Abstract 5403
Background
Perioperative chemotherapy improves cure rate in locally advanced esophagogastric and gastric adenocarcinoma. Immunotherapy is active at the metastatic stage. Our hypothesis is that the addition of avelumab, an anti-PD-L1 antibody, to perioperative chemotherapy, will increase pathologic complete response (pCR), a potential surrogate for overall survival, compared to historical controls.
Methods
Single-arm phase II study of avelumab + chemotherapy (modified DCF) given every 2 weeks for 4 cycles before and after surgery. Main inclusion criteria: gastric or gastro-esophageal adenocarcinoma, locally advanced disease, adequate organ function, performance status 0-1, stages Ib, II and III. Main exclusion criteria: other histologies, metastatic disease, use of immunosuppressants, serious autoimmune disease, daily intake of more than 10 mg of prednisone (or equivalent). Statistical hypothesis: this experimental regimen will result in a 20% pCR rate compared to 7% observed with chemotherapy alone. Optimal Simon 2-stage design: if less than 2 pCR/near-pCR are identified in the first 16 cases, the study will be closed for futility. The experimental regimen will be considered for further study if at least 6 pCR are identified in 50 operated patients. Adverse effects are prospectively recorded according to CTCAE guidelines.
Results
From February 2018 to March 2019, 18 patients have been enrolled. Two withdrew consent after starting treatment. Of 16 active patients, 14 were staged as cT3, and 12 as cN+. Thirteen have been operated to date, none having shown radiologic or PET progression. All resections are R0. Eight patients have pN0 status. Two have shown near-pCR (tumor regression score 1). There is one instance of grade 4 hematological toxicity (neutropenia without fever). Grade 3-4 nonhematological toxicity consists of: stomatitis, nausea, diarrhea, all in one patient; arthralgia in one patient; aspiration pneumonia (esophageal obstruction) and postoperative pneumonia, one patient each.
Conclusions
Our findings indicate encouraging safety and activity of avelumab + mDCF as a perioperative regimen. Complete interim analysis results will be presented at the meeting.
Clinical trial identification
NCT03288350.
Editorial acknowledgement
Legal entity responsible for the study
Research Institute of McGill University Health Centre.
Funding
EMD Serono, Research Institute of McGill University Health Centre.
Disclosure
T. Alcindor: Research grant / Funding (self): EMD Serono; Advisory / Consultancy: Astellas; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Taiho; Advisory / Consultancy: Shire; Advisory / Consultancy: BMS. All other authors have declared no conflicts of interest.
Resources from the same session
4732 - Progesterone Receptor Isoform Ratio Dictates Antiprogestins/Progestins Effects on Metastatic Breast Cancer Models
Presenter: Maria Abascal
Session: Poster Display session 2
Resources:
Abstract
5737 - PAM50 and CGH-array genomic characterization of HER2-Equivocal Breast Cancers defined by the 2018 ASCO/CAP recommendations.
Presenter: Carine Ngo
Session: Poster Display session 2
Resources:
Abstract
1096 - OncotypeDX® predictive nomogram for recurrence score output: a machine learning system based on quantitative immunochemistry analysis - ADAPTED01
Presenter: Fabio Marazzi
Session: Poster Display session 2
Resources:
Abstract
5426 - Geriatric parameters predict both disease-related and patient-reported outcomes in older patients with breast cancer
Presenter: Willeke van der Plas-Krijgsman
Session: Poster Display session 2
Resources:
Abstract
5865 - Patients with a 21-gene assay in South East London differ from the TAILORx trial population
Presenter: Charalampos Gousis
Session: Poster Display session 2
Resources:
Abstract
1312 - Predictive tools in adjuvant breast cancer – what is the standard of evidence supporting their utility? A literature review examining validation of Adjuvant!, Cancermath and NHS Predict
Presenter: Alice Loft
Session: Poster Display session 2
Resources:
Abstract
2445 - Oncologic outcome of invasive lobular carcinoma: Is it different from that of invasive ductal carcinoma?
Presenter: Hee Jun Choi
Session: Poster Display session 2
Resources:
Abstract
2476 - Pathologic response and survival efficacy in patients with initial nodal involvement after neoadjuvant chemotherapy in early breast cancer
Presenter: SERAFIN MORALES Murillo
Session: Poster Display session 2
Resources:
Abstract
3761 - Chemotherapy-induced amenorrhea: prognostic impact on premenopausal Egyptian patients with breast cancer
Presenter: Khaled Abdel Karim
Session: Poster Display session 2
Resources:
Abstract
4687 - Predicting the presence of breast cancer using circulating small RNA in the serum
Presenter: Yumiko Koi
Session: Poster Display session 2
Resources:
Abstract