Abstract 1666P
Background
The GARIBALDI study investigated the impact of oncology center volume, type, and accrual rate on the prognosis of the overall therapeutic management of patients (pts) with non-metastatic Pancreatic Ductal Adenocarcinoma (nmPDAC).
Methods
Consenting treatment-naïve pts ≥ 18-year with pathological diagnosis of nmPDAC were eligible. Participating centers were categorized according to the self-declared expertise, the type and the accrual rate. Survival curves were estimated by the Kaplan–Meier method and compared by the log-rank test. Overall Survival (OS) was defined as the time from the date of medical therapy start to death for any cause.
Results
Between July 2017 and October 2019, 402 pts with nmPDAC from 44 centers were enrolled. Median age was 69 (range 36-89); 50% females; 93% ECOG PS 0-1; 33% overweight/obese; 17%, 38.7%, 44.3% with stage I, II, III, respectively; median CA19.9 177 (range 0-350,933); 17% with prior cancer history. Median diagnosis to treatment interval was 26 days. 68.4% had baseline CT >25 days before treatment start. 64% received chemotherapy upfront mainly consisting of nab-paclitaxel+gemcitabine (55%), gemcitabine alone (12%) or FOLFIRINOX (27%); 50% were submitted to surgery; 32% received radiotherapy. The median follow-up was 43.7 months and 274 pts died. The table provides the median OS estimates.
Table: 1666P
Deaths/N | Overall survival (Median [95%CI]) | Log-rank p-value | |
Self-declared expertise | 0.0036 | ||
Low-volume (<25 pts/year) | 46/61 | 15.5 [11.7-21.8] | |
Medium-volume (25-50 pts/year) | 48/69 | 21.6 [16.9-24.5] | |
High-volume (>50 pts/year) | 174/260 | 23.2 [19.2-27.1] | |
Type | 0.0714 | ||
Community hospitals | 108/154 | 20.6 [16.6-23.2] | |
Academic centers | 166/248 | 22.0 [18.7-26.9] | |
Accrual rate | 0.0238 | ||
Low-accrual (<10 pts/year) | 114/161 | 18.7 [15.8-23.6] | |
Medium-accrual (10-50 pts/year) | 107/149 | 21.6 [18.6-25.1] | |
High-accrual (> 50 pts/year) | 53/92 | 29.3 [18.1-35.6] |
Conclusions
A statistically significant difference in OS was found based on center volume and accrual rate, while a clinical difference was highlighted based on center type.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Associazione Italiana di Oncologia Medica (AIOM).
Funding
Celgene S.r.l.
Disclosure
C. Pinto: Financial Interests, Institutional, Funding: Eli Lilly, Bayer, Roche; Financial Interests, Personal, Advisory Board, DSMB: BMS, Eli Lilly, Novartis and Merck; Financial Interests, Personal, Advisory Board: Novartis, BMS, Amgen. M. Milella: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Pfizer, Merck, Novartis, Ipsen, Viatris; Financial Interests, Personal, Steering Committee Member: Novartis; Financial Interests, Institutional, Funding: Roche. F. Bergamo: Financial Interests, Personal, Invited Speaker: Lilly, BMS, MSD, EISAI, Bayer; Financial Interests, Personal, Advisory Board: Servier, AAA; Other, Other, congress: Bayer, Ipsen, AAA. M.C. Di Marco: Financial Interests, Personal, Advisory Board, DSMC: OncoSil. G.G. Cardellino: Financial Interests, Personal, Other, Attending Meeting and/or travel: Incyte, Eli Lilly, Amgen, MSD; Financial Interests, Personal, Advisory Board: Eli Lilly, MSD, AstraZeneca. L. Cavanna: Financial Interests, Personal, Other, Consulting fees: AstraZeneca, Merck; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Pfizer, Ipsen, Celgene. E. Giommoni: Financial Interests, Personal, Invited Speaker: Viatris, Amgen, AstraZeneca; Financial Interests, Personal, Advisory Board: Viatris, Amgen, Viatris, Ipsen. M. Reni: Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Personal, Advisory Board, and DSMC: Eli Lilly, Panavance, Celgene, AstraZeneca, Viatris, Merck Sharp & Dohme, Servier, Sotio, Baxter. All other authors have declared no conflicts of interest.
Resources from the same session
1589P - Systemic treatment strategies and outcomes of patients with peritoneal metastases of gastric origin
Presenter: Niels Guchelaar
Session: Poster session 22
1590P - Real-world gastric cancer (GC) in Latin America (LATAM) and Europe (EU)
Presenter: Berenice Freile
Session: Poster session 22
1591P - Gastric cancer in young patients under 40 years: 5-year analyses of Georgian cancer registry
Presenter: Tamar Esakia
Session: Poster session 22
1617P - PRODIGE 29-UCGI 26 (NEOPAN): Quality of life results of a phase III randomised trial comparing chemotherapy with folfirinox (FFX) or gemcitabine (gem) in locally advanced pancreatic carcinoma (LAPC)
Presenter: Michel Ducreux
Session: Poster session 22
1618P - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
Presenter: Alison Schram
Session: Poster session 22
1620P - A phase II study of perioperative nalirifox in patients with resectable pancreatic ductal adenocarcinoma (rPDAC): Survival update and biomarkers analysis of the NITRO trial
Presenter: Davide Melisi
Session: Poster session 22
1621P - Efficacy and safety of erdafitinib in adults with pancreatic cancer and prespecified fibroblast growth factor receptor alterations (FGFRalt) in the phase II open-label: Single-arm RAGNAR trial
Presenter: Shubham Pant
Session: Poster session 22
1622P - D-1553 in patients with KRAS G12C mutated advanced pancreatic cancer (pca)
Presenter: Shunsuke Kondo
Session: Poster session 22
1623P - Pelareorep (pela) + atezolizumab (atezo) and chemotherapy in first-line (1L) advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients: Results from the GOBLET study
Presenter: Dirk Arnold
Session: Poster session 22