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The goal of this observational study is to assess survival outcomes and treatment-related toxicity in patients with early-stage breast cancer receiving adjuvant therapies, using high-quality individual patient data pooled from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG), including 3 phase III trials and 4 observational studies. This study aims to assess long-term disease-free survival (DFS) and overall survival (OS), as well as the toxicity patterns associated with dose-dense sequential chemotherapy in intermediate or high-rsk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Breast Cancer Cohort | Patients with early-stage breast cancer included in pooled individual patient data from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG). Patients received adjuvant treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | Disease-Free survival is defined as the time from diagnosis or surgery to the first documented recurrence of breast cancer (local, regional, or distant) or death from any cause. Patients without an event are censored at the last follow-up. | From date of diagnosis or surgery to first documented recurrence or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS is defined as the time from diagnosis or surgery to death from any cause. Patients alive at the last follow-up are censored. Analyses are performed using pooled individual patient data from studies conducted by the Hellenic Cooperative Oncology Group (HeCOG) | From date of diagnosis or surgery to death from any cause. Patients alive at last follow-up are censored at that date |
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Inclusion Criteria:
Exclusion Criteria:
Patients who did not receive dose-dense sequential chemotherapy.
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The study population includes 5,378 patients with early-stage, surgically resected breast cancer of high or intermediate risk who participated in seven observational studies (three phase III trials and four observational studies) conducted by the Hellenic Cooperative Oncology Group (HeCOG). All patients received adjuvant dose-dense sequential chemotherapy (ddsc), and individual patient-level data were available for demographic, pathological, treatment, and outcome variables.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens | 11526 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Breast Cancer. NCCN clinical practice guideline in Oncology.https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf | ||
| 25026897 | Background | Fountzilas G, Dafni U, Papadimitriou C, Timotheadou E, Gogas H, Eleftheraki AG, Xanthakis I, Christodoulou C, Koutras A, Papandreou CN, Papakostas P, Miliaras S, Markopoulos C, Dimitrakakis C, Korantzopoulos P, Karanikiotis C, Bafaloukos D, Kosmidis P, Samantas E, Varthalitis I, Pavlidis N, Pectasides D, Dimopoulos MA. Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial. BMC Cancer. 2014 Jul 15;14:515. doi: 10.1186/1471-2407-14-515. | |
| 18568771 |
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FFPE, peripheral blood
| Treatment-related toxicity | Ī¤reatment-related toxicities observed during adjuvant or neoadjuvant therapy in patients with early breast cancer will be analyzed using pooled individual patient data from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG). This includes hematologic and non-hematologic adverse events reported during therapy. | From the first dose of treatment until 5 years after the last dose |
| Overall survival | Overall survival was defined as the time from the date of diagnosis to the date of death. Patients are censored at last follow-up | From the date of diagnosis to the date of death |
| Background |
| Papadimitriou CA, Papakostas P, Timotheadou E, Aravantinos G, Bamias A, Fountzilas G. Adjuvant dose-dense sequential chemotherapy with epirubicin, CMF and weekly paclitaxel in patients with resected high-risk breast cancer: a Hellenic Cooperative Oncology Group (HeCOG) study. Cancer Invest. 2008 Jun;26(5):491-8. doi: 10.1080/07357900701829785. |
| 17303906 | Background | Fountzilas G, Pectasides D, Christodoulou C, Timotheadou E, Economopoulos T, Papakostas P, Papadimitriou C, Gogas H, Efstratiou I, Skarlos D. Adjuvant dose-dense sequential chemotherapy with epirubicin, CMF, and weekly docetaxel is feasible and safe in patients with operable breast cancer. Med Oncol. 2006;23(4):479-88. doi: 10.1385/MO:23:4:479. |
| 22187126 | Background | Gogas H, Dafni U, Karina M, Papadimitriou C, Batistatou A, Bobos M, Kalofonos HP, Eleftheraki AG, Timotheadou E, Bafaloukos D, Christodoulou C, Markopoulos C, Briasoulis E, Papakostas P, Samantas E, Kosmidis P, Stathopoulos GP, Karanikiotis C, Pectasides D, Dimopoulos MA, Fountzilas G. Postoperative dose-dense sequential versus concomitant administration of epirubicin and paclitaxel in patients with node-positive breast cancer: 5-year results of the Hellenic Cooperative Oncology Group HE 10/00 phase III Trial. Breast Cancer Res Treat. 2012 Apr;132(2):609-19. doi: 10.1007/s10549-011-1913-4. Epub 2011 Dec 21. |
| 16148021 | Background | Fountzilas G, Skarlos D, Dafni U, Gogas H, Briasoulis E, Pectasides D, Papadimitriou C, Markopoulos C, Polychronis A, Kalofonos HP, Siafaka V, Kosmidis P, Timotheadou E, Tsavdaridis D, Bafaloukos D, Papakostas P, Razis E, Makrantonakis P, Aravantinos G, Christodoulou C, Dimopoulos AM. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol. 2005 Nov;16(11):1762-71. doi: 10.1093/annonc/mdi366. Epub 2005 Sep 7. |
| 25919529 | Background | Stewart LA, Clarke M, Rovers M, Riley RD, Simmonds M, Stewart G, Tierney JF; PRISMA-IPD Development Group. Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement. JAMA. 2015 Apr 28;313(16):1657-65. doi: 10.1001/jama.2015.3656. |
| 29242041 | Background | Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. Lancet Oncol. 2018 Jan;19(1):27-39. doi: 10.1016/S1470-2045(17)30777-5. Epub 2017 Dec 11. |
| 30739743 | Background | Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019 Apr 6;393(10179):1440-1452. doi: 10.1016/S0140-6736(18)33137-4. Epub 2019 Feb 8. |
| 34339645 | Background | Early Breast Cancer Trialists' Collaborative group (EBCTCG). Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials. Lancet Oncol. 2021 Aug;22(8):1139-1150. doi: 10.1016/S1470-2045(21)00288-6. |
| 34678571 | Background | Paakkola NM, Karakatsanis A, Mauri D, Foukakis T, Valachis A. The prognostic and predictive impact of low estrogen receptor expression in early breast cancer: a systematic review and meta-analysis. ESMO Open. 2021 Dec;6(6):100289. doi: 10.1016/j.esmoop.2021.100289. Epub 2021 Oct 19. |
| 29117498 | Background | Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, Peto R, Pritchard KI, Bergh J, Dowsett M, Hayes DF; EBCTCG. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. N Engl J Med. 2017 Nov 9;377(19):1836-1846. doi: 10.1056/NEJMoa1701830. |
| 11813224 | Background | Berlin JA, Santanna J, Schmid CH, Szczech LA, Feldman HI; Anti-Lymphocyte Antibody Induction Therapy Study Group. Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med. 2002 Feb 15;21(3):371-87. doi: 10.1002/sim.1023. |
| 35367784 | Background | Kerr AJ, Dodwell D, McGale P, Holt F, Duane F, Mannu G, Darby SC, Taylor CW. Adjuvant and neoadjuvant breast cancer treatments: A systematic review of their effects on mortality. Cancer Treat Rev. 2022 Apr;105:102375. doi: 10.1016/j.ctrv.2022.102375. Epub 2022 Mar 4. |
| 31161190 | Background | Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, Zackrisson S, Senkus E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019 Aug 1;30(8):1194-1220. doi: 10.1093/annonc/mdz173. No abstract available. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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