Effect of enrollment in a clinical trial on treatment outcomes of patients with pancreas cancer.

Abstract

e16445 Background: Clinical trials serve as a critical pathway to novel, potentially life-saving treatments and provide structured care, rigorous monitoring, and additional resources for patients undergoing cancer treatments. We hypothesize that clinical trial enrollment may improve survival outcomes by standardizing therapy and ensuring equitable follow-up. This study aims to evaluate whether participation in a clinical trial enhances survival for patients with pancreas cancer (PC) and closes the survival gap between Black and White patients. Methods: This is a retrospective analysis of a prospectively maintained database of patients with PC at a single high-volume tertiary referral center. The study was approved by the institutional IRB. Patients with biopsy-proven resectable (R) or borderline resectable (BLR) PC who were diagnosed between 2014-2023 and received neoadjuvant therapy (NeoTx) were included. The cohort was divided into two groups: patients enrolled in ≥ 1 clinical trials (Trial) vs. not enrolled (NoTrial). Results: 634 consecutive patients were included: 266 (42%) with R-PC and 368 (58%) with BLR-PC. Median age was 67 yrs (IQR 13), 281 (44%) patients were female, and 571 (90%) were White. Of the 634 patients, 414 (65%) were in the NoTrial group and 220 (35%) in the Trial group. All patients received NeoTx; 93 (15%) received chemoradiation alone, 61 (9%) received chemotherapy alone, and 480 (76%) received both. Patients enrolled in a clinical trial were twice as likely to complete neoadjuvant therapy and surgery with an OR: 2.18, 95%CI [1.41 – 3.38], p < 0.001, after controlling for variables associated with trial enrollment, including age, race, comorbidities, area deprivation index, radiographic stage at diagnosis, and type of NeoTx.In contrast, patients with multiple comorbidities or BLR-PC had decreased odds of completing all intended therapies with OR:0.58, 95%CI [0.37 – 0.90], p = 0.02 and OR:0.34, 95%CI [0.22 – 0.52], p < 0.001 respectively. Median overall survival (mOS) for all 634 patients was 28 months; 41 months for the 435 (69%) who completed all intended NeoTx and surgery. mOS was significantly longer in Trial vs. NoTrial; 33 months vs. 26 months, p = 0.006. mOS for White, Trial vs. NoTrial patients was 34 months vs. 26 months, p = 0.006. There was a trend towards improved survival in Black Trial vs. NoTrial patients (24 months vs. 18 months, p = 0.27). Conclusions: Enrollment in clinical trials significantly improved completion rates of neoadjuvant therapy and surgery and was associated with improved survival outcomes in patients with R-PC and BLR-PC. Our data provides a signal that clinical trial enrollment may ameliorate disparities in PC survival outcomes in minorized patient populations. Demographics summary and pretreatment disease characteristics. No trial(n=414) Trial(n=220) All(n=634) p-value Age, median (IQR) 68 (14) 65 (13) 67 (13) <0.001 Gender, n (%) Female Male 188 (45)226 (55) 93 (42)127 (58) 281 (44)353 (56) 0.449 Race, n (%) White Black Other/Unknown 382 (92)22 (5)10 (3) 189 (86)18 (8)13 (6) 571 (90)40 (6)23 (4) 0.025 Area Deprivation Index, n (%) <50 >50 252 (63)149 (37) 143 (67)71 (33) 395 (64)220 (36) 0.327 BMI (kg/m 2 ), median (IQR) 27.0 (6.5) 28.2 (6.9) 27.3 (6.9) 0.009 Age adjusted Charlson Comorbidity Index, mean (SD) 5.6 (2.2) 4.8 (1.4) 5.3 (2.0) <0.001 CA19-9 at diagnosis (U/ml), median (IQR) 74 (407) 125 (427) 92 (407) 0.070 Clinical and radiographic stage at diagnosis, n (%) Resectable Borderline 159 (38)255 (62) 107 (49)113 (51) 266 (42)368 (58) 0.013 Neoadjuvant treatment, n (%) Chemoradiation alone Chemotherapy alone Both 72 (18)30 (7)312 (75) 21 (10)31 (14)168 (76) 93 (15)61 (9)480 (76) 0.001