Phase I and pharmacologic study of irinotecan in combination with cisplatin for advanced lung cancer
1993

Irinotecan and Cisplatin for Advanced Lung Cancer

Sample size: 14 publication Evidence: moderate

Author Information

Author(s): N. Masudal, M. Fukuoka, S. Kudohl, Y. Kusunoki, K. Matsui, N. Takifuji, K. Nakagawa, M. Tamanoil, T. Nitta, T. Hirashimal, S. Negoro, M. Takadal

Primary Institution: Osaka Prefectural Habikino Hospital

Hypothesis

What is the maximum tolerated dose of CPT-11 in combination with cisplatin for patients with advanced lung cancer?

Conclusion

The study found that the combination of CPT-11 and cisplatin resulted in an overall response rate of 43% with diarrhea being the main dose-limiting toxicity.

Supporting Evidence

  • Diarrhea was the principal dose-limiting toxicity observed in the study.
  • An overall response rate of 43% was achieved among the patients.
  • One complete response and five partial responses were recorded.
  • The maximum tolerated dose for future studies was recommended to be 80 mg m-2 of CPT-11.

Takeaway

Doctors tested a new cancer treatment using two drugs and found that it helped some patients, but it also caused a lot of diarrhea.

Methodology

Patients received escalating doses of CPT-11 along with a fixed dose of cisplatin, and their responses and toxicities were monitored.

Limitations

The study had a small sample size and was limited to previously untreated patients.

Participant Demographics

{"total_patients":14,"sex":{"male":8,"female":6},"age":{"median":61,"range":"43-74"},"performance_status":{"0-1":10,"2":4},"stage":{"IIIB":7,"IV":7}}

Statistical Information

P-Value

0.0027

Statistical Significance

p<0.05

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