ESOPEC
Trial question
What is the role of perioperative chemotherapy in patients with resectable esophageal adenocarcinoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
11.0% female
89.0% male
N = 438
438 patients (47 female, 391 male).
Inclusion criteria: patients with resectable esophageal adenocarcinoma.
Key exclusion criteria: tumors of squamous or other non-adenocarcinoma histology; advanced inoperable or metastatic esophageal adenocarcinoma; gastric carcinoma; prior chemotherapy; clinically significant cardiac or lung disease; peripheral neuropathy grade > 1.
Interventions
N=221 perioperative chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel plus surgery).
N=217 preoperative chemoradiotherapy (radiotherapy at a dose of 41.4 Gy and carboplatin and paclitaxel plus surgery).
Primary outcome
Overall survival at 3 years
57.4%
50.7%
57.4 %
43.0 %
28.7 %
14.3 %
0.0 %
Perioperative
chemotherapy
Preoperative
chemoradiotherapy
Significant
increase ▲
NNT = 14
Significant increase in overall survival at 3 years (57.4% vs. 50.7%; HR 1.43, 95% CI 1.09 to 1.89).
Secondary outcomes
Significant increase in progression-free survival at 3 years (51.6% vs. 35%; HR 1.52, 95% CI 1.18 to 1.96).
Safety outcomes
No significant difference in postoperative complications.
Conclusion
In patients with resectable esophageal adenocarcinoma, perioperative chemotherapy was superior to preoperative chemoradiotherapy with respect to overall survival at 3 years.
Reference
Jens Hoeppner, Thomas Brunner, Claudia Schmoor et al. Perioperative Chemotherapy or Preoperative Chemoradiotherapy in Esophageal Cancer. N Engl J Med. 2025 Jan 23;392(4):323-335.
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