TOPLINE:

In a phase 2 trial, maintenance therapy with capecitabine significantly increased progression-free survival (PFS) compared with active surveillance in patients with advanced oesophagogastric adenocarcinoma (OGA) who achieved disease control after first-line chemotherapy.

METHODOLOGY:

• Researchers conducted an open-label, multicentre, randomised phase 2 trial that included 266 adult patients with HER2-negative advanced OGA who achieved response or stable disease after 18 weeks of first-line platinum-based chemotherapy across 46 centres in the UK between May 2015 and May 2024.
• Patients were randomly assigned in a 1:1 ratio to either surveillance (n = 129; median age, 63 years; 20% women) or maintenance capecitabine (n = 137; median age, 66 years; 32% women). Capecitabine was administered at 1250 mg/m²/d continuously on a 21-day cycle until progression, death, or toxicity, whereas surveillance visits occurred every 28 days.
• The primary endpoint was PFS, and secondary endpoints included overall survival and safety.
• The median follow-up duration was 70.7 months, and 248 PFS events occurred (242 due to disease progression and six due to death without prior progression), meeting the required number for primary analysis.

TAKEAWAY:

• Maintenance capecitabine significantly improved PFS compared with surveillance (hazard ratio [HR], 0.69; P = .002), representing a 31% reduction in the risk for progression or death.
• The 12-month PFS rates were 19.9% with capecitabine vs 6.8% with surveillance, and the 24-month rates were 8.1% vs 4.3%, suggesting a modest tail effect in a subset of patients with sustained disease control beyond 2 years.
• No difference in overall survival was observed between the two groups (HR, 0.87; P = .143), and 12-month overall survival rates were similar at 44.1% for capecitabine vs 45.7% for surveillance.
• Grade ≥ 3 adverse events were more frequent with capecitabine (46%) than with surveillance (29%). Treatment-related adverse events were observed in 89% of patients on capecitabine, with 25% experiencing grade 3 events; however, no grade 5 events were reported.

IN PRACTICE:

"These findings support the rationale for a treatment approach [maintenance therapy] that, despite the lack of formal endorsement in current guidelines, is already in routine use across many global centres," the authors wrote.

SOURCE:

The study was led by Anderley Gordon, Gastrointestinal & Lymphoma Unit, Royal Marsden Hospital, London and Surrey, England. It was published online on April 21 in the British Journal of Cancer.

LIMITATIONS:

The study was limited by the absence of quality-of-life data and the evolving standard of care for first-line treatment of patients with HER2-negative advanced OGA.

DISCLOSURES:

The study was funded by the National Institute for Health Research Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research in London. Seven authors reported receiving honoraria, expenses, or speaker fees from Servier or serving in advisory roles at the company. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.