Epirubicin-Paclitaxel-Cyclophosphamide Methotrexate Fluorouracil (E-T-CMF) versus Epirubicin-Cyclophosphamide Methotrexate Fluorouracil (E-CMF) as adjuvant chemotherapy in high risk patients with operable breast cancer. A phase III study conducted by the Hellenic Cooperative Oncology Group (HE10/97)

Conditions

None listed

Brief summary

The aim of this phase III, randomized study was to explore the effect of dose-dense sequential chemotherapy with or without paclitaxel primarily on disease-free survival (DFS) and secondarily on overall survival (OS) in patients with high-risk operable breast cancer. Acute toxicity and quality of life were also investigated. Translational research studies were also performed.

Schmidt M, Weyer-Elberich V, Hengstler JG, Heimes AS, Almstedt K, Gerhold-Ay A, Lebrecht A, Battista MJ, Hasenburg A, Sahin U, Kalogeras KT, Kellokumpu-Lehtinen PL, Fountzilas G, Wirtz RM, Joensuu H.

2018-02-2667 citations

10.1186/s13058-018-0942-x

Association of osteopontin with specific prognostic factors and survival in adjuvant breast cancer trials of the Hellenic Cooperative Oncology Group.

Psyrri A, Kalogeras KT, Wirtz RM, Kouvatseas G, Karayannopoulou G, Goussia A, Zagouri F, Veltrup E, Timotheadou E, Gogas H, Koutras A, Lazaridis G, Christodoulou C, Pentheroudakis G, Economopoulou P, Laskarakis A, Arapantoni-Dadioti P, Batistatou A, Sotiropoulou M, Aravantinos G, Papakostas P, Kosmidis P, Pectasides D, Fountzilas G.

2017-02-1316 citations

10.1186/s12967-017-1134-7

alphaB-crystallin is a marker of aggressive breast cancer behavior but does not independently predict for patient outcome: a combined analysis of two randomized studies

Triantafyllia Κoletsa, Flora Stavridi, Mattheos Bobos, Ioannis Kostopoulos, Vassiliki Kotoula et al. (16 authors)

BMC Clinical Pathology2014-06-2316 citations

10.1186/1472-6890-14-28

Evaluation of the prognostic role of centromere 17 gain and HER2/topoisomerase II alpha gene status and protein expression in patients with breast cancer treated with anthracycline-containing adjuvant chemotherapy: pooled analysis of two Hellenic Cooperative Oncology Group (HeCOG) phase III trials.

Fountzilas G, Dafni U, Bobos M, Kotoula V, Batistatou A, Xanthakis I, Papadimitriou C, Kostopoulos I, Koletsa T, Tsolaki E, Televantou D, Timotheadou E, Koutras A, Klouvas G, Samantas E, Pisanidis N, Karanikiotis C, Sfakianaki I, Pavlidis N, Gogas H, Linardou H, Kalogeras KT, Pectasides D, Dimopoulos MA.

2013-03-2824 citations

10.1186/1471-2407-13-163

The prognostic and predictive value of mRNA expression of vascular endothelial growth factor family members in breast cancer: a study in primary tumors of high-risk early breast cancer patients participating in a randomized Hellenic Cooperative Oncology Group trial.

Linardou H, Kalogeras KT, Kronenwett R, Kouvatseas G, Wirtz RM, Zagouri F, Gogas H, Christodoulou C, Koutras AK, Samantas E, Pectasides D, Bafaloukos D, Fountzilas G.

2012-11-1234 citations

10.1186/bcr3354

HER2 and TOP2A in high-risk early breast cancer patients treated with adjuvant epirubicin-based dose-dense sequential chemotherapy.

Fountzilas G, Valavanis C, Kotoula V, Eleftheraki AG, Kalogeras KT, Tzaida O, Batistatou A, Kronenwett R, Wirtz RM, Bobos M, Timotheadou E, Soupos N, Pentheroudakis G, Gogas H, Vlachodimitropoulos D, Polychronidou G, Aravantinos G, Koutras A, Christodoulou C, Pectasides D, Arapantoni P.

2012-01-1236 citations

10.1186/1479-5876-10-10

Interventions

epirubicin [110 milligram/square meter (mg/m2) intravenously infused over 30 minutes] every 2 weeks for 3 cycles followed by 3 cycles of paclitaxel (250 mg/m2, intravenously infused over 3 hours) every 2 weeks and 3 cycles of CMF (cyclophosphamide; 840 mg/m2, methotrexate; 57 mg/m2 and fluorouracil; 840 mg/m2 intravenously infused over 30 minutes) every 2 weeks

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

-Histologically-confirmed epithelial cancer of the mammary gland. -Premenopausal patients with T1 to T2 classification with histologically-confirmed invasion of axillary lymph nodes (N1 classification) or T3 and N0 or N1 classification. -Postmenopausal patients with T1 to T2 classification and > 4 positive axillary nodes or T3 and N0 or N1 classification. - White Blood Cells (WBC) >4x10^9/litre, platelets >100 x10^9 /litre. -Serum creatinine, Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltranspeptidase (gamma-GT), serum bilirubin < = 1.3 milligram/milliliter (mg/ml) or inside the normal range of the participating hospital. -Performance status (World Health Organization) 0 or 1. -Age >= 18 years. -Previous surgical treatment: Either radical surgery (i.e. total, radical or modified radical mastectomy), or, for a partial mastectomy, a histologically confirmed sane margin of 2 cm or more and the results of the axillary node dissection available. -Time from surgery 2 to 4 weeks -Informed consent of the patient according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments and to individual institutional policy.

Exclusion criteria

- Previous antitumor chemotherapy or radiation - History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (Blood Pressure>= 200/110 millimetres of mercury (mmHg). In high risk patients a normal baseline left ventricular ejection fraction (LVEF) should be demonstrated by Multi Gated Acquisition Scan (MUGA) scan or echocardiogram (ECHO).

Outcome results