TY - JOUR
T1 - Randomized trial on the effect of radiotherapy in addition to 6 cycles CMF in node-positive breast-cancer patients
AU - Schmoor, Claudia
AU - Bastert, Gunther
AU - Dunst, Jürgen
AU - Bojar, Hans
AU - Christmann, Dietmar
AU - Unbehaun, Volker
AU - Tümmers, Gerhard
AU - Bauer, Wolfgang
AU - Sauerbrei, Willi
AU - Schumacher, Martin
N1 - Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2000
Y1 - 2000
N2 - In 1984 the GBSG started a multicenter randomized trial to compare the effectiveness of 6 cycles of cyclophosphamide, methotrexate and fluorouracil (CMF) with or without radiotherapy (RT) as adjuvant treatment in node- positive breast-cancer patients treated by mastectomy. During 5 years, 199 patients were randomized. After a median follow-up of about 9 years, the treatment groups 6 x CMF and 6 x CMF + RT were compared regarding time to recurrence and death. As the first event of failure, we observed locoregional recurrence in 22 patients, distant metastases in 66 patients, a secondary malignancy in 9 patients and death without previous event in 5 patients. For event-free survival (EFS), no significant difference was observed [relative risk (RR) 6 x CMF + RT vs. 6 x CMF 0.82, 95% confidence interval (CI) 0.55- 1.21]. Event-specific analysis showed a significant decreased risk after radiotherapy for locoregional recurrence. The risk for distant metastases was estimated as slightly decreased and the risk for secondary malignancy and for death without previous event was estimated as increased in treatment group 6 x CMF + RT in comparison with treatment group 6 x CMF, but these effects were not significant. For overall survival (OS) and breast-cancer-specific survival (BCS), no significant treatment effect could be demonstrated. There is a beneficial effect of radiotherapy on locoregional recurrence. For EFS and BCS, a tendency in favour of radiotherapy is observed, but this is not significant; for OS, no difference can be demonstrated, but the power of the study is too low to detect small treatment effects. (C) 2000 Wiley-Liss, Inc.
AB - In 1984 the GBSG started a multicenter randomized trial to compare the effectiveness of 6 cycles of cyclophosphamide, methotrexate and fluorouracil (CMF) with or without radiotherapy (RT) as adjuvant treatment in node- positive breast-cancer patients treated by mastectomy. During 5 years, 199 patients were randomized. After a median follow-up of about 9 years, the treatment groups 6 x CMF and 6 x CMF + RT were compared regarding time to recurrence and death. As the first event of failure, we observed locoregional recurrence in 22 patients, distant metastases in 66 patients, a secondary malignancy in 9 patients and death without previous event in 5 patients. For event-free survival (EFS), no significant difference was observed [relative risk (RR) 6 x CMF + RT vs. 6 x CMF 0.82, 95% confidence interval (CI) 0.55- 1.21]. Event-specific analysis showed a significant decreased risk after radiotherapy for locoregional recurrence. The risk for distant metastases was estimated as slightly decreased and the risk for secondary malignancy and for death without previous event was estimated as increased in treatment group 6 x CMF + RT in comparison with treatment group 6 x CMF, but these effects were not significant. For overall survival (OS) and breast-cancer-specific survival (BCS), no significant treatment effect could be demonstrated. There is a beneficial effect of radiotherapy on locoregional recurrence. For EFS and BCS, a tendency in favour of radiotherapy is observed, but this is not significant; for OS, no difference can be demonstrated, but the power of the study is too low to detect small treatment effects. (C) 2000 Wiley-Liss, Inc.
UR - http://www.scopus.com/inward/record.url?scp=0034181451&partnerID=8YFLogxK
U2 - 10.1002/(sici)1097-0215(20000501)86:3<408::aid-ijc16>3.0.co;2-3
DO - 10.1002/(sici)1097-0215(20000501)86:3<408::aid-ijc16>3.0.co;2-3
M3 - Journal articles
C2 - 10760830
AN - SCOPUS:0034181451
SN - 0020-7136
VL - 89
SP - 408
EP - 415
JO - International Journal of Cancer
JF - International Journal of Cancer
IS - 2
ER -