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Clinical Trial
. 2021 May;124(11):1795-1802.
doi: 10.1038/s41416-021-01284-2. Epub 2021 Mar 24.

Conventional versus reverse sequence of neoadjuvant epirubicin/cyclophosphamide and docetaxel: sequencing results from ABCSG-34

Rupert Bartsch  1 , Christian F Singer  2 , Georg Pfeiler  2 , Michael Hubalek  3 , Herbert Stoeger  4 , Angelika Pichler  5 , Edgar Petru  6 , Vesna Bjelic-Radisic  6   7 , Richard Greil  8 , Margaretha Rudas  9 , Tea Maria Muy-Kheng  2 , Viktor Wette  10 , Andreas L Petzer  11 , Paul Sevelda  12 , Daniel Egle  13 , Peter C Dubsky  14   15 , Martin Filipits  16 , Florian Fitzal  14 , Ruth Exner  14 , Raimund Jakesz  14 , Marija Balic  17 , Christoph Tinchon  5 , Zsuzsanna Bago-Horvath  9 , Sophie Frantal  18 , Michael Gnant  19 ; Austrian Breast and Colorectal Cancer Study Group
Affiliations
Clinical Trial

Conventional versus reverse sequence of neoadjuvant epirubicin/cyclophosphamide and docetaxel: sequencing results from ABCSG-34

Rupert Bartsch et al. Br J Cancer. 2021 May.

Abstract

Background: Preoperative chemotherapy containing anthracyclines and taxanes is well established in early-stage breast cancer. Previous studies have suggested that the chemotherapy sequence may matter but definitive evidence is missing. ABCSG trial 34 evaluated the activity of the MUC1 vaccine tecemotide when added to neoadjuvant treatment; the study provided the opportunity for the second randomisation to compare two different anthracycline/taxane sequences.

Methods: HER2-negative early-stage breast cancer patients were recruited to this randomised multicentre Phase 2 study. Patients in the chemotherapy cohort (n = 311) were additionally randomised to a conventional or reversed sequence of epirubicin/cyclophosphamide and docetaxel. Residual cancer burden (RCB) with/without tecemotide was defined as primary study endpoint; RCB in the two chemotherapy groups was a key secondary endpoint.

Results: No significant differences in terms of RCB 0/I (40.1% vs. 37.2%; P = 0.61) or pathologic complete response (pCR) rates (24.3% vs. 25%, P = 0.89) were observed between conventional or reverse chemotherapy sequence. No new safety signals were reported, and upfront docetaxel did not result in decreased rates of treatment delay or discontinuation.

Conclusion: Upfront docetaxel did not improve chemotherapy activity or tolerability; these results suggest that upfront neoadjuvant treatment with anthracyclines remains a valid option.

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Conflict of interest statement

R.B. reports advisory roles at AstraZeneca, Celgene, Daiichi, Eisai, Eli-Lilly, MSD, Novartis, Pfizer, Pierre-Fabre, Puma, Roche, Samsung, lecture honoraria: Accord, AstraZeneca, BMS, Celgene, Eli-Lilly, Novartis, Pfizer, Pierre-Fabre, Roche, Sandoz and received research support from Daiichi, Novartis and Roche, all outside of the submitted work. M.H. reports honoraria and/or travel support from Amgen, AstraZeneca, Celgene, Eli-Lilly, Pfizer, Novartis, Roche all outside the submitted work. A.L.P. reports honoraria and/or travel support from Abbvie, Amgen, AstraZeneca, Bayer, Celgene, Gilead, Janssen, Eli-Lilly, MSD, Pfizer, Novartis, Roche, Sanofi and Takeda all outside the submitted work. D.E. reports honoraria/travel support from Amgen, AstraZeneca, Celgene, Eli-Lilly, MSD, Novartis, Pfizer, Roche and Myriad all outside of the submitted work. M.F. has received honoraria for advisory boards from AstraZeneca, Bayer, Biomedica, Boehringer Ingelheim, Eli-Lilly, Merck Sharp & Dohme, Myriad Genetics Inc., Pfizer and Roche. M.G. reports personal fees/travel support from Amgen, AstraZeneca, Celgene, Eli-Lilly, Invectys, Pfizer, Novartis, Puma, Nanostring, Roche, Medison, LifeBrain, all outside the submitted work; an immediate family member is employed by Sandoz. Z.B.-H. has advisory roles at Biomedica, Roche and Novartis, received lecture honoraria and travel support from Roche and research support from Boehringer Ingelheim. C.F.S., G.P., H.S., A.P., E.P., V.B.-R., R.G., M.R., M.K.T., V.W., P.S., P.D., F.F., R.E., R.J., M.B., C.T. and S.F. declare no competing interests.

Figures

Fig. 1
Fig. 1. Consort diagram: ABCSG-34 trial overview.
ITT intent-to-treat, SoC Standard-of-Care, AI aromatase inhibitor.
Fig. 2
Fig. 2. RCB 0/1 rate and pCR rate in patients with conventional and reverse chemotherapy sequence.
RCB residual cancer burden, pCR pathologic complete remission. Conventional vs. reverse in chemotherapy patients (a) RCB 0/I rate, (b) pCR rate.
Fig. 3
Fig. 3. RCB 0/1 rate and pCR rate in patients with conventional and reverse chemotherapy sequence with or without L-BLP25.
RCB residual cancer burden, pCR pathologic complete remission. With vs. without L-BLP25 (a) conventional chemotherapy patients and RCB 0/I rate, (b) reverse chemotherapy patients and RCB 0/I rate, (c) conventional chemotherapy patients and pCR rate, (d) reverse chemotherapy patients and pCR rate.
See this image and copyright information in PMC

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