Highlights
- •In high-risk early breast cancer (BC), pathological complete response (pCR) rates of intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly paclitaxel plus non-pegylated liposomal doxorubicin with additional carboplatin in triple-negative breast cancer PM(Cb) were similar.
- •Weekly PM(Cb) led to more dose reductions, treatment delays and overall toxicity.
- •In patients with lymphocyte-predominant BC, pCR rate was significantly higher with iddEPC.
Abstract
Background
GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early
breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel,
and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated
liposomal doxorubicin (M, Myocet®) with additional carboplatin (PM(Cb)) in triple-negative
BC (TNBC).
Patients and methods
Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor
(HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like
tumours only if pN+.
Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC)
to receive 18 weeks of E (150 mg/m2) followed by P (225 mg/m2) followed by C (2000 mg/m2), each q2w for 3 cycles or weekly P (80 mg/m2) plus M (20 mg/m2) plus, in TNBC, Cb (area under curve (AUC) 1.5). HER2-positive BC patients additionally
received trastuzumab (6 [loading dose 8]mg/kg q3w) and pertuzumab (420 [840]mg q3w)
with all P and C cycles. Primary end-point was pathological complete response (pCR,
ypT0/is ypN0), secondary end-points included other pCR definitions, pCR in stratified
subpopulations, tolerability and compliance. This trial is registered with ClinicalTrials.gov number NCT02125344.
Results
945/961 randomised patients started treatment. The median age was 48 years; 7.6% had
cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%,
with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence
interval 0.77–1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal
B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died.
Conclusions
In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment
with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective dose-dense
regimens feasible in daily practice.
Keywords
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Article info
Publication history
Published online: December 04, 2018
Accepted:
October 29,
2018
Received in revised form:
October 8,
2018
Received:
July 11,
2018
Footnotes
☆Results were presented in part at the Annual ASCO Meeting 2017, June 2–6, 2017, Chicago, Illinois, USA.
Identification
Copyright
© 2018 Elsevier Ltd. All rights reserved.
