Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes

Musat, Elena;Kirkove, Carine;Poortmans, Philip;Van den Bogaert, Walter;Collette, Laurence;et.al.
(2007) European Journal of Cancer — Vol. 43, n° 4, p. 718-724 (2007)

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Authors
  • Musat, Elena
    Author
  • Kirkove, CarineUCLouvain
    Author
  • Poortmans, Philip
    Author
  • Van den Bogaert, Walter
    Author
  • Collette, Laurence
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Abstract
The EORTC 22922/10925 trial randomly compares irradiation or no irradiation of the internal mammary and medio supraclavicular ( M-MS) nodes for stage I-III breast cancer. We report on the characteristics of 4004 participating patients, aspects of quality assurance and compliance to protocol treatment. The actual population has intermediate-risk disease: 51.8% stage II, 56% positive axillary nodes. The allocated treatment was not followed in 3.2% in the IM-MS irradiation arm versus 2% in the no IM-MS irradiation arm. In the IMMS arm, there were major deviations for dose in 0.8%, surgery- to-radiotherapy time interval in 3.9% and in overall treatment time in 0.9% cases. Major deviations were found in 7.9% patients in the IM-MS group and in 2% patients in the no IM-MS group. In the final trial analysis, a sensitivity analysis should evaluate the subgroup of patients receiving an optimal treatment to verify the robustness of the results and the true impact of IM-MS irradiation. (c) 2006 Elsevier Ltd. All rights reserved.
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Citations

Musat, E., Kirkove, C., Poortmans, P., Van den Bogaert, W., Struikmans, H., Fourquet, A., Bartelink, H., Budach, V., Pierart, M., & Collette, L. (2007). Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. European Journal of Cancer, 43(4), 718-724. https://doi.org/10.1016/j.ejca.2006.11.015 (Original work published 2007)