Moawia Mohammed Ali Elhassan, Associate Professor at the University of Gezira and Consultant in Clinical and Radiation Oncology at Universal Hospital, Sudan, shared on LinkedIn:
“Adjuvant Chemoradiotherapy in Resected Pancreatic Cancer: Results from NRG Oncology/RTOG 0848
The randomized Phase III #NRGOncology/RTOG0848 trial, recently published in the Journal of Clinical Oncology, provides critical answers while defining modern safety standards.
After 5 cycles of gemcitabine versus gemcitabine + erlotinib patients without progression randomly assignment to sixth chemotherapy cycle ± CRT (50.4 Gy/28 fractions to the postoperative tumor bed, the pancreatojejunostomy, and the regional nodes with either continuous infusion 5FU or oral capecitabine starting on day 1 of RT)
Key Findings
- Overall Population: Adjuvant #chemoradiotherapy did not achieve a statistically significant #OS benefit across the unselected cohort (HR = 0.96, P = .77).
– Chemotherapy Alone: Median OS 2.6 years | 5-Year OS 23.1%
– Chemotherapy + CRT: Median OS 2.3 years | 5-Year OS 27.9% - Node-Negative Subgroup Benefit: A significant treatment-by-nodal-status interaction was observed. CRT significantly improved both OS (P = .0063) and DFS (P = .014) in node-negative patients.
Safety Profile:
- Grade 3 adverse events were higher in the CRT arm (38% vs. 19\%, P < .001), driven by manageable gastrointestinal #toxicity (diarrhea) & lymphopenia. Crucially, there was no increase in Grade 4/5 toxicity (6% vs. 5%, P = .68).
Trial Limitations
Accrual required nearly 9 years, driven by two evolving landscape factors:
- Trial accrual coincided with major shifts in standard chemotherapy, as the LAP07 trial demonstrated that adding erlotinib provided no survival benefit futile and mFOLFIRINOX established itself as the superior adjuvant regimen for fit patients.
- Safety concerns from ESPAC-1 previously generated hesitation around postoperative RT, which this trial’s rigorous central QA now effectively these concerns puts to rest.
The Bottom Line
- Following curative-intent resection of #Pancreatic Adenocarcinoma, patients completing adjuvant therapy should not routinely receive CRT.
- Signals of benefit from the addition of CRT to the therapeutic strategy are reported in the node-negative subgroup but this finding would need confirmation in independent trials including FOLFOXIRI as the current standard-of-care for adjuvant therapy.”
Title: Adjuvant Chemotherapy ± Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head: Results of the Radiotherapy Random Assignment of NRG Oncology/RTOG 0848
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, Jennifer Moughan, Christopher H. Crane
Other articles about Pancreatic Cancer and radiation therapy on OncoDaily.