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Capecitabine significantly improves progression-free survival (HR 0.69) in advanced oesophagogastric adenocarcinomaTrial shows capecitabine extends disease control for advanced stomach cancer

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Key Takeaway
Consider maintenance capecitabine to extend progression-free survival in HER2-negative advanced oesophagogastric adenocarcinoma.

This Phase II randomized trial enrolled 266 HER2-negative patients with advanced OGA who had achieved response or stable disease after 18 weeks of first-line chemotherapy. The study compared maintenance capecitabine against surveillance over a median follow-up of 70.7 months.

Capecitabine significantly improved progression-free survival (PFS) with an HR of 0.69 (95% CI 0.54-0.89; p = 0.002). The median PFS was 5.0 months in the capecitabine group versus 2.8 months in the surveillance group. One-year PFS rates were 19.9% vs 6.8%, and two-year rates were 8.1% vs 4.3%.

Overall survival (OS) did not show a significant difference between groups (HR 0.87; 95% CI 0.67-1.12; p = 0.143). Median OS was 10.5 months for capecitabine and 10.0 months for surveillance, with two-year rates of 18.8% and 16.8% respectively.

Regarding safety, Grade $\geq$3 adverse events were more frequent in the capecitabine group (46% vs 29%), and 21% of patients in that group experienced grade 3 treatment-related events. Maintenance capecitabine may be considered to extend disease control in advanced OGA despite higher rates of severe adverse events.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in the management of oesophagogastric adenocarcinoma by providing data on maintenance therapy for patients with stable disease. While previous coverage noted that second-line immunotherapy combination with etoposide and capecitabine improves extracranial disease control in pulmonary choriocarcinoma, this study specifically evaluates the role of capecitabine as a monotherapy for maintaining progression-free survival in advanced OGA.

Living with advanced oesophagogastric adenocarcinoma (a type of cancer in the esophagus or stomach) means facing a difficult road. For patients who have finished their first round of chemotherapy but still have stable disease, finding ways to maintain that stability is vital. This study looked at how adding capecitabine as a maintenance treatment affects these patients compared to just watching the disease closely.

The trial included 266 patients and found that those taking capecitabine saw their cancer stay stable for a longer period of time. Specifically, the median progression-free survival was 5 months with the drug compared to just 2.8 months without it. While the drug did not change the overall survival rates between the two groups, it did significantly improve the amount of time patients lived without their disease getting worse.

It is important to note that while the treatment helped control the cancer's growth, it did come with some risks. About 46% of patients taking capecitabine experienced more severe side effects compared to 29% in the group not taking the drug. Because this was a Phase II trial, these results provide helpful evidence for managing disease progression, but you should always talk to your doctor about how these findings apply to your specific treatment plan.

What this means for you:
Capecitabine helps keep advanced stomach cancer from progressing longer than observation alone.

Common questions

How does capecitabine affect how long the cancer stays stable?

Patients taking capecitabine saw their cancer stay stable for a median of 5 months, while those not taking it had a median of 2.8 months. This means the drug significantly improved progression-free survival compared to just watching the disease.

Does this treatment help people live longer?

The study did not find a significant difference in overall survival between those who took capecitabine and those who did not. While it helped keep the cancer from progressing for a longer time, it did not change the total length of life.

Are there side effects to this treatment?

Yes, more severe side effects were more common with capecitabine. About 46% of patients in the capecitabine group experienced grade 3 adverse events, compared to 29% in the group that did not receive the drug.

Study Details

Study typeRct
Sample sizen = 266
EvidenceLevel 2
Follow-up4.2 mo
PublishedJul 2026
View Original Abstract ↓
BACKGROUND: PLATFORM is an adaptive phase II trial assessing maintenance therapies in advanced oesophagogastric adenocarcinoma (OGA). We evaluated maintenance capecitabine in patients with disease control after first-line chemotherapy. METHODS: HER2-negative patients with advanced OGA who had response or stable disease after 18 weeks of first-line chemotherapy were randomised (1:1) to surveillance or capecitabine. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS) and safety. RESULTS: Between May 2015 and May 2024, 266 patients were randomised (129 surveillance, 137 capecitabine). Median follow up was 70.7 months. Capecitabine significantly improved PFS (HR 0.69; 95% CI 0.54-0.89; p = 0.002), with median PFS of 5.0 vs 2.8 months. One-year PFS rates were 19.9% vs 6.8%; and two-year rates 8.1% vs 4.3%. No OS difference was observed (median OS: 10.5 vs 10.0 months; HR 0.87; 95% CI 0.67-1.12; p = 0.143). One and two-year OS rates were similar (1-year: 44.1% vs 45.7%; 2-year: 18.8% vs 16.8%). Grade ≥3 adverse events were more frequent with capecitabine (46% vs 29%), with 21% experiencing grade 3 treatment related events. DISCUSSION: Maintenance capecitabine significantly prolonged PFS compared to surveillance, meeting the primary endpoint and supporting its use to extend disease control in advanced OGA.
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