Abstract 1664P
Background
The present analyses from the GARIBALDI was aimed to addressing the role of oncology center volume, type and accrual rate on the prognosis of patients (pts) with metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).
Methods
Consenting treatment-naïve pts ≥ 18-year with pathological diagnosis of mPDAC were enrolled. 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, 475 pts enrolled in 44 centers were eligible for these analyses. Median age was 69 (range 36-90); 46% females; 90% ECOG PS 0-1; 38% overweight/obese; 66% with liver metastases; median CA19.9 789 (range 0-1,374,500); 8% with prior PDAC resection; 17% with prior cancer history. Median time from diagnosis to treatment was 33 days. 65.2% of pts started therapy >25 days from baseline CT; 70.7% of pts received nab-paclitaxel+gemcitabine; 16.7% gemcitabine alone; 7.7% FOLFIRINOX; 37% received a second-line therapy. The median follow-up was 50 months and 405 pts died. The table provide the median OS estimates.
Table: 1664P
Deaths/N | Overall survival (Median [95%CI]) | Log-rank p-value | |
Self-declared expertise | 0.24483 | ||
Low-volume (<25 pts/year) | 50/58 | 7.3 [5.6-9.0] | |
Medium-volume (25-50 pts/year) | 101/125 | 8.8 [6.7-11.5] | |
High-volume (>50 pts/year) | 234/267 | 10.1 [9.1-11.2] | |
Type | 0. 3610 | ||
Community hospitals | 183/224 | 7.9 [6.7-9.6] | |
Academic centers | 222/251 | 10.1 [9.1-11.2] | |
Accrual rate | 0.6348 | ||
Low-accrual (<10 pts/year) | 173/210 | 7.9 [6.7-9.5] | |
Medium-accrual (10-50 pts/year) | 173/201 | 9.6 [8.5-11.2] | |
High-accrual (> 50 pts/year) | 59/64 | 12.0 [9.7-14.9] |
Conclusions
Although not statically significant, the GARIBALDI survey detected a clinical difference in OS based on center volume, type, and accrual rate.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Associazione Italiana di Oncologia Medica (AIOM), Milan.
Funding
Celgene S.r.l.
Disclosure
M. Reni: Financial Interests, Advisory Board: AstraZeneca, Eli Lilly, Panavance, Celgene, Viatris, Merck Sharp& Dohme, Sotio, Baxter. E. Giommoni: Financial Interests, Invited Speaker: Viatris, Amgen, AstraZeneca; Financial Interests, Other, Support for attending meetings and/or travel: Viatris, Amgen, AstraZeneca. 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. L. Cavanna: Financial Interests, Other, Consulting fees: AstraZeneca, Merck; Financial Interests, Other, Support for attending meetings and/or travel: Pfizer, Ipsen, Celgene. M. Spada: Financial Interests, Invited Speaker: Eli Lilly, Roche, Pfizer, Janssen, Italfarmaco, BMS; Financial Interests, Advisory Board: Eli Lilly, Merck, Pfizer, Janssen, BMS. S.S. Cordio: Financial Interests, Invited Speaker: Amgen, Merck, Merck Sharp & Dohme, Servier, Bayer, Sanofi; Financial Interests, Other, Support for attending meetings and/or travel: MSD, Merck, Servier. A. Spallanzani: Financial Interests, Advisory Board: Pierre Fabre, Lilly, Merck, Viatris, MSD; Financial Interests, Invited Speaker: Pierre Fabre, Lilly, Merck, Viatris, MSD. M.C. Di Marco: Financial Interests, Advisory Board: Oncosil Olaparib. L. Procaccio: Financial Interests, Personal, Other, scientific consultancy: AstraZeneca. All other authors have declared no conflicts of interest.
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