Abstract 146P
Background
Our aim was to evaluate long-term clinical outcomes in patients with triple-negative breast cancer (TNBC) treated with adjuvant dose-dense sequential chemotherapy (ddsc).
Methods
Data from patients with TNBC treated with adjuvant ddsc in the context of 3 phase III and 4 observational studies were retrieved from the HeCOG electronic database. All 7 studies included node-positive or “intermediate” high-risk node-negative patients. To examine the risk factors associated with disease-free survival (DFS) and overall survival (OS), Cox regression was applied. A random forest approach was employed by two distinct machine learning models to predict DFS and OS. Using these models, the clinical importance of input variables was determined.
Results
In total, 831 patients with early-stage TNBC were included, median age 52 years. With a median follow-up of 10.7 years, disease progression was reported in 179 (21.7%) patients, while 201 (24.2%) patients died. Thirty seven (4.5%) patients developed a second malignancy. 5-year (yr) and 10-yr DFS was 78% and 74%, while 5-yr and 10-yr OS was 84% and 76%, respectively. The majority of progression events (141, 78.8%) occurred within the first 3 years, while disease progression was reported in 17 (2.1%) patients after 5 years from diagnosis. The random survival forest identified the number of infiltrated lymph nodes as the most important risk factor for both DFS and OS, followed by the size of the primary tumor, age at diagnosis, CD8 T cells, menopausal status at diagnosis, neuropathy, tumor-infiltrating lymphocytes and radiation therapy. Most frequent adverse events were nausea (41.6%), fatigue (32.7%), neuropathy sensory (27.7%), arthralgia (19.2%), myalgia (17.2%), vomiting (16.9%), constipation (12.8%), diarrhea (9.9%), mucositis (9.7%), hand-foot syndrome (6.7%) and allergic reactions (5.8%).
Conclusions
In this study, we assessed 10-yr outcomes in patients with early-stage TNBC treated with ddsc within seven clinical trials. Clinical and pathological factors need to be combined to accurately predict which patients with recur after treatment.
Legal entity responsible for the study
Hellenic Cooperative Oncology Group (HeCOG).
Funding
Has not received any funding.
Disclosure
E. Fountzilas: Financial Interests, Personal, Advisory Role: Amgen, LEO Pharma; Financial Interests, Personal, Invited Speaker: Roche, Pfizer, AstraZeneca, Amgen; Financial Interests, Personal, Other, Travel grant: AstraZeneca, Merck, Pfizer, DEMO; Financial Interests, Personal, Stocks/Shares: Genprex Inc., Deciphera Pharmaceuticals Inc. F. Zagouri: Financial Interests, Personal, Advisory Role: AstraZeneca, Daiichi, Eli Lilly, Merck, MSD, Genesis Pharma, Roche, Novartis, Gilead, Pfizer; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Daiichi, Eli Lilly, Merck, MSD, Novartis, Pfizer, Genesis Pharma, Roche, Gilead. H. Gogas: Financial Interests, Personal, Advisory Board: MSD, BMS, Pierre Fabre, Sanofi; Financial Interests, Personal, Invited Speaker: MSD, BMS, Novartis, Pierre Fabre, Sanofi; Financial Interests, Invited Speaker: Amgen, Replimmune; Financial Interests, Institutional, Invited Speaker: Amgen, MSD, BMS, Replimmune, Iovance, Bayer; Financial Interests, Institutional, Research Grant: BMS, Pfizer, Lilly, Pierre Fabre. D.G. Pectasides: Financial Interests, Personal, Advisory Role: Roche, MSD, Astellas; Financial Interests, Personal, Other, Honoraria: Roche, MSD, Astellas. G. Aravantinos: Financial Interests, Personal, Advisory Board: Novartis, BMS, Roche, AstraZeneca, Sanofi, Amgen, Genesis Pharma, Merck, Pfizer. A. Koutras: Financial Interests, Personal, Advisory Board: Pierre Fabre, AstraZeneca, Gilead, Pfizer, Genesis, MSD, BMS, Gilead, Pfizer, Integris, BMS, AstraZeneca; Financial Interests, Personal, Invited Speaker: Sanofi, Gilead, AstraZeneca, Sandoz, Gilead; Financial Interests, Personal, Other, TRAVEL, accommodations: Rafarm, Lilly, Ipsen, Gilead, Pfizer; Financial Interests, Personal, Other, Travel, Accommodations: Genesis, AstraZeneca; Financial Interests, Personal, Other, Conference registration (Web): Ipsen; Financial Interests, Institutional, Funding: Lilly, Pfizer, Merck, AstraZeneca, Gilead; Financial Interests, Institutional, Research Grant: AstraZeneca, Pierre Fabre, BMS, DEMO, FARAN, Amgen, Roche, Ipsen, Galenica, Win Medica; Financial Interests, Personal, Funding: Merck. H. Linardou: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, Merck, Takeda, Bristol Myers Squibb, Lilly, Pfizer, GSK; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, Bristol Myers Squibb, Pfizer, Amgen, Novartis; Financial Interests, Personal, Stocks/Shares: BioPath Innovations S.A.; Financial Interests, Personal and Institutional, Invited Speaker: Bristol Myers Squibb, Boehringer Ingelheim, Roche, AbbVie, Lilly, Novartis, AstraZeneca, Amgen, PPD, Parexel ILR, Qualitis, Health Data Specialist; Financial Interests, Institutional, Invited Speaker: GSK; Non-Financial Interests, Principal Investigator: Hellenic Cooperative Oncology Group; Non-Financial Interests, Leadership Role, Elected Chair of the Scientific Committee: Hellenic Cooperative Oncology Group; Non-Financial Interests, Member of Board of Directors: Women 4 Oncology - Hellas, Fairlife Lung Cancer Care, Hellenic Cooperative Oncology Group, Hellenic Foundation for Cancer Research; Non-Financial Interests, Leadership Role, Legal Representattive: Women 4 Oncology- Hellas. E. Razis: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Servier; Financial Interests, Personal, Funding: Tesaro, Exelixis, AstraZeneca, PPD, MSD; Financial Interests, Personal, Invited Speaker: IQVIA; Non-Financial Interests, Member: ASCO, EANO, SNO, SNOSSA, EUSOMA, BIG; Other, Travel, Accommodations, Expenses: Roche, Pfizer, Karyo, Genesis Pharmaceuticals; Other, Travel to conference support: Servier; Other, Conference attendance support: Gilead, AstraZeneca. D. Tryfonopoulos: Financial Interests, Personal, Other, Honoraria: Pfizer, Novartis, Lilly, AstraZeneca. A. Koumarianou: Financial Interests, Institutional, Research Grant: Merck. P.A. Kosmidis: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Other, registration in congress: Pfizer; Financial Interests, Personal, Other, registration to congress: Sanofi; Financial Interests, Personal, Ownership Interest: Careacross Digital Health Company. A. Psyrri: Financial Interests, Personal, Invited Speaker: MSD, Merck Serono, EPICS; Financial Interests, Personal, Advisory Board: Pfizer, Sanofi, MSD, AstraZeneca, BMS, Leo, Rakuten, eTheRNA immunotherapies, Merck Serono, Seagen, Merus; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Iovance, Pfizer, Pfizer, Roche, GSK, Genesis, Incyte, Amgen, Debiopharm, MSD, Janssen, Lilly, Regeneron, Sanofi, BI, Roche, Peregrine, Oncolytics Biotech; Financial Interests, Invited Speaker: AstraZeneca, Kura Oncology; Financial Interests, Institutional, Invited Speaker: Kura Oncology, Novartis, Replimmune; Financial Interests, Personal and Institutional, Funding: Kura Oncology, BMS, Roche, DEMO, Amgen, BI, Genesis, BMS, Pfizer, Oncolytics Biotech; Financial Interests, Institutional, Funding: Merck Serono, Pfizer; Financial Interests, Personal, Other, Educational activity: MEDSCAPE, PrimeOncology; Non-Financial Interests, Project Lead, Medical Education with honoraria: MEDSCAPE. G. Fountzilas: Financial Interests, Personal, Advisory Board: Pfizer, Novartis; Financial Interests, Personal, Other, Honoraria: Novartis, Astra; Financial Interests, Personal, Stocks/Shares: Genprex, Daiichi Sankyo, RFL Holdings, Formycon. All other authors have declared no conflicts of interest.