Dr Goodman on the Addition of CRT to Adjuvant Chemo in Pancreatic Head Adenocarcinomas

Karyn A. Goodman, MD, MS, professor, vice chair, Research and Quality, Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai;, associate director, Clinical Research, Tisch Cancer Institute, and; co-director, Center of Excellence for Pancreatic Cancer, Mount Sinai, discusses results from the randomized portion of the phase 3 NRG/RTOG 0848 trial (NCT01013649), which evaluated the use of adjuvant chemotherapy with or without 5-fluorouracil (5-FU)– or capecitabine-sensitized radiotherapy in patients with resected head of pancreas adenocarcinoma of the pancreatic head.

Patients with resected disease initially received adjuvant therapy consisting of gemcitabine alone or in combination with erlotinib (Tarceva). Those who did not experience disease progression were then randomly assigned to receive 1 month of gemcitabine or combination chemotherapy alone; or 1 month of gemcitabine or combination chemotherapy followed by radiation combined with 5-FU or capecitabine.

Findings presented at the 2024 ASCO Annual Meeting showed that the addition of chemoradiation did not improve overall survival (OS) in the overall population; however, it did lead to a statistically significant improvement in disease-free survival (DFS), Goodman says. The median OS was 2.3 years (90% CI, 2.0-2.6) in the chemotherapy/chemoradiation arm (n = 180) vs 2.6 years (90% CI, 2.1-3.1) in the chemotherapy alone arm (n = 174; HR, 0.97; 90% CI, 0.79-1.18; P = .38). The median DFS was 1.3 years (90% CI, 1.1-1.6) in experimental arm and 1.0 years (90% CI, 0.8-1.3) in the control arm (HR, 0.82; 90% CI, 0.68-0.99; P = .045).

Patients with node-negative disease treated in the chemoradiation arm (n = 49) experienced a median OS of 3.9 years (95% CI, 2.5–not reached) vs 3.0 years (95% CI, 2.3-4.0) in the chemotherapy alone arm (n = 42; HR, 0.57; 95% CI, 0.33-0.98; P = .03). The observed benefit in patients with node-negative disease was attributed to a lower risk of systemic progression, making locoregional therapy more advantageous, Goodman says. In contrast, patients who were node positive had a higher risk of systemic progression and did not experience an OS benefit from the addition of chemoradiation. She notes concludes that gemcitabine—the primary chemotherapy used for patients during this study—was limited in controlling systemic disease.