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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

3525 - Anti-proliferative effect of oral metronomic vinorelbine in PAM50 Luminal/HER2-negative early breast cancer (SOLTI-1501 VENTANA): an open-label, randomized, three-arm, multicenter, window-of-opportunity study

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Aleix Prat

Citation

Annals of Oncology (2018) 29 (suppl_8): viii58-viii86. 10.1093/annonc/mdy270

Authors

A. Prat1, B. Adamo1, J.A. Perez Fidalgo2, S. Blanch3, N. Martinez4, P. Gomez Pardo5, A. López González6, L. Murillo Juso7, K. Amillano8, M. Vidal1, T. Pascual9, L. Pare10, J. Canes11, P. Galvan12, B. Gonzalez Farre13, V. Ortega Cebrian14, X. Gonzalez15, M. Bellet Ezquerra16, P. Villagrasa11, E.M. Ciruelos17

Author affiliations

  • 1 Medical Oncology  , Hospital Clinic i Provincial de Barcelona, 08036 - Barcelona/ES
  • 2 Medical Oncology, Hospital Clínico Universitario de Valencia / INCLIVA / CIBERONC, 46010 - Valencia/ES
  • 3 Medical Oncology  , Fundación Instituto Valenciano de Oncología, 46009 - Valencia/ES
  • 4 Medical Oncology  , Hospital Universitario Ramón y Cajal, 28034 - Madrid/ES
  • 5 Medical Oncology  , Vall d'Hebron University Hospital, 8035 - Barcelona/ES
  • 6 Medical Oncology  , Complejo Asistencial Universitario de León, León/ES
  • 7 Medical Oncology  , Hospital Clinico Universitario Lozano Blesa, 50009 - Zaragoza/ES
  • 8 Medical Oncology  , University Hospital St. Joan de Reus, 43204 - Reus/ES
  • 9 Medical Oncology  , Hospital Clinic i Provincial de Barcelona / IDIBAPS / SOLTI Breast Cancer Research Group, 08036 - Barcelona/ES
  • 10 Bioinformatics, IDIBAPS / SOLTI Breast Cancer Research Group, 08036 - Barcelona/ES
  • 11 Scientific Department, SOLTI Breast Cancer Research Group, 08008 - Barcelona/ES
  • 12 Medical Oncology  , IDIBAPS / Hospital Clinic i Provincial de Barcelona, 08036 - Barcelona/ES
  • 13 Pathological Anatomy, Hospital Clinic i Provincial de Barcelona, 08036 - Barcelona/ES
  • 14 Medical Oncology  , Hospital General de Granollers, 8400 - Granollers/ES
  • 15 Instituto Oncológico Dr Rosell, Hospital General de Catalunya / SOLTI Breast Cancer Research Group, 8028 - Barcelona/ES
  • 16 Medical Oncology  , Vall d'Hebron University Hospital / Vall d'Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 17 Medical Oncology  , Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
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Resources

Abstract 3525

Background

The anti-proliferative effect of oral metronomic vinorelbine (mVNB) alone or in combination with endocrine therapy in patients with hormone receptor (HR)-positive/HER2- breast cancer has been scarcely addressed.

Methods

Postmenopausal women with untreated stage I-III breast cancer were randomized (1:1:1) to receive 3 weeks of letrozole (LTZ) 2.5mg/day, oral mVNB 50mg 3 days/week or the combination. The 1ary objective was to evaluate, within PAM50 Luminal A/B disease, if the anti-proliferative effect of mVNB+LTZ was superior to monotherapy. An anti-proliferative effect was defined as the mean relative decrease of the PAM50 11-gene Proliferation Score in each arm. 2ary objectives included safety and the comparison of the anti-proliferative effect between arms. An unplanned analysis of stromal tumor infiltrating lymphocytes (TILs) was performed. PAM50 analyses were performed using the nCounter®-based Breast Cancer 360TM panel.

Results

A total of 61 patients were randomized and 54 paired samples (89%) were analyzed. Main patient characteristics were mean age 67, mean tumor size 1.7 cm, stage I (55.7%) and grade 1-2 (90%). Grade 3 toxicities occurred in 3.3% of cases. Most baseline samples were Luminal A (74.1%) or B (22.2%). The anti-proliferative effect of mVNB+LTZ (-73.2%) was superior to both monotherapy arms combined (-49.9%; p = 0.001) and mVNB (-19.1%; p < 0.001). The anti-proliferative effect of mVNB+LTZ (-73.2%) was higher compared to LTZ (-65.7%) but did not reach statistical significance (p = 0.328). Stromal TILs (≥10% at week 3) were observed across arms in 6.6% (mVNB), 15% (LTZ) and 26% (mVNB+LTZ) of the cases. In tumors with ≤10% TILs at baseline, a significant increase in TILs was observed following VNB+LTZ (paired analysis p = 0.012).

Conclusions

mVNB is well-tolerated and presents antiproliferative activity alone and in combination with LTZ. Further investigation comparing these biological results with other metronomic schedules or drug combinations is warranted. Of note, the increase of TILs observed with the combination opens the possibility of studying this combination with immunotherapy.

Clinical trial identification

NCT02802748.

Legal entity responsible for the study

SOLTI Breast Cancer Research Group.

Funding

Pierre Fabre Médicament.

Editorial Acknowledgement

Disclosure

A. Prat: Consultancy: Pfizer, Eli Lilly, Novartis, Nanostring Technologies; Research funding: Novartis, Nanostring Technologies; Scientific advisory board: Oncolytics Biotech. J.A. Perez Fidalgo: Advisory board: Clinigen, Pharmamar, Clovis; Other: Substantiate relationships (speaker) Roche, Pharmamar, AstraZeneca, Ipsen. All other authors have declared no conflicts of interest.

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