Adjuvant Chemotherapy ± Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head: Results of the Radiotherapy Random Assignment of NRG Oncology/RTOG 0848.

Publication Title

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Authors

• Ross A Abrams
• Kathryn A Winter
• Karyn A Goodman
• William F Regine
• Howard P Safran
• Chandan S Guha
• Lisa A Kachnic
• Michael T Gillin
• Philip A Philip
• Andrew M Lowy
• Eileen O'Reilly
• Jean-Luc Van Laethem
• Samantha A Seaward
• Abraham J Wu
• Jennifer J Wu
• Raid M Aljumaily
• Thomas A DiPetrillo
• Ravit Geva
• Pramila Rani Anne
• Darla K Liles
• Diane C Ling
• Alison Conlin, Department of Medical Oncology, Providence Cancer Institute, Portland, OR.Follow
• Jennifer Moughan
• Christopher H Crane

Document Type

Article

Publication Date

8-20-2026

Keywords

Humans; Female; Pancreatic Neoplasms; Male; Chemotherapy, Adjuvant; Gemcitabine; Deoxycytidine; Middle Aged; Antineoplastic Combined Chemotherapy Protocols; Adenocarcinoma; Erlotinib Hydrochloride; Aged; Disease-Free Survival; Adult; oregon; portland

Abstract

PURPOSE: To assess whether adding fluoropyrimidine sensitized radiotherapy (CXRT) to adjuvant chemotherapy improves overall survival (OS) after curative intent resection of the pancreatic head.

METHODS: This was a multicenter, randomized phase III, two step trial. Step 1: gemcitabine versus gemcitabine + erlotinib (previously reported). Step 2: random assignment to sixth chemotherapy cycle ± CXRT after five cycles of step 1 chemotherapy without progression. Outcomes of step 2 random assignment are reported here. Assuming 17 months median OS (chemotherapy alone), the sample size was 354 patients (hazard ratio [HR], 0.76, 80% power, one-sided α = .05, 316 OS events). OS/disease-free survival (DFS) were estimated by Kaplan-Meier and arms compared using the log-rank test.

RESULTS: A total of 354 patients (median age 63, 55% male, 56% performance status, 1) were randomly assigned to chemotherapy (174) or chemotherapy + CXRT (180). Univariable median and 5-year OS (90% CIs) were 2.6 years (2.1-3.1) and 23.1% (17.7-28.6) for chemotherapy alone, and 2.3 years (2.0-2.6) and 27.9% (22.2-33.6) for chemotherapy + CXRT. The OS primary end point was not met (HR, 0.96 [90% CI, 0.79 to 1.18]; one-sided

CONCLUSION: Overall, the addition of adjuvant CXRT to adjuvant gemcitabine did not statistically significantly improve OS, DFS, or increase grade 4/5 toxicity. For node-negative patients, CXRT improved OS and DFS. These results, if confirmed in studies with current or future systemic therapies, would support the use of adjuvant/neoadjuvant CXRT for node-negative patients.

Area of Special Interest

Cancer

Specialty/Research Institute

Oncology

Specialty/Research Institute

Pharmacy

DOI

10.1200/JCO-25-02520