{"entity":{"id":"idfs","kind":"term","name":"Invasive disease-free survival (iDFS)","aka":["iDFS","Invasive disease-free survival","Invasive breast cancer-free survival (IBCFS)","STEEP end points","Disease-free survival in adjuvant breast cancer trials"],"tldr":"Invasive disease-free survival is the yardstick of most trials that treat early breast cancer after surgery. A patient counts as an event if the cancer comes back anywhere as invasive disease, a new invasive cancer appears in either breast or elsewhere, or she dies of any cause; it deliberately ignores non-invasive recurrences. OlympiA used it to show that a year of olaparib helped BRCA carriers.","summary":"The Standardized Definitions for Efficacy End Points (STEEP) system was proposed in 2007 by a panel of medical oncologists, biostatisticians and correlative scientists so that a given end point term in an adjuvant breast cancer trial always encompasses the same set of events and each event is defined the same way across end points and studies, permitting cross-trial comparison and meta-analysis (Hudis 2007). Invasive disease-free survival is the STEEP end point that counts invasive recurrence in the ipsilateral breast, chest wall or regional nodes, distant recurrence, a new invasive cancer in the contralateral breast, a second non-breast primary cancer and death from any cause, and excludes in situ recurrences. STEEP version 2.0 (2021) found that of 11 phase III breast cancer trials with primary efficacy end points only three followed STEEP criteria, showed by simulation that including second non-breast primary cancers can reduce power and mask differences in recurrence when recurrence rates are low, and recommended an additional end point, invasive breast cancer-free survival, which drops second non-breast primaries, for trials of agents with known toxicity and a small second-cancer risk (Tolaney 2021). In OlympiA, 1,836 patients with germline BRCA1 or BRCA2 pathogenic variants and high-risk HER2-negative early breast cancer were randomised to a year of olaparib or placebo after local treatment and chemotherapy; three-year invasive disease-free survival was 85.9 against 77.1 percent (hazard ratio 0.58) and distant disease-free survival 87.5 against 80.4 percent (0.57), with fewer deaths on olaparib (59 against 86) that did not reach the interim boundary (Tutt 2021); the parent page's history carries the later overall survival update. Event-free survival, the KEYNOTE-522 end point, differs in starting before surgery so that progression precluding surgery counts as an event.","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Survival_rate","links":[{"label":"Hudis, J Clin Oncol 2007: standardised definitions for efficacy end points in adjuvant breast cancer trials (STEEP)","url":"https://doi.org/10.1200/jco.2006.10.3523"},{"label":"Tolaney, J Clin Oncol 2021: STEEP version 2.0","url":"https://doi.org/10.1200/jco.20.03613"},{"label":"Tutt, N Engl J Med 2021: OlympiA, adjuvant olaparib for BRCA1- or BRCA2-mutated breast cancer (invasive disease-free survival)","url":"https://doi.org/10.1056/nejmoa2105215"}],"tags":["breast","tnbc"],"related":[],"cancers":["tnbc","tnbc-early","brca-associated-tnbc","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":["pcr","rcb"],"trials":["olympia","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Endpoints"},"route":"/terms/idfs/","neighbours":{"cancer":[{"id":"brca-associated-tnbc","kind":"cancer","name":"BRCA-associated triple-negative breast cancer","route":"/cancers/brca-associated-tnbc/"},{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"drug":[{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"term":[{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"},{"id":"rcb","kind":"term","name":"Residual cancer burden (RCB)","route":"/terms/rcb/"}],"trial":[{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"},{"id":"olympia","kind":"trial","name":"OlympiA","route":"/trials/olympia/"}]}}