A phase II study of irinotecan plus chronomodulated oxaliplatin, 5-fluorouracil and folinic acid in advanced colorectal cancer patients
2003

Study on New Drug Combination for Colorectal Cancer

Sample size: 35 publication Evidence: moderate

Author Information

Author(s): Garufi C, Bria E, Vanni B, Zappalà A M R, Sperduti I, Terzoli E

Primary Institution: Istituto Regina Elena, Roma, Italy

Hypothesis

Can the combination of irinotecan, oxaliplatin, 5-fluorouracil, and folinic acid improve treatment outcomes in advanced colorectal cancer patients?

Conclusion

The study found that the combination treatment is feasible with acceptable toxicity in heavily pretreated patients.

Supporting Evidence

  • The combination of irinotecan and oxaliplatin showed activity in heavily pretreated patients.
  • Patients experienced manageable side effects, primarily nausea and diarrhea.
  • Overall response rate was 22.9%, with one complete response and seven partial responses.

Takeaway

Doctors tested a new mix of medicines to help people with advanced colon cancer, and it seemed to work well without making patients too sick.

Methodology

The study involved a phase II trial with patients receiving a combination of drugs through a specific timing schedule to reduce side effects.

Limitations

The study was limited to heavily pretreated patients, which may affect the generalizability of the results.

Participant Demographics

{"median_age":58,"gender_distribution":{"male":21,"female":14},"performance_status":{"0":26,"1":8,"2":1},"primary_tumor":{"colon":26,"rectum":9}}

Statistical Information

Confidence Interval

{"overall_response_rate":"9–36.8","complete_response":"0–8.4","partial_response":"6.8–33.3","stable_disease":"26.5–59.3","progression_disease":"18.6–50"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601382

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