Trial | NSABP-17 | EORTC10853 | UKCCCR | SWE-DCIS |
---|---|---|---|---|
Characteristic | ||||
Date | 1985–1990 | 1986–1996 | 1990–1998 | 1987–1999 |
Patients Randomised | 818 | 1010 | 1030 | 1046 |
Median follow-up | 12 YEARS | 4 YEARS | 4.3 YEARS | 5.2 YEARS |
Symptomatic | 19% | 28% | NA | 12.9% |
Central path review | 76% | 85% | 79% | 20% |
Dose | 50 Gy/25 Fraction | 50 Gy/25 Fractions | 50 Gy/25 Fractions | 50 – 54 Gy/25–27 fractions |
Quality by Jadad | 4 | 4 | 4 | 4 |
Population | Pre- and post-menopausal Pts. All pts had tumour free margins after BCT. Women with localized ductal carcinoma in situ detected by physical examination or mammography were eligible, both ductal carcinoma in situ and lobular carcinoma in situ were also eligible. RT 411 pts BCT403 pts | DCIS<5 cm 1 002/1 010 pts analysed Extent of free margins was not specified, evidence of invasive carcinoma or Paget's disease of the nipple, were ineligible for the study. RT 502 pts BCT 500 pts | Screening detected tumor, complete excision of the carcinoma, free margins. typical ductal hiperplasia excluded. Excluded patients with lobular carcinoma in situ or atypical ductal hyperplasia in the absence of ductal carcinoma in situ, those in whom pathological margins of disease were uncertain, and people with Paget's disease of the nipple. RT 267 BCT 544 | Pathology margins clear, DCIS grade I and II B/2 mm were classified as atypical ductal hyperplasia Exclusion criteria were Paget's disease of the nipple, invasive carcinoma or intracystic carcinoma in situ, ongoing pregnancy or a history of previous or concurrent malignancy RT 534 BCT 533 |