Abstract 1429P
Background
There is a debate about whether patients (pts) with MSI should receive neoadjuvant chemotherapy. DANTE evaluates perioperative FLOT vs. FLOT/atezolizumab for resectable gastric or GEJ adenocarcinoma. Here, we report preliminary data for the pathological (path) regression in pts with MSI.
Methods
DANTE is a bi-national, multicenter, investigator-initiated, phase IIb trial. Pts with resectable adenocarcinoma of the stomach and GEJ (≥cT2 and/or N+) were randomized to either receive 4+4 cycles of periop. FLOT q2w or 4+4 cycles of periop. FLOT + atezolizumab at 840 mg q2w followed by atezolizumab monotherapy for 8 cycles at 1200 mg q3w. MSI and path regression (Becker-Classification) have been centrally evaluated in 195 pts, so far.
Results
By Oct 2020, the trial was fully recruited with 295 pts. Median age was 61y, with 74% male pts. 42% of pts had an intestinal type acc. to Laurén and 61% had GEJ adenocarcinoma. Overall, 22 pts (7%) were assessed MSI. Rate of path complete regression (TRG1a) was higher in pts with MSI than those with MSS (10/22 pts [46%] vs. 41/173 pts [24%]). Among MSI pts, rates of path complete or subtotal regression (TRG1a/b) were 80% (8/10) after FLOT/atezolizumab vs. 59% (7/12) after FLOT. Table: 1429P
Path regression by MSI status and treatment arm
| MSI (n=22) | ||
| Path regression | FLOT n=12 | Atezo/FLOT n=10 |
| Complete (pCR/TRG1a) | 5 (42%) | 5 (50%) |
| Subtotal (pSR/TRG1b) | 2 (17%) | 3 (30%) |
| Partial (PR/TRG2) | 1 (8%) | 1 (10%) |
| Minor or no regression | 4 (33%) | 1 (10%) |
Conclusions
Pts with MSI generally achieved very high rates of path regression following FLOT or FLOT/atezolizumab. Contrary to previous retrospective studies, our study supports offering perioperative therapy to pts with MSI and gastric and GEJ adenocarcinoma.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest.
Funding
Hoffmann-La Roche Ltd.
Disclosure
S. Al-Batran: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Nordic Bioscience; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Speaker’s Bureau: Lilly; Financial Interests, Personal, Speaker’s Bureau: Celgene; Financial Interests, Personal, Speaker’s Bureau: AIO gGmbH; Financial Interests, Personal, Speaker’s Bureau: Forum für Medizinische Fortbildung; Financial Interests, Personal, Speaker’s Bureau: MCI group; Financial Interests, Personal, Speaker’s Bureau: Nordic Bioscience; Financial Interests, Personal, Ownership Interest: Institut für Klinische Krebsforschung IKF GmbH; Non-Financial Interests, Personal and Institutional, Funding: Celgene; Non-Financial Interests, Personal and Institutional, Funding: Lilly; Non-Financial Interests, Personal and Institutional, Funding: Medac; Non-Financial Interests, Personal and Institutional, Funding: Hospira; Non-Financial Interests, Personal and Institutional, Funding: Sanofi; Non-Financial Interests, Personal and Institutional, Funding: German Cancer Aid; Non-Financial Interests, Personal and Institutional, Funding: German Research Foundation; Non-Financial Interests, Personal and Institutional, Funding: Federal Ministry of Education and Research; Non-Financial Interests, Personal and Institutional, Funding: Merck; Non-Financial Interests, Personal and Institutional, Funding: Roche; Non-Financial Interests, Personal and Institutional, Funding: Vifor Pharma. P.C. Thuss-Patience: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Servier. A. Kretzschmar: Financial Interests, Personal, Advisory Role: Teva; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Shire; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Other, Travel: PharmaMar; Financial Interests, Personal, Other, Travel: Merck Serono; Financial Interests, Personal, Other, Travel: Ipsen; Financial Interests, Personal, Other, Travel: Medac; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: Merck Serono; Financial Interests, Personal, Other, Honoraria: Shire; Financial Interests, Personal, Other, Honoraria: Amgen; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Medac; Financial Interests, Personal, Other, Honoraria: Eisai; Financial Interests, Personal, Other, Honoraria: Servier; Financial Interests, Personal, Other, Honoraria: Sanofi. E. Goekkurt: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Merck. G.M. Haag: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: EsoCap; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Other, Honoraria: Servier; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Lilly; Non-Financial Interests, Personal and Institutional, Research Grant: Nordic Pharma; Non-Financial Interests, Personal and Institutional, Research Grant: Taiho Pharmaceutical; Non-Financial Interests, Personal and Institutional, Research Grant: MSD; Financial Interests, Personal, Other, Travel: BMS; Financial Interests, Personal, Other, Travel: Lilly. C. Bolling: Non-Financial Interests, Personal and Institutional, Research Grant: MOLOGEN; Non-Financial Interests, Personal and Institutional, Research Grant: PledPharma. N. Irahara: Financial Interests, Personal, Full or part-time Employment: Roche. T.O. Götze: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Invited Speaker: Servier; Non-Financial Interests, Personal and Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Personal and Institutional, Research Grant: Deutsche Forschungsgemeinschaft (DFG); Non-Financial Interests, Personal and Institutional, Research Grant: Deutsche Krebshilfe; Non-Financial Interests, Personal and Institutional, Research Grant: Gemeinsamer Bundesausschuss; Non-Financial Interests, Personal and Institutional, Research Grant: Lilly. All other authors have declared no conflicts of interest.