1666P - Non-metastatic cohort of the Italian Association for Medical Oncology (AIOM) guideline application in real-world: Multi-Institutional based survey of adjuvant and first-line pancreatic ductal adenocarcinoma treatment in Italy (GARIBALDI)

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

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.