Neoadjuvant SBRT plus regional nodal irradiation with concurrent capecitabine for patients with resectable pancreatic cancer: Survival analysis of prospective phase 1 trial.

Authors

Mustafa Basree

Mustafa Basree

Department of Human Oncology, University of Wisconsin–Madison, Madison, WI

Mustafa Basree , Jacob Witt , Sharon M. Weber , Nataliya Volodymyrivna Uboha , Rebecca Minter , Meghan G. Lubner , Daniel Erik Abbott , Dustin A. Deming , Noelle K. LoConte , Syed Nabeel Zafar , Monica Arun Patel , Sam Joseph Lubner , Jeremy D. Kratz , Mark A. Ritter , Pranshu Mohindra , Michael F. Bassetti

Organizations

Department of Human Oncology, University of Wisconsin–Madison, Madison, WI, Cancer Care Center of O’Fallon, O'fallon, IL, Department of Surgery, University of Wisconsin–Madison, Madison, WI, University of Wisconsin Carbone Cancer Center, Madison, WI, Department of Radiology, University of Wisconsin–Madison, Madison, WI, University of Maryland Baltimore, Baltimore, MD

Research Funding

No funding sources reported

Background: Radiation may have a role in management of patients with early-stage pancreatic cancer. However, the role of regional nodal irradiation (RNI) is not well defined despite the high frequency of occult nodal disease. The goal of this trial was to evaluate the safety and feasibility of stereotactic body radiation therapy (SBRT) to primary disease with RNI, combined with capecitabine as a neoadjuvant approach for patients with resectable pancreatic cancer. Updated survival analysis will be presented here. Methods: This is a prospective, single institution, phase IA/B dose-escalation trial that enrolled patients with biopsy-proven, resectable, pancreatic adenocarcinoma between 2014 – 2019 (NCT1918644). Patients were enrolled into one of the 3 cohorts with escalating dose levels. Neoadjuvant SBRT to the primary tumor was delivered in 5 fractions of 5, 6, or 7 Gy with concomitant capecitabine. All patients received RNI 5 Gy x 5 fractions. Our initial report found no dose-limiting toxicities (Witt et al IJROBP 2020). Clinicopathologic features were summarized using descriptive statistics. Kaplan-Meier curves were employed for survival analysis. Results: Seventeen patients were enrolled on the protocol with sixteen evaluable (94.1%). Thirteen (76.5%) patients proceeded to surgery. Median follow up was 31.1 months (2.0 – 73.2). Among the evaluable patients, 63% were male, median age at diagnosis was 73 years (63 – 84), pre-treatment CA 19-9 149.5 U/mL (2.0 – 19358.0). The majority of patients had cT2-3 (94%) and cN0 (87.5%) disease. In patients who underwent resection, median time from radiation to surgery was 19.7 days (14.8 – 42.4), with median of 18 lymph nodes removed (11 – 27). Pathologically involved nodes were present in 69.2% of patients with a median of 2 nodes (1 – 10). Five patients (31.3%) received neoadjuvant chemotherapy, and ten (62.5%) received adjuvant chemotherapy. At the time of data cutoff, median overall survival was 31.1 months (2.3 – 73.6), and median locoregional control and distant metastasis free survivals were 32.8 months (4.0 – 59.5) and 15.3 months (0.4 – 73.6), respectively. No further radiation related toxicities were noted since the prior report. Conclusions: Neoadjuvant chemoradiation with SBRT and capecitabine to primary disease with RNI is feasible and provided a promising signal of durable local control in our study, despite high rates of pathological nodal involvement. Further investigation of this strategy is warranted in a larger cohort of patients. Clinical trial information: NCT1918644.

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Abstract Details

Meeting

2024 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT1918644

Citation

J Clin Oncol 42, 2024 (suppl 3; abstr 652)

DOI

10.1200/JCO.2024.42.3_suppl.652

Abstract #

652

Poster Bd #

L1

Abstract Disclosures

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