Abstract 154P
Background
PREDICT, an online prognostic tool developed from population registries, estimates the potential benefit of different treatments (i.e., surgery alone, chemotherapy, trastuzumab, endocrine therapy, and/or bisphosphonates) for early-stage BC patients (pts). We aim to investigate its prognostic performance among pts enrolled in randomized trials (RCTs) using individual patient data from the GIM and MIG adjuvant studies.
Methods
We evaluated the performance of PREDICT on a population enrolled in five RCTs (i.e., MIG1, MIG5, GIM2, GIM3, GIM6) between 1992 and 2012 with complete baseline information. We used Uno’s concordance index (C-index) to assess the model’s discriminative power over all the time range, and Poisson regressions to assess the 5- and 10-year predictions calibration.
Results
A total of 6205 pts were included. The median age at BC diagnosis was 57 (IQR 48-65), with 5364 (86.5%) pts having estrogen receptor-positive, 2226 (35.9%) pts having node negative and 2088 (33.7%) pts having grade 3 tumors. Median tumor size was 18 mm (interquartile range (IQR) 13-25 mm). After a median follow-up of 9.3 years (IQR, 5.9–14.8), 1083 deaths were observed. PREDICT assigned higher risk to subjects who had earlier events 62% of the times (C-index 0.62 95%CI 58–65). Overall, the 5- and 10-year OS was underestimated by 5.1% (95%CI 3.9–6.4; observed 5-year OS was 92.2% vs. predicted 87.1%) and by 2.1% (95%CI 0.3–4.0; observed 10-year OS was 74.4% vs. predicted 72.3%), respectively; with 60% and 93% of the expected events respectively observed (calibration intercepts -0.50 and -0.08). The OS underestimation was consistent across subgroups, with worse predictive performance for pts with estrogen receptor-negative, large tumor size, or HER2-positive disease.
Conclusions
Our analysis showed that PREDICT underestimates 5- and 10-year OS. Oncologists need to be aware of this limitation when they use this tool to provide prognostic information to pts with early-stage BC treated with modern chemotherapy and endocrine regimens.
Legal entity responsible for the study
IRCCS AOU Policlinico San Martino – IST.
Funding
Has not received any funding.
Disclosure
E. Blondeaux: Financial Interests, Institutional, Funding: Gilead; Financial Interests, Personal, Invited Speaker: Eli Lilly. M. De Laurentiis: Financial Interests, Advisory Board, activities as a speaker, travel grants, consultancy: Eli Lilly, Novartis, Seagen, Takeda, Roche, Daiichi Sankyo, Tomalab, Gilead, Genetic, Menarini, Sophos, AstraZeneca, Pfizer, Sanofi, Ipsen, Pierre Fabre. G. Arpino: Financial Interests, Writing Engagements: AstraZeneca; Financial Interests, Advisory Board, travel grants, activities as a speaker, consultancy: AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Exact Science, Novartis, Roche, Seagen, Viatris. F. Puglisi: Financial Interests, Personal, Advisory Board: AstraZeneca, Eli Lilly, Eisai, Daiichi Sankyo, Exact Sciences, Gilead, Menarini, MSD, Novartis, Pierre Fabre, Pfizer; Financial Interests, Funding: AstraZeneca, Eisai, Roche; Financial Interests, Other, Travel: AstraZeneca, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pfizer, Roche, Seagen; Financial Interests, Other, Honoraria: AstraZeneca, Eli Lilly, Eisai, Daiichi Sankyo, Exact Sciences, Gilead, Menarini, Pierre Fabre, Pfizer. A. Fabi: Financial Interests, Advisory Board: Roche, Novartis, Eli Lilly, Pfizer, MSD, Pierre Fabre, Eisai, Gilead, Seagen, AstraZeneca, Exact Sciences; Financial Interests, Other, consulting fees: Dompé Farmaceutici S.p.A. F. Poggio: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Eli Lilly, Novartis, Daiichi Sankyo, Gilead. M. Lambertini: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Lilly, Novartis, Pfizer, Exact Sciences, MSD, Seagen, Gilead; Financial Interests, Personal, Invited Speaker: Takeda, Sandoz, Ipsen, Libbs, Knight, Daiichi Sankyo, Lilly, Pfizer, Novartis, Roche; Financial Interests, Personal, Other, Travel grant to attend ASCO 2022: Gilead; Financial Interests, Institutional, Invited Speaker, 2-year research grant paid to my Institution: Gilead. L. Del Mastro: Financial Interests, Personal, Invited Speaker, Educational meeting: Novartis, Symposia, Andromeda E20, Vyvamed S.r.l.; Financial Interests, Personal, Invited Speaker, Lecture: Ipsen; Financial Interests, Personal, Advisory Board, Her2+ and TN breast cancer: Roche; Financial Interests, Personal, Invited Speaker, Consultancy for TNBC text: Roche; Financial Interests, Personal, Advisory Board, denosumab: Amgen; Financial Interests, Personal, Advisory Board, Early and metastatic BC: Eli Lilly; Financial Interests, Personal, Invited Speaker, CDK4-6 inhibitors: Eli Lilly; Financial Interests, Personal, Advisory Board, tucatinib: Seagen Int; Financial Interests, Personal, Advisory Board, Oncotype dx: Exact sciences, Havas life; Financial Interests, Personal, Advisory Board, Neratinib: Pierre Fabre; Financial Interests, Personal, Invited Speaker, Internal training: MSD; Financial Interests, Personal, Invited Speaker, Educational meetings: Accademia Nazionale Medicina; Financial Interests, Personal, Invited Speaker, Author for BC text: Pensiero Scientifico Editore; Financial Interests, Personal, Advisory Board, Breast cancer: Uvet; Financial Interests, Personal, Other, Author slide kits and interviews: Think2it; Financial Interests, Personal, Advisory Board, Palbociclib: Pfizer; Financial Interests, Personal, Invited Speaker, Breast cancer: Aristea, Meeting S.r.l.; Financial Interests, Personal, Other, Author slide kits: Forum service; Financial Interests, Personal, Other, Author text about biosimilars: Edizioni Minerva Medica; Financial Interests, Personal, Other, consultant: Kardo S.r.l.; Financial Interests, Personal, Invited Speaker, Breast cancer meetings: Delphi international, Over S.r.l.; Financial Interests, Personal, Invited Speaker: Prex S.r.l., Editree; Financial Interests, Personal, Advisory Board: Uvet, Collage SpA, Daiichi Sankyo, AstraZeneca, Agendia, Gilead, GSK, Eisai, Stemline Menarini; Financial Interests, Personal, Other, Interview: Infomedica S.r.l.; Financial Interests, Personal, Other, Consultant: Sharing progress in cancer care - Switzerland; Financial Interests, Personal, Other, Consultancy: Eli Lilly, Gilead; Financial Interests, Institutional, Funding, National coordinating PI: Roche; Financial Interests, Institutional, Funding, Local PI: AstraZeneca, Roche, Eli Lilly, Daiichi Sankyo, Novella Clinical, Novartis; Financial Interests, Institutional, Invited Speaker: Gilead, Seagen; Financial Interests, Institutional, Research Grant: Pfizer; Non-Financial Interests, Institutional, Product Samples, Genomic Test: FoundationOne. All other authors have declared no conflicts of interest.