badiyan, Martin Keisch, Douglas W Arthur, Maureen LydenAbstract:Background The purpose of this study was to examine data on treatment efficacy, Cosmesis and toxicities for the final analysis of the American Society of Breast Surgeons MammoSite® breast brachytherapy registry trial.
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brachytherapy based partial breast irradiation is associated with low rates of complications and excellent Cosmesis
Brachytherapy, 2013Co-Authors: P. Beitsch, Chirag Shah, Ben J Wilkinson, Frank A Vicini, Martin Keisch, Douglas W Arthur, S S Khwaja, Shahed N Badiyan, Maureen LydenAbstract:Abstract Background Recent retrospective, claims-based analyses have suggested a potential increased rate of toxicities associated with brachytherapy-based accelerated partial breast irradiation (APBI). The purpose of this analysis was to examine Cosmesis and toxicity data from the prospective American Society of Breast Surgeons (ASBS) breast brachytherapy registry trial to compare to the findings from the claims analyses. Methods The ASBS breast brachytherapy registry is a prospective nonblinded multi-institutional registry trial. Patients with Stage 0–II breast cancer undergoing breast conserving therapy were eligible. A total of 1665 patients were enrolled and 1449 treated between 2002 and 2004 with a median followup of 63 months. All patients were treated with the MammoSite (Hologic, Inc.) single-lumen device to deliver adjuvant APBI (34 Gy in 3.4 Gy fractions). Results The rate of excellent/good Cosmesis was 90.6% at 84 months. The rate of a complication (symptomatic seroma, infection, fat necrosis, telangiectasias) at 1 year/any time point was 24.2%/38.5%, whereas the rate of noninfectious complications at 1 year/any time point was 14.8%/28.9%. The rate of symptomatic seroma, fat necrosis, infection, and telangiectasia at any time was 13.4%, 2.5%, 9.6%, and 13.0%, respectively. Conclusions The final toxicity analysis from ASBS breast brachytherapy registry trial confirms the previously noted excellent Cosmesis and toxicity profiles and fails to confirm retrospective claims analyses that have suggested higher rates of toxicity for brachytherapy-based APBI.
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five year outcomes and toxicities using 3 dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation
Clinical Breast Cancer, 2013Co-Authors: Chirag Shah, Ben J Wilkinson, Thomas B Lanni, M S Jawad, Jessica Wobb, Ashley Fowler, Michelle Wallace, Peter Y Chen, I S Grills, Frank A ViciniAbstract:Abstract Background Limited 5-year data exist on clinical outcomes and toxicities for patients undergoing 3-dimensional conformal radiation therapy (3D-CRT) APBI. Patients and Methods Two hundred five patients were treated with 3D-CRT APBI between August, 2000 and December, 2011. Cases with > 1 year of follow-up were analyzed for Cosmesis, chronic toxicities, and clinical outcomes. Outcome by American Society for Radiation Oncology (ASTRO) Consensus Panel (CP) group were also compared. Rates of excellent and good Cosmesis for 3D-CRT were evaluated over time for stability. Results One hundred ninety-two patients were evaluated; median follow-up was 4.8 years (range, 1.0–11.2 years). Seventy-two patients (37.5%) were categorized as ASTRO CP subgroup ‘suitable,' 89 (46.4%) ‘cautionary,' and 31 (16.1%) ‘unsuitable.' At 5 years, the rate of IBTR, regional recurrence, distant metastases, cause-specific survival, and overall survival were 0%, 0%, 2%, 99%, and 92%, respectively. Thirty-seven percent of patients had excellent Cosmesis, 44% good Cosmesis, 15% fair Cosmesis, and 4% poor Cosmesis. No statistically significant differences in excellent (37% vs. 37%; P = .99) or good (49% vs. 37%; P = .28) Cosmesis were noted between patients with Conclusion In the largest group of patients published to date using 3D-CRT to deliver APBI, no local recurrences were noted at 5 years. More than 80% of patients had excellent or good Cosmesis.
Tamer Soror - One of the best experts on this subject based on the ideXlab platform.
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kobcs a novel software calculator program of the objective breast Cosmesis scale obcs
Breast Cancer, 2020Co-Authors: Tamer Soror, Vito Lanzotti, Calogero Casà, Luca Tagliaferri, F. Barberini, Cynthia Aristei, Valentina Lancellotta, Gyorgy Kovacs, Mohamed MahmoudAbstract:PURPOSE The Objective Breast Cosmesis Scale (OBCS) is an objective method that documents the aesthetic changes in breast cancer patients. This work evaluates the kOBCS© software (http://www.kobcs.info) which simplifies the estimation of the OBCS values. METHODS Five schematic drawings were photographed and imported into the kOBCS©. Thirty photos of breast cancer patients were imported into kOBCS©; 20 users (experts and non-experts) evaluated the photographs on two different settings. Subjective evaluation was performed using the Harvard breast Cosmesis scale. RESULTS There was a highly significant correlation between the OBCS values based on hand measurements and the values estimated by kOBCS© (r = 0.997, P < 0.001). Agreement among the users using the kOBCS© was strong with high statistical significance (ICC = 0.846, P < 0.001, 95% CI 0.774-0.910, Cronbach's alpha = 0.991). Results of the subjective analyses and mean OBCS values as estimated by kOBCS© correlated significantly (r = 0.961, P < 0.001). CONCLUSIONS The kOBCS© is a reliable and reproducible easy-to-use software for reporting breast Cosmesis following breast-conserving therapy.
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kOBCS^©: a novel software calculator program of the Objective Breast Cosmesis Scale (OBCS)
Breast Cancer, 2019Co-Authors: Tamer Soror, Vito Lanzotti, Calogero Casà, Luca Tagliaferri, F. Barberini, Cynthia Aristei, Valentina Lancellotta, Gyorgy Kovacs, Mohamed Mahmoud, Harun BadakhshiAbstract:PurposeThe Objective Breast Cosmesis Scale (OBCS) is an objective method that documents the aesthetic changes in breast cancer patients. This work evaluates the kOBCS^© software ( http://www.kobcs.info ) which simplifies the estimation of the OBCS values.MethodsFive schematic drawings were photographed and imported into the kOBCS^©. Thirty photos of breast cancer patients were imported into kOBCS^©; 20 users (experts and non-experts) evaluated the photographs on two different settings. Subjective evaluation was performed using the Harvard breast Cosmesis scale.ResultsThere was a highly significant correlation between the OBCS values based on hand measurements and the values estimated by kOBCS^© ( r = 0.997, P
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kOBCS © : a novel software calculator program of the Objective Breast Cosmesis Scale (OBCS)
Breast cancer (Tokyo Japan), 2019Co-Authors: Tamer Soror, Vito Lanzotti, Calogero Casà, Luca Tagliaferri, F. Barberini, Cynthia Aristei, Valentina Lancellotta, Gyorgy Kovacs, Mohamed Mahmoud, Harun BadakhshiAbstract:PURPOSE The Objective Breast Cosmesis Scale (OBCS) is an objective method that documents the aesthetic changes in breast cancer patients. This work evaluates the kOBCS© software (http://www.kobcs.info) which simplifies the estimation of the OBCS values. METHODS Five schematic drawings were photographed and imported into the kOBCS©. Thirty photos of breast cancer patients were imported into kOBCS©; 20 users (experts and non-experts) evaluated the photographs on two different settings. Subjective evaluation was performed using the Harvard breast Cosmesis scale. RESULTS There was a highly significant correlation between the OBCS values based on hand measurements and the values estimated by kOBCS© (r = 0.997, P
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kOBCS�: A Novel Software Calculator Program Of The Objective Breast Cosmesis Scale (OBCS) (Preprint)
2018Co-Authors: Tamer Soror, Vito Lanzotti, Calogero Casà, Luca Tagliaferri, F. Barberini, Cynthia Aristei, Gyorgy Kovacs, Mohamed Mahmoud, Valentina Lancellotti, Harun BadakhshiAbstract:BACKGROUND The Objective Breast Cosmesis Scale (OBCS) was introduced as an objective method to document the breast cosmetic changes using non-standardized photographs without scale-calibration. OBJECTIVE This work test the accuracy and reproducibility of the kOBCS© software tool which invented to simplify the measurement of the OBCS values. METHODS to prove the mathematical accuracy five schematic drawings of breast-shaped figures were digitally photographed and imported into the kOBCS©. Thirty different photos of breast cancer patients were imported into kOBCS©, twenty different users (experts and non-experts) used the program to evaluate the photographs on two different occasions one week apart. Additionally, a subjective evaluation of each photo was performed throughout the evaluation panel using the Harvard breast Cosmesis scale and the results were categorized in two groups; favorable versus adverse Cosmesis. RESULTS The OBCS values as estimated by the kOBCS© ranged between 1.5 and 13.0 with median value of 4.6. There is a highly significant correlation between the OBCS values based on hand measurements and the OBCS values estimated by the kOBCS©, both values correlate nearly 100% (r= 0.997, p<0.001). There is a strong correlation between the repeated measurements for each user, indicating reliable reproducibility of the program in estimating the OBCS values. Agreement among the users using the kOBCS© was strong with high statistical significance (ICC=0.846, p<0.001, 95% CI: 0.774-0.910, Cronbach’s alpha=0.991). Results of the subjective analyses and mean OBCS values as estimated by kOBCS© correlated significantly (r=0.961, p<0.001). CONCLUSIONS The kOBCS© is a reliable and reproducible easy-to-use software for reporting breast Cosmesis following BCT. The kOBCS© offers a wide range of potential use in different clinical studies that report on the breast Cosmesis as one of the outcomes.
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Cosmetic changes following surgery and accelerated partial breast irradiation using HDR interstitial brachytherapy
Strahlentherapie und Onkologie, 2017Co-Authors: Tamer Soror, Gyorgy Kovacs, Corinna Melchert, Kristin Baumann, Eike Wenzel, Nina Seibold, Suzana Stojanovic-rundicAbstract:Einleitung Brustkrebspatientinnen im Frühstadium können nach einer brusterhaltenden Operation (BCS) von einer adjuvanten akzelerierten Teilbrustbestrahlung (APBI) profitieren. Die vorliegende Arbeit berichtet über die kosmetischen Ergebnisse nach APBI mittels HDR-interstitieller Brachytherapie (HDR-IBT) in Multikatheter-Technik. Methoden Zwischen2006 und 2014 hatten 114 Patientinnen eine adjuvante APBI mittels Mulitkatheter-HDR-IBT erhalten. Von jeder Patientin wurden 2 Fotografien analysiert: die erste wurde nach der Operation, aber vor Implantation der Brachytherapiekatheter (Basisbild) aufgenommen, die zweite bei der letzten Nachuntersuchung. Die kosmetische Bewertung wurde durch ein multidisziplinäres Multigender-Team anhand der „Harvard-Breast-Cosmesis“-Skala bewertet. Dosis-Volumen-Histogramm-(DVH-)Parameter und die beobachteten kosmetischen Veränderungen wurden auf mögliche Korrelationen untersucht. Ergebnisse Die mediane Nachbeobachtungszeit betrug 3,5 Jahre (Spanne 0,6–8,5 Jahre). Die endgültige kosmetische Bewertung war bei 30 % ausgezeichnet, bei 52 % gut, bei 14,5 % fair und bei 3,5 % schlecht. Ein Vergleich der Basis- und Nachsorge-Bilder ergab bei 59,6% keine Veränderung, bei 36% ein besseres und bei 4,4 % ein schlechteres Ergebnis. Nur niedrigere ‚‚Dose-non-uniformity-ratio‛‛-(DNR-)Werte (0,3 vs. 0,26; p = 0,009) waren signifikant mit einem verbesserten kosmetischen Ergebnis assoziiert. Schlussfolgerung APBI mittels HDR-IBT ergibt ein günstiges endgültiges kosmetisches Ergebnis. Eine Verschlechterung der Kosmetik der Brust tritt bei weniger als 5 % der Patientinnen ein. Die endgültigen kosmetischen Ergebnisse bei mit BCS und HDR-IBT behandelten Patientinnen werden vor allem durch das kosmetische Ergebnis der Operation beeinflusst. Background Patients with early-stage breast cancer can benefit from adjuvant accelerated partial breast irradiation (APBI) following breast-conserving surgery (BCS). This work reports on cosmetic results following APBI using multicatheter high-dose-rate interstitial brachytherapy (HDR-IBT). Patients and methods Between 2006 and 2014, 114 patients received adjuvant APBI using multicatheter HDR-IBT. For each patient, two photographs were analyzed: the first was taken after surgery (baseline image) and the second at the last follow-up visit. Cosmesis was assessed by a multigender multidisciplinary team using the Harvard Breast Cosmesis Scale. Dose–volume histogram (DVH) parameters and the observed cosmetic results were investigated for potential correlations. Results The median follow-up period was 3.5 years (range 0.6–8.5 years). The final cosmetic scores were 30% excellent, 52% good, 14.5% fair, and 3.5% poor. Comparing the baseline and follow-up photographs, 59.6% of patients had the same score, 36% had a better final score, and 4.4% had a worse final score. Only lower target dose nonuniformity ratio (DNR) values (0.3 vs. 0.26; p = 0.009) were significantly associated with improved cosmetic outcome vs. same/worse Cosmesis. Conclusion APBI using multicatheter HDR-IBT adjuvant to BCS results in favorable final Cosmesis. Deterioration in breast Cosmesis occurs in less than 5% of patients. The final breast cosmetic outcome in patients treated with BCS and APBI using multicatheter HDR-IBT is influenced primarily by the cosmetic result of the surgery. A lower DNR value is significantly associated with a better cosmetic outcome.
Maureen Lyden - One of the best experts on this subject based on the ideXlab platform.
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treatment efficacy with accelerated partial breast irradiation apbi final analysis of the american society of breast surgeons mammosite breast brachytherapy registry trial
Annals of Surgical Oncology, 2013Co-Authors: Chirag Shah, P. Beitsch, Ben J Wilkinson, Frank A Vicini, Shahed Badiyan, Martin Keisch, Douglas W Arthur, Maureen LydenAbstract:Background The purpose of this study was to examine data on treatment efficacy, Cosmesis and toxicities for the final analysis of the American Society of Breast Surgeons MammoSite® breast brachytherapy registry trial.
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brachytherapy based partial breast irradiation is associated with low rates of complications and excellent Cosmesis
Brachytherapy, 2013Co-Authors: P. Beitsch, Chirag Shah, Ben J Wilkinson, Frank A Vicini, Martin Keisch, Douglas W Arthur, S S Khwaja, Shahed N Badiyan, Maureen LydenAbstract:Abstract Background Recent retrospective, claims-based analyses have suggested a potential increased rate of toxicities associated with brachytherapy-based accelerated partial breast irradiation (APBI). The purpose of this analysis was to examine Cosmesis and toxicity data from the prospective American Society of Breast Surgeons (ASBS) breast brachytherapy registry trial to compare to the findings from the claims analyses. Methods The ASBS breast brachytherapy registry is a prospective nonblinded multi-institutional registry trial. Patients with Stage 0–II breast cancer undergoing breast conserving therapy were eligible. A total of 1665 patients were enrolled and 1449 treated between 2002 and 2004 with a median followup of 63 months. All patients were treated with the MammoSite (Hologic, Inc.) single-lumen device to deliver adjuvant APBI (34 Gy in 3.4 Gy fractions). Results The rate of excellent/good Cosmesis was 90.6% at 84 months. The rate of a complication (symptomatic seroma, infection, fat necrosis, telangiectasias) at 1 year/any time point was 24.2%/38.5%, whereas the rate of noninfectious complications at 1 year/any time point was 14.8%/28.9%. The rate of symptomatic seroma, fat necrosis, infection, and telangiectasia at any time was 13.4%, 2.5%, 9.6%, and 13.0%, respectively. Conclusions The final toxicity analysis from ASBS breast brachytherapy registry trial confirms the previously noted excellent Cosmesis and toxicity profiles and fails to confirm retrospective claims analyses that have suggested higher rates of toxicity for brachytherapy-based APBI.
