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
5063 - Does Nutritional Status Affect Treatment Tolarability, Response and Survival in Metastatic Gastric Cancer Patients? Results of Prospective Multicenter Study
Presenter: Senem Karabulut
Session: Poster Display session 2
Resources:
Abstract
2717 - Ramucirumab use in patients with Advanced Gastric Cancer (AGC) or gastro-oesophageal junction (GEJ) adenocarcinoma in Spain: RAMIS observational study
Presenter: Federico Longo Munoz
Session: Poster Display session 2
Resources:
Abstract
3187 - Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor: Exploratory analysis in the patients who were enrolled in JCOG0705/KGCA01 phase III trial (REGATTA) and could continue chemotherapy
Presenter: Takaki Yoshikawa
Session: Poster Display session 2
Resources:
Abstract
4765 - A prospective observational study on the optimal maintenance strategy in HER2-positive advanced gastric cancer treated with trastuzumab based therapy
Presenter: Qian Li
Session: Poster Display session 2
Resources:
Abstract
3500 - Randomised phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma (SEED)
Presenter: Peter Petersen
Session: Poster Display session 2
Resources:
Abstract
5197 - Ramucirumab in the treatment of refractory metastatic gastric cancer: results from the RamSelGa trial.
Presenter: Alexey Tryakin
Session: Poster Display session 2
Resources:
Abstract
2011 - Regorafenib in combination with Paclitaxel for beyond first-line treatment of advanced esophagogastric cancer (REPEAT): a phase Ib trial with expansion cohort
Presenter: Mohammed Khurshed
Session: Poster Display session 2
Resources:
Abstract
2117 - The relationship between the survival and fixed dosing of S-1 in advanced gastric cancer patients by pooled analysis using individual data from four Japanese randomized phase III trials
Presenter: Wataru Ichikawa
Session: Poster Display session 2
Resources:
Abstract
2669 - A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric or Esophageal Cancers who failed previous chemotherapy
Presenter: Ming Huang Chen
Session: Poster Display session 2
Resources:
Abstract
3240 - Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in European patients with heavily pretreated metastatic gastric cancer (mGC): an analysis of the TAGS study
Presenter: Maria Alsina
Session: Poster Display session 2
Resources:
Abstract