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ePoster

15P - The CelTIL score as an early predictor of anti-tumour response following neoadjuvant therapy (NAT): A SOLTI biomarker analysis

Date

24 May 2020

Session

ePoster

Presenters

Blanca González-Farré

Citation

Annals of Oncology (2020) 31 (suppl_2): S15-S41. 10.1016/annonc/annonc117

Authors

B. González-Farré1, P. Nuciforo2, L. Pare Brunet3, J. Cortés4, A. Llombart Cussac5, J. Gavila Gregori6, E. Sanfeliu1, N. Chic7, M. Vidal7, B. Adamo7, M. Muñoz7, P. Galván8, D. Martínez8, P. Villagrasa3, T. Pascual7, A. Prat7

Author affiliations

  • 1 Pathology, Hospital Clinic of Barcelona, 08036 - Barcelona/ES
  • 2 Molecular Oncology Group, Vall d´Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 3 Breast Cancer Research Group, SOLTI, 08008 - Barcelona/ES
  • 4 Oncology Department, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 5 Medical Oncology, Hospital Universitario Arnau de Vilanova, 46015 - Valencia/ES
  • 6 Medical Oncology, IVO - Fundación Instituto Valenciano de Oncología, 46009 - Valencia/ES
  • 7 Medical Oncology Department, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 8 Translational Genomics And Targeted Therapeutics In Solid Tumors, IDIBAPS, 08036 - Barcelona/ES
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Abstract 15P

Background

Tumor cellularity and tumor-infiltrating lymphocyte score (CelTIL) measured at day (D) 15 following anti-HER2 therapy was found associated with pathologic complete response (pCR) (Nuciforo. Ann Oncol 2018). Here, we explored the dynamics of CelTIL across 3 trials to determine its value as an early read-out of NAT efficacy.

Methods

Samples and clinical information from 369 patients (pts) across 3 trials (CORALLEEN, PAMELA and NEOERIBULIN) were explored. In CORALLEEN, 106 pts with Luminal B/HER2- breast cancer (BC) were randomized to 6 months of letrozole + ribociclib (LTZ+RIB) or AC x 4 + paclitaxel x 12. In PAMELA, 151 pts with HER2+ BC were treated with lapatinib + trastuzumab (hormonal therapy if hormone receptor [HR]-positive) for 18 weeks. In NEOERIBULIN, 101 HR+/HER2- and 73 triple-negative pts were treated with eribulin x 4. In each trial, TILs and tumor cellularity were determined at baseline and at D15 (PAMELA and CORALLEEN) or D21 (NEOERIBULIN) of treatment. CelTIL is calculated following this formula: −0.8 × tumor cellularity (%) + 1.3 × TILs (%). Changes in CelTIL between baseline and D15/21 samples and associations with response (RCB) were explored.

Results

In CORALLEEN, LTZ+RIB (n=49) or one dose of AC (n=47) did not show a significant change in CelTIL (mean -7.9; p=0.14 and +2.2; p=0.62). In NEOERIBULIN (n=132), eribulin significantly increased CelTIL in all pts (MD +10.0; p=0.03), both in HR+ (mean difference +4.8) and HR- (MD +11.1) BC. CelTIL changes were found significantly associated with both pCR and RCB0/1, independently of HR status. In PAMELA (n=141), NAT significantly increased CelTIL in all pts (MD +31.4; p<0.01), both in HR+ (MD +32.2) and HR- (MD +40.4) BC. CelTIL changes were found significantly associated with pCR and RCB0/1, independently of HR status. Finally, difference in CelTIL (D15-baseline) was found significantly associated with RCB0/1 (odds ratio=1.02, p<0.001) independently of trial and HR status.

Conclusions

Early and absolute changes in CelTIL following NAT are associated with tumor shrinkage at surgery. This biomarker could be used as an early read-out of drug activity and these data should help estimate power and sample size for future trials.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

SOLTI Breast Cancer Research Group.

Funding

Pas a Pas, Save the Mama.

Disclosure

P. Nuciforo: Advisory/Consultancy: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis. J. Cortés: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: Celgene; Advisory/Consultancy: Cellestia; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Biothera Pharmaceutical; Advisory/Consultancy: Merus; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Erytech; Advisory/Consultancy: Athenex Polyphor; Honoraria (self), Advisory/Consultancy: Lilly; Advisory/Consultancy: Servier; Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme; Honoraria (self): Novartis; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self): Samsung; Research grant/Funding (institution): Ariad pharmaceuticals; Research grant/Funding (institution): Baxalta/Servier Affaires; Research grant/Funding (institution): Bayer Healthcare. A. Llombart Cussac: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Eli Lilly; Research grant/Funding (institution), Travel/Accommodation/Expenses: EISAI; Advisory/Consultancy, Research grant/Funding (institution): Genomic Health; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: MSD. J. Gavila Gregori: Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Roche. N. Chic: Travel/Accommodation/Expenses: Novartis. M. Vidal: Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self): Daiichi Sankyo. M. Muñoz: Honoraria (self): Lilly; Honoraria (self), Travel/Accommodation/Expenses: Roche Genentech; Honoraria (self): Eisai; Honoraria (self): Merck; Honoraria (self), Travel/Accommodation/Expenses: Novartis. P. Villagrasa: Speaker Bureau/Expert testimony: NanoString. A. Prat: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): MSD Oncology; Honoraria (self): Lilly; Honoraria (self), Travel/Accommodation/Expenses: Daiichi Sankyo; Advisory/Consultancy: NanoString; Advisory/Consultancy: Amgen; Advisory/Consultancy: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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