A phase I/II trial of irinotecan–cisplatin combined with an anti-late-diarrhoeal programme to evaluate the safety and antitumour response of this combination therapy in patients with advanced non-small-cell lung cancer
2005

Irinotecan and Cisplatin for Advanced Lung Cancer

Sample size: 77 publication 10 minutes Evidence: moderate

Author Information

Author(s): Takeda Y, Tsuduki E, Izumi S, Hojo M, Kamimura M, Naka G, Kobayashi K, Kudo K

Primary Institution: International Medical Center of Japan

Hypothesis

Can an anti-late-diarrhoeal program improve the safety and efficacy of irinotecan and cisplatin in patients with advanced non-small-cell lung cancer?

Conclusion

The combination of irinotecan and cisplatin with an anti-late-diarrhoeal program showed promising efficacy and acceptable toxicity in patients with advanced non-small-cell lung cancer.

Supporting Evidence

  • 63% of patients showed a response to the treatment.
  • Median survival was 52 weeks.
  • Grade 3/4 toxicities included neutropenia in 65% of patients.
  • 90% of patients did not experience a decline in performance status after treatment.

Takeaway

Doctors tested a new treatment for lung cancer that combines two medicines and a special program to prevent diarrhea, and it worked well for many patients.

Methodology

A phase I/II trial with 77 chemotherapy-naive patients, evaluating the safety and efficacy of irinotecan and cisplatin with an anti-late-diarrhoeal program.

Potential Biases

Potential bias due to the single-institution study design and lack of a control group.

Limitations

The study was limited to patients with advanced non-small-cell lung cancer and may not be generalizable to other populations.

Participant Demographics

Median age of participants was 64 years, with 93% having a performance status of 0 or 1.

Statistical Information

P-Value

0.018

Confidence Interval

95% CI, 47–76%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602866

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