Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes.
The EORTC 22922/10925 trial randomly compares irradiation or no irradiation of the internal mammary and medio supraclavicular (IM-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 IM-MS 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.
Musat
Elena
E
EORTC, Avenue E. Mounierlaan, 83/11, 1200 Brussels, Belgium. elena.musat@eortc.be
Poortmans
Philip
P
Van den Bogaert
Walter
W
Struikmans
Henk
H
Fourquet
Alain
A
Bartelink
Harry
H
Kirkove
Carine
C
Budach
Volker
V
Pierart
Marianne
M
Collette
Laurence
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D001365:Axilla; D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis / Q000532:radiotherapy*; D008875:Middle Aged; D010349:Patient Compliance; D011785:Quality Assurance, Health Care; D013997:Time Factors