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Multimodal CROSS Regimen vs Perioperative Chemotherapy for Locally Advanced Gastroesophageal Junction Adenocarcinoma
According to the randomized Neo-AEGIS trial, no evidence was found to suggest that perioperative chemotherapy led to inferior overall survival compared with multimodal therapy for patients with locally advanced gastroesophageal junction adenocarcinoma.
Results from this trial were presented on Thursday, January 19, 2023, at the American Society of Clinical Oncologists Gastrointestinal Cancers Symposium in San Francisco, CA, by Maeve Lowery, MD, St James’s Hospital, Dublin, Ireland.
According to first author John Reynolds, MD, St James’s Hospital, Dublin, Ireland and coauthors, the optimal approach for this patient population “remains controversial, specifically whether multimodal therapy or perioperative chemotherapy is superior.”
This phase 3 trial enrolled 377 patients with locally advanced gastroesophageal junction adenocarcinoma, randomized to receive either the multimodal CROSS regimen (carboplatin/paclitaxel for 5 cycles and radiation therapy for 4.5 weeks prior to surgery) or perioperative chemotherapy (pre-2018: modified MAGIC [epirubicin, cisplatin/oxaliplatin, fluorouracil/capecitabine] regimen for 3 cycles pre- and 3 cycles post-surgery ; 2019/2020: FLOT [docetaxel, fluorouracil, leucovorin, oxaliplatin] regimen for 4 cycles pre- and 4 cycles post-surgery) across 24 sites. Of those 377 patients, 362 were evaluable with 178 in the CROSS arm and 184 in the MAGIC/FLOT arm (MAGIC n = 157; FLOT n = 27). The primary outcome was overall survival (OS).
The median follow-up duration was 34.2 months. The 3-year estimated survival probability was 57% (95% confidence interval [CI], 49 to 64) for the CROSS arm and 55% (95% CI, 47 to 62) for the MAGIC/FLOT arm (hazard ratio [HR] 1.03; 95% CI, 0.77 to 1.38). In the MAGIC/FLOT arm, 82% of patients achieved R0/negative margins compared with 95% in the CROSS arm (P < .05). There were a total of 186 deaths, 91 in the CROSS arm and 95 in the MAGIC/FLOT arm.
Dr Reynolds, et al, concluded, “These data strongly suggest non-inferiority and support equipoise in clinical decision-making in modern practice.”
Source:
Reynolds JV, Preston SR, O’Neill B, et al. Neo-AEGIS (Neoadjuvant Trial in Adenocarcinoma of the Esophagus and Esophago-Gastric Junction International Study): Final primary outcome analysis. Presented at 2023 ASCO Gastrointestinal Cancers Symposium; January 19-21, 2023; San Francisco, CA. Abstract 295