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Maureen Lyden - One of the best experts on this subject based on the ideXlab platform.

  • optimal application of the contura multilumen balloon breast Brachytherapy Catheter vacuum port to deliver accelerated partial breast irradiation
    Brachytherapy, 2011
    Co-Authors: Kenneth M Tokita, Douglas W Arthur, Frank A Vicini, Thomas B Julian, Laurie W Cuttino, Dorin A Todor, Maureen Lyden
    Abstract:

    Abstract Purpose The impact of using the Contura multilumen balloon (MLB) (SenoRx, Inc., Irvine, CA) breast Brachytherapy Catheter’s vacuum port in patients treated with accelerated partial breast irradiation (APBI) was analyzed. Methods and Materials Data from 32 patients at two sites were reviewed. Variables analyzed included the seroma fluid (SF):air volume around the MLB before and after vacuum port use and on its ability to improve ( 1 ) the eligibility of patients for APBI and ( 2 ) dose coverage of the planning target volume for evaluation (PTV_EVAL) in eligible patients. Results The median SF/air volume before vacuum removal was 6.8 cc vs. 0.8 cc after vacuum removal (median reduction in SF/air volume was 90.5%). Before vacuum port use, the median SF/air volume expressed as percentage of the PTV_EVAL was 7.8% (range, 1.9–26.6) in all patients. After application of the vacuum, this was reduced to 1.2%. Before vacuum port use, 10 (31.3%) patients were not considered acceptable candidates for APBI because the SF/air volume:PTV_EVAL ratio (SF:PTV) was greater than 10% (range, 10.1–26.6%; median, 15.2%). After vacuum port use, the median SF:PTV ratio was 1.6% for a median reduction of 91.5%. In addition, the percentage of the prescribed dose covering greater than or equal to 90% of the PTV_EVAL proportionally increased a median of 8% (range, 3–10%) in eligible patients. Conclusion Use of the Contura MLB vacuum port significantly improved the conformity of the target tissue to the balloon surface, leading to reproducible dose delivery and increased target volume coverage. In addition, application of the vacuum allowed the safe treatment of unacceptable patients with APBI.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Abstract Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing ( Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • improvements in critical dosimetric endpoints using the contura multilumen balloon breast Brachytherapy Catheter to deliver accelerated partial breast irradiation preliminary dosimetric findings of a phase iv trial
    International Journal of Radiation Oncology Biology Physics, 2011
    Co-Authors: Douglas W Arthur, Frank A Vicini, D Todor, Thomas B Julian, Maureen Lyden
    Abstract:

    Purpose Dosimetric findings in patients treated with the Contura multilumen balloon (MLB) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI) on a multi-institutional Phase IV registry trial are presented. Methods and Materials Computed tomography–based three-dimensional planning with dose optimization was performed. For the trial, new ideal dosimetric goals included (1) ≥95% of the prescribed dose (PD) covering ≥90% of the target volume, (2) a maximum skin dose ≤125% of the PD, (3) maximum rib dose ≤145% of the PD, and (4) the V150 ≤50 cc and V200 ≤10 cc. The ability to concurrently achieve these dosimetric goals using the Contura MLB was analyzed. Results 144 cases were available for review. Using the MLB, all dosimetric criteria were met in 76% of cases. Evaluating dosimetric criteria individually, 92% and 89% of cases met skin and rib dose criteria, respectively. In 93% of cases, ideal target volume coverage goals were met, and in 99%, dose homogeneity criteria (V150 and V200) were satisfied. When skin thickness was ≥5 mm to Conclusion The Contura MLB Catheter provided the means of achieving the imposed higher standard of dosimetric goals in the majority of clinical scenarios encountered.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing (<7 mm) and rib spacing (<7 mm) than in MS patients (45.5% vs. 12.1%, p = 0.0057 and 57.6 vs. 33.3, p = 0.0131, respectively). Despite closer skin spacing, the overall median skin dose was significantly lower in C-MLB patients (112% of the PD vs. 134%, p = 0.0282). No statistically significant differences in the V150 or V200 were observed. In patients with very limited rib spacing (<4 mm), the C-MLB delivered significantly lower rib doses than the MS (144% of the PD vs. 191%, p = 0.0107). In all clinical scenarios, coverage of the PTV with the C-MLB was either equal to or significantly better than with the MS (p = 0.0024). Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • Ductal Carcinoma in Situ of the Breast Treated with Accelerated Partial Breast Irradiation Using Balloon-Based Brachytherapy
    Annals of Surgical Oncology, 2010
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Mark Mclaughlin, Frank Vicini, Keri Grier, Maureen Lyden
    Abstract:

    Background We reviewed our institution’s experience treating patients with ductal carcinoma in situ (DCIS) of the breast with balloon-based accelerated partial breast irradiation (APBI) to determine the efficacy of this treatment approach in this group of patients. Materials and Methods A total of 126 cases of DCIS seen and treated with APBI using balloon-based Brachytherapy constitute the study population. The median age at diagnosis was 59 years (range, 37–82) with 21% younger than age 50. Nuclear grade distribution was 52.5, 41.4, and 6.1% high, intermediate and low, respectively. Of these patients, 86% had estrogen receptor positive DCIS. The median tumor size was 6 mm (range, 1–26). Margins of excision were negative in 98.4% of patients. All patients were treated with 34 Gy in 10 fractions using either the MammoSite™ or Contura™ breast Brachytherapy Catheter. A total of 87 patients (73.1%) were placed on adjuvant tamoxifen or arimedex. Results With a median follow-up of 24 months (range, 0.7–73.9), three (2.4%) ipsilateral breast tumor recurrences (IBTRs) developed for a 2-year actuarial rate of 0.81%. Recurrences developed 4.8, 24.7, and 24.9 months after treatment. On univariate analysis, no variable was associated with IBTR. A subset analysis of the first 50 consecutive patients treated was also performed. With a median follow-up of 40 months (range, 15.6–73.9), one IBTR developed for a 3-year actuarial rate of 2.15%. Conclusions Early results in patients with DCIS treated with APBI using balloon-based Brachytherapy produced results similar to those with invasive cancer treated with APBI or DCIS treated with whole breast irradiation.

Philip Z Israel - One of the best experts on this subject based on the ideXlab platform.

  • three year clinical outcome using the contura multilumen balloon breast Brachytherapy Catheter to deliver accelerated partial breast irradiation apbi improving radiation standards for the optimal application of apbi
    Brachytherapy, 2012
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Sheree Brown, Mark Mclaughlin, Keith Pope
    Abstract:

    Abstract Purpose We reviewed our institution’s 3-year clinical experience in treating patients with the Contura multilumen balloon (SenoRx, Inc., Aliso Viejo, CA) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI). Methods and Materials Forty-six patients treated with breast-conserving therapy received adjuvant radiation using the Contura Catheter (34 Gy in 3.4 Gy fractions). Fourteen patients had Stage 0, 24 had Stage I, and 8 had Stage II breast cancer. Median follow-up was 36 months (range, 1–44 months). Results Only one local recurrence developed (2%). The rate of persistent seroma formation at latest reported follow-up was 4.3% (2 patients) and the incidence of any clinically detectable telengiectasias was 2.2%. No major toxicities (0% Grade III) have occurred. The median skin dose (% of the prescribed dose) was 99.7. The median dose to 95% of the planning target volume for evaluation was 98.8%. The percentage of patients with excellent/good cosmetic results at 24 (n = 23) and 36 (n = 22) months was 100% and 97%, respectively. Conclusion Adjuvant APBI using the Contura multilumen balloon Catheter exhibited similar locoregional control, cosmesis, and toxicities to other forms of APBI with similar lengths of follow-up. In addition, improved radiation standards for the delivery of APBI were demonstrated.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Abstract Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing ( Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing (<7 mm) and rib spacing (<7 mm) than in MS patients (45.5% vs. 12.1%, p = 0.0057 and 57.6 vs. 33.3, p = 0.0131, respectively). Despite closer skin spacing, the overall median skin dose was significantly lower in C-MLB patients (112% of the PD vs. 134%, p = 0.0282). No statistically significant differences in the V150 or V200 were observed. In patients with very limited rib spacing (<4 mm), the C-MLB delivered significantly lower rib doses than the MS (144% of the PD vs. 191%, p = 0.0107). In all clinical scenarios, coverage of the PTV with the C-MLB was either equal to or significantly better than with the MS (p = 0.0024). Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • Ductal Carcinoma in Situ of the Breast Treated with Accelerated Partial Breast Irradiation Using Balloon-Based Brachytherapy
    Annals of Surgical Oncology, 2010
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Mark Mclaughlin, Frank Vicini, Keri Grier, Maureen Lyden
    Abstract:

    Background We reviewed our institution’s experience treating patients with ductal carcinoma in situ (DCIS) of the breast with balloon-based accelerated partial breast irradiation (APBI) to determine the efficacy of this treatment approach in this group of patients. Materials and Methods A total of 126 cases of DCIS seen and treated with APBI using balloon-based Brachytherapy constitute the study population. The median age at diagnosis was 59 years (range, 37–82) with 21% younger than age 50. Nuclear grade distribution was 52.5, 41.4, and 6.1% high, intermediate and low, respectively. Of these patients, 86% had estrogen receptor positive DCIS. The median tumor size was 6 mm (range, 1–26). Margins of excision were negative in 98.4% of patients. All patients were treated with 34 Gy in 10 fractions using either the MammoSite™ or Contura™ breast Brachytherapy Catheter. A total of 87 patients (73.1%) were placed on adjuvant tamoxifen or arimedex. Results With a median follow-up of 24 months (range, 0.7–73.9), three (2.4%) ipsilateral breast tumor recurrences (IBTRs) developed for a 2-year actuarial rate of 0.81%. Recurrences developed 4.8, 24.7, and 24.9 months after treatment. On univariate analysis, no variable was associated with IBTR. A subset analysis of the first 50 consecutive patients treated was also performed. With a median follow-up of 40 months (range, 15.6–73.9), one IBTR developed for a 3-year actuarial rate of 2.15%. Conclusions Early results in patients with DCIS treated with APBI using balloon-based Brachytherapy produced results similar to those with invasive cancer treated with APBI or DCIS treated with whole breast irradiation.

  • initial surgical experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the contura multi lumen balloon breast Brachytherapy Catheter
    American Surgeon, 2009
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Kenneth Haile, Keith Pope
    Abstract:

    We reviewed our surgical experience with the Contura® Multi Lumen Balloon breast Brachytherapy Catheter used to deliver accelerated partial breast irradiation and determined short-term treatment ef...

Sheree Brown - One of the best experts on this subject based on the ideXlab platform.

  • three year clinical outcome using the contura multilumen balloon breast Brachytherapy Catheter to deliver accelerated partial breast irradiation apbi improving radiation standards for the optimal application of apbi
    Brachytherapy, 2012
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Sheree Brown, Mark Mclaughlin, Keith Pope
    Abstract:

    Abstract Purpose We reviewed our institution’s 3-year clinical experience in treating patients with the Contura multilumen balloon (SenoRx, Inc., Aliso Viejo, CA) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI). Methods and Materials Forty-six patients treated with breast-conserving therapy received adjuvant radiation using the Contura Catheter (34 Gy in 3.4 Gy fractions). Fourteen patients had Stage 0, 24 had Stage I, and 8 had Stage II breast cancer. Median follow-up was 36 months (range, 1–44 months). Results Only one local recurrence developed (2%). The rate of persistent seroma formation at latest reported follow-up was 4.3% (2 patients) and the incidence of any clinically detectable telengiectasias was 2.2%. No major toxicities (0% Grade III) have occurred. The median skin dose (% of the prescribed dose) was 99.7. The median dose to 95% of the planning target volume for evaluation was 98.8%. The percentage of patients with excellent/good cosmetic results at 24 (n = 23) and 36 (n = 22) months was 100% and 97%, respectively. Conclusion Adjuvant APBI using the Contura multilumen balloon Catheter exhibited similar locoregional control, cosmesis, and toxicities to other forms of APBI with similar lengths of follow-up. In addition, improved radiation standards for the delivery of APBI were demonstrated.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Abstract Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing ( Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing (<7 mm) and rib spacing (<7 mm) than in MS patients (45.5% vs. 12.1%, p = 0.0057 and 57.6 vs. 33.3, p = 0.0131, respectively). Despite closer skin spacing, the overall median skin dose was significantly lower in C-MLB patients (112% of the PD vs. 134%, p = 0.0282). No statistically significant differences in the V150 or V200 were observed. In patients with very limited rib spacing (<4 mm), the C-MLB delivered significantly lower rib doses than the MS (144% of the PD vs. 191%, p = 0.0107). In all clinical scenarios, coverage of the PTV with the C-MLB was either equal to or significantly better than with the MS (p = 0.0024). Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • initial radiation experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the contura multi lumen balloon breast Brachytherapy Catheter
    Brachytherapy, 2009
    Co-Authors: Sheree Brown, Kenneth Haile, Keith Pope, Mark Mclaughlin, Laurie Hughes, Philip Z Israel
    Abstract:

    PURPOSE: We reviewed our institution's experience treating patients with the Contura Multi-Lumen Balloon (SenoRx, Inc., Irvine, CA) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation. METHODS AND MATERIALS: Forty-one patients treated with breast-conserving therapy received adjuvant radiation using the Contura Catheter (34 Gy in 3.4 Gy fractions). Thirteen patients had Stage 0, 21 had Stage I, and 7 had Stage II breast cancer. Median followup was 8 months (range, 1e17). RESULTS: Median, minimum skin spacing was 10 mm (range, 2e17). Median, maximum skin doses (% of prescribed dose (PD)) were 99.7 (range, 57.1e124.1). Eight patients were treated with a skin spacing <5 mm and 2 had a spacing of 2 mm. Median, maximum rib doses were 102.6% of PD (10.0e187.7), and the median percentage of the planning target volume for evaluation (PTV_EVAL) receiving 95% of the PD was 98.8 (range, 79.4e107.4). The median volume receiving 200% of the PD was 5.7 cc (range, 1.3e9.9). The percentage of patients with excel- lent/good cosmetic results at 6 months (n 5 15) and 12 months (n 5 12) was 100%. Patient toler- ance was assessed on a scale 0e10 (0 5 no pain, 10 5 requiring narcotic analgesics). In 37 out of 38 patients, pain was graded <3 at the time of Catheter insertion. Four breast infections (11%) and one transient symptomatic seroma (3%) developed. CONCLUSION: Adjuvant accelerated partial breast irradiation using the Contura Multi-Lumen Balloon Catheter exhibited similar toxicities to standard single lumen balloon Brachytherapy with improvements in dosimetric capabilities (i.e., reduced skin and rib doses and improved PTV_EVAL coverage). 2009 Published by Elsevier Inc on behalf of American Brachytherapy Society.

  • Initial radiation experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the Contura Multi-Lumen Balloon breast Brachytherapy Catheter
    Brachytherapy, 2009
    Co-Authors: Sheree Brown, Kenneth Haile, Mark Mclaughlin, D. Keith Pope, Laurie Hughes, Philip Z Israel
    Abstract:

    PURPOSE: We reviewed our institution's experience treating patients with the Contura Multi-Lumen Balloon (SenoRx, Inc., Irvine, CA) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation. METHODS AND MATERIALS: Forty-one patients treated with breast-conserving therapy received adjuvant radiation using the Contura Catheter (34 Gy in 3.4 Gy fractions). Thirteen patients had Stage 0, 21 had Stage I, and 7 had Stage II breast cancer. Median followup was 8 months (range, 1e17). RESULTS: Median, minimum skin spacing was 10 mm (range, 2e17). Median, maximum skin doses (% of prescribed dose (PD)) were 99.7 (range, 57.1e124.1). Eight patients were treated with a skin spacing

Frank A Vicini - One of the best experts on this subject based on the ideXlab platform.

  • long term results from the contura multilumen balloon breast Brachytherapy Catheter phase 4 registry trial
    International Journal of Radiation Oncology Biology Physics, 2014
    Co-Authors: Laurie W Cuttino, Douglas W Arthur, Frank A Vicini, D Todor, Thomas B Julian, Nitai Mukhopadhyay
    Abstract:

    Purpose To describe the long-term outcomes from a completed, multi-institutional phase 4 registry trial using the Contura multilumen balloon (CMLB) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer. Methods and Materials Three hundred forty-two evaluable patients were enrolled by 23 institutions between January 2008 and February 2011. All patients received 34 Gy in 10 fractions, delivered twice daily. Rigorous target coverage and normal tissue dose constraints were observed. Results The median follow-up time was 36 months (range, 1-54 months). For the entire patient cohort of 342 patients, 10 patients experienced an ipsilateral breast tumor recurrence (IBTR). Eight of these IBTR were classified as true recurrences/marginal miss (TRMM), and 2 were elsewhere failures (EF). Local recurrence-free survival was 97.8% at 3 years. For the entire cohort, 88% of patients had good to excellent overall cosmesis. The overall incidence of infection was 8.5%. Symptomatic seroma was reported in only 4.4% of patients. A separate analysis was performed to determine whether improved outcomes would be observed for patients treated at high-volume centers with extensive Brachytherapy experience. Three IBTR were observed in this cohort, only 1 of which was classified as a TRMM. Local recurrence-free survival at high-volume centers was 98.1% at 3 years. Overall cosmetic outcome and toxicity were superior in patients treated at high-volume centers. In these patients, 95% had good to excellent overall cosmesis. Infection was observed in only 2.9% of patients, and symptomatic seroma was reported in only 1.9%. Conclusion Use of the CMLB for APBI delivery is associated with acceptable long-term local control and toxicity. Local recurrence-free survival was 97.8% at 3 years. Significant (grade 3) toxicity was uncommon, and no grade 4 toxicity was observed. Treatment at high-volume centers was associated with decreased late toxicity.

  • contura multi lumen balloon breast Brachytherapy Catheter comparative dosimetric findings of a phase 4 trial
    International Journal of Radiation Oncology Biology Physics, 2013
    Co-Authors: Douglas W Arthur, Frank A Vicini, D Todor, Thomas B Julian, Laurie W Cuttino, Nitai Mukhopadhyay
    Abstract:

    Purpose Final dosimetric findings of a completed, multi-institutional phase 4 registry trial using the Contura Multi-Lumen Balloon (MLB) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer are presented. Methods and Materials Three dosimetric plans with identical target coverage were generated for each patient for comparison: multilumen multidwell (MLMD); central-lumen multidwell (CLMD); and central-lumen single-dwell (CLSD) loading of the Contura Catheter. For this study, a successful treatment plan achieved ideal dosimetric goals and included the following: ≥95% of the prescribed dose (PD) covering ≥95% of the target volume (TV); maximum skin dose ≤125% of the PD; maximum rib dose ≤145% of the PD; and V150 ≤50 cc and V200 ≤10 cc. Results Between January 2008 and February 2011, 23 institutions participated. A total of 318 patients were available for dosimetric review. Using the Contura MLB, all dosimetric criteria were met in 78.93% of cases planned with MLMD versus 55.38% with the CLMD versus 37.66% with the CLSD ( P ≤.0001). Evaluating all patients with the full range of skin to balloon distance represented, median maximum skin dose was reduced by 12% and median maximum rib dose by 13.9% when using MLMD-based dosimetric plans compared to CLSD. The dosimetric benefit of MLMD was further demonstrated in the subgroup of patients where skin thickness was Conclusions Use of the Contura MLB Catheter produced statistically significant improvements in dosimetric capabilities between CLSD and CLMD treatments. This device approach demonstrates the ability not only to overcome the barriers of limited skin thickness and close rib proximity, but to consistently achieve a higher standard of dosimetric planning goals.

  • optimal application of the contura multilumen balloon breast Brachytherapy Catheter vacuum port to deliver accelerated partial breast irradiation
    Brachytherapy, 2011
    Co-Authors: Kenneth M Tokita, Douglas W Arthur, Frank A Vicini, Thomas B Julian, Laurie W Cuttino, Dorin A Todor, Maureen Lyden
    Abstract:

    Abstract Purpose The impact of using the Contura multilumen balloon (MLB) (SenoRx, Inc., Irvine, CA) breast Brachytherapy Catheter’s vacuum port in patients treated with accelerated partial breast irradiation (APBI) was analyzed. Methods and Materials Data from 32 patients at two sites were reviewed. Variables analyzed included the seroma fluid (SF):air volume around the MLB before and after vacuum port use and on its ability to improve ( 1 ) the eligibility of patients for APBI and ( 2 ) dose coverage of the planning target volume for evaluation (PTV_EVAL) in eligible patients. Results The median SF/air volume before vacuum removal was 6.8 cc vs. 0.8 cc after vacuum removal (median reduction in SF/air volume was 90.5%). Before vacuum port use, the median SF/air volume expressed as percentage of the PTV_EVAL was 7.8% (range, 1.9–26.6) in all patients. After application of the vacuum, this was reduced to 1.2%. Before vacuum port use, 10 (31.3%) patients were not considered acceptable candidates for APBI because the SF/air volume:PTV_EVAL ratio (SF:PTV) was greater than 10% (range, 10.1–26.6%; median, 15.2%). After vacuum port use, the median SF:PTV ratio was 1.6% for a median reduction of 91.5%. In addition, the percentage of the prescribed dose covering greater than or equal to 90% of the PTV_EVAL proportionally increased a median of 8% (range, 3–10%) in eligible patients. Conclusion Use of the Contura MLB vacuum port significantly improved the conformity of the target tissue to the balloon surface, leading to reproducible dose delivery and increased target volume coverage. In addition, application of the vacuum allowed the safe treatment of unacceptable patients with APBI.

  • improvements in critical dosimetric endpoints using the contura multilumen balloon breast Brachytherapy Catheter to deliver accelerated partial breast irradiation preliminary dosimetric findings of a phase iv trial
    International Journal of Radiation Oncology Biology Physics, 2011
    Co-Authors: Douglas W Arthur, Frank A Vicini, D Todor, Thomas B Julian, Maureen Lyden
    Abstract:

    Purpose Dosimetric findings in patients treated with the Contura multilumen balloon (MLB) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI) on a multi-institutional Phase IV registry trial are presented. Methods and Materials Computed tomography–based three-dimensional planning with dose optimization was performed. For the trial, new ideal dosimetric goals included (1) ≥95% of the prescribed dose (PD) covering ≥90% of the target volume, (2) a maximum skin dose ≤125% of the PD, (3) maximum rib dose ≤145% of the PD, and (4) the V150 ≤50 cc and V200 ≤10 cc. The ability to concurrently achieve these dosimetric goals using the Contura MLB was analyzed. Results 144 cases were available for review. Using the MLB, all dosimetric criteria were met in 76% of cases. Evaluating dosimetric criteria individually, 92% and 89% of cases met skin and rib dose criteria, respectively. In 93% of cases, ideal target volume coverage goals were met, and in 99%, dose homogeneity criteria (V150 and V200) were satisfied. When skin thickness was ≥5 mm to Conclusion The Contura MLB Catheter provided the means of achieving the imposed higher standard of dosimetric goals in the majority of clinical scenarios encountered.

  • Status of Accelerated Partial Breast Irradiation
    Current Breast Cancer Reports, 2010
    Co-Authors: Simona F. Shaitelman, Frank A Vicini
    Abstract:

    Breast-conserving therapy is accepted as a standard of care option for patients with early-stage breast cancer. However, studies examining patterns of failure after treatment suggest that a lengthy course of adjuvant whole breast irradiation delivered as a component of breast-conserving therapy may not always be necessary; indeed, in appropriately selected patients, radiation therapy delivered only to the tumor bed may be acceptable. Several modalities of delivering accelerated partial breast irradiation (APBI) have been developed, the most prevalent being multi-Catheter interstitial Brachytherapy, the MammoSite breast Brachytherapy Catheter (Hologic Corporation, Bedford, MA) and three-dimensional conformal external-beam radiation therapy. The purpose of this article is to review the published experiences on the most common modalities of delivering APBI and to outline the current open national phase 3 trial. To date, phase 1/2 studies have demonstrated excellent local control and cosmetic outcomes in early-stage breast cancer patients treated with APBI. As increasing knowledge is accumulated regarding the efficacy and safety of APBI, a consensus will emerge regarding its potential replacement of whole breast irradiation in selected early-stage breast cancer patients.

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  • three year clinical outcome using the contura multilumen balloon breast Brachytherapy Catheter to deliver accelerated partial breast irradiation apbi improving radiation standards for the optimal application of apbi
    Brachytherapy, 2012
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Sheree Brown, Mark Mclaughlin, Keith Pope
    Abstract:

    Abstract Purpose We reviewed our institution’s 3-year clinical experience in treating patients with the Contura multilumen balloon (SenoRx, Inc., Aliso Viejo, CA) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation (APBI). Methods and Materials Forty-six patients treated with breast-conserving therapy received adjuvant radiation using the Contura Catheter (34 Gy in 3.4 Gy fractions). Fourteen patients had Stage 0, 24 had Stage I, and 8 had Stage II breast cancer. Median follow-up was 36 months (range, 1–44 months). Results Only one local recurrence developed (2%). The rate of persistent seroma formation at latest reported follow-up was 4.3% (2 patients) and the incidence of any clinically detectable telengiectasias was 2.2%. No major toxicities (0% Grade III) have occurred. The median skin dose (% of the prescribed dose) was 99.7. The median dose to 95% of the planning target volume for evaluation was 98.8%. The percentage of patients with excellent/good cosmetic results at 24 (n = 23) and 36 (n = 22) months was 100% and 97%, respectively. Conclusion Adjuvant APBI using the Contura multilumen balloon Catheter exhibited similar locoregional control, cosmesis, and toxicities to other forms of APBI with similar lengths of follow-up. In addition, improved radiation standards for the delivery of APBI were demonstrated.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Abstract Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing ( Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • a dosimetric comparison of the contura multilumen balloon breast Brachytherapy Catheter vs the single lumen mammosite balloon device in patients treated with accelerated partial breast irradiation at a single institution
    Brachytherapy, 2011
    Co-Authors: Sheree Brown, Philip Z Israel, Kenneth Haile, Mark Mclaughlin, Doyle Keith Pope, Lorie Hughes, Maureen Lyden
    Abstract:

    Purpose A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast Brachytherapy Catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. Methods and Materials CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34 Gy in 3.4 Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. Results The C-MLB was placed more frequently in patients with closer skin spacing (<7 mm) and rib spacing (<7 mm) than in MS patients (45.5% vs. 12.1%, p = 0.0057 and 57.6 vs. 33.3, p = 0.0131, respectively). Despite closer skin spacing, the overall median skin dose was significantly lower in C-MLB patients (112% of the PD vs. 134%, p = 0.0282). No statistically significant differences in the V150 or V200 were observed. In patients with very limited rib spacing (<4 mm), the C-MLB delivered significantly lower rib doses than the MS (144% of the PD vs. 191%, p = 0.0107). In all clinical scenarios, coverage of the PTV with the C-MLB was either equal to or significantly better than with the MS (p = 0.0024). Conclusion The C-MLB Catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.

  • Ductal Carcinoma in Situ of the Breast Treated with Accelerated Partial Breast Irradiation Using Balloon-Based Brachytherapy
    Annals of Surgical Oncology, 2010
    Co-Authors: Philip Z Israel, Angela B Robbins, Paulomi Shroff, Mark Mclaughlin, Frank Vicini, Keri Grier, Maureen Lyden
    Abstract:

    Background We reviewed our institution’s experience treating patients with ductal carcinoma in situ (DCIS) of the breast with balloon-based accelerated partial breast irradiation (APBI) to determine the efficacy of this treatment approach in this group of patients. Materials and Methods A total of 126 cases of DCIS seen and treated with APBI using balloon-based Brachytherapy constitute the study population. The median age at diagnosis was 59 years (range, 37–82) with 21% younger than age 50. Nuclear grade distribution was 52.5, 41.4, and 6.1% high, intermediate and low, respectively. Of these patients, 86% had estrogen receptor positive DCIS. The median tumor size was 6 mm (range, 1–26). Margins of excision were negative in 98.4% of patients. All patients were treated with 34 Gy in 10 fractions using either the MammoSite™ or Contura™ breast Brachytherapy Catheter. A total of 87 patients (73.1%) were placed on adjuvant tamoxifen or arimedex. Results With a median follow-up of 24 months (range, 0.7–73.9), three (2.4%) ipsilateral breast tumor recurrences (IBTRs) developed for a 2-year actuarial rate of 0.81%. Recurrences developed 4.8, 24.7, and 24.9 months after treatment. On univariate analysis, no variable was associated with IBTR. A subset analysis of the first 50 consecutive patients treated was also performed. With a median follow-up of 40 months (range, 15.6–73.9), one IBTR developed for a 3-year actuarial rate of 2.15%. Conclusions Early results in patients with DCIS treated with APBI using balloon-based Brachytherapy produced results similar to those with invasive cancer treated with APBI or DCIS treated with whole breast irradiation.

  • initial radiation experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the contura multi lumen balloon breast Brachytherapy Catheter
    Brachytherapy, 2009
    Co-Authors: Sheree Brown, Kenneth Haile, Keith Pope, Mark Mclaughlin, Laurie Hughes, Philip Z Israel
    Abstract:

    PURPOSE: We reviewed our institution's experience treating patients with the Contura Multi-Lumen Balloon (SenoRx, Inc., Irvine, CA) breast Brachytherapy Catheter to deliver accelerated partial breast irradiation. METHODS AND MATERIALS: Forty-one patients treated with breast-conserving therapy received adjuvant radiation using the Contura Catheter (34 Gy in 3.4 Gy fractions). Thirteen patients had Stage 0, 21 had Stage I, and 7 had Stage II breast cancer. Median followup was 8 months (range, 1e17). RESULTS: Median, minimum skin spacing was 10 mm (range, 2e17). Median, maximum skin doses (% of prescribed dose (PD)) were 99.7 (range, 57.1e124.1). Eight patients were treated with a skin spacing <5 mm and 2 had a spacing of 2 mm. Median, maximum rib doses were 102.6% of PD (10.0e187.7), and the median percentage of the planning target volume for evaluation (PTV_EVAL) receiving 95% of the PD was 98.8 (range, 79.4e107.4). The median volume receiving 200% of the PD was 5.7 cc (range, 1.3e9.9). The percentage of patients with excel- lent/good cosmetic results at 6 months (n 5 15) and 12 months (n 5 12) was 100%. Patient toler- ance was assessed on a scale 0e10 (0 5 no pain, 10 5 requiring narcotic analgesics). In 37 out of 38 patients, pain was graded <3 at the time of Catheter insertion. Four breast infections (11%) and one transient symptomatic seroma (3%) developed. CONCLUSION: Adjuvant accelerated partial breast irradiation using the Contura Multi-Lumen Balloon Catheter exhibited similar toxicities to standard single lumen balloon Brachytherapy with improvements in dosimetric capabilities (i.e., reduced skin and rib doses and improved PTV_EVAL coverage). 2009 Published by Elsevier Inc on behalf of American Brachytherapy Society.