Phase II study of capecitabine and cisplatin as first-line combination therapy in patients with gastric cancer recurrent after fluoropyrimidine-based adjuvant chemotherapy
2005

Capecitabine and Cisplatin for Recurrent Gastric Cancer

Sample size: 32 publication Evidence: moderate

Author Information

Author(s): Kang H J, Chang H M, Kim T W, Ryu M-H, Sohn H J, Yook J H, Oh S T, Kim B S, Lee J-S, Kang Y-K

Primary Institution: Asan Medical Center

Hypothesis

To evaluate the efficacy and safety of capecitabine and cisplatin in patients with recurrent gastric cancer after fluoropyrimidine-based adjuvant therapy.

Conclusion

The combination of capecitabine and cisplatin is effective and well tolerated as a first-line treatment for gastric cancer recurrent after prior fluoropyrimidine-based adjuvant chemotherapy.

Supporting Evidence

  • One patient achieved a complete response and eight had partial responses, giving an overall response rate of 28%.
  • The median time to progression was 5.8 months and median overall survival was 11.2 months.
  • Grade 3 neutropenia occurred in 38% of patients, but no grade 4 toxicity or treatment-related deaths were observed.

Takeaway

This study tested a new medicine combination for stomach cancer that came back after treatment, and it worked well for many patients.

Methodology

Patients with advanced gastric cancer received oral capecitabine and intravenous cisplatin every 3 weeks, and their responses were evaluated.

Limitations

The study population was limited to patients with gastric cancer recurrent after previous adjuvant chemotherapy, which may affect the generalizability of the results.

Participant Demographics

{"age":{"median":60,"range":"38-73"},"sex":{"male":22,"female":10},"performance_status":{"0":1,"1":30,"2":1}}

Statistical Information

P-Value

P=0.427

Confidence Interval

{"overall_response_rate":"95% CI, 13–44%","median_time_to_progression":"95% CI, 4.1–7.5 months","median_overall_survival":"95% CI, 5.5–16.9 months"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602336

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