Acta Oncologica

ISSN: 0284-186X (Print) 1651-226X (Online) Journal homepage: https://www.tandfonline.com/loi/ionc20

Concurrent Tamoxifen (TAM) + Cyclophosphamide,

Epirubicin, and Fluorouracil (CEF) Versus Tam +
Delayed Cef After Six Months of Endocrine Therapy
in Metastatic Breast Cancer a Randomized Trial
from the Danish Breast Cancer Cooperative Group
(DBCG)

P. Pfeiffer, C. Rose, B. Ejlertsen, M. Andersson, D. Pedersen & H. T. Mouridsen

To cite this article: P. Pfeiffer, C. Rose, B. Ejlertsen, M. Andersson, D. Pedersen & H. T.

Mouridsen (1996) Concurrent Tamoxifen (TAM) + Cyclophosphamide, Epirubicin, and Fluorouracil
(CEF) Versus Tam + Delayed Cef After Six Months of Endocrine Therapy in Metastatic Breast
Cancer a Randomized Trial from the Danish Breast Cancer Cooperative Group (DBCG), Acta
Oncologica, 35:sup5, 57-57, DOI: 10.3109/02841869609083970

To link to this article: https://doi.org/10.3109/02841869609083970

Published online: 08 Jul 2009.

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 CONCURRENT TAMOXIFEN (TAM) + CYCLOPHOSPHAMIDE, EPIRUBICIN,
AND FLUOROURACIL (CEF) VERSUS TAM + DELAYED CEF AFTER SIX
MONTHS OF ENDOCRINE THERAPY IN METASTATIC BREAST CANCER
A randomized trial from the Danish Breast Cancer Cooperative Group (DBCG)
P. PFEIFFER,C. ROSE, B. EJLERTSEN,M. ANDERSSON,
D. PEDERSEN,
The fundamental assumptions and the key to the design
of our study are non-cross resistance between endocrine
therapy (ET) and cytotoxic therapy (CT), and that ET and
CT produce similar responses in patients with steroid
receptor (estrogen or progesterone receptor) positive dis-
ease (SR +). Based upon these assumptions, the DBCG
85-R1 trial was initiated in 1985 with the aim of compar-
ing Treatment A: concurrent administration of TAM (30
+
mg/d) CEF (C 600 mg/m2, E 60 mg/m2, F 600 mg/m2;
all iv day 1 every 3 weeks) with Treatment B: sequential
administration of TAM for six months followed by
TAM + CEF. TAM was continued until progression (PD),
but was discontinued in patients on treatment B and PD
within six months and replaced by CEF. CEF was contin-
ued up until PD for a maximum of 18 months. Methotrex-
ate (40 mg/m2) replaced E when the cumulative dose
reached 1000 mg/m2.
The trial recruited E R + or PgR+, pre- or post-
From the Department of Oncology R (P. Pfeiffer, C. Rose),
Odense University Hospital, DK-5000 Odense C, Denmark, De-
partment of Oncology (B. Ejlertsen, H.T. Mouridsen), Rigshospi-
talet, Blegdamsvej 9, DK-2100 Copenhagen Iz(, Denmark,
Department of Oncology ( M. Anderson), University Hospital
Herlev, DK-2730 Herlev, Denmark, and Radiumstation (D.
Pedersen), Aalborg Hospital South, 9100 Aalborg, Denmark.
Correspondence to: Per Pfeiffer, Dept. of Oncology, Odense Uni-
versity Hospital, DK-5000 Odense C.
and H. T. MOURIDSEN
menopausal women to first-line systemic therapy for
metastatic breast cancer.
Two hundred and seventy-three patients were random-
ized and 246 (91%) were deemed eligible. Characteristics in
the two groups were comparable: median age 54 years,
median performance status 1 (range: 0-3), and median
observation time, currently 66 months.
Results
Median time to progression: A: 18.1 months; B: 18.4
months ( p = 0.50, log rank).
Median survival: A: 25.7 months; B: 26.6 months ( p = 0.28,
log rank).
Response rate in regimen B to six months of Tam: B: CR
2%, PR 22%.
Cumulative response rates (Tam+CEF): A: CR 19%, PR
35%; B: CR 5%, PR 39% (CR: p=O.OOl; C R + P R :
p = 0.1 1, chi-square).
Performance status, receptor status, site of recurrent
disease and menopausal status, but not dose intensity of
CEF, were predictive factors for outcome.
Concurrent CEF definitely increases response rates but
does not improve the therapeutic outcome in patients with
advanced SR + breast cancer treated initially with TAM.
We conclude that TAM alone is appropriate in patients
with asymptomatic SR+ advanced breast cancer but in
symptomatic patients, we recommend concurrent treat-
ment with TAM and CEF.
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