Dose-dense FEC followed by docetaxel versus docetaxel plus cyclophosphamide as adjuvant chemotherapy in women with HER2-negative, axillary lymph node-positive early breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG)

Mavroudis, Dimitriοs; Matikas, Alexios; Malamos, Nikos; Papakotoulas, Pavlos; Kakolyris, Stylianos; Boukovinas, Ioannis; Athanasiadis, A.; Kentepozidis, Nikolaos; Ziras, N.; Katsaounis, Panagiotis; Saloustros, Emmanouil; Georgoulias, Vassilis

doi:10.1093/annonc/mdw274

Cited by 22 publications

(19 citation statements)

References 16 publications

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“…Early breast cancer (EBC) [4] defined as the absence of malignant spread beyond the breast and the axillary lymph nodes is the stage of the disease most frequently diagnosed [1]. The implementation of adjuvant therapy based on combinations of cytotoxic drugs, endocrine and biologic therapies for the eradication of microscopic systemic disease, has a major impact on recurrence, disease-free survival (DFS) and overall survival (OS) of women with EBC [5–10].…”

Section: Introductionmentioning

confidence: 99%

“…The docetaxel-cyclophosphamide (TC) combination is a non-anthracycline containing regimen that has demonstrated superior efficacy in terms of DFS and OS compared to doxorubicin-cyclophosphamide (AC) [15–17]. However, AC is considered obsolete with contemporary standards [5] and AC in sequence or concurrent with a taxane (TaxAC) is usually preferred to treat high risk patients [8, 15, 18–20].…”

Section: Introductionmentioning

confidence: 99%

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Taxane & cyclophosphamide vs anthracycline & taxane-based chemotherapy as adjuvant treatment for breast cancer: a pooled analysis of randomized controlled trials by the Hellenic Academy of Oncology

et al. 2019

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Background Adjuvant chemotherapy has an indisputable value for early breast cancer patients. Anthracycline and taxane-based regimens (TaxAC) have not been proven superior to taxane & cyclophosphamide (TC), a less toxic combination. Our objective was to estimate the cumulative evidence for non-inferiority of TC against TaxAC, in the adjuvant setting of patients with HER2-negative, breast cancer. Results Overall, 7,341 patients were included in this analysis. Superiority of TaxAC or non-inferiority of TC was not established either for the overall population (DFS HR, 1.11; 95% CI, 0.95–1.30; p = 0.18), or for the node-negative patients (HR, 1.05; 95% CI, 0.82–1.34; p = 0.71). A difference in DFS of 1.28% (TC DFS, 89.04%; 95% CI, 88%–90% & TaxAC DFS, 90.32%; 95% CI, 89%–91%) was found in favor of TaxAC. Lower risk of death was not established for either treatment regimen (OS-HR, 1.02; 95% CI, 0.82–1.25; p = 0.88). Overall, the toxicity profile favored TC. Conclusion Although non-inferiority of TC was not proven, superiority of TaxAC is still questioned. The present analysis narrows the risk of recurrence between the treatment groups. Considering TC has a more favorable safety profile, the question as to which treatment regimen should be preferred under what circumstances, needs to be individualized according to patients’ characteristics and desires. Methods Treatment efficacy data from The ABC trials, the Plan B trial and a trial by the Hellenic Oncology Research group (HORG) were pooled. Disease free survival (DFS) and overall survival (OS) were scrutinized. A HR of 1.18 for TC versus TaxAC was chosen to demonstrate inferiority.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Taxane & cyclophosphamide vs anthracycline & taxane-based chemotherapy as adjuvant treatment for breast cancer: a pooled analysis of randomized controlled trials by the Hellenic Academy of Oncology

et al. 2019

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“…However, in contrary to the NSABP B30 trial ( Swain et al , 2010 ), which suggested that both a longer course (sequential regimen) and a higher dose of docetaxel are important for maximum efficacy, our study showed that for node-negative patients, less chemotherapy administered over a longer course is actually more beneficial. Given the results from recently presented trials, showing that in terms of invasive DFS, docetaxel plus cyclophosphamide × 6 was inferior to taxane plus anthracycline ( Blum et al , 2017 ; Mavroudis et al , 2016 ), we conclude that for high-risk node-negative patients anthracyclines and taxanes are crucial for maximising clinical benefit. However, our study raises the question whether maximum benefit can be achieved with less cumulative chemotherapy dose.…”

Section: Discussionmentioning

confidence: 63%

Sequential vs concurrent epirubicin and docetaxel as adjuvant chemotherapy for high-risk, node-negative, early breast cancer: an interim analysis of a randomised phase III study from the Hellenic Oncology Research Group

Mavroudis

Saloustros

Boukovinas³

et al. 2017

Br J Cancer

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Background:Sequential anthracyclines and taxanes are standard adjuvant chemotherapy for patients with high-risk axillary node-positive breast cancer. We compared a sequential to a concurrent regimen in high-risk node-negative early breast cancer.Methods:Patients were eligible if they had tumours >2 cm or T1c with two of the following characteristics: no oestrogen receptor (ER) and progesterone receptor (PR) expression, histological grade III, Ki67 >40% and vascular, lymphovascular or perineural invasion. They were randomised to receive four cycles of epirubicin 90 mg m−2 followed by four cycles of docetaxel 75 mg m−2 (sequential regimen) or six cycles of epirubicin 75 mg m−2 plus docetaxel 75 mg m−2 (concurrent regimen). All chemotherapy cycles were administered every 21 days with G-CSF prophylaxis only for the concurrent arm. The primary endpoint was disease-free survival (DFS).Results:Between 2001 and 2013, 658 women received the sequential (n=329) or the concurrent (n=329) regimen. The median age was 53 years, 43.9% of the patients were premenopausal and of the tumours 44.2% were ⩽2 cm, 52.7% histological grade 3 and 35.3% hormone receptor-negative. After a median follow-up of 70.5 months, there were 29 (8.8%) vs 42 (12.8%) disease relapses (P=0.102) and 11 (3.3%) vs 19 (5.8%) deaths (P=0.135), in the sequential and concurrent arm, respectively. The 5-year DFS rates were 92.6% vs 88.2% for sequential and concurrent arm, respectively (hazard ratio (HR): 1.591; 95% confidence interval (CI): 0.990–2.556; P=0.055). Toxicity included grade 2–4 neutropenia in 54% vs 41% (P=0.001), febrile neutropenia 2.7% vs 6.1% (P=0.06), nausea/vomiting 18.5% vs 12.4% (P=0.03) of patients in the sequential and concurrent arm. There were no toxic deaths.Conclusions:Sequential compared with the concurrent administration of anthracyclines and taxanes is associated with a non-significant but possibly clinically meaningful improvement in DFS. In the era of molecular selection of patients for adjuvant chemotherapy, this study offers valuable information for the optimal administration of anthracyclines and taxanes in patients with node-negative disease.

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“…The invasive DFS rates at 4 years were 88.2% and 90.7% for the TC and anthracycline-based groups, respectively (HR ¼ 1.23, 95% CI 1.01-1.50, p ¼ .04) [27]. This finding of the non-inferiority of TC was shared by a smaller trial conducted by the Hellenic Oncology Research Group [28]. Although it is unclear whether these results are owed to the omission of anthracyclines or to the DD regimens, they propose DD-CT as the treatment of choice when compared to yet another contemporary standard of care, the TC regimen.…”

Section: Dose Dense Versus Conventional Chemotherapymentioning

confidence: 86%

Dose intense, dose dense and tailored dose adjuvant chemotherapy for early breast cancer: an evolution of concepts

2017

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Dose-dense FEC followed by docetaxel versus docetaxel plus cyclophosphamide as adjuvant chemotherapy in women with HER2-negative, axillary lymph node-positive early breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG)

Abstract: NCT01985724.

Cited by 22 publications

References 16 publications

Taxane & cyclophosphamide vs anthracycline & taxane-based chemotherapy as adjuvant treatment for breast cancer: a pooled analysis of randomized controlled trials by the Hellenic Academy of Oncology

Taxane & cyclophosphamide vs anthracycline & taxane-based chemotherapy as adjuvant treatment for breast cancer: a pooled analysis of randomized controlled trials by the Hellenic Academy of Oncology

Sequential vs concurrent epirubicin and docetaxel as adjuvant chemotherapy for high-risk, node-negative, early breast cancer: an interim analysis of a randomised phase III study from the Hellenic Oncology Research Group

Dose intense, dose dense and tailored dose adjuvant chemotherapy for early breast cancer: an evolution of concepts

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