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

Musat, Elena; Poortmans, Philip; Van den Bogaert, Walter; Struikmans, Henk; Fourquet, Alain; Bartelink, Harry; Kirkove, Carine; Budach, Volker; Pierart, Marianne; Collette, Laurence

doi:10.1016/J.EJCA.2006.11.015

Title

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

Author

Musat, Elena

Poortmans, Philip

Van den Bogaert, Walter

Struikmans, Henk

Fourquet, Alain

Bartelink, Harry

Kirkove, Carine

Budach, Volker

Pierart, Marianne

Collette, Laurence

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.

Language

English

Source (journal)

European journal of cancer. - Oxford, 1990, currens

Publication

Oxford : 2007

ISSN

0959-8049 [print]

1879-0852 [online]

DOI

10.1016/J.EJCA.2006.11.015

Volume/pages