A phase II trial of capecitabine (Xeloda®) in recurrent ovarian cancer
2003

Capecitabine for Recurrent Ovarian Cancer

Sample size: 29 publication Evidence: moderate

Author Information

Author(s): Vasey P A, McMahon L, Paul J, Reed N, Kaye S B

Primary Institution: Beatson Oncology Centre, Western Infirmary, Glasgow, UK

Hypothesis

Can capecitabine be an effective treatment for patients with recurrent ovarian cancer?

Conclusion

Capecitabine showed a response rate of 29% in patients with previously treated ovarian cancer and had a manageable safety profile.

Supporting Evidence

  • Capecitabine resulted in a response rate of 29% in a population of 28 evaluable patients.
  • Median progression-free survival was 3.7 months and overall survival was 8.0 months.
  • Capecitabine was well tolerated with manageable side effects.

Takeaway

This study tested a pill called capecitabine for women with ovarian cancer that came back after treatment, and it helped some of them feel better.

Methodology

This was an open-label, phase II trial assessing the efficacy and safety of capecitabine in women with platinum-pretreated epithelial ovarian cancer.

Potential Biases

Potential bias due to the open-label design and lack of randomization.

Limitations

The small sample size and the lack of a control group limit the generalizability of the findings.

Participant Demographics

{"median_age":57,"age_range":"38-78","performance_status":{"0":8,"1":17,"2":1,"unknown":3},"disease_stage_at_diagnosis":{"Ic":1,"II":1,"III":17,"IV":10},"prior_chemotherapy":{"1_course":4,"2_courses":13,">2_courses":12}}

Statistical Information

P-Value

0.47

Confidence Interval

{"response_rate":"95% CI, 13–49%","progression_free_survival":"95% CI, 2.8–4.6","overall_survival":"95% CI, 4.1–11.8"}

Statistical Significance

p=0.47

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601381

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication