Abstract 5812
Background
The density of tumor-infiltrating lymphocytes (TIL) is a predictive factor for response to neoadjuvant systemic therapy (NAST) in breast cancer. High TIL density correlates with higher complete pathologic remission (pCR) in triple negative and HER2 positive breast cancer. Additionally, not only TIL density but also subsets of immune cells in tumor stroma seem to play an important role in cancer and immune cell interaction and response to chemotherapy. Our aim is to determine TIL density and expression of CD 20, CD3, CD8, PD-L1, FOXP3 and PGM1 on core biopsy specimen and find a correlation with pCR.
Trial design
We will conduct a prospective study on early breast cancer patients (n = 180) treated with NAST. Patients with breast tumor >2 cm will be suitable. All patients will underwent mammography, MR of breast, core biopsy of breast tumor, implantation of radiopaque marker into tumor, axillary ultrasound and fine needle biopsy of suspect nodes, CT scan of thorax and abdomen and bone scintigraphy. On core biopsy specimen histologic type, grade, estrogen and progesterone receptors, HER 2 status and MIB-1 will be determined. Additionally, TIL density will be determined on stromal part of tumor on H&E slides in accordance with International TIL Working Group. TIL density will be defined as the percentage of lymphocytes in tumor stroma: as a continuous variable and as two categories: low (0-59%) or high (60-100%). Immunohistochemical detection of CD 20, CD3, CD8, PD-L1, FOXP3 and PGM1 will be performed and each subpopulation of immune cells defined as percentage of all immune cells in tumor stroma. Patients with metastatic tumours and luminal A-like characteristics will be excluded. All other patients will undergo NAST with anthracyclines and taxanes and anti-HER2 therapy if indicated, followed by surgical treatment. The breast and axilla specimen will undergo pathologic examination. pCR will be defined as absence of invasive and carcinoma in situ in breast and axillary nodes. The primary objective will be correlation of CD20, CD3, CD8, PD-L1, FOXP3 and PGM1 with TIL density. The secondary objective will be correlation of subsets of immune cells in tumor stroma with pCR.
Clinical trial identification
EudraCT: 2018-000 547-11.
Editorial acknowledgement
Legal entity responsible for the study
Institute of Oncology Ljubljana.
Funding
Slovenian Research Agency P3-0321.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5747 - The routine use of sentinel lymph node biopsy in high risk DCIS lesions is not justified
Presenter: Fanny Preat
Session: Poster Display session 2
Resources:
Abstract
1837 - Oncological impact of re-excision for positive margin status after breast conserving surgery in invasive breast cancer
Presenter: Kenjiro Jimbo
Session: Poster Display session 2
Resources:
Abstract
4347 - Pneumonitis and fibrosis after breast cancer radiation.
Presenter: Jarle Karlsen
Session: Poster Display session 2
Resources:
Abstract
2280 - Prognosis of mastectomy with reconstruction after neoadjuvant chemotherapy: a nationwide study in Korean Breast Cancer Society
Presenter: Sungmin Park
Session: Poster Display session 2
Resources:
Abstract
804 - A negative prognosis of radiotherapy-induced lower lymphocyte to monocyte ratio in patients with breast cancer
Presenter: Chang-ik Yoon
Session: Poster Display session 2
Resources:
Abstract
2701 - Patient data to monitor clinical patterns in early and advanced breast cancer in Europe
Presenter: Francesco Giusti
Session: Poster Display session 2
Resources:
Abstract
1437 - A critical appraisal of quality indicators of breast cancer treatment in Belgium
Presenter: Didier Verhoeven
Session: Poster Display session 2
Resources:
Abstract
1534 - Predictors of adherence among post-menopausal women receiving adjuvant endocrine therapy for breast cancer in Ontario, Canada
Presenter: Phillip Blanchette
Session: Poster Display session 2
Resources:
Abstract
4363 - Evaluation of endocrine therapy and patients preferences in early breast cancer: results of Elena study
Presenter: Emilia Montagna
Session: Poster Display session 2
Resources:
Abstract
2679 - Baseline Quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): the French multicentric prospective CANTO cohort study
Presenter: Idlir Licaj
Session: Poster Display session 2
Resources:
Abstract