Abstract 1563P
Background
Therapeutic resources in advanced pancreatic cancers (PDAC) are limited and the prognosis remains poor. Phase I trials are a therapeutic alternative for patients who failed standard of care. However, overall efficacy data of phase I for PDACs are not well known. The objective of this retrospective study was to determine the potential benefit of phase I trials in PDAC.
Methods
In this retrospective analysis, we included all patients with PDAC referred to Drug Development Department (DITEP) at Gustave Roussy for a phase I clinical trial. Demographic, clinical and radiological data were collected. The primary objective was to determine the overall response rate (ORR). The secondary objectives were progression-free survival (PFS) and overall survival (OS).
Results
Between 2009 and 2019, 790 patients were referred to be treated in a phase I trial and 154 (19.5%) were enrolled. A majority of patients were not included due to a lack of available slots. Out of 154 patients, 113 (73.4%) received the phase I treatment while 41 (26.6%) were screen failure largely due to rapid tumor progression. Main characteristics of the patients were as follow: median age 69 y/o, median number of metastatic sites 2 (range: 1 - 4), LDH 192 UI/L (IQR: 159 - 215), albumin 38 g/L (IQR 35-40), neutrophil/lymphocyte (NLR) ratio 3.4 (IQR: 2.3 – 5.4) and dNLR ratio (neutrophil/(leukocyte-lymphocyte) 2.0 (IQR: 1.5 – 3). In terms of efficacy, 10 patients (8.8%) experienced a partial response and 36 patients (31.9%) had a stable disease. Partial responses were observed in patients treated with tyrosine kinase inhibitor (TKI) or combination of TKI (N=4), cytotoxic or cytotoxic plus TKI (N=4), cytotoxic plus anti-PDL1 (N=1) or a combination of immunotherapy (N=1). The median progression-free survival was 2.2 months (IQR: 1.05 – 2.8) while overall survival was 6.8 months (IQR: 2.22 – 7.2).
Conclusions
This study shows that many patients with PDAC are looking for innovative treatment and that a small minority have access to it. The efficacy of phase I trials for PDAC does not appear to be inferior to a second line chemotherapy.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.