Phase I study of cisplatin, irinotecan, and epirubicin administered every 3 weeks in patients with advanced solid tumours
2003

Combining Chemotherapy Drugs for Advanced Solid Tumors

Sample size: 35 publication 10 minutes Evidence: moderate

Author Information

Author(s): Chen X, Oza A M, Kusenda Z, Yi Q-L, Kochman D, Moore M J, Davis A J, Siu L L

Primary Institution: Princess Margaret Hospital, University Health Network

Hypothesis

A combination chemotherapy regimen consisting of irinotecan, cisplatin, and epirubicin (PIE regimen) would have synergistic activity against solid tumours.

Conclusion

The combination of irinotecan, cisplatin, and epirubicin showed promising antitumour activity in patients with advanced solid tumors.

Supporting Evidence

  • 10 patients achieved a major objective response: one complete response and nine partial responses.
  • 34 patients were evaluable for tumor response, with 13 patients having stable disease.
  • The recommended phase II doses were determined to be irinotecan 110 mg/m², cisplatin 50 mg/m², and epirubicin 60 mg/m².

Takeaway

Doctors tested a mix of three cancer-fighting medicines to see if they work better together, and they found that they helped some patients get better.

Methodology

Patients with advanced solid tumors received a combination of irinotecan, cisplatin, and epirubicin every three weeks, with dose adjustments based on toxicity.

Potential Biases

Potential bias due to the single-institution study design and the specific patient population selected.

Limitations

The study was limited by its small sample size and the focus on safety rather than definitive efficacy.

Participant Demographics

The median age of participants was 53 years, with 51.4% male and 48.6% female.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI: 0–8.5% for complete response; 95% CI: 11.7–41.2% for partial responses.

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601147

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