1
142348
http://www.ncbi.nlm.nih.gov/pubmed/23728947
MDACC recent publication. Dr. Smith writes articles about the increased cost and overutilization of breast IMRT but yet is co-author on an APBI study with protons which is frankly ridiculous when looking at cost. He has presented several retrospective, observational studies about the negatives of breast brachy that fly in the face of prospective data but then thinks that small single institution proton APBI studies make sense. I struggle with the logic here when you have good data on 3D-CRT APBI (Dr. Julian presented at ASCO in 2012) and several randomized Phase IIIs which will be published in the next few years. Does anyone really think that APBI with protons is a reasonable future compared with APBI with multilumen brachy or even IMRT (like the recent Rocky Mountain study that was published)?
Early toxicity results with 3D conformal external beam therapy (CEBT) from the NSABP B-39/RTOG 0413 accelerated partial breast irradiation (APBI) trial.
Subcategory:
Local Therapy
Category:
Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy
Meeting:
2011 ASCO Annual Meeting
Session Type and Session Title:
Poster Discussion Session, Breast Cancer - Triple-negative/Cytotoxics/Local Therapy
Abstract Number:
1011
Citation:
J Clin Oncol 29: 2011 (suppl; abstr 1011)
Author(s):
T. B. Julian, J. P. Costantino, F. A. Vicini, J. R. White, K. A. Winter, D. W. Arthur, R. R. Kuske, R. Rabinovitch, D. S. Parda, E. P. Mamounas, W. J. Curran, N. Wolmark; National Surgical Adjuvant Breast and Bowel Project and Allegheny General Hospital, Pittsburgh, PA; Biostatistical Center, National Surgical Adjuvant Breast and Bowel Project and Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA; William Beaumont Hospital, Royal Oak, MI; Radiation Therapy Oncology Group and Medical College of Wisconsin, Milwaukee, WI; RTOG Statistical Center, Philadelphia, PA; National Surgical Adjuvant Breast and Bowel Project and Virginia Commonwealth University, Richmond, VA; National Surgical Adjuvant Breast and Bowel Project and Arizona Breast Cancer Specialists, Scottsdale, AZ; NSABP; University of Colorado, Aurora, CO; NSABP and Allegheny General Hospital, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and Aultman Health Foundation, Canton, OH; Radiation Therapy Oncology Group and Emory University, Atlanta, GA
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Abstract Disclosures
Abstract:
Background: APBI is now being used clinically and is being evaluated in 6 clinical trials in which several forms of fractionated external beam for APBI are being used. Recent publications and presentations from small single-institution series have reported significant short-term toxicities related to 3-D CEBT, a type of APBI under evaluation in NSABP B-39/RTOG 0413. Given those results, we believe it necessary to report the current levels of toxicity in the 3-D conformal portion of the APBI arm of our trial. Methods: NSABP B-39/RTOG 0413, a multi-institutional randomized phase III trial, compares whole-breast irradiation with APBI. Included is an electronic CT- data submission process that serves as the basis of a rigorous QA program used in all 3 types of APBI, assuring dosimetric compliance. Closely monitored data on patients randomized to the APBI arm and undergoing 3-D CEBT were reviewed for overall toxicity, specifically for toxicity related to fibrosis-cosmesis and fibrosis-deep connective tissue, based on CTCAEv3.0 and NSABP/RTOG CTCAE criteria. Results: 3,862 patients are enrolled (89.8% of target accrual). Toxicity data are available for 1386 patients randomized to APBI who have received 3-D CEBT, with 974 of the latter group in their 3rd year of follow-up. With a mean time on study of 41.0 months, no significant toxicity-related issues have been raised. The rates of fibrosis-cosmesis and fibrosis-deep connective tissue toxicities are: Grade 2 ≤12%, Grade 3 ≤3% and Grade 4/5 =0% for the 3-D CEBT used in the trial. Conclusions: Contrary to findings in recent published reports the 3-D conformal APBI toxicity rates in our trial are acceptably low. Our trial surpasses others reported in patient number and length of follow-up, emphasizing the importance of large phase III randomized trials with rigorous QA to determine treatment outcomes and avoid the bias that can arise from small single-institution series. The continuation of accrual to this trial is critically important so that APBI efficacy, long-term toxicity, and QOL outcomes can be accurately assessed. Supported by NCI-U10-CA-12027, U10-CA-37377, U10-CA-69974, U10-CA-69651, and U10-CA-21661.
MDACC recent publication. Dr. Smith writes articles about the increased cost and overutilization of breast IMRT but yet is co-author on an APBI study with protons which is frankly ridiculous when looking at cost. He has presented several retrospective, observational studies about the negatives of breast brachy that fly in the face of prospective data but then thinks that small single institution proton APBI studies make sense. I struggle with the logic here when you have good data on 3D-CRT APBI (Dr. Julian presented at ASCO in 2012) and several randomized Phase IIIs which will be published in the next few years. Does anyone really think that APBI with protons is a reasonable future compared with APBI with multilumen brachy or even IMRT (like the recent Rocky Mountain study that was published)?
Early toxicity results with 3D conformal external beam therapy (CEBT) from the NSABP B-39/RTOG 0413 accelerated partial breast irradiation (APBI) trial.
Subcategory:
Local Therapy
Category:
Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy
Meeting:
2011 ASCO Annual Meeting
Session Type and Session Title:
Poster Discussion Session, Breast Cancer - Triple-negative/Cytotoxics/Local Therapy
Abstract Number:
1011
Citation:
J Clin Oncol 29: 2011 (suppl; abstr 1011)
Author(s):
T. B. Julian, J. P. Costantino, F. A. Vicini, J. R. White, K. A. Winter, D. W. Arthur, R. R. Kuske, R. Rabinovitch, D. S. Parda, E. P. Mamounas, W. J. Curran, N. Wolmark; National Surgical Adjuvant Breast and Bowel Project and Allegheny General Hospital, Pittsburgh, PA; Biostatistical Center, National Surgical Adjuvant Breast and Bowel Project and Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA; William Beaumont Hospital, Royal Oak, MI; Radiation Therapy Oncology Group and Medical College of Wisconsin, Milwaukee, WI; RTOG Statistical Center, Philadelphia, PA; National Surgical Adjuvant Breast and Bowel Project and Virginia Commonwealth University, Richmond, VA; National Surgical Adjuvant Breast and Bowel Project and Arizona Breast Cancer Specialists, Scottsdale, AZ; NSABP; University of Colorado, Aurora, CO; NSABP and Allegheny General Hospital, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and Aultman Health Foundation, Canton, OH; Radiation Therapy Oncology Group and Emory University, Atlanta, GA
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Abstract Disclosures
Abstract:
Background: APBI is now being used clinically and is being evaluated in 6 clinical trials in which several forms of fractionated external beam for APBI are being used. Recent publications and presentations from small single-institution series have reported significant short-term toxicities related to 3-D CEBT, a type of APBI under evaluation in NSABP B-39/RTOG 0413. Given those results, we believe it necessary to report the current levels of toxicity in the 3-D conformal portion of the APBI arm of our trial. Methods: NSABP B-39/RTOG 0413, a multi-institutional randomized phase III trial, compares whole-breast irradiation with APBI. Included is an electronic CT- data submission process that serves as the basis of a rigorous QA program used in all 3 types of APBI, assuring dosimetric compliance. Closely monitored data on patients randomized to the APBI arm and undergoing 3-D CEBT were reviewed for overall toxicity, specifically for toxicity related to fibrosis-cosmesis and fibrosis-deep connective tissue, based on CTCAEv3.0 and NSABP/RTOG CTCAE criteria. Results: 3,862 patients are enrolled (89.8% of target accrual). Toxicity data are available for 1386 patients randomized to APBI who have received 3-D CEBT, with 974 of the latter group in their 3rd year of follow-up. With a mean time on study of 41.0 months, no significant toxicity-related issues have been raised. The rates of fibrosis-cosmesis and fibrosis-deep connective tissue toxicities are: Grade 2 ≤12%, Grade 3 ≤3% and Grade 4/5 =0% for the 3-D CEBT used in the trial. Conclusions: Contrary to findings in recent published reports the 3-D conformal APBI toxicity rates in our trial are acceptably low. Our trial surpasses others reported in patient number and length of follow-up, emphasizing the importance of large phase III randomized trials with rigorous QA to determine treatment outcomes and avoid the bias that can arise from small single-institution series. The continuation of accrual to this trial is critically important so that APBI efficacy, long-term toxicity, and QOL outcomes can be accurately assessed. Supported by NCI-U10-CA-12027, U10-CA-37377, U10-CA-69974, U10-CA-69651, and U10-CA-21661.
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