title: Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: the observational step of the CirCe01 phase III trial.
abstract: The clinical validity of circulating tumor cell (CTC) count changes during chemotherapy in metastatic breast cancer patients has been validated, but its clinical utility remains to be demonstrated. We report here the non-randomized run-in phase of the CirCe01 trial which was designed to evaluate CTC changes and thresholds to other palliative prognostic scores and establish CTC thresholds to be used in the randomized part of the study. CTC count (CellSearch®) and other prognostic parameters (serum albumin level, lymphocyte level, LDH level, prognostic inflammatory and nutritional index (PINI) and Barbot's score) were assessed in 56 metastatic breast cancer patients before the first cycle of third line chemotherapy. Early changes of CTC count were correlated with treatment outcome. Independent prognostic markers in multivariate analysis were: low serum albumin (HR = 11.1), poor performance status (HR = 3.8), ≥5 CTC/7.5 ml (HR = 3.8) and triple negative subtype (HER2+ and hormone positive vs triple negative: both HR = 0.2). Among patients with ≥5 CTC/7.5 ml at baseline, a composite criteria (<5 CTC/7.5 ml or relative decrease ≥-70% of the baseline CTC count) showed better prognostication for PFS (p=0.002).
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: Helissey
authors.affiliation: Department of Clinical Research, Institut Curie, Paris, France; INSERM U900, Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Berger
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Cottu
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, France; Department of Clinical Research, Institut Curie, Paris, France.
authors.forename: V
authors.initials: V
authors.lastname: Diéras
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, France.
authors.forename: L
authors.initials: L
authors.lastname: Mignot
authors.affiliation: Department of Radiology, Institut Curie, Paris, France.
authors.forename: V
authors.initials: V
authors.lastname: Servois
authors.affiliation: Department of Supportive Care, Institut Curie, Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: Bouleuc
authors.affiliation: Department of Clinical Research, Institut Curie, Paris, France.
authors.forename: B
authors.initials: B
authors.lastname: Asselain
authors.affiliation: Department of Clinical Research, Institut Curie, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Pelissier
authors.affiliation: Department of Supportive Care, Institut Curie, Paris, France.
authors.forename: I
authors.initials: I
authors.lastname: Vaucher
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, France; Circulating Tumor Biomarkers Laboratory, SIRIC, Institut Curie, Paris, France; University Paris Descartes, Paris, France. Electronic address: jean-yves.pierga@curie.fr.
authors.forename: J Y
authors.initials: JY
authors.lastname: Pierga
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, France; Circulating Tumor Biomarkers Laboratory, SIRIC, Institut Curie, Paris, France.
authors.forename: F C
authors.initials: FC
authors.lastname: Bidard
mesh_terms: D001943:Breast Neoplasms / Q000097:blood* / Q000188:drug therapy / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009360:Neoplastic Cells, Circulating / Q000473:pathology*; D016032:Randomized Controlled Trials as Topic; D015996:Survival Rate
keywords: CirCe01; Circulating tumor cells; Metastatic breast cancer