Survival analysis of the 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: Non-metastatic pancreatic ductal adenocarcinoma (PDAC) presents a challenging scenario: the rarity of the disease, the limited number of completed prospective trials, and the shortcomings of comparability across series produce several controversial topics and unanswered questions. Guideline recommendations usually include all the different therapeutic options, de facto transferring to the multidisciplinary team the responsibility on the final decision. This secondary analysis of the GARIBALDI study was aimed to explore the correlation of center type, self-declared volume, and commitment with the overall survival (OS) in patients with non-metastatic PDAC.

Patients and methods: Treatment-naïve patients aged ≥18 years with a pathological diagnosis of non-metastatic PDAC, enrolled between July 2017 and October 2019, were analyzed. OS was defined as the time from treatment start to death. The impact of centers and clinical-demographic characteristics on OS was evaluated using Cox models.

Results: Overall, 402 patients enrolled in 41 centers were eligible for this analysis. The median age was 68.4 years (range 35.6-88.8 years), 49.5% were females, 93.5% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, 16.7% had prior cancer history, and the median CA 19-9 level was 171.5 IU/ml (first-third quartile 24.5-937.5 IU/ml). For 79.8% of patients treatment started within 1 month from diagnosis. Thirty six point six percent of patients underwent upfront surgery and 91.8% of these received a subsequent adjuvant chemotherapy; 14.2% received chemotherapy followed by surgery and 49.3% chemotherapy without surgery. The preferred chemotherapy schemes were gemcitabine (54.8%) for adjuvant chemotherapy and nab-paclitaxel + gemcitabine (55.3%) for upfront chemotherapy. The median follow-up was 57.6 months and 300 patients died. A statistically significant shorter OS was observed in both low- [hazard ratio (HR) 1.61, 95% confidence interval (CI) 1.12-2.32, P = 0.0099] and medium-commitment (HR 1.57, 95% CI 1.10-2.23, P = 0.0120) compared to high-commitment institutions, when adjusting for clinically relevant covariates.

Conclusion: The GARIBALDI study suggests that the volume and the academic brand are not associated with OS in patients with non-metastatic PDAC, while center commitment warrants further exploration.