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Background  Circulating tumor cells (CTCs) are prognostic in patients with advanced breast cancer (ABC). However, no data exist about their use in patients treated with palbociclib. We analyzed the prognostic role of CTC counts in patients enrolled in the cTREnd study, a pre-planned translational sub-study of TREnd (NCT02549430), that randomized patients with ABC to palbociclib alone or palbociclib plus the endocrine therapy received in the prior line of treatment. Moreover, we evaluated  RB1  gene expression on CTCs and explored its prognostic role within the cTREnd subpopulation.    Methods  Forty-six patients with ER-positive, HER2-negative ABC were analyzed. Blood samples were collected before starting palbociclib treatment (timepoint T0), after the first cycle of treatment (timepoint T1), and at disease progression (timepoint T2). CTCs were isolated and counted by CellSearch® System using the CellSearch™Epithelial Cell kit. Progression-free survival (PFS), clinical benefit (CB) during study treatment, and time to treatment failure (TTF) after study treatment were correlated with CTC counts. Samples with ≥ 5 CTCs were sorted by DEPArray system® (DA).  RB1  and  GAPDH  gene expression levels were measured by ddPCR.    Results  All 46 patients were suitable for CTCs analysis. CTC count at T0 did not show significant prognostic value in terms of PFS and CB. Patients with at least one detectable CTC at T1 ( n  = 26) had a worse PFS than those with 0 CTCs ( n  = 16) ( p  = 0.02). At T1, patients with an increase of at least three CTCs showed reduced PFS compared to those with no increase (mPFS = 3 versus 9 months, ( p  = 0.004). Finally, patients with ≥ 5 CTCs at T2 ( n  = 6/23) who received chemotherapy as post-study treatment had a shorter TTF ( p  = 0.02). Gene expression data for  RB1  were obtained from 19 patients. CTCs showed heterogeneous  RB1  expression. Patients with detectable expression of  RB1  at any timepoint showed better, but not statistically significant, outcomes than those with undetectable levels.    Conclusions  CTC count seems to be a promising modality in monitoring palbociclib response. Moreover, CTC count at the time of progression could predict clinical outcome post-palbociclib.  RB1  expression analysis on CTCs is feasible and may provide additional prognostic information. Results should be interpreted with caution given the small studied sample size.    Supplementary Information  The online version contains supplementary material available at 10.1186/s13058-021-01415-w.

breast cancer research

Circulating tumor cells and palbociclib treatment in patients with ER-positive, HER2-negative advanced breast cancer: results from a translational sub-study of the TREnd trial