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
3902 - The efficacy of preoperative breast cancer chemotherapy without anti-HER2-targeted treatment – single center experience in setting of no reimbursement in Poland (2011-2015)
Presenter: Agnieszka Badora-Rybicka
Session: Poster Display session 2
Resources:
Abstract
4733 - A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial)
Presenter: Jean-Marc Nabholtz
Session: Poster Display session 2
Resources:
Abstract
5227 - Outcome of Non-metastatic Male Breast Cancer: 222 patients
Presenter: Ulku Yalcintas Arslan
Session: Poster Display session 2
Resources:
Abstract
5943 - Effects of delayed initiation of adjuvant trastuzumab for non-metastatic, Her2 positive breast cancer in a limited resources setting: ML25232 study final results
Presenter: Samir Beslija
Session: Poster Display session 2
Resources:
Abstract
1725 - Final results of scalp cooling for hair preservation: A single- institution prospective study.
Presenter: Dario Loparco
Session: Poster Display session 2
Resources:
Abstract
3713 - Adjuvant Systemic Therapy in Women with Early Breast Cancer and Intermediate Prosigna ROR Scores: Is Chemotherapy Use Declining? Evidence From a Large Practice
Presenter: Lowell Hart
Session: Poster Display session 2
Resources:
Abstract
818 - Management of early breast cancer in women over 90: A 10 year experience
Presenter: Emily Coffey
Session: Poster Display session 2
Resources:
Abstract
1141 - Evolution in the risk of adverse events of adjuvant endocrine therapy in postmenopausal women with early- stage breast cancer.
Presenter: Daniel Reinhorn
Session: Poster Display session 2
Resources:
Abstract
2277 - Hepatitis B screening and incidence of flare among non-metastatic breast cancer patients treated with anthracyclines
Presenter: Zewen Zhang
Session: Poster Display session 2
Resources:
Abstract
2781 - Effect of denosumab on low bone mineral density in postmenopausal Japanese early breast cancer patients receiving aromatase nhibitors : 36-month results
Presenter: Koichi Sakaguchi
Session: Poster Display session 2
Resources:
Abstract