Abstract 5368
Background
Immunotherapy with anti PD-1/PD-L1 antibodies as a monotherapy showed promising results with limited success in triple negative breast cancer. As the combination of paclitaxel and anti PD-L1 was likely synergistic, our aim was to test safety, toxicities, tolerability and efficacy of this combination.
Methods
We have initiated an open label, interventional phase I/II clinical trial to test the safety and efficacy of a combination of Durvalumab (therapeutic anti-PD-L1 antibody) and paclitaxel for the treatment of metastatic triple negative breast cancer (TNBC). After 1 cycle of weekly paclitaxel alone, Durvalumab was given every two weeks in combination with paclitaxel that was delivered on days 1, 8 and 15 of each 28 days’ cycle.
Results
Between 2017-2019, we enrolled 19 patients (25-61 years old) of which 14 were treated with the combination therapy, while the remaining 5 dropped out due to tumor progression (n = 3) or intolerance to first cycle of paclitaxel alone (n = 2). Patients had metastatic infiltrating ductal carcinoma with two patients having a metaplastic pathological subtype. No dose limiting toxicity was reported. Patients who received combination therapy are still alive except two dead due to progression of disease. The most common adverse effects, regardless of grade, were: anemia 25%, neutropenia, and leukopenia (20% each). In addition, neuropathy, and dyspnea were seen in 15% of patients (each). Grade 3/4 adverse effects were anemia, neutropenia, leukocytopenia, headache, fatigue and abdominal pain. There was one case of colitis (grade 2). Among evaluable combination treated patients (n = 12), 5 patients (42%) initially showed objective response with a median duration of 7.1 months, while the disease control rate was 67%. However, 6 (55%) showed signs of progression later on leaving only 1 patient with CR, and another with SD. So far there is a definite increase in survival of TNBC with the combination therapy compared to historical rates of paclitaxel alone. However, the end point has not been reached yet.
Conclusions
Combination of Durvalumab and Paclitaxel is safe with very promising efficacy in metastatic TNBC.
Clinical trial identification
NCT02628132.
Editorial acknowledgement
Legal entity responsible for the study
Hazem Ghebeh PhD and Taher Twegieri MD.
Funding
AstraZeneca (ESR-14-10649) and KFSH&RC (RAC# 2151-169).
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5579 - Quality of informed consent in clinical trials patients
Presenter: Gianluca Catania
Session: Poster Display session 3
Resources:
Abstract
5147 - Patient's rights: Where do we stand?
Presenter: Maja Kozuh
Session: Poster Display session 3
Resources:
Abstract
1279 - The oncology nurse coordinator’s role in a digestive oncology department: Impact on patient and hospital
Presenter: Fouad Awada
Session: Poster Display session 3
Resources:
Abstract
1670 - Nursing model for a breast cancer unit at the Catalan Institute of Oncology
Presenter: Ana Rodriguez-ortega
Session: Poster Display session 3
Resources:
Abstract
3936 - Role of cancer nurse in the prevention and control of acute deterioration for oncohematologic patient
Presenter: Raquel Azor Portolés
Session: Poster Display session 3
Resources:
Abstract
2789 - Standardized nursing care in the department of radiotherapy of a network of cancer centres
Presenter: José Delgado
Session: Poster Display session 3
Resources:
Abstract
4482 - Exploring anxiety, depression and quality of life of ambulatory cancer patients during chemotherapy.
Presenter: Theodoula Adamakidou
Session: Poster Display session 3
Resources:
Abstract
3075 - Implementing a Cancer Survivorship Program for Individuals with Recurrent Breast Cancer
Presenter: Darcy Burbage
Session: Poster Display session 3
Resources:
Abstract
3869 - The perceptions of parents/guardians regarding their child/adolescent’s experience of reflexology or non-specific foot massage The perceptions of parents/guardians regarding their child/adolescents experience of reflexology or non-specific foot massage
Presenter: Patricia Fox
Session: Poster Display session 3
Resources:
Abstract
4064 - Quality of life in survivors of adult haematological malignancies
Presenter: Anita Immanuel
Session: Poster Display session 3
Resources:
Abstract