Abstract 358P
Background
Early-phase clinical trials are crucial for advancing drug development. While metastatic pancreatic adenocarcinoma (mPAC) is associated with a poor prognosis, only limited data are available on the outcomes of chemo-refractory mPAC patients enrolled in phase I clinical trials. Therefore, the present study evaluated the characteristics associated with survival in patients with mPAC who participated in phase I clinical trials for solid tumors to find the optimal dosage of new agents.
Methods
All patients with chemo-refractory mPAC who participated in phase I clinical trials at our institution from January 2019 to December 2023, and received at least one dose of the study drug, were included. Survival analyses were performed using the Kaplan-Meier method. The Cox proportional hazards models used to estimate the hazard ratios (HRs) of potential prognostic factors for survival.
Results
Forty-three patients were included in the analysis. The patients’ characteristics were as follows: median age, 63 years (range, 40–77 years); male/female, 24/19; ECOG-PS 0/1/2, 26/16/1; and median number of prior systemic therapies, 2 (range, 1–4). Phase I treatment included molecular-targeted therapy (47%), immunotherapy (51%), and cytotoxic agents (2%), and 42% of the patients received molecularly matched therapy. The objective response rate was 11% and the disease control rate was 40%. The median progression-free survival (PFS) was 1.9 (95% confidence interval [CI]: 1.3-2.8) months and overall survival (OS) was 5.6 (95% CI: 3.8-8.6) months. Univariate analysis of OS revealed that a neutrophil-to-lymphocyte ratio (NLR) of >5 (HR: 3.3, 95% CI: 1.36-8.02, p=0.008) and modified Glasgow Prognostic Score (mGPS) of >1 (HR: 2.8, 95% CI: 1.17-6.52, p=0.02) were significantly associated with poor prognosis.
Conclusions
Chemo-refractory mPAC with NLR>5 or mGPS>1 requires caution when participating in phase I trials.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
H. Imaoka: Financial Interests, Personal, Invited Speaker: Yakult Honsha, AstraZeneca, Nihon Servier, Kaneka Medix, Medico's Hirata, SB Kawasumi Laboratories; Financial Interests, Personal, Advisory Board: Nihon Servier; Financial Interests, Personal, Expert Testimony: Kaneka Medix; Financial Interests, Institutional, Invited Speaker: Ono Pharmaceutical, Novartis, Nihon Servier. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eisai, Nihon Servier, Novartis, Bristol Myers Squibb, MSD, Boehringer Ingelheim, Astellas Pharma, GSK; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, Nihon Servier, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Fujifilm Toyama Chemical, Incyte Biosciences Japan, Takeda, Ono, MSD, Taisho Pharmaceutical, Nippon Kayaku, Guardant Health Japan, Nobelpharma, Chugai, NIHON Servier, Takeda, Novartis, Eisai, Rakuten Medical; Financial Interests, Institutional, Invited Speaker: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, MSD, Ono, Novartis, J-Pharma, Chiome Bioscience, Nihon Servier, Delta-Fly Pharma, Syneos Health, Merus. N.V., Merck Biopharma, Boehringer Ingelheim, Invitae, Nobelpharma. All other authors have declared no conflicts of interest.